Kaustubh G. Joshi, MD

Disasters—both natural and human-caused—can strike at any time, causing severe trauma for those impacted. Disasters may create circumstances where the need for mental health resources could exceed capacity, and hospitals and clinics would be unable to meet the needs of the affected communities. As psychiatric clinicians, we may want to provide our services in such situations; however, we are still at risk for civil, criminal, or constitutional liability claims against us if we fail to meet our legal obligations related to psychiatric practice. Ideally, whether we live and work in an area affected by a disaster or volunteer from other states, we should be able to care for patients without fear of facing unreasonable liability risks. Although an exhaustive list of all relevant federal and state laws and regulations is beyond the scope of this article, here I discuss some of the federal and state laws and regulations that could provide protection from these risks, and some limitations of liability protection.

A familiar list of liability concerns

From a liability perspective, what should we be aware of when practicing during disasters? The same liability concerns we have during our day-to-day practice also exist during disasters, especially when there are suboptimal or adverse outcomes. Negligence, practicing without a proper state medical license, and abandonment are among the liability concerns that we could face when practicing during a disaster (Box^1,2).

Box

Liability protections

There are no comprehensive national liability protections for all practitioners during disasters.¹ Limited immunity is often provided through a patchwork of federal and state laws and regulations, which can be complex and are often modified. This immunity depends on several factors, such as applicable regulations, the type of services that are provided, and whether the clinicians are volunteering their services (ie, they are not being paid for providing services).² There is usually no immunity due to willful or wanton acts, gross negligence, providing care while intoxicated, or criminal acts.²

Federal laws and regulations

Most of the federal laws that provide liability protections are activated once a disaster is declared. However, some laws provide liability protections without requiring such declarations. Additional federal laws and regulations that provide additional liability protections, especially to volunteers, can be enacted after disasters occur.

Federal Tort Claims Act

The Federal Tort Claims Act (FTCA)³ protects federal government employees from tort liability by substituting the federal government as the defendant in certain types of suits brought against the federal government. These suits may involve injury, loss of personal property, personal injury, or death by the negligent or wrongful act or omission of any federal government employees while acting in the scope of their office or employment.^3,4 It does not require that an emergency be declared before immunity is conferred. FTCA covers all federal government employees, including volunteers.⁴ In the context of an emergency response, volunteers can assert the liability protections afforded to federal employees if they are designated as unpaid employees of the federal government.⁴ Federal employees are immune from suit under state tort law.⁴

Volunteer Protection Act

The Volunteer Protection Act (VPA) of 1997⁵ provides liability protections to uncompensated volunteer health professionals (VHPs) who perform services for nonprofit organizations or government entities against claims of ordinary negligence committed within the scope of their volunteer responsibilities.⁴ It does not require that an emergency be declared before immunity is conferred. Although VHPs are not liable for economic damages caused by providing medical care within the scope of their volunteer responsibilities, this exemption does not extend to non-economic damages, such as losses for suffering and mental anguish.⁵ VPA does not protect VHPs working in businesses (including for-profit hospitals) and organizational entities of any type (including nonprofit or governmental organizations) that use VHPs.⁴

VPA only protects VHPs practicing with a license as required by law in the state where the harm occurred, unless state authorities allow for licensure exceptions. VPA overrides state laws that are inconsistent with VPA, unless those state laws provide greater liability protection for VHPs.⁴ However, VPA protections are limited. VPA protects only volunteers, not clinicians working in their regular nonemergency roles and capacities.⁶ A nonprofit or government agent can still bring civil claims against VHPs.⁶ VPA does not override certain state laws that put conditions on volunteers, such as risk management requirements, vicarious liability, and a financially secure form of recovery for intended victims.⁶

Continue to: Health Insurance Portability and Accountability Act

The Health Insurance Portability and Accountability Act (HIPAA) of 1996,⁷ specifically Section 194, extends eligibility for FTCA liability protections to VHPs at qualifying free clinics, provided the clinic sponsors the VHPs by applying to the Health Resources and Services Administration.⁸ It does not require that an emergency be declared before immunity is conferred.

Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness (PREP) Act of 2005⁹ authorizes the US Department of Health and Human Services (HHS) Secretary to issue a declaration that provides immunity to VHPs from tort liability for claims of loss caused by the use of authorized countermeasures (eg, vaccines) against diseases or other threats of public health emergencies.⁴ A separate emergency determination under Public Health Service Act Section 319 or another statute is not required for PREP Act immunities to take effect.⁴ The PREP Act covers individual persons and entities involved in the manufacture, testing, distribution, administration, and use of covered countermeasures.⁴

PREP Act immunity is not absolute and does not protect against claims of willful misconduct, violation of the Americans with Disabilities Act (ADA), or other civil rights violations.⁴ Liability protection under the PREP Act is limited to a specific emergency and includes only the countermeasures and other conditions listed in the PREP Act declaration by the HHS Secretary.⁴

State laws and regulations

States have a variety of standing liability protections that could apply to VHPs who provide care in an emergency. Some states have crafted executive orders to be put into effect during a disaster. Most of these executive orders, which can include extending liability protections, are similar to what other states have done by adopting model acts such as Model State Emergency Health Powers Act.⁶ These orders are not actually laws; they only become effective when the governor signs them at the time of the disaster. These orders also are time-limited and must be reissued in subsequent disasters.

State tort claims acts and state claims acts

Similar to the federal government, some states have waived sovereign immunity in certain circumstances through state tort claims or state claims acts.

Continue to: State tort claims act

State tort claims acts either abolish state sovereign immunity generally and provide immunity only in specific circumstances, or preserve sovereign immunity generally but identify certain exceptions in which immunity is waived.⁴

State claims acts limit state sovereign immunity by establishing procedures for making claims against the state.⁴ These acts typically immunize state government employees from tort liability for acts or omissions committed within the scope of their employment.⁴ Some states extend these protections to volunteers, and some states declare volunteers to be unpaid state employees during an emergency, which allows volunteers to assert the liability protections afforded of state employees.⁴

Emergency power statutes

State emergency laws can trigger additional powers, suspend certain administrative requirements, and provide or enhance liability protections to specified groups of volunteers and other responders upon a gubernatorial declaration of emergency.⁴ These statutes can extend the rights and immunities provided to governmental employees to volunteers performing work that is eligible for coverage under governmental immunity and state tort claims acts.⁴ There is a wide range in the types and degrees of coverage provided to volunteers under emergency powers statutes, and these provisions can be broad or duplicative of other provisions in state law.⁴

State volunteer protection statutes

All states have some statutory provisions for volunteers. Similar to the VPA, these state volunteer protection statutes generally do not require that an emergency be declared, apply to uncompensated individual volunteers for nonprofit and government entities only, and apply only to individuals and not to organizations.⁴ Many states have adopted specific liability protections for VHPs in addition to or to supplement their emergency powers and general volunteer protection statutes.⁴ These statutes confer immunity from civil liability provided that certain conditions are met and are not dependent on the declaration of an emergency.⁴ Each state statute differs in regard to who receives immunity, which acts are immune from liability, and what liability protections are available.

Good Samaritan laws

All 50 states and the District of Columbia have enacted Good Samaritan laws. These laws, which do not need an official declaration of an emergency in order to be applicable, generally protect VHPs from liability when volunteering in good faith and without compensation at the scene of an emergency.² Good Samaritan protections may also apply to care provided by VHPs in a hospital if the VHP is not on duty and does not charge a fee.² However, the effect and scope of Good Samaritan laws vary dramatically from state to state. Some states include hospital settings as an emergency scene in their statutes, while others expressly exclude hospitals from their statutes.⁶ Some state statutes only include declared emergencies, while others are drawn to broadly cover all emergency situations.⁶

Continue to: Limitations

Limitations. Many Good Samaritan statutes apply only to volunteers, and not all states have statutes that allow clinicians to be designated as such,⁶ so receiving compensation would take a clinician outside the scope of the statute. Further, most states only shield action taken at the scene of an accident, and immunity would not extend to a hospital emergency department, or in the aftermath of an emergency as normal conditions slowly return.⁶ Therefore, Good Samaritan liability protection would apply to the common scenario of assisting at the scene of a car crash, but not necessarily to treating individuals in the emergency department after a hurricane or during a pandemic.⁶ State laws vary considerably on what constitutes “good faith” and “without compensation,” which would determine whether protection applies for a clinician who is otherwise salaried in a regular job.¹

Mutual aid agreements

Mutual aid agreements are mechanisms through which jurisdictions can aid other jurisdictions during emergencies.⁴ These agreements also include provisions for reimbursing expenses, providing liability protections to governmental employees and volunteers who provide aid, and awarding compensation for injuries to personnel deployed under the agreement.⁴ These protections are not automatic and are limited in their applicability.

The Emergency Management Assistance Compact (EMAC), the most widely adopted mutual aid agreement in the United States, has been adopted by all 50 states, the District of Columbia, and some territories.¹⁰ It only becomes effective once an emergency has been declared. EMAC provides immunity to officers from the state that is rendering aid to the state requesting aid, in which officers are considered agents of the requesting state for tort liability and immunity purposes.⁸ These individuals, who must be properly dispatched in response to an EMAC request, are not to be held liable for acts or omissions rendered in good faith; however, EMAC does not provide liability protection for actions constituting willful misconduct, gross negligence, or recklessness.⁶ EMAC also provides reciprocity for individuals who are properly dispatched in response to an EMAC request who hold medical licenses to practice medicine in the receiving state, subject to any limitations imposed by the receiving state.⁴ Clinicians can familiarize themselves with a state’s medical licensing requirements by reviewing that state’s medical board website. For EMAC protections to apply, a state must make a request to another/other state(s) through EMAC, and such requests must be formally accepted by the rendering state.⁸ EMAC does not require participating states to actually provide aid.¹⁰

Non-volunteer health care clinicians

Non-volunteer (salaried or paid) health care clinicians are more likely to bear the brunt of providing care during a disaster, especially in the early stages before VHPs arrive; however, most legislation does not address the associated disproportionate liability risk burden of non-volunteer health care clinicians.^1,11 As opposed to VHPs and government employees, non-volunteer health care clinicians performing their regular job duties during a disaster are generally not provided immunity from negligence by most legislation.^1,6 One exception is the PREP Act, which provides immunity for all clinicians from claims that may arise from dispensing a specific counter­measure during a declared public health emergency.^1,9 Some states have enacted the Model State Emergency Health Powers Act, which may offer immunity from negligence if the non-volunteer clinician is rendering care under contract with or at the request of a state¹; however, non-volunteer clinicians who practice from their office or a local hospital will not receive protection through these laws.¹ Good Samaritan laws may not apply unless care is provided at a scene of an emergency.

A few states have attempted to narrow this legislative gap by enacting laws that provide immunity more broadly for clinicians, regardless of their volunteer or compensation status.¹ Elements of these states’ laws include acting in response to a declared emergency or disaster in which there is a recognized depletion of resources attributable to the disaster, at express or implied request of the state government, and consistent with emergency plans.¹

Continue to: Bottom Line

There are potential liability risks when treating patients during a disaster. Statutory protections that limit liability may be enacted when the US President or a state Governor declares an official state of emergency. Although some federal and state laws and regulations provide liability protections during these situations, there is a discrepancy in the protections offered to non-volunteer vs volunteer clinicians.

Related Resources

• Federal Emergency Management Agency. https://www.fema.gov/
• Federation of State Medical Boards. https://www.fsmb.org

Disasters—both natural and human-caused—can strike at any time, causing severe trauma for those impacted. Disasters may create circumstances where the need for mental health resources could exceed capacity, and hospitals and clinics would be unable to meet the needs of the affected communities. As psychiatric clinicians, we may want to provide our services in such situations; however, we are still at risk for civil, criminal, or constitutional liability claims against us if we fail to meet our legal obligations related to psychiatric practice. Ideally, whether we live and work in an area affected by a disaster or volunteer from other states, we should be able to care for patients without fear of facing unreasonable liability risks. Although an exhaustive list of all relevant federal and state laws and regulations is beyond the scope of this article, here I discuss some of the federal and state laws and regulations that could provide protection from these risks, and some limitations of liability protection.

A familiar list of liability concerns

From a liability perspective, what should we be aware of when practicing during disasters? The same liability concerns we have during our day-to-day practice also exist during disasters, especially when there are suboptimal or adverse outcomes. Negligence, practicing without a proper state medical license, and abandonment are among the liability concerns that we could face when practicing during a disaster (Box^1,2).

Box

Liability protections

There are no comprehensive national liability protections for all practitioners during disasters.¹ Limited immunity is often provided through a patchwork of federal and state laws and regulations, which can be complex and are often modified. This immunity depends on several factors, such as applicable regulations, the type of services that are provided, and whether the clinicians are volunteering their services (ie, they are not being paid for providing services).² There is usually no immunity due to willful or wanton acts, gross negligence, providing care while intoxicated, or criminal acts.²

Federal laws and regulations

Most of the federal laws that provide liability protections are activated once a disaster is declared. However, some laws provide liability protections without requiring such declarations. Additional federal laws and regulations that provide additional liability protections, especially to volunteers, can be enacted after disasters occur.

Federal Tort Claims Act

The Federal Tort Claims Act (FTCA)³ protects federal government employees from tort liability by substituting the federal government as the defendant in certain types of suits brought against the federal government. These suits may involve injury, loss of personal property, personal injury, or death by the negligent or wrongful act or omission of any federal government employees while acting in the scope of their office or employment.^3,4 It does not require that an emergency be declared before immunity is conferred. FTCA covers all federal government employees, including volunteers.⁴ In the context of an emergency response, volunteers can assert the liability protections afforded to federal employees if they are designated as unpaid employees of the federal government.⁴ Federal employees are immune from suit under state tort law.⁴

Volunteer Protection Act

The Volunteer Protection Act (VPA) of 1997⁵ provides liability protections to uncompensated volunteer health professionals (VHPs) who perform services for nonprofit organizations or government entities against claims of ordinary negligence committed within the scope of their volunteer responsibilities.⁴ It does not require that an emergency be declared before immunity is conferred. Although VHPs are not liable for economic damages caused by providing medical care within the scope of their volunteer responsibilities, this exemption does not extend to non-economic damages, such as losses for suffering and mental anguish.⁵ VPA does not protect VHPs working in businesses (including for-profit hospitals) and organizational entities of any type (including nonprofit or governmental organizations) that use VHPs.⁴

VPA only protects VHPs practicing with a license as required by law in the state where the harm occurred, unless state authorities allow for licensure exceptions. VPA overrides state laws that are inconsistent with VPA, unless those state laws provide greater liability protection for VHPs.⁴ However, VPA protections are limited. VPA protects only volunteers, not clinicians working in their regular nonemergency roles and capacities.⁶ A nonprofit or government agent can still bring civil claims against VHPs.⁶ VPA does not override certain state laws that put conditions on volunteers, such as risk management requirements, vicarious liability, and a financially secure form of recovery for intended victims.⁶

Continue to: Health Insurance Portability and Accountability Act

The Health Insurance Portability and Accountability Act (HIPAA) of 1996,⁷ specifically Section 194, extends eligibility for FTCA liability protections to VHPs at qualifying free clinics, provided the clinic sponsors the VHPs by applying to the Health Resources and Services Administration.⁸ It does not require that an emergency be declared before immunity is conferred.

Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness (PREP) Act of 2005⁹ authorizes the US Department of Health and Human Services (HHS) Secretary to issue a declaration that provides immunity to VHPs from tort liability for claims of loss caused by the use of authorized countermeasures (eg, vaccines) against diseases or other threats of public health emergencies.⁴ A separate emergency determination under Public Health Service Act Section 319 or another statute is not required for PREP Act immunities to take effect.⁴ The PREP Act covers individual persons and entities involved in the manufacture, testing, distribution, administration, and use of covered countermeasures.⁴

PREP Act immunity is not absolute and does not protect against claims of willful misconduct, violation of the Americans with Disabilities Act (ADA), or other civil rights violations.⁴ Liability protection under the PREP Act is limited to a specific emergency and includes only the countermeasures and other conditions listed in the PREP Act declaration by the HHS Secretary.⁴

State laws and regulations

States have a variety of standing liability protections that could apply to VHPs who provide care in an emergency. Some states have crafted executive orders to be put into effect during a disaster. Most of these executive orders, which can include extending liability protections, are similar to what other states have done by adopting model acts such as Model State Emergency Health Powers Act.⁶ These orders are not actually laws; they only become effective when the governor signs them at the time of the disaster. These orders also are time-limited and must be reissued in subsequent disasters.

State tort claims acts and state claims acts

Similar to the federal government, some states have waived sovereign immunity in certain circumstances through state tort claims or state claims acts.

Continue to: State tort claims act

State tort claims acts either abolish state sovereign immunity generally and provide immunity only in specific circumstances, or preserve sovereign immunity generally but identify certain exceptions in which immunity is waived.⁴

State claims acts limit state sovereign immunity by establishing procedures for making claims against the state.⁴ These acts typically immunize state government employees from tort liability for acts or omissions committed within the scope of their employment.⁴ Some states extend these protections to volunteers, and some states declare volunteers to be unpaid state employees during an emergency, which allows volunteers to assert the liability protections afforded of state employees.⁴

Emergency power statutes

State emergency laws can trigger additional powers, suspend certain administrative requirements, and provide or enhance liability protections to specified groups of volunteers and other responders upon a gubernatorial declaration of emergency.⁴ These statutes can extend the rights and immunities provided to governmental employees to volunteers performing work that is eligible for coverage under governmental immunity and state tort claims acts.⁴ There is a wide range in the types and degrees of coverage provided to volunteers under emergency powers statutes, and these provisions can be broad or duplicative of other provisions in state law.⁴

State volunteer protection statutes

All states have some statutory provisions for volunteers. Similar to the VPA, these state volunteer protection statutes generally do not require that an emergency be declared, apply to uncompensated individual volunteers for nonprofit and government entities only, and apply only to individuals and not to organizations.⁴ Many states have adopted specific liability protections for VHPs in addition to or to supplement their emergency powers and general volunteer protection statutes.⁴ These statutes confer immunity from civil liability provided that certain conditions are met and are not dependent on the declaration of an emergency.⁴ Each state statute differs in regard to who receives immunity, which acts are immune from liability, and what liability protections are available.

Good Samaritan laws

All 50 states and the District of Columbia have enacted Good Samaritan laws. These laws, which do not need an official declaration of an emergency in order to be applicable, generally protect VHPs from liability when volunteering in good faith and without compensation at the scene of an emergency.² Good Samaritan protections may also apply to care provided by VHPs in a hospital if the VHP is not on duty and does not charge a fee.² However, the effect and scope of Good Samaritan laws vary dramatically from state to state. Some states include hospital settings as an emergency scene in their statutes, while others expressly exclude hospitals from their statutes.⁶ Some state statutes only include declared emergencies, while others are drawn to broadly cover all emergency situations.⁶

Continue to: Limitations

Limitations. Many Good Samaritan statutes apply only to volunteers, and not all states have statutes that allow clinicians to be designated as such,⁶ so receiving compensation would take a clinician outside the scope of the statute. Further, most states only shield action taken at the scene of an accident, and immunity would not extend to a hospital emergency department, or in the aftermath of an emergency as normal conditions slowly return.⁶ Therefore, Good Samaritan liability protection would apply to the common scenario of assisting at the scene of a car crash, but not necessarily to treating individuals in the emergency department after a hurricane or during a pandemic.⁶ State laws vary considerably on what constitutes “good faith” and “without compensation,” which would determine whether protection applies for a clinician who is otherwise salaried in a regular job.¹

Mutual aid agreements

Mutual aid agreements are mechanisms through which jurisdictions can aid other jurisdictions during emergencies.⁴ These agreements also include provisions for reimbursing expenses, providing liability protections to governmental employees and volunteers who provide aid, and awarding compensation for injuries to personnel deployed under the agreement.⁴ These protections are not automatic and are limited in their applicability.

The Emergency Management Assistance Compact (EMAC), the most widely adopted mutual aid agreement in the United States, has been adopted by all 50 states, the District of Columbia, and some territories.¹⁰ It only becomes effective once an emergency has been declared. EMAC provides immunity to officers from the state that is rendering aid to the state requesting aid, in which officers are considered agents of the requesting state for tort liability and immunity purposes.⁸ These individuals, who must be properly dispatched in response to an EMAC request, are not to be held liable for acts or omissions rendered in good faith; however, EMAC does not provide liability protection for actions constituting willful misconduct, gross negligence, or recklessness.⁶ EMAC also provides reciprocity for individuals who are properly dispatched in response to an EMAC request who hold medical licenses to practice medicine in the receiving state, subject to any limitations imposed by the receiving state.⁴ Clinicians can familiarize themselves with a state’s medical licensing requirements by reviewing that state’s medical board website. For EMAC protections to apply, a state must make a request to another/other state(s) through EMAC, and such requests must be formally accepted by the rendering state.⁸ EMAC does not require participating states to actually provide aid.¹⁰

Non-volunteer health care clinicians

Non-volunteer (salaried or paid) health care clinicians are more likely to bear the brunt of providing care during a disaster, especially in the early stages before VHPs arrive; however, most legislation does not address the associated disproportionate liability risk burden of non-volunteer health care clinicians.^1,11 As opposed to VHPs and government employees, non-volunteer health care clinicians performing their regular job duties during a disaster are generally not provided immunity from negligence by most legislation.^1,6 One exception is the PREP Act, which provides immunity for all clinicians from claims that may arise from dispensing a specific counter­measure during a declared public health emergency.^1,9 Some states have enacted the Model State Emergency Health Powers Act, which may offer immunity from negligence if the non-volunteer clinician is rendering care under contract with or at the request of a state¹; however, non-volunteer clinicians who practice from their office or a local hospital will not receive protection through these laws.¹ Good Samaritan laws may not apply unless care is provided at a scene of an emergency.

A few states have attempted to narrow this legislative gap by enacting laws that provide immunity more broadly for clinicians, regardless of their volunteer or compensation status.¹ Elements of these states’ laws include acting in response to a declared emergency or disaster in which there is a recognized depletion of resources attributable to the disaster, at express or implied request of the state government, and consistent with emergency plans.¹

Continue to: Bottom Line

There are potential liability risks when treating patients during a disaster. Statutory protections that limit liability may be enacted when the US President or a state Governor declares an official state of emergency. Although some federal and state laws and regulations provide liability protections during these situations, there is a discrepancy in the protections offered to non-volunteer vs volunteer clinicians.

Related Resources

• Federal Emergency Management Agency. https://www.fema.gov/
• Federation of State Medical Boards. https://www.fsmb.org

Disasters—both natural and human-caused—can strike at any time, causing severe trauma for those impacted. Disasters may create circumstances where the need for mental health resources could exceed capacity, and hospitals and clinics would be unable to meet the needs of the affected communities. As psychiatric clinicians, we may want to provide our services in such situations; however, we are still at risk for civil, criminal, or constitutional liability claims against us if we fail to meet our legal obligations related to psychiatric practice. Ideally, whether we live and work in an area affected by a disaster or volunteer from other states, we should be able to care for patients without fear of facing unreasonable liability risks. Although an exhaustive list of all relevant federal and state laws and regulations is beyond the scope of this article, here I discuss some of the federal and state laws and regulations that could provide protection from these risks, and some limitations of liability protection.

A familiar list of liability concerns

From a liability perspective, what should we be aware of when practicing during disasters? The same liability concerns we have during our day-to-day practice also exist during disasters, especially when there are suboptimal or adverse outcomes. Negligence, practicing without a proper state medical license, and abandonment are among the liability concerns that we could face when practicing during a disaster (Box^1,2).

Box

Liability protections

There are no comprehensive national liability protections for all practitioners during disasters.¹ Limited immunity is often provided through a patchwork of federal and state laws and regulations, which can be complex and are often modified. This immunity depends on several factors, such as applicable regulations, the type of services that are provided, and whether the clinicians are volunteering their services (ie, they are not being paid for providing services).² There is usually no immunity due to willful or wanton acts, gross negligence, providing care while intoxicated, or criminal acts.²

Federal laws and regulations

Most of the federal laws that provide liability protections are activated once a disaster is declared. However, some laws provide liability protections without requiring such declarations. Additional federal laws and regulations that provide additional liability protections, especially to volunteers, can be enacted after disasters occur.

Federal Tort Claims Act

The Federal Tort Claims Act (FTCA)³ protects federal government employees from tort liability by substituting the federal government as the defendant in certain types of suits brought against the federal government. These suits may involve injury, loss of personal property, personal injury, or death by the negligent or wrongful act or omission of any federal government employees while acting in the scope of their office or employment.^3,4 It does not require that an emergency be declared before immunity is conferred. FTCA covers all federal government employees, including volunteers.⁴ In the context of an emergency response, volunteers can assert the liability protections afforded to federal employees if they are designated as unpaid employees of the federal government.⁴ Federal employees are immune from suit under state tort law.⁴

Volunteer Protection Act

The Volunteer Protection Act (VPA) of 1997⁵ provides liability protections to uncompensated volunteer health professionals (VHPs) who perform services for nonprofit organizations or government entities against claims of ordinary negligence committed within the scope of their volunteer responsibilities.⁴ It does not require that an emergency be declared before immunity is conferred. Although VHPs are not liable for economic damages caused by providing medical care within the scope of their volunteer responsibilities, this exemption does not extend to non-economic damages, such as losses for suffering and mental anguish.⁵ VPA does not protect VHPs working in businesses (including for-profit hospitals) and organizational entities of any type (including nonprofit or governmental organizations) that use VHPs.⁴

VPA only protects VHPs practicing with a license as required by law in the state where the harm occurred, unless state authorities allow for licensure exceptions. VPA overrides state laws that are inconsistent with VPA, unless those state laws provide greater liability protection for VHPs.⁴ However, VPA protections are limited. VPA protects only volunteers, not clinicians working in their regular nonemergency roles and capacities.⁶ A nonprofit or government agent can still bring civil claims against VHPs.⁶ VPA does not override certain state laws that put conditions on volunteers, such as risk management requirements, vicarious liability, and a financially secure form of recovery for intended victims.⁶

Continue to: Health Insurance Portability and Accountability Act

The Health Insurance Portability and Accountability Act (HIPAA) of 1996,⁷ specifically Section 194, extends eligibility for FTCA liability protections to VHPs at qualifying free clinics, provided the clinic sponsors the VHPs by applying to the Health Resources and Services Administration.⁸ It does not require that an emergency be declared before immunity is conferred.

Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness (PREP) Act of 2005⁹ authorizes the US Department of Health and Human Services (HHS) Secretary to issue a declaration that provides immunity to VHPs from tort liability for claims of loss caused by the use of authorized countermeasures (eg, vaccines) against diseases or other threats of public health emergencies.⁴ A separate emergency determination under Public Health Service Act Section 319 or another statute is not required for PREP Act immunities to take effect.⁴ The PREP Act covers individual persons and entities involved in the manufacture, testing, distribution, administration, and use of covered countermeasures.⁴

PREP Act immunity is not absolute and does not protect against claims of willful misconduct, violation of the Americans with Disabilities Act (ADA), or other civil rights violations.⁴ Liability protection under the PREP Act is limited to a specific emergency and includes only the countermeasures and other conditions listed in the PREP Act declaration by the HHS Secretary.⁴

State laws and regulations

States have a variety of standing liability protections that could apply to VHPs who provide care in an emergency. Some states have crafted executive orders to be put into effect during a disaster. Most of these executive orders, which can include extending liability protections, are similar to what other states have done by adopting model acts such as Model State Emergency Health Powers Act.⁶ These orders are not actually laws; they only become effective when the governor signs them at the time of the disaster. These orders also are time-limited and must be reissued in subsequent disasters.

State tort claims acts and state claims acts

Similar to the federal government, some states have waived sovereign immunity in certain circumstances through state tort claims or state claims acts.

Continue to: State tort claims act

State tort claims acts either abolish state sovereign immunity generally and provide immunity only in specific circumstances, or preserve sovereign immunity generally but identify certain exceptions in which immunity is waived.⁴

State claims acts limit state sovereign immunity by establishing procedures for making claims against the state.⁴ These acts typically immunize state government employees from tort liability for acts or omissions committed within the scope of their employment.⁴ Some states extend these protections to volunteers, and some states declare volunteers to be unpaid state employees during an emergency, which allows volunteers to assert the liability protections afforded of state employees.⁴

Emergency power statutes

State emergency laws can trigger additional powers, suspend certain administrative requirements, and provide or enhance liability protections to specified groups of volunteers and other responders upon a gubernatorial declaration of emergency.⁴ These statutes can extend the rights and immunities provided to governmental employees to volunteers performing work that is eligible for coverage under governmental immunity and state tort claims acts.⁴ There is a wide range in the types and degrees of coverage provided to volunteers under emergency powers statutes, and these provisions can be broad or duplicative of other provisions in state law.⁴

State volunteer protection statutes

All states have some statutory provisions for volunteers. Similar to the VPA, these state volunteer protection statutes generally do not require that an emergency be declared, apply to uncompensated individual volunteers for nonprofit and government entities only, and apply only to individuals and not to organizations.⁴ Many states have adopted specific liability protections for VHPs in addition to or to supplement their emergency powers and general volunteer protection statutes.⁴ These statutes confer immunity from civil liability provided that certain conditions are met and are not dependent on the declaration of an emergency.⁴ Each state statute differs in regard to who receives immunity, which acts are immune from liability, and what liability protections are available.

Good Samaritan laws

All 50 states and the District of Columbia have enacted Good Samaritan laws. These laws, which do not need an official declaration of an emergency in order to be applicable, generally protect VHPs from liability when volunteering in good faith and without compensation at the scene of an emergency.² Good Samaritan protections may also apply to care provided by VHPs in a hospital if the VHP is not on duty and does not charge a fee.² However, the effect and scope of Good Samaritan laws vary dramatically from state to state. Some states include hospital settings as an emergency scene in their statutes, while others expressly exclude hospitals from their statutes.⁶ Some state statutes only include declared emergencies, while others are drawn to broadly cover all emergency situations.⁶

Continue to: Limitations

Limitations. Many Good Samaritan statutes apply only to volunteers, and not all states have statutes that allow clinicians to be designated as such,⁶ so receiving compensation would take a clinician outside the scope of the statute. Further, most states only shield action taken at the scene of an accident, and immunity would not extend to a hospital emergency department, or in the aftermath of an emergency as normal conditions slowly return.⁶ Therefore, Good Samaritan liability protection would apply to the common scenario of assisting at the scene of a car crash, but not necessarily to treating individuals in the emergency department after a hurricane or during a pandemic.⁶ State laws vary considerably on what constitutes “good faith” and “without compensation,” which would determine whether protection applies for a clinician who is otherwise salaried in a regular job.¹

Mutual aid agreements

Mutual aid agreements are mechanisms through which jurisdictions can aid other jurisdictions during emergencies.⁴ These agreements also include provisions for reimbursing expenses, providing liability protections to governmental employees and volunteers who provide aid, and awarding compensation for injuries to personnel deployed under the agreement.⁴ These protections are not automatic and are limited in their applicability.

The Emergency Management Assistance Compact (EMAC), the most widely adopted mutual aid agreement in the United States, has been adopted by all 50 states, the District of Columbia, and some territories.¹⁰ It only becomes effective once an emergency has been declared. EMAC provides immunity to officers from the state that is rendering aid to the state requesting aid, in which officers are considered agents of the requesting state for tort liability and immunity purposes.⁸ These individuals, who must be properly dispatched in response to an EMAC request, are not to be held liable for acts or omissions rendered in good faith; however, EMAC does not provide liability protection for actions constituting willful misconduct, gross negligence, or recklessness.⁶ EMAC also provides reciprocity for individuals who are properly dispatched in response to an EMAC request who hold medical licenses to practice medicine in the receiving state, subject to any limitations imposed by the receiving state.⁴ Clinicians can familiarize themselves with a state’s medical licensing requirements by reviewing that state’s medical board website. For EMAC protections to apply, a state must make a request to another/other state(s) through EMAC, and such requests must be formally accepted by the rendering state.⁸ EMAC does not require participating states to actually provide aid.¹⁰

Non-volunteer health care clinicians

Non-volunteer (salaried or paid) health care clinicians are more likely to bear the brunt of providing care during a disaster, especially in the early stages before VHPs arrive; however, most legislation does not address the associated disproportionate liability risk burden of non-volunteer health care clinicians.^1,11 As opposed to VHPs and government employees, non-volunteer health care clinicians performing their regular job duties during a disaster are generally not provided immunity from negligence by most legislation.^1,6 One exception is the PREP Act, which provides immunity for all clinicians from claims that may arise from dispensing a specific counter­measure during a declared public health emergency.^1,9 Some states have enacted the Model State Emergency Health Powers Act, which may offer immunity from negligence if the non-volunteer clinician is rendering care under contract with or at the request of a state¹; however, non-volunteer clinicians who practice from their office or a local hospital will not receive protection through these laws.¹ Good Samaritan laws may not apply unless care is provided at a scene of an emergency.

A few states have attempted to narrow this legislative gap by enacting laws that provide immunity more broadly for clinicians, regardless of their volunteer or compensation status.¹ Elements of these states’ laws include acting in response to a declared emergency or disaster in which there is a recognized depletion of resources attributable to the disaster, at express or implied request of the state government, and consistent with emergency plans.¹

Continue to: Bottom Line

There are potential liability risks when treating patients during a disaster. Statutory protections that limit liability may be enacted when the US President or a state Governor declares an official state of emergency. Although some federal and state laws and regulations provide liability protections during these situations, there is a discrepancy in the protections offered to non-volunteer vs volunteer clinicians.

Related Resources

• Federal Emergency Management Agency. https://www.fema.gov/
• Federation of State Medical Boards. https://www.fsmb.org

Telepsychiatry appointments (eg, video conferencing) initially replaced face-to-face outpatient encounters during the first phase of the COVID-19 pandemic. However, as offices reopened for in-person appointments, many patients still prefer “virtual” appointments. Telepsychiatry allows for easier delivery of mental health services, including psychotherapy, and may become the new normal.

Although therapy conducted via video conferencing allows you to connect with patients at a safe distance, it alters the basic conditions under which therapy occurs, such as being in the same room.¹ While focusing on preserving the verbal elements of communication, you might inadvertently forget the nonverbal elements, which at times might render your words ineffective.¹ The main elements of nonverbal communication are facial expression, gaze, posture, gesture, and proxemics (ie, how much space you take up, and your distance from others).² The following tips can help you preserve the nonverbal elements of communication when conducting telepsychiatry sessions.

Reduce gaze error. Gaze error is the deviation from direct eye contact that occurs during video conferencing. It results from the distance between the image of the person on your screen and the camera above it.¹ Gaze error can muddy intended cues and communicate unintended cues.² Examples of gaze errors include downcast eyes (the most common gaze error), sideways gaze, or gazing over the person’s head.² These errors can communicate social deference, evasion, insincerity, or even boredom.² To lessen gaze error, move the patient’s image as close as possible to your camera.¹ In addition, avoid looking at yourself on the screen; some video conferencing platforms allow users to hide their self-view.

Create distance and incorporate upper body language. In the office, sitting very close to your patient and staring directly at their face for an hour would be awkward and intrusive.¹ Doing so online is no different. While you may be tempted to move close to the screen to compensate for feeling distant or having difficulty hearing or seeing your patient, you should back away from the camera. Doing so will help both parties feel less self-conscious, more at ease, and more focused on the session.¹ Backing up from the camera will allow patients to see your upper body language (eg, hand gestures, posture) as well as your facial expressions.¹ Empathy improves when patients can see your upper-body cues.² Keep in mind that the angle of your camera is just as important as the distance. For example, if your camera is positioned so that it is looking up toward your eyes, patients may perceive that you are looking down at them.¹ This problem can be remedied by stacking books under the monitor to raise the camera.

Be aware of your facial expressions, posture, gestures, and proxemics. Ensure that your face does not go slack when you are listening to patients talk.³ Just as you would do in person, a slight head tilt and occasional head nod lets patients know that you are engaged and actively listening.³ Maintain an open body posture by keeping your feet firmly on the ground and putting your hands on the table in front of you.³ Lean in when patients share intimate information, just as you would in person. Avoid hunching over the laptop/keyboard because this could make you seem tired or tense.³ Pay attention to your arm and hand movements so that you do not exaggerate them.

Maintain office professionalism. The office setting conveys a therapeutic formality that can get lost online.¹ As tempting as it may be to conduct online sessions in pajamas or sweatpants, continue to dress as if you were in the office. Be mindful of your backdrop, set all cell phones to silent, turn off your email alerts, and lock the room.^1,3 Stick to the clock as you would in the office, and encourage patients to do the same.

Minor technological improvements—such as headphones with a built-in microphone, a high-definition camera, a larger monitor, or a faster internet connection—might be needed to improve your nonverbal communication during telepsychiatry sessions.¹ Although this is not an exhaustive list, these tips can serve as a starting point to ensure effective communication while you are physically distanced from your patients.

Telepsychiatry appointments (eg, video conferencing) initially replaced face-to-face outpatient encounters during the first phase of the COVID-19 pandemic. However, as offices reopened for in-person appointments, many patients still prefer “virtual” appointments. Telepsychiatry allows for easier delivery of mental health services, including psychotherapy, and may become the new normal.

Although therapy conducted via video conferencing allows you to connect with patients at a safe distance, it alters the basic conditions under which therapy occurs, such as being in the same room.¹ While focusing on preserving the verbal elements of communication, you might inadvertently forget the nonverbal elements, which at times might render your words ineffective.¹ The main elements of nonverbal communication are facial expression, gaze, posture, gesture, and proxemics (ie, how much space you take up, and your distance from others).² The following tips can help you preserve the nonverbal elements of communication when conducting telepsychiatry sessions.

Reduce gaze error. Gaze error is the deviation from direct eye contact that occurs during video conferencing. It results from the distance between the image of the person on your screen and the camera above it.¹ Gaze error can muddy intended cues and communicate unintended cues.² Examples of gaze errors include downcast eyes (the most common gaze error), sideways gaze, or gazing over the person’s head.² These errors can communicate social deference, evasion, insincerity, or even boredom.² To lessen gaze error, move the patient’s image as close as possible to your camera.¹ In addition, avoid looking at yourself on the screen; some video conferencing platforms allow users to hide their self-view.

Create distance and incorporate upper body language. In the office, sitting very close to your patient and staring directly at their face for an hour would be awkward and intrusive.¹ Doing so online is no different. While you may be tempted to move close to the screen to compensate for feeling distant or having difficulty hearing or seeing your patient, you should back away from the camera. Doing so will help both parties feel less self-conscious, more at ease, and more focused on the session.¹ Backing up from the camera will allow patients to see your upper body language (eg, hand gestures, posture) as well as your facial expressions.¹ Empathy improves when patients can see your upper-body cues.² Keep in mind that the angle of your camera is just as important as the distance. For example, if your camera is positioned so that it is looking up toward your eyes, patients may perceive that you are looking down at them.¹ This problem can be remedied by stacking books under the monitor to raise the camera.

Be aware of your facial expressions, posture, gestures, and proxemics. Ensure that your face does not go slack when you are listening to patients talk.³ Just as you would do in person, a slight head tilt and occasional head nod lets patients know that you are engaged and actively listening.³ Maintain an open body posture by keeping your feet firmly on the ground and putting your hands on the table in front of you.³ Lean in when patients share intimate information, just as you would in person. Avoid hunching over the laptop/keyboard because this could make you seem tired or tense.³ Pay attention to your arm and hand movements so that you do not exaggerate them.

Maintain office professionalism. The office setting conveys a therapeutic formality that can get lost online.¹ As tempting as it may be to conduct online sessions in pajamas or sweatpants, continue to dress as if you were in the office. Be mindful of your backdrop, set all cell phones to silent, turn off your email alerts, and lock the room.^1,3 Stick to the clock as you would in the office, and encourage patients to do the same.

Minor technological improvements—such as headphones with a built-in microphone, a high-definition camera, a larger monitor, or a faster internet connection—might be needed to improve your nonverbal communication during telepsychiatry sessions.¹ Although this is not an exhaustive list, these tips can serve as a starting point to ensure effective communication while you are physically distanced from your patients.

Telepsychiatry appointments (eg, video conferencing) initially replaced face-to-face outpatient encounters during the first phase of the COVID-19 pandemic. However, as offices reopened for in-person appointments, many patients still prefer “virtual” appointments. Telepsychiatry allows for easier delivery of mental health services, including psychotherapy, and may become the new normal.

Although therapy conducted via video conferencing allows you to connect with patients at a safe distance, it alters the basic conditions under which therapy occurs, such as being in the same room.¹ While focusing on preserving the verbal elements of communication, you might inadvertently forget the nonverbal elements, which at times might render your words ineffective.¹ The main elements of nonverbal communication are facial expression, gaze, posture, gesture, and proxemics (ie, how much space you take up, and your distance from others).² The following tips can help you preserve the nonverbal elements of communication when conducting telepsychiatry sessions.

Reduce gaze error. Gaze error is the deviation from direct eye contact that occurs during video conferencing. It results from the distance between the image of the person on your screen and the camera above it.¹ Gaze error can muddy intended cues and communicate unintended cues.² Examples of gaze errors include downcast eyes (the most common gaze error), sideways gaze, or gazing over the person’s head.² These errors can communicate social deference, evasion, insincerity, or even boredom.² To lessen gaze error, move the patient’s image as close as possible to your camera.¹ In addition, avoid looking at yourself on the screen; some video conferencing platforms allow users to hide their self-view.

Create distance and incorporate upper body language. In the office, sitting very close to your patient and staring directly at their face for an hour would be awkward and intrusive.¹ Doing so online is no different. While you may be tempted to move close to the screen to compensate for feeling distant or having difficulty hearing or seeing your patient, you should back away from the camera. Doing so will help both parties feel less self-conscious, more at ease, and more focused on the session.¹ Backing up from the camera will allow patients to see your upper body language (eg, hand gestures, posture) as well as your facial expressions.¹ Empathy improves when patients can see your upper-body cues.² Keep in mind that the angle of your camera is just as important as the distance. For example, if your camera is positioned so that it is looking up toward your eyes, patients may perceive that you are looking down at them.¹ This problem can be remedied by stacking books under the monitor to raise the camera.

Be aware of your facial expressions, posture, gestures, and proxemics. Ensure that your face does not go slack when you are listening to patients talk.³ Just as you would do in person, a slight head tilt and occasional head nod lets patients know that you are engaged and actively listening.³ Maintain an open body posture by keeping your feet firmly on the ground and putting your hands on the table in front of you.³ Lean in when patients share intimate information, just as you would in person. Avoid hunching over the laptop/keyboard because this could make you seem tired or tense.³ Pay attention to your arm and hand movements so that you do not exaggerate them.

Maintain office professionalism. The office setting conveys a therapeutic formality that can get lost online.¹ As tempting as it may be to conduct online sessions in pajamas or sweatpants, continue to dress as if you were in the office. Be mindful of your backdrop, set all cell phones to silent, turn off your email alerts, and lock the room.^1,3 Stick to the clock as you would in the office, and encourage patients to do the same.

Minor technological improvements—such as headphones with a built-in microphone, a high-definition camera, a larger monitor, or a faster internet connection—might be needed to improve your nonverbal communication during telepsychiatry sessions.¹ Although this is not an exhaustive list, these tips can serve as a starting point to ensure effective communication while you are physically distanced from your patients.

Credit cards have made it easier for psychiatrists who work in outpatient settings to collect payment for their services. Accepting credit cards saves time in sessions for clinical matters, leads to higher rates of collecting payments for patients who do not show up for appointments, and avoids having to manage bounced checks and collection agencies.¹ No federal or state laws prohibit businesses from storing consumers’ credit card information. However, psychiatric practices are legally obligated to have safeguards in place to protect sensitive information and limit liability exposures.² There are several steps to take when storing your patients’ credit card information.

Establish a payment policy. Create a policy that outlines your practice’s credit card procedures, including when credit cards will be charged and under what circumstances, how patients will be notified, and how credit card information will be stored.² Give your patients a copy of this policy and review it with them at their first appointment and any time you change this policy.² Get consent from your patients before using and storing their credit card information.²

Use secure methods to store this information. Most medical practices photocopy/write down their patients’ credit card information and store it in the patient’s electronic/paper medical record, or they use an online service to store it electronically.² Online services usually provide a higher level of protection than the patient’s medical record.² Ensure that electronic data that includes credit card numbers is robustly encrypted, or that paper records are locked in a secure place, such as in a safe or file drawer that requires a key/combination lock.³ Payment Card Industry (PCI) regulations prohibit storing a credit card’s security code (a three- or four-digit number on the front or back of the card).³ This code is used to allow merchants to verify whether a customer authorizing a transaction over the phone or via the internet physically possesses the card.³ PCI regulations also prohibit storing data contained in the card’s magnetic strip.³ This data contains information about the account that is not displayed on the card, assists with authorizing transactions, and ensures that credit cards cannot be easily counterfeited.³

Understand all federal and state laws and regulations. If your practice collects patient billing information, you are considered a “merchant” and are subject to federal and state laws and regulations that protect consumer credit card information.² These laws and regulations include (but are not limited to)²:

• Health Insurance Portability and Accountability Act (HIPAA) and similar state privacy laws
• Federal Trade Commission Act (FTCA) and similar state business laws
• Payment Card Industry Data Security Standard (PCI DSS), which was not devised by federal or state government.

HIPAA and state privacy laws require psychiatrists to implement “reasonable” security measures to protect payment information, regardless of how that information is stored.^2,4 Because HIPAA does not define “reasonable,” psychiatrists have latitude in determining which security measures to implement.^2,4 Locking the information in a file cabinet and locking the room where the file cabinet is kept (for paper storage) or using HIPAA-compliant encrypted storage programs (for electronic storage) are examples of “reasonable” security measures.²

FTCA requires businesses to use “appropriate” and “reasonable” security measures to protect credit card information.^2,5 Because FTCA does not specify these terms,^2,5 psychiatrists have leeway in determining which security measures to implement. Federal law requires all businesses to delete a card’s expiration date and shorten the account information to include no more than the last 5 digits of the card number that is printed on all sales receipts.⁶ FTCA also requires businesses to get prior authorization from individuals before charging their credit card.² For example, if a patient previously used a credit card to pay for a session, the psychiatrist cannot later use the credit card to charge for a missed appointment without notifying the patient and getting their authorization.²

PCI DSS applies to entities that store, process, and/or transmit cardholder data.⁷ Any business that accepts credit card payments must comply with PCI DSS, which includes 12 requirements.⁷ Examples of these requirements include using firewalls to protect cardholder data and restricting access to cardholder data to a “need-to-know” basis. Businesses that do not comply with PCI DSS can be subjected to fines and/or have their contracts terminated by the credit card companies.² Fines can range from $5,000 to $100,000 per month for data breaches where you are found negligible.¹

Credit cards have made it easier for psychiatrists who work in outpatient settings to collect payment for their services. Accepting credit cards saves time in sessions for clinical matters, leads to higher rates of collecting payments for patients who do not show up for appointments, and avoids having to manage bounced checks and collection agencies.¹ No federal or state laws prohibit businesses from storing consumers’ credit card information. However, psychiatric practices are legally obligated to have safeguards in place to protect sensitive information and limit liability exposures.² There are several steps to take when storing your patients’ credit card information.

Establish a payment policy. Create a policy that outlines your practice’s credit card procedures, including when credit cards will be charged and under what circumstances, how patients will be notified, and how credit card information will be stored.² Give your patients a copy of this policy and review it with them at their first appointment and any time you change this policy.² Get consent from your patients before using and storing their credit card information.²

Use secure methods to store this information. Most medical practices photocopy/write down their patients’ credit card information and store it in the patient’s electronic/paper medical record, or they use an online service to store it electronically.² Online services usually provide a higher level of protection than the patient’s medical record.² Ensure that electronic data that includes credit card numbers is robustly encrypted, or that paper records are locked in a secure place, such as in a safe or file drawer that requires a key/combination lock.³ Payment Card Industry (PCI) regulations prohibit storing a credit card’s security code (a three- or four-digit number on the front or back of the card).³ This code is used to allow merchants to verify whether a customer authorizing a transaction over the phone or via the internet physically possesses the card.³ PCI regulations also prohibit storing data contained in the card’s magnetic strip.³ This data contains information about the account that is not displayed on the card, assists with authorizing transactions, and ensures that credit cards cannot be easily counterfeited.³

Understand all federal and state laws and regulations. If your practice collects patient billing information, you are considered a “merchant” and are subject to federal and state laws and regulations that protect consumer credit card information.² These laws and regulations include (but are not limited to)²:

• Health Insurance Portability and Accountability Act (HIPAA) and similar state privacy laws
• Federal Trade Commission Act (FTCA) and similar state business laws
• Payment Card Industry Data Security Standard (PCI DSS), which was not devised by federal or state government.

HIPAA and state privacy laws require psychiatrists to implement “reasonable” security measures to protect payment information, regardless of how that information is stored.^2,4 Because HIPAA does not define “reasonable,” psychiatrists have latitude in determining which security measures to implement.^2,4 Locking the information in a file cabinet and locking the room where the file cabinet is kept (for paper storage) or using HIPAA-compliant encrypted storage programs (for electronic storage) are examples of “reasonable” security measures.²

FTCA requires businesses to use “appropriate” and “reasonable” security measures to protect credit card information.^2,5 Because FTCA does not specify these terms,^2,5 psychiatrists have leeway in determining which security measures to implement. Federal law requires all businesses to delete a card’s expiration date and shorten the account information to include no more than the last 5 digits of the card number that is printed on all sales receipts.⁶ FTCA also requires businesses to get prior authorization from individuals before charging their credit card.² For example, if a patient previously used a credit card to pay for a session, the psychiatrist cannot later use the credit card to charge for a missed appointment without notifying the patient and getting their authorization.²

PCI DSS applies to entities that store, process, and/or transmit cardholder data.⁷ Any business that accepts credit card payments must comply with PCI DSS, which includes 12 requirements.⁷ Examples of these requirements include using firewalls to protect cardholder data and restricting access to cardholder data to a “need-to-know” basis. Businesses that do not comply with PCI DSS can be subjected to fines and/or have their contracts terminated by the credit card companies.² Fines can range from $5,000 to $100,000 per month for data breaches where you are found negligible.¹

Credit cards have made it easier for psychiatrists who work in outpatient settings to collect payment for their services. Accepting credit cards saves time in sessions for clinical matters, leads to higher rates of collecting payments for patients who do not show up for appointments, and avoids having to manage bounced checks and collection agencies.¹ No federal or state laws prohibit businesses from storing consumers’ credit card information. However, psychiatric practices are legally obligated to have safeguards in place to protect sensitive information and limit liability exposures.² There are several steps to take when storing your patients’ credit card information.

Establish a payment policy. Create a policy that outlines your practice’s credit card procedures, including when credit cards will be charged and under what circumstances, how patients will be notified, and how credit card information will be stored.² Give your patients a copy of this policy and review it with them at their first appointment and any time you change this policy.² Get consent from your patients before using and storing their credit card information.²

Use secure methods to store this information. Most medical practices photocopy/write down their patients’ credit card information and store it in the patient’s electronic/paper medical record, or they use an online service to store it electronically.² Online services usually provide a higher level of protection than the patient’s medical record.² Ensure that electronic data that includes credit card numbers is robustly encrypted, or that paper records are locked in a secure place, such as in a safe or file drawer that requires a key/combination lock.³ Payment Card Industry (PCI) regulations prohibit storing a credit card’s security code (a three- or four-digit number on the front or back of the card).³ This code is used to allow merchants to verify whether a customer authorizing a transaction over the phone or via the internet physically possesses the card.³ PCI regulations also prohibit storing data contained in the card’s magnetic strip.³ This data contains information about the account that is not displayed on the card, assists with authorizing transactions, and ensures that credit cards cannot be easily counterfeited.³

Understand all federal and state laws and regulations. If your practice collects patient billing information, you are considered a “merchant” and are subject to federal and state laws and regulations that protect consumer credit card information.² These laws and regulations include (but are not limited to)²:

• Health Insurance Portability and Accountability Act (HIPAA) and similar state privacy laws
• Federal Trade Commission Act (FTCA) and similar state business laws
• Payment Card Industry Data Security Standard (PCI DSS), which was not devised by federal or state government.

HIPAA and state privacy laws require psychiatrists to implement “reasonable” security measures to protect payment information, regardless of how that information is stored.^2,4 Because HIPAA does not define “reasonable,” psychiatrists have latitude in determining which security measures to implement.^2,4 Locking the information in a file cabinet and locking the room where the file cabinet is kept (for paper storage) or using HIPAA-compliant encrypted storage programs (for electronic storage) are examples of “reasonable” security measures.²

FTCA requires businesses to use “appropriate” and “reasonable” security measures to protect credit card information.^2,5 Because FTCA does not specify these terms,^2,5 psychiatrists have leeway in determining which security measures to implement. Federal law requires all businesses to delete a card’s expiration date and shorten the account information to include no more than the last 5 digits of the card number that is printed on all sales receipts.⁶ FTCA also requires businesses to get prior authorization from individuals before charging their credit card.² For example, if a patient previously used a credit card to pay for a session, the psychiatrist cannot later use the credit card to charge for a missed appointment without notifying the patient and getting their authorization.²

PCI DSS applies to entities that store, process, and/or transmit cardholder data.⁷ Any business that accepts credit card payments must comply with PCI DSS, which includes 12 requirements.⁷ Examples of these requirements include using firewalls to protect cardholder data and restricting access to cardholder data to a “need-to-know” basis. Businesses that do not comply with PCI DSS can be subjected to fines and/or have their contracts terminated by the credit card companies.² Fines can range from $5,000 to $100,000 per month for data breaches where you are found negligible.¹

Emerging data demonstrate that untreated perinatal anxiety is associated with negative outcomes, including an increased risk for suicide.¹ A 2017 systematic review and meta-analysis that included 102 studies with a total of 221,974 women from 34 countries found that the prevalence of self-reported anxiety symptoms and any anxiety disorder was 22.9% and 15.2%, respectively, across the 3 trimesters.¹ During pregnancy, anxiety disorders (eg, generalized anxiety disorder) and anxiety-related disorders (eg, obsessive-compulsive disorder [OCD] and posttraumatic stress disorder [PTSD]) can present as new illnesses or as a reoccurrence of an existing illness. Patients with pre-existing OCD may notice that the nature of their obsessions is changing. Women with pre-existing PTSD may have their symptoms triggered by pregnancy or delivery or may develop PTSD as a result of a traumatic delivery. Anxiety is frequently comorbid with depression, and high anxiety during pregnancy is one of the strongest risk factors for depression.^1,2

In light of this data, awareness and recognition of perinatal anxiety is critical. In this article, we describe how to accurately assess perinatal anxiety by avoiding assumptions and asking key questions during the clinical interview.

Avoid these common assumptions

Assessment begins with avoiding assumptions typically associated with maternal mental health. One common assumption is that pregnancy is a joyous occasion for all women. Pregnancy can be a stressful time that has its own unique difficulties, including the potential to develop or have a relapse of a mental illness. Another assumption is that the only concern is “postpartum depression.” In actuality, a significant percentage of women will experience depression during their pregnancy (not just in the postpartum period), and many other psychiatric illnesses are common during the perinatal period, including anxiety disorders.

Conduct a focused interview

Risk factors associated with antenatal anxiety include²:

• previous history of mental illness (particularly a history of anxiety and depression and a history of psychiatric treatment)
• lack of partner or social support
• history of abuse or domestic violence
• unplanned or unwanted pregnancy
• adverse events in life and high perceived stress
• present/past pregnancy complications
• pregnancy loss.

Symptoms of anxiety. The presence of anxiety or worrying does not necessarily mean a mother has an anxiety disorder. Using the DSM-5 as a guide, we should use the questions outlined in the following sections to inquire about all of the symptoms related to a particular illness, the pervasiveness of these symptoms, and to what extent these symptoms impair a woman’s ability to function and carry out her usual activities.³

Past psychiatric history. Ask your patient the following: Have you previously experienced anxiety and/or depressive symptoms? Were those symptoms limited only to times when you were pregnant or postpartum? Were your symptoms severe enough to disrupt your life (job, school, relationships, ability to complete daily tasks)? What treatments were effective for your symptoms? What treatments were ineffective?³

Social factors. Learn more about your patient’s support systems by asking: Who do you consider to be part of your social support? How is your relationship with your social support? Are there challenges in your relationship with your friends, family, or partner? If yes, what are those challenges? Are there other children in the home, and do you have support for them? Is your home environment safe? Do you feel that you have what you need for the baby? What stressors are you currently experiencing? Do you attend support groups for expectant mothers? Are you engaged in perinatal care?³

Continue to: Given the high prevalence...

Given the high prevalence of interpersonal violence in women of reproductive age, all patients should be screened for this. The American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women recommends screening for interpersonal violence at the first visit during the perinatal period, during each trimester, and at the postpartum visit (at minimum).⁴ Potential screening questions include (but are not limited to): Have you and/or your children ever been threatened by or felt afraid of your partner? When you argue with your partner, do either of you get physical? Has your partner ever physically hurt you (eg, hit, choked)? Do you feel safe at home? Do you have a safe place to go with resources you and your children will need in case of an emergency?^4-6

Feelings toward pregnancy, past/current pregnancy complications, and pregnancy loss. Ask your patient: Was this pregnancy planned? How do you feel about your pregnancy? How do you see yourself as a mother? Do you currently have pregnancy complications and/or have had them in the past, and, if so, what are/were they? Have you lost a pregnancy? If so, what was that like? Do you have fears related to childbirth, and, if so, what are they?³

Intrusive thoughts about harming the baby. Intrusive thoughts are common in postpartum women with anxiety disorders, including OCD.⁷ Merely asking patients if they’ve had thoughts of harming their baby is incomplete and insufficient to assess for intrusive thoughts. This question does not distinguish between intrusive thoughts and homicidal ideation; this distinction is absolutely necessary given the difference in potential risk to the infant.

Intrusive thoughts are generally associated with a low risk of mothers acting on their thoughts. These thoughts are typically ego dystonic and, in the most severe form, can be distressing to an extent that they cause behavioral changes, such as avoiding bathing the infant, avoiding diaper changes, avoiding knives, or separating themselves from the infant.⁷ On the contrary, having homicidal ideation carries a higher risk for harm to the infant. Homicidal ideation may be seen in patients with co-occurring psychosis, poor reality testing, and delusions.^5,7

Questions such as “Do you worry about harm coming to your baby?” “Do you worry about you causing harm to your baby?” and “Have you had an upsetting thought about harming your baby?” are more likely to reveal intrusive thoughts and prompt further exploration. Statements such as “Some people tell me that they have distressing thoughts about harm coming to their baby” can gently open the door to a having a dialogue about such thoughts. This dialogue is significantly important in making informed assessments as we develop comprehensive treatment plans.

Emerging data demonstrate that untreated perinatal anxiety is associated with negative outcomes, including an increased risk for suicide.¹ A 2017 systematic review and meta-analysis that included 102 studies with a total of 221,974 women from 34 countries found that the prevalence of self-reported anxiety symptoms and any anxiety disorder was 22.9% and 15.2%, respectively, across the 3 trimesters.¹ During pregnancy, anxiety disorders (eg, generalized anxiety disorder) and anxiety-related disorders (eg, obsessive-compulsive disorder [OCD] and posttraumatic stress disorder [PTSD]) can present as new illnesses or as a reoccurrence of an existing illness. Patients with pre-existing OCD may notice that the nature of their obsessions is changing. Women with pre-existing PTSD may have their symptoms triggered by pregnancy or delivery or may develop PTSD as a result of a traumatic delivery. Anxiety is frequently comorbid with depression, and high anxiety during pregnancy is one of the strongest risk factors for depression.^1,2

In light of this data, awareness and recognition of perinatal anxiety is critical. In this article, we describe how to accurately assess perinatal anxiety by avoiding assumptions and asking key questions during the clinical interview.

Avoid these common assumptions

Assessment begins with avoiding assumptions typically associated with maternal mental health. One common assumption is that pregnancy is a joyous occasion for all women. Pregnancy can be a stressful time that has its own unique difficulties, including the potential to develop or have a relapse of a mental illness. Another assumption is that the only concern is “postpartum depression.” In actuality, a significant percentage of women will experience depression during their pregnancy (not just in the postpartum period), and many other psychiatric illnesses are common during the perinatal period, including anxiety disorders.

Conduct a focused interview

Risk factors associated with antenatal anxiety include²:

• previous history of mental illness (particularly a history of anxiety and depression and a history of psychiatric treatment)
• lack of partner or social support
• history of abuse or domestic violence
• unplanned or unwanted pregnancy
• adverse events in life and high perceived stress
• present/past pregnancy complications
• pregnancy loss.

Symptoms of anxiety. The presence of anxiety or worrying does not necessarily mean a mother has an anxiety disorder. Using the DSM-5 as a guide, we should use the questions outlined in the following sections to inquire about all of the symptoms related to a particular illness, the pervasiveness of these symptoms, and to what extent these symptoms impair a woman’s ability to function and carry out her usual activities.³

Past psychiatric history. Ask your patient the following: Have you previously experienced anxiety and/or depressive symptoms? Were those symptoms limited only to times when you were pregnant or postpartum? Were your symptoms severe enough to disrupt your life (job, school, relationships, ability to complete daily tasks)? What treatments were effective for your symptoms? What treatments were ineffective?³

Social factors. Learn more about your patient’s support systems by asking: Who do you consider to be part of your social support? How is your relationship with your social support? Are there challenges in your relationship with your friends, family, or partner? If yes, what are those challenges? Are there other children in the home, and do you have support for them? Is your home environment safe? Do you feel that you have what you need for the baby? What stressors are you currently experiencing? Do you attend support groups for expectant mothers? Are you engaged in perinatal care?³

Continue to: Given the high prevalence...

Given the high prevalence of interpersonal violence in women of reproductive age, all patients should be screened for this. The American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women recommends screening for interpersonal violence at the first visit during the perinatal period, during each trimester, and at the postpartum visit (at minimum).⁴ Potential screening questions include (but are not limited to): Have you and/or your children ever been threatened by or felt afraid of your partner? When you argue with your partner, do either of you get physical? Has your partner ever physically hurt you (eg, hit, choked)? Do you feel safe at home? Do you have a safe place to go with resources you and your children will need in case of an emergency?^4-6

Feelings toward pregnancy, past/current pregnancy complications, and pregnancy loss. Ask your patient: Was this pregnancy planned? How do you feel about your pregnancy? How do you see yourself as a mother? Do you currently have pregnancy complications and/or have had them in the past, and, if so, what are/were they? Have you lost a pregnancy? If so, what was that like? Do you have fears related to childbirth, and, if so, what are they?³

Intrusive thoughts about harming the baby. Intrusive thoughts are common in postpartum women with anxiety disorders, including OCD.⁷ Merely asking patients if they’ve had thoughts of harming their baby is incomplete and insufficient to assess for intrusive thoughts. This question does not distinguish between intrusive thoughts and homicidal ideation; this distinction is absolutely necessary given the difference in potential risk to the infant.

Intrusive thoughts are generally associated with a low risk of mothers acting on their thoughts. These thoughts are typically ego dystonic and, in the most severe form, can be distressing to an extent that they cause behavioral changes, such as avoiding bathing the infant, avoiding diaper changes, avoiding knives, or separating themselves from the infant.⁷ On the contrary, having homicidal ideation carries a higher risk for harm to the infant. Homicidal ideation may be seen in patients with co-occurring psychosis, poor reality testing, and delusions.^5,7

Questions such as “Do you worry about harm coming to your baby?” “Do you worry about you causing harm to your baby?” and “Have you had an upsetting thought about harming your baby?” are more likely to reveal intrusive thoughts and prompt further exploration. Statements such as “Some people tell me that they have distressing thoughts about harm coming to their baby” can gently open the door to a having a dialogue about such thoughts. This dialogue is significantly important in making informed assessments as we develop comprehensive treatment plans.

Emerging data demonstrate that untreated perinatal anxiety is associated with negative outcomes, including an increased risk for suicide.¹ A 2017 systematic review and meta-analysis that included 102 studies with a total of 221,974 women from 34 countries found that the prevalence of self-reported anxiety symptoms and any anxiety disorder was 22.9% and 15.2%, respectively, across the 3 trimesters.¹ During pregnancy, anxiety disorders (eg, generalized anxiety disorder) and anxiety-related disorders (eg, obsessive-compulsive disorder [OCD] and posttraumatic stress disorder [PTSD]) can present as new illnesses or as a reoccurrence of an existing illness. Patients with pre-existing OCD may notice that the nature of their obsessions is changing. Women with pre-existing PTSD may have their symptoms triggered by pregnancy or delivery or may develop PTSD as a result of a traumatic delivery. Anxiety is frequently comorbid with depression, and high anxiety during pregnancy is one of the strongest risk factors for depression.^1,2

In light of this data, awareness and recognition of perinatal anxiety is critical. In this article, we describe how to accurately assess perinatal anxiety by avoiding assumptions and asking key questions during the clinical interview.

Avoid these common assumptions

Assessment begins with avoiding assumptions typically associated with maternal mental health. One common assumption is that pregnancy is a joyous occasion for all women. Pregnancy can be a stressful time that has its own unique difficulties, including the potential to develop or have a relapse of a mental illness. Another assumption is that the only concern is “postpartum depression.” In actuality, a significant percentage of women will experience depression during their pregnancy (not just in the postpartum period), and many other psychiatric illnesses are common during the perinatal period, including anxiety disorders.

Conduct a focused interview

Risk factors associated with antenatal anxiety include²:

• previous history of mental illness (particularly a history of anxiety and depression and a history of psychiatric treatment)
• lack of partner or social support
• history of abuse or domestic violence
• unplanned or unwanted pregnancy
• adverse events in life and high perceived stress
• present/past pregnancy complications
• pregnancy loss.

Symptoms of anxiety. The presence of anxiety or worrying does not necessarily mean a mother has an anxiety disorder. Using the DSM-5 as a guide, we should use the questions outlined in the following sections to inquire about all of the symptoms related to a particular illness, the pervasiveness of these symptoms, and to what extent these symptoms impair a woman’s ability to function and carry out her usual activities.³

Past psychiatric history. Ask your patient the following: Have you previously experienced anxiety and/or depressive symptoms? Were those symptoms limited only to times when you were pregnant or postpartum? Were your symptoms severe enough to disrupt your life (job, school, relationships, ability to complete daily tasks)? What treatments were effective for your symptoms? What treatments were ineffective?³

Social factors. Learn more about your patient’s support systems by asking: Who do you consider to be part of your social support? How is your relationship with your social support? Are there challenges in your relationship with your friends, family, or partner? If yes, what are those challenges? Are there other children in the home, and do you have support for them? Is your home environment safe? Do you feel that you have what you need for the baby? What stressors are you currently experiencing? Do you attend support groups for expectant mothers? Are you engaged in perinatal care?³

Continue to: Given the high prevalence...

Given the high prevalence of interpersonal violence in women of reproductive age, all patients should be screened for this. The American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women recommends screening for interpersonal violence at the first visit during the perinatal period, during each trimester, and at the postpartum visit (at minimum).⁴ Potential screening questions include (but are not limited to): Have you and/or your children ever been threatened by or felt afraid of your partner? When you argue with your partner, do either of you get physical? Has your partner ever physically hurt you (eg, hit, choked)? Do you feel safe at home? Do you have a safe place to go with resources you and your children will need in case of an emergency?^4-6

Feelings toward pregnancy, past/current pregnancy complications, and pregnancy loss. Ask your patient: Was this pregnancy planned? How do you feel about your pregnancy? How do you see yourself as a mother? Do you currently have pregnancy complications and/or have had them in the past, and, if so, what are/were they? Have you lost a pregnancy? If so, what was that like? Do you have fears related to childbirth, and, if so, what are they?³

Intrusive thoughts about harming the baby. Intrusive thoughts are common in postpartum women with anxiety disorders, including OCD.⁷ Merely asking patients if they’ve had thoughts of harming their baby is incomplete and insufficient to assess for intrusive thoughts. This question does not distinguish between intrusive thoughts and homicidal ideation; this distinction is absolutely necessary given the difference in potential risk to the infant.

Intrusive thoughts are generally associated with a low risk of mothers acting on their thoughts. These thoughts are typically ego dystonic and, in the most severe form, can be distressing to an extent that they cause behavioral changes, such as avoiding bathing the infant, avoiding diaper changes, avoiding knives, or separating themselves from the infant.⁷ On the contrary, having homicidal ideation carries a higher risk for harm to the infant. Homicidal ideation may be seen in patients with co-occurring psychosis, poor reality testing, and delusions.^5,7

Questions such as “Do you worry about harm coming to your baby?” “Do you worry about you causing harm to your baby?” and “Have you had an upsetting thought about harming your baby?” are more likely to reveal intrusive thoughts and prompt further exploration. Statements such as “Some people tell me that they have distressing thoughts about harm coming to their baby” can gently open the door to a having a dialogue about such thoughts. This dialogue is significantly important in making informed assessments as we develop comprehensive treatment plans.

In 2009, the Health Information Technology for Economic and Clinical Health Act (HITECH Act), which is part of the American Recovery and Reinvestment Act, provided several billion dollars of grants and incentives to stimulate the implementation of electronic health records (EHRs) and supporting technology in the United States.¹ Since then, almost all health care organizations have employed EHRs and supporting technologies. Unfortunately, this has created new liability risks. One potential risk is that in malpractice claims, there is more discoverable evidence, including metadata, with which to prove the claims.² In this article, I explain what metadata is and how it can be used in medical malpractice cases. In addition, because we cannot change metadata, I provide guidance on making corrections in your EHR documentation to minimize liability in medical malpractice cases.

What is metadata?

Metadata—commonly described as data about data—lurk behind the words and images we can see on our computer screens. Metadata can be conceptualized as data that provides details about the information we enter into a computer system, creating a permanent electronic footprint that can be used to track our activity.^2,3 Examples of metadata include (but are not limited to) the user’s name, date and time of a record entry, changes or deletions made to the record, the date an entry was created or modified, annotations that the user added over a period of time, and any other data that the software captures without the user manually entering the information.³ Metadata is typically stored on a server or file that users cannot access, which ensures data integrity because a user cannot alter a patient’s medical record without those changes being captured.³

How metadata is used in malpractice claims

When a psychiatrist is sued for medical negligence, the integrity of the EHR is an important aspect of defending against the lawsuit. A plaintiff’s (patient’s) attorney can more readily discover changes to the patient’s medical record by requesting the metadata and having it analyzed by an information technology specialist. Because the computer system captures everything a user does, it is difficult to alter a patient’s record without being detected. Consequently, plaintiff attorneys frequently request metadata during discovery in the hopes of learning whether the defendant psychiatrist altered or attempted to hide information that was contained or missing from the original version of the medical record.³ If the medical record was revised at a time unrelated to the treatment, metadata can raise suspicion of deception, even in the absence of wrongdoing.² Alternatively, metadata can be used to validate that the EHR was changed when treatment occurred, which can bolster a defendant psychiatrist’s ability to rely on the EHR against a claim of medical negligence.²

Depending on the jurisdiction, metadata may or may not be discoverable. The Federal Rules of Civil Procedure emphasize producing documents in their original format.⁴ For federal cases, these rules suggest that the parties discuss discovery of this material when they are initially conferring; however, the rules do not specify whether a party must produce metadata, which leaves the courts to refine these rules through case law.^4,5 In one case, a federal court ruled that a party had to produce documents with metadata intact.⁵ Without an agreement between both parties to exclude metadata from produced documents, the parties must produce the metadata.⁵ State laws differ in regards to the discoverability of metadata.

Corrections vs alterations

A patient’s medical record is the best evidence of the care we provided, should that care ever be challenged in court. We can preserve the medical record’s effectiveness through appropriate changes to it. Appropriately executed corrections are a normal part of documentation, whereas alterations to the medical record can cast doubt on our credibility and lead an otherwise defensible case to require a settlement.⁶

Corrections are changes to a patient’s medical record during the normal course of treatment.⁶ These are acceptable, provided the changes are made appropriately. Health care facilities and practices have their own policies for making appropriate corrections and addendums to the medical record. Once a correction and/or addendum is made, do not remove or delete the erroneous entry, because health care colleagues may have relied on it, and deleting an erroneous entry also would alter the integrity of the medical record.⁶ When done appropriately, corrections will not be misconstrued as alterations.

Alterations are changes to a patient’s medical record after a psychiatrist receives notice of a lawsuit and “clarifies” certain points in the medical record to aid the defense against the claim.⁶ Alterations are considered deliberate misrepresentations of facts and, if discovered during litigation, can significantly impact the ability to defend against a claim.⁶ In addition, many medical liability policies exclude coverage for claims in which the medical record was altered, which might result in a psychiatrist having to pay for the judgment and defense costs out of pocket.⁶ Psychiatrists facing litigation who have a legitimate need to change an EHR entry after a claim is filed should consult with legal counsel or a risk management professional for guidance before making any changes.³ If they concur with updating the patient’s record to correct an error (including an addendum or a late entry; see below), the original entry, date, and time stamp must be accessible.³ This should also include the current date/time of the amended entry, the name of the person making the change, and the reasons for the change.³

Continue to: How to handle corrections and late entries

Sometimes situations occur that require us to make late entries, enter addendums, or add clarification notes to patient information in the EHRs. Regardless of your work environment (ie, hospital, your own practice), there should be clear procedures in place for correcting patients’ EHRs that are in accordance with applicable federal and state laws. Correcting an error in the EHR should follow the same basic principles of correcting paper records: do not obscure the original entry, make timely corrections, sign all entries, ensure the person making the change is identified, and document the reason(s) for the correction.⁷ The EHR must be able to track corrections or changes to an entry once they are entered or authenticated. Any physical copies of documentation must also have the same corrections or changes if they have been previously printed from the EHR.

You may need to make an entry that is late (out of sequence) or provides additional documentation to supplement previously written entries.⁷ A late entry should be used to record information when a pertinent entry was missed or not written in a timely manner.⁷ Label the new entry as a “late entry,” enter the current date and time (do not give the appearance that the entry was made on a previous date or at an earlier time), and identify or refer to the date and incident for which the late entry is written.⁷ If the late entry is used to document an omission, validate the source of additional information as best you can (ie, details of where you obtained the information to write the late entry).⁷ Make late entries as soon as possible after the original entry; although there is no time limit on writing a late entry, delays in corrections might diminish the credibility of the changes.

Addendums are used to provide additional information in conjunction with a previous entry.⁷ They also provide additional information to address a specific situation or incident referenced in a previous note. Addendums should not be used to document information that was forgotten or written in error.⁷ A clarification note is used to avoid incorrect interpretation of previously documented information.⁷ When writing an addendum or a clarification note, you should label it as an “addendum” or a “clarification note”; document the current date and time; state the reason for the addendum (referring back to the original entry) or clarification note (referring back to the entry being clarified); and identify any sources of information used to support an addendum or a clarification note.⁷

In 2009, the Health Information Technology for Economic and Clinical Health Act (HITECH Act), which is part of the American Recovery and Reinvestment Act, provided several billion dollars of grants and incentives to stimulate the implementation of electronic health records (EHRs) and supporting technology in the United States.¹ Since then, almost all health care organizations have employed EHRs and supporting technologies. Unfortunately, this has created new liability risks. One potential risk is that in malpractice claims, there is more discoverable evidence, including metadata, with which to prove the claims.² In this article, I explain what metadata is and how it can be used in medical malpractice cases. In addition, because we cannot change metadata, I provide guidance on making corrections in your EHR documentation to minimize liability in medical malpractice cases.

What is metadata?

Metadata—commonly described as data about data—lurk behind the words and images we can see on our computer screens. Metadata can be conceptualized as data that provides details about the information we enter into a computer system, creating a permanent electronic footprint that can be used to track our activity.^2,3 Examples of metadata include (but are not limited to) the user’s name, date and time of a record entry, changes or deletions made to the record, the date an entry was created or modified, annotations that the user added over a period of time, and any other data that the software captures without the user manually entering the information.³ Metadata is typically stored on a server or file that users cannot access, which ensures data integrity because a user cannot alter a patient’s medical record without those changes being captured.³

How metadata is used in malpractice claims

When a psychiatrist is sued for medical negligence, the integrity of the EHR is an important aspect of defending against the lawsuit. A plaintiff’s (patient’s) attorney can more readily discover changes to the patient’s medical record by requesting the metadata and having it analyzed by an information technology specialist. Because the computer system captures everything a user does, it is difficult to alter a patient’s record without being detected. Consequently, plaintiff attorneys frequently request metadata during discovery in the hopes of learning whether the defendant psychiatrist altered or attempted to hide information that was contained or missing from the original version of the medical record.³ If the medical record was revised at a time unrelated to the treatment, metadata can raise suspicion of deception, even in the absence of wrongdoing.² Alternatively, metadata can be used to validate that the EHR was changed when treatment occurred, which can bolster a defendant psychiatrist’s ability to rely on the EHR against a claim of medical negligence.²

Depending on the jurisdiction, metadata may or may not be discoverable. The Federal Rules of Civil Procedure emphasize producing documents in their original format.⁴ For federal cases, these rules suggest that the parties discuss discovery of this material when they are initially conferring; however, the rules do not specify whether a party must produce metadata, which leaves the courts to refine these rules through case law.^4,5 In one case, a federal court ruled that a party had to produce documents with metadata intact.⁵ Without an agreement between both parties to exclude metadata from produced documents, the parties must produce the metadata.⁵ State laws differ in regards to the discoverability of metadata.

Corrections vs alterations

A patient’s medical record is the best evidence of the care we provided, should that care ever be challenged in court. We can preserve the medical record’s effectiveness through appropriate changes to it. Appropriately executed corrections are a normal part of documentation, whereas alterations to the medical record can cast doubt on our credibility and lead an otherwise defensible case to require a settlement.⁶

Corrections are changes to a patient’s medical record during the normal course of treatment.⁶ These are acceptable, provided the changes are made appropriately. Health care facilities and practices have their own policies for making appropriate corrections and addendums to the medical record. Once a correction and/or addendum is made, do not remove or delete the erroneous entry, because health care colleagues may have relied on it, and deleting an erroneous entry also would alter the integrity of the medical record.⁶ When done appropriately, corrections will not be misconstrued as alterations.

Alterations are changes to a patient’s medical record after a psychiatrist receives notice of a lawsuit and “clarifies” certain points in the medical record to aid the defense against the claim.⁶ Alterations are considered deliberate misrepresentations of facts and, if discovered during litigation, can significantly impact the ability to defend against a claim.⁶ In addition, many medical liability policies exclude coverage for claims in which the medical record was altered, which might result in a psychiatrist having to pay for the judgment and defense costs out of pocket.⁶ Psychiatrists facing litigation who have a legitimate need to change an EHR entry after a claim is filed should consult with legal counsel or a risk management professional for guidance before making any changes.³ If they concur with updating the patient’s record to correct an error (including an addendum or a late entry; see below), the original entry, date, and time stamp must be accessible.³ This should also include the current date/time of the amended entry, the name of the person making the change, and the reasons for the change.³

Continue to: How to handle corrections and late entries

Sometimes situations occur that require us to make late entries, enter addendums, or add clarification notes to patient information in the EHRs. Regardless of your work environment (ie, hospital, your own practice), there should be clear procedures in place for correcting patients’ EHRs that are in accordance with applicable federal and state laws. Correcting an error in the EHR should follow the same basic principles of correcting paper records: do not obscure the original entry, make timely corrections, sign all entries, ensure the person making the change is identified, and document the reason(s) for the correction.⁷ The EHR must be able to track corrections or changes to an entry once they are entered or authenticated. Any physical copies of documentation must also have the same corrections or changes if they have been previously printed from the EHR.

You may need to make an entry that is late (out of sequence) or provides additional documentation to supplement previously written entries.⁷ A late entry should be used to record information when a pertinent entry was missed or not written in a timely manner.⁷ Label the new entry as a “late entry,” enter the current date and time (do not give the appearance that the entry was made on a previous date or at an earlier time), and identify or refer to the date and incident for which the late entry is written.⁷ If the late entry is used to document an omission, validate the source of additional information as best you can (ie, details of where you obtained the information to write the late entry).⁷ Make late entries as soon as possible after the original entry; although there is no time limit on writing a late entry, delays in corrections might diminish the credibility of the changes.

Addendums are used to provide additional information in conjunction with a previous entry.⁷ They also provide additional information to address a specific situation or incident referenced in a previous note. Addendums should not be used to document information that was forgotten or written in error.⁷ A clarification note is used to avoid incorrect interpretation of previously documented information.⁷ When writing an addendum or a clarification note, you should label it as an “addendum” or a “clarification note”; document the current date and time; state the reason for the addendum (referring back to the original entry) or clarification note (referring back to the entry being clarified); and identify any sources of information used to support an addendum or a clarification note.⁷

In 2009, the Health Information Technology for Economic and Clinical Health Act (HITECH Act), which is part of the American Recovery and Reinvestment Act, provided several billion dollars of grants and incentives to stimulate the implementation of electronic health records (EHRs) and supporting technology in the United States.¹ Since then, almost all health care organizations have employed EHRs and supporting technologies. Unfortunately, this has created new liability risks. One potential risk is that in malpractice claims, there is more discoverable evidence, including metadata, with which to prove the claims.² In this article, I explain what metadata is and how it can be used in medical malpractice cases. In addition, because we cannot change metadata, I provide guidance on making corrections in your EHR documentation to minimize liability in medical malpractice cases.

What is metadata?

Metadata—commonly described as data about data—lurk behind the words and images we can see on our computer screens. Metadata can be conceptualized as data that provides details about the information we enter into a computer system, creating a permanent electronic footprint that can be used to track our activity.^2,3 Examples of metadata include (but are not limited to) the user’s name, date and time of a record entry, changes or deletions made to the record, the date an entry was created or modified, annotations that the user added over a period of time, and any other data that the software captures without the user manually entering the information.³ Metadata is typically stored on a server or file that users cannot access, which ensures data integrity because a user cannot alter a patient’s medical record without those changes being captured.³

How metadata is used in malpractice claims

When a psychiatrist is sued for medical negligence, the integrity of the EHR is an important aspect of defending against the lawsuit. A plaintiff’s (patient’s) attorney can more readily discover changes to the patient’s medical record by requesting the metadata and having it analyzed by an information technology specialist. Because the computer system captures everything a user does, it is difficult to alter a patient’s record without being detected. Consequently, plaintiff attorneys frequently request metadata during discovery in the hopes of learning whether the defendant psychiatrist altered or attempted to hide information that was contained or missing from the original version of the medical record.³ If the medical record was revised at a time unrelated to the treatment, metadata can raise suspicion of deception, even in the absence of wrongdoing.² Alternatively, metadata can be used to validate that the EHR was changed when treatment occurred, which can bolster a defendant psychiatrist’s ability to rely on the EHR against a claim of medical negligence.²

Depending on the jurisdiction, metadata may or may not be discoverable. The Federal Rules of Civil Procedure emphasize producing documents in their original format.⁴ For federal cases, these rules suggest that the parties discuss discovery of this material when they are initially conferring; however, the rules do not specify whether a party must produce metadata, which leaves the courts to refine these rules through case law.^4,5 In one case, a federal court ruled that a party had to produce documents with metadata intact.⁵ Without an agreement between both parties to exclude metadata from produced documents, the parties must produce the metadata.⁵ State laws differ in regards to the discoverability of metadata.

Corrections vs alterations

A patient’s medical record is the best evidence of the care we provided, should that care ever be challenged in court. We can preserve the medical record’s effectiveness through appropriate changes to it. Appropriately executed corrections are a normal part of documentation, whereas alterations to the medical record can cast doubt on our credibility and lead an otherwise defensible case to require a settlement.⁶

Corrections are changes to a patient’s medical record during the normal course of treatment.⁶ These are acceptable, provided the changes are made appropriately. Health care facilities and practices have their own policies for making appropriate corrections and addendums to the medical record. Once a correction and/or addendum is made, do not remove or delete the erroneous entry, because health care colleagues may have relied on it, and deleting an erroneous entry also would alter the integrity of the medical record.⁶ When done appropriately, corrections will not be misconstrued as alterations.

Alterations are changes to a patient’s medical record after a psychiatrist receives notice of a lawsuit and “clarifies” certain points in the medical record to aid the defense against the claim.⁶ Alterations are considered deliberate misrepresentations of facts and, if discovered during litigation, can significantly impact the ability to defend against a claim.⁶ In addition, many medical liability policies exclude coverage for claims in which the medical record was altered, which might result in a psychiatrist having to pay for the judgment and defense costs out of pocket.⁶ Psychiatrists facing litigation who have a legitimate need to change an EHR entry after a claim is filed should consult with legal counsel or a risk management professional for guidance before making any changes.³ If they concur with updating the patient’s record to correct an error (including an addendum or a late entry; see below), the original entry, date, and time stamp must be accessible.³ This should also include the current date/time of the amended entry, the name of the person making the change, and the reasons for the change.³

Continue to: How to handle corrections and late entries

Sometimes situations occur that require us to make late entries, enter addendums, or add clarification notes to patient information in the EHRs. Regardless of your work environment (ie, hospital, your own practice), there should be clear procedures in place for correcting patients’ EHRs that are in accordance with applicable federal and state laws. Correcting an error in the EHR should follow the same basic principles of correcting paper records: do not obscure the original entry, make timely corrections, sign all entries, ensure the person making the change is identified, and document the reason(s) for the correction.⁷ The EHR must be able to track corrections or changes to an entry once they are entered or authenticated. Any physical copies of documentation must also have the same corrections or changes if they have been previously printed from the EHR.

You may need to make an entry that is late (out of sequence) or provides additional documentation to supplement previously written entries.⁷ A late entry should be used to record information when a pertinent entry was missed or not written in a timely manner.⁷ Label the new entry as a “late entry,” enter the current date and time (do not give the appearance that the entry was made on a previous date or at an earlier time), and identify or refer to the date and incident for which the late entry is written.⁷ If the late entry is used to document an omission, validate the source of additional information as best you can (ie, details of where you obtained the information to write the late entry).⁷ Make late entries as soon as possible after the original entry; although there is no time limit on writing a late entry, delays in corrections might diminish the credibility of the changes.

Addendums are used to provide additional information in conjunction with a previous entry.⁷ They also provide additional information to address a specific situation or incident referenced in a previous note. Addendums should not be used to document information that was forgotten or written in error.⁷ A clarification note is used to avoid incorrect interpretation of previously documented information.⁷ When writing an addendum or a clarification note, you should label it as an “addendum” or a “clarification note”; document the current date and time; state the reason for the addendum (referring back to the original entry) or clarification note (referring back to the entry being clarified); and identify any sources of information used to support an addendum or a clarification note.⁷

Nonsuicidal self-injury (NSSI) is the direct and deliberate destruction of body tissue without intent to die.¹ Cutting is the most common form of NSSI; other methods include burning, scraping/scratching skin, interfering with wound healing, hitting, biting, self-poisoning, and purposeful non-recreational risk-taking.^2,3 Although most individuals who engage in NSSI have no intention to die, suicidal ideation often precedes the initial engagement in NSSI,⁴ and a history of repeated NSSI is a risk factor for suicide attempts.⁴ In a systematic review, Cipriano et al⁵ found that NSSI is most common among adolescents and young adults, with onset most often occurring between age 12 and 14. Prevalence rates of NSSI are 7.5% to 46.5% in adolescents, 38.9% in university students, and 4% to 23% in adults.⁵

Although no medications have consistently shown efficacy for treating NSSI, research suggests cognitive-behavioral therapy and dialectical behavioral therapy may be helpful. Unfortunately, these therapies are often not available during a patient’s acute crisis.³ Because a thorough review of the treatment options for NSSI is beyond the scope of this article, here I offer tips for caring for adults who engage in NSSI. Although there are slight differences in managing NSSI in adolescents (eg, the need for parental monitoring and reducing risk of contagion), these tips also can be used with adolescents.

Explore why your patient engages in NSSI. Identifying the reasons for our patients’ NSSI makes it easier for us to empathize with them, and puts us in a better position to treat them.³ The most widely reported reasons for NSSI are to cope with distress/anguish and to exert influence on others.⁶ In a systematic review, self-reported reasons for NSSI also included punishing oneself for having positive feelings, punishing others, managing dissociation (ie, active pursuit of numbness), sensation-seeking (ie, to generate excitement or exhilaration), averting suicide (ie, warding off suicidal thoughts), maintaining or exploring boundaries, and expressing or coping with sexuality.⁶ When exploring your patient’s reasons for NSSI, determine if the behavior is based on a true suicidal desire. Because NSSI is associated with mood disorders, anxiety disorders, personality disorders, and other disorders, also assess for any underlying psychiatric conditions, and treat them accordingly because mental health treatment has been empirically proven to reduce suicide rates.^2,7

Conduct a suicide risk assessment. Regardless of your patient’s reasons for NSSI, an individualized and thorough suicide risk assessment is needed to identify modifiable, non-modifiable, and protective factors that you can consider when developing a treatment plan. Key components of such assessments include (but are not limited to) current and past urges to engage in NSSI, past NSSI and suicide attempts, access to lethal means, and ability to follow a safety plan.

Avoid exaggerating the danger and importance of NSSI. Treating a patient who engages in NSSI who is motivated by a true suicidal desire and/or has underlying psychiatric conditions may prompt you to consider hospitalization and/or prescribing psychotropic medications.³ However, because most NSSI is not due to a true suicidal desire, overreacting may unwittingly communicate to the patient that self-harm is a way to sustain someone’s attention, thus reinforcing that such behaviors can help them obtain support when distressed.³ Further, overreacting will not help patients comprehend and better cope with the reasons for their self-injurious behaviors.³

Restrict your patient’s access to lethal means. Restricting access to items such as firearms, sharp objects (eg, knives and razors), medications, implements for suffocation/hanging (eg, belts), and household poisons has been empirically proven to reduce suicide rates.⁷ Such restrictions can also potentially reduce the likelihood of NSSI. It is important to repeatedly ask your patient if they have acquired any new means, and to listen for information that indicates they possess means that they did not previously disclose. It is also important to ask if the patient has moved existing means to an area for easier access to use them.

Create a safety plan. Written safety plans can include a list of warning signs (thoughts, images, mood, situations, behaviors) that a crisis is developing, coping strategies (eg, going for a walk, exercising, engaging in a hobby, socializing with friends or family), and contact information for 24-hour crisis hotlines, emergency rooms, and mental health clinicians.⁸ The Suicide Prevention Resource Center offers a safety plan template at www.sprc.org/sites/default/files/resource-program/Brown_StanleySafetyPlanTemplate.pdf.⁸ 

Offer empathy. Individuals who engage in NSSI are making a desperate call for help that requires concerned and supportive responses.³ One such response is to provide empathy. In addition to expressing concern and compassion, empathy involves recognizing and sharing your patients’ emotions. Empathy also can help you avoid any resistance during the visit by considering what is appropriate to say to patients.

Manage countertransference. You may have negative feelings toward a patient who engages in NSSI, or may even view self-harm as a willful act designed to gain attention. However, such feelings could lead you to minimize or dismiss the importance of your patient’s behaviors, which may push them to engage in more dangerous self-harm.³ Acknowledging any feelings of derision for a patient who engages in NSSI and understanding why you have these emotions will help you better understand your patient, improve rapport, and ensure that you are not impeding the delivery of appropriate clinical care.

Nonsuicidal self-injury (NSSI) is the direct and deliberate destruction of body tissue without intent to die.¹ Cutting is the most common form of NSSI; other methods include burning, scraping/scratching skin, interfering with wound healing, hitting, biting, self-poisoning, and purposeful non-recreational risk-taking.^2,3 Although most individuals who engage in NSSI have no intention to die, suicidal ideation often precedes the initial engagement in NSSI,⁴ and a history of repeated NSSI is a risk factor for suicide attempts.⁴ In a systematic review, Cipriano et al⁵ found that NSSI is most common among adolescents and young adults, with onset most often occurring between age 12 and 14. Prevalence rates of NSSI are 7.5% to 46.5% in adolescents, 38.9% in university students, and 4% to 23% in adults.⁵

Although no medications have consistently shown efficacy for treating NSSI, research suggests cognitive-behavioral therapy and dialectical behavioral therapy may be helpful. Unfortunately, these therapies are often not available during a patient’s acute crisis.³ Because a thorough review of the treatment options for NSSI is beyond the scope of this article, here I offer tips for caring for adults who engage in NSSI. Although there are slight differences in managing NSSI in adolescents (eg, the need for parental monitoring and reducing risk of contagion), these tips also can be used with adolescents.

Explore why your patient engages in NSSI. Identifying the reasons for our patients’ NSSI makes it easier for us to empathize with them, and puts us in a better position to treat them.³ The most widely reported reasons for NSSI are to cope with distress/anguish and to exert influence on others.⁶ In a systematic review, self-reported reasons for NSSI also included punishing oneself for having positive feelings, punishing others, managing dissociation (ie, active pursuit of numbness), sensation-seeking (ie, to generate excitement or exhilaration), averting suicide (ie, warding off suicidal thoughts), maintaining or exploring boundaries, and expressing or coping with sexuality.⁶ When exploring your patient’s reasons for NSSI, determine if the behavior is based on a true suicidal desire. Because NSSI is associated with mood disorders, anxiety disorders, personality disorders, and other disorders, also assess for any underlying psychiatric conditions, and treat them accordingly because mental health treatment has been empirically proven to reduce suicide rates.^2,7

Conduct a suicide risk assessment. Regardless of your patient’s reasons for NSSI, an individualized and thorough suicide risk assessment is needed to identify modifiable, non-modifiable, and protective factors that you can consider when developing a treatment plan. Key components of such assessments include (but are not limited to) current and past urges to engage in NSSI, past NSSI and suicide attempts, access to lethal means, and ability to follow a safety plan.

Avoid exaggerating the danger and importance of NSSI. Treating a patient who engages in NSSI who is motivated by a true suicidal desire and/or has underlying psychiatric conditions may prompt you to consider hospitalization and/or prescribing psychotropic medications.³ However, because most NSSI is not due to a true suicidal desire, overreacting may unwittingly communicate to the patient that self-harm is a way to sustain someone’s attention, thus reinforcing that such behaviors can help them obtain support when distressed.³ Further, overreacting will not help patients comprehend and better cope with the reasons for their self-injurious behaviors.³

Restrict your patient’s access to lethal means. Restricting access to items such as firearms, sharp objects (eg, knives and razors), medications, implements for suffocation/hanging (eg, belts), and household poisons has been empirically proven to reduce suicide rates.⁷ Such restrictions can also potentially reduce the likelihood of NSSI. It is important to repeatedly ask your patient if they have acquired any new means, and to listen for information that indicates they possess means that they did not previously disclose. It is also important to ask if the patient has moved existing means to an area for easier access to use them.

Create a safety plan. Written safety plans can include a list of warning signs (thoughts, images, mood, situations, behaviors) that a crisis is developing, coping strategies (eg, going for a walk, exercising, engaging in a hobby, socializing with friends or family), and contact information for 24-hour crisis hotlines, emergency rooms, and mental health clinicians.⁸ The Suicide Prevention Resource Center offers a safety plan template at www.sprc.org/sites/default/files/resource-program/Brown_StanleySafetyPlanTemplate.pdf.⁸ 

Offer empathy. Individuals who engage in NSSI are making a desperate call for help that requires concerned and supportive responses.³ One such response is to provide empathy. In addition to expressing concern and compassion, empathy involves recognizing and sharing your patients’ emotions. Empathy also can help you avoid any resistance during the visit by considering what is appropriate to say to patients.

Manage countertransference. You may have negative feelings toward a patient who engages in NSSI, or may even view self-harm as a willful act designed to gain attention. However, such feelings could lead you to minimize or dismiss the importance of your patient’s behaviors, which may push them to engage in more dangerous self-harm.³ Acknowledging any feelings of derision for a patient who engages in NSSI and understanding why you have these emotions will help you better understand your patient, improve rapport, and ensure that you are not impeding the delivery of appropriate clinical care.

Nonsuicidal self-injury (NSSI) is the direct and deliberate destruction of body tissue without intent to die.¹ Cutting is the most common form of NSSI; other methods include burning, scraping/scratching skin, interfering with wound healing, hitting, biting, self-poisoning, and purposeful non-recreational risk-taking.^2,3 Although most individuals who engage in NSSI have no intention to die, suicidal ideation often precedes the initial engagement in NSSI,⁴ and a history of repeated NSSI is a risk factor for suicide attempts.⁴ In a systematic review, Cipriano et al⁵ found that NSSI is most common among adolescents and young adults, with onset most often occurring between age 12 and 14. Prevalence rates of NSSI are 7.5% to 46.5% in adolescents, 38.9% in university students, and 4% to 23% in adults.⁵

Although no medications have consistently shown efficacy for treating NSSI, research suggests cognitive-behavioral therapy and dialectical behavioral therapy may be helpful. Unfortunately, these therapies are often not available during a patient’s acute crisis.³ Because a thorough review of the treatment options for NSSI is beyond the scope of this article, here I offer tips for caring for adults who engage in NSSI. Although there are slight differences in managing NSSI in adolescents (eg, the need for parental monitoring and reducing risk of contagion), these tips also can be used with adolescents.

Explore why your patient engages in NSSI. Identifying the reasons for our patients’ NSSI makes it easier for us to empathize with them, and puts us in a better position to treat them.³ The most widely reported reasons for NSSI are to cope with distress/anguish and to exert influence on others.⁶ In a systematic review, self-reported reasons for NSSI also included punishing oneself for having positive feelings, punishing others, managing dissociation (ie, active pursuit of numbness), sensation-seeking (ie, to generate excitement or exhilaration), averting suicide (ie, warding off suicidal thoughts), maintaining or exploring boundaries, and expressing or coping with sexuality.⁶ When exploring your patient’s reasons for NSSI, determine if the behavior is based on a true suicidal desire. Because NSSI is associated with mood disorders, anxiety disorders, personality disorders, and other disorders, also assess for any underlying psychiatric conditions, and treat them accordingly because mental health treatment has been empirically proven to reduce suicide rates.^2,7

Conduct a suicide risk assessment. Regardless of your patient’s reasons for NSSI, an individualized and thorough suicide risk assessment is needed to identify modifiable, non-modifiable, and protective factors that you can consider when developing a treatment plan. Key components of such assessments include (but are not limited to) current and past urges to engage in NSSI, past NSSI and suicide attempts, access to lethal means, and ability to follow a safety plan.

Avoid exaggerating the danger and importance of NSSI. Treating a patient who engages in NSSI who is motivated by a true suicidal desire and/or has underlying psychiatric conditions may prompt you to consider hospitalization and/or prescribing psychotropic medications.³ However, because most NSSI is not due to a true suicidal desire, overreacting may unwittingly communicate to the patient that self-harm is a way to sustain someone’s attention, thus reinforcing that such behaviors can help them obtain support when distressed.³ Further, overreacting will not help patients comprehend and better cope with the reasons for their self-injurious behaviors.³

Restrict your patient’s access to lethal means. Restricting access to items such as firearms, sharp objects (eg, knives and razors), medications, implements for suffocation/hanging (eg, belts), and household poisons has been empirically proven to reduce suicide rates.⁷ Such restrictions can also potentially reduce the likelihood of NSSI. It is important to repeatedly ask your patient if they have acquired any new means, and to listen for information that indicates they possess means that they did not previously disclose. It is also important to ask if the patient has moved existing means to an area for easier access to use them.

Create a safety plan. Written safety plans can include a list of warning signs (thoughts, images, mood, situations, behaviors) that a crisis is developing, coping strategies (eg, going for a walk, exercising, engaging in a hobby, socializing with friends or family), and contact information for 24-hour crisis hotlines, emergency rooms, and mental health clinicians.⁸ The Suicide Prevention Resource Center offers a safety plan template at www.sprc.org/sites/default/files/resource-program/Brown_StanleySafetyPlanTemplate.pdf.⁸ 

Offer empathy. Individuals who engage in NSSI are making a desperate call for help that requires concerned and supportive responses.³ One such response is to provide empathy. In addition to expressing concern and compassion, empathy involves recognizing and sharing your patients’ emotions. Empathy also can help you avoid any resistance during the visit by considering what is appropriate to say to patients.

Manage countertransference. You may have negative feelings toward a patient who engages in NSSI, or may even view self-harm as a willful act designed to gain attention. However, such feelings could lead you to minimize or dismiss the importance of your patient’s behaviors, which may push them to engage in more dangerous self-harm.³ Acknowledging any feelings of derision for a patient who engages in NSSI and understanding why you have these emotions will help you better understand your patient, improve rapport, and ensure that you are not impeding the delivery of appropriate clinical care.

Online reviews have become a popular method for patients to rate their psychiatrists. Patients’ online reviews can help other patients make more informed decisions about pursuing treatment, offer us valuable feedback on our performance, and help improve standards of care.¹ However, during the course of our careers, we may receive negative online reviews. These reviews may range from mild dissatisfaction to abusive comments, and they could have adverse personal and professional consequences.² For example, online discussions might make current patients question your practices or consider ending their treatment with you.² Also, potential patients might decide to not inquire about your services.² Here I offer suggestions for approaching negative online reviews, and point out some potential pitfalls of responding to them.

Remain professional. You might become upset or frazzled after reading online criticisms about your performance, particularly if the information is erroneous or deceptive. As much as you would like to immediately respond, a public tit-for-tat could prolong or fuel a conflict, or make you come across as angry.²

There may be occasions, however, when it would be appropriate to respond. If you choose to respond to a negative online review, you need to have a methodical plan. Avoid reacting in a knee-jerk manner because this is usually unproductive. In addition, ensure that your response is professional and polite, because an intemperate response could undermine the public’s confidence in our profession.²

Maintain patient confidentiality. Although patients are free to post anything they desire, psychiatrists must maintain confidentiality. The Health Insurance Portability and Accountability Act (HIPAA) applies to online reviews, which prevents us from disclosing information about patients without their permission, including even acknowledging that someone is our patient.³ Your patients’ disclosures are not permission to disclose their health information. Potential patients might avoid us or existing patients may end their treatment with us if they believe their personal information could be disclosed online without their consent. To avoid such concerns, reply to online reviews with generic comments about your practice’s general policies without violating confidentiality. Also, to avoid violating HIPAA rules, you may want to contact your malpractice carrier or your facility’s legal department before replying.¹

Invite patients to discuss their grievances. If your patients identify themselves in a review, or if you are able to identify them, consider inviting them to discuss their concerns with you (over the phone, face-to-face, or via video conferencing). During such conversations, thank the patient for their review, and do not ask them to delete it.² Focus on addressing their concerns and resolving any problems they experienced during treatment; doing so can help improve your practice. This approach also might lead a patient to remove their negative review or to write a review that lets other patients know that you are listening to them.

Even if you choose not to invite your patients to air their concerns, do not entirely dismiss negative reviews. Instead, try to step back from your emotions and take an objective look at such reviews so you can determine what steps to take to improve your practices. Improving your communication with patients could decrease the likelihood that they will write negative reviews in the first place.

Take action on fake reviews. If a negative review is fake (not written by one of your patients) or blatantly untrue, contact the web site administrator and provide evidence to support having the review deleted, especially if it violates the site’s terms of service.¹ However, this approach may not be fruitful. Web sites can be manipulated, and many do not require users to authenticate that they are actual patients.¹ Although most web sites would not want their reputation damaged by users posting fake reviews, more dramatic reviews could help lead to increased traffic, which lowers an administrator’s incentive to remove negative reviews.¹

Continue to: Consider legal repercussions

Consider legal repercussions. Stay up-to-date with online reviews about you by conducting internet searches once every 3 months.¹ Consider notifying your malpractice carrier or facility’s legal department if a review suggests a patient or family might initiate legal action against you or the facility.¹ You might consider pursuing legal action if an online review is defamatory, but such claims often are difficult to prove in court.¹ Even if you win, such a case could later be repeatedly mentioned in articles and journals, thus creating a permanent record of the negative review in the literature.¹

Enlist help with your online image. If financially feasible, hire a professional service to help improve your online image or assist in responding to negative reviews.¹ Build your profile on review web sites to help frame your online image, and include information that mentions the pertinent steps you are taking to address any legitimate concerns your patients raise in their reviews. Encourage your patients to post reviews because that could produce a more equitable sample and paint a more accurate picture of your practice.

Lobby professional medical organizations to take action to protect psychiatrists from negative online reviews by creating legislation that holds web sites accountable for their content.¹

Stay positive. Unfounded or not, negative online reviews are an inevitable part of a psychiatrist’s professional life.² One negative review (or even several) is not going to destroy your reputation or career. Do not feel alone if you receive a negative review. Seek advice from colleagues who have received negative reviews; in addition to offering advice, they can also provide a listening ear.²

Online reviews have become a popular method for patients to rate their psychiatrists. Patients’ online reviews can help other patients make more informed decisions about pursuing treatment, offer us valuable feedback on our performance, and help improve standards of care.¹ However, during the course of our careers, we may receive negative online reviews. These reviews may range from mild dissatisfaction to abusive comments, and they could have adverse personal and professional consequences.² For example, online discussions might make current patients question your practices or consider ending their treatment with you.² Also, potential patients might decide to not inquire about your services.² Here I offer suggestions for approaching negative online reviews, and point out some potential pitfalls of responding to them.

Remain professional. You might become upset or frazzled after reading online criticisms about your performance, particularly if the information is erroneous or deceptive. As much as you would like to immediately respond, a public tit-for-tat could prolong or fuel a conflict, or make you come across as angry.²

There may be occasions, however, when it would be appropriate to respond. If you choose to respond to a negative online review, you need to have a methodical plan. Avoid reacting in a knee-jerk manner because this is usually unproductive. In addition, ensure that your response is professional and polite, because an intemperate response could undermine the public’s confidence in our profession.²

Maintain patient confidentiality. Although patients are free to post anything they desire, psychiatrists must maintain confidentiality. The Health Insurance Portability and Accountability Act (HIPAA) applies to online reviews, which prevents us from disclosing information about patients without their permission, including even acknowledging that someone is our patient.³ Your patients’ disclosures are not permission to disclose their health information. Potential patients might avoid us or existing patients may end their treatment with us if they believe their personal information could be disclosed online without their consent. To avoid such concerns, reply to online reviews with generic comments about your practice’s general policies without violating confidentiality. Also, to avoid violating HIPAA rules, you may want to contact your malpractice carrier or your facility’s legal department before replying.¹

Invite patients to discuss their grievances. If your patients identify themselves in a review, or if you are able to identify them, consider inviting them to discuss their concerns with you (over the phone, face-to-face, or via video conferencing). During such conversations, thank the patient for their review, and do not ask them to delete it.² Focus on addressing their concerns and resolving any problems they experienced during treatment; doing so can help improve your practice. This approach also might lead a patient to remove their negative review or to write a review that lets other patients know that you are listening to them.

Even if you choose not to invite your patients to air their concerns, do not entirely dismiss negative reviews. Instead, try to step back from your emotions and take an objective look at such reviews so you can determine what steps to take to improve your practices. Improving your communication with patients could decrease the likelihood that they will write negative reviews in the first place.

Take action on fake reviews. If a negative review is fake (not written by one of your patients) or blatantly untrue, contact the web site administrator and provide evidence to support having the review deleted, especially if it violates the site’s terms of service.¹ However, this approach may not be fruitful. Web sites can be manipulated, and many do not require users to authenticate that they are actual patients.¹ Although most web sites would not want their reputation damaged by users posting fake reviews, more dramatic reviews could help lead to increased traffic, which lowers an administrator’s incentive to remove negative reviews.¹

Continue to: Consider legal repercussions

Consider legal repercussions. Stay up-to-date with online reviews about you by conducting internet searches once every 3 months.¹ Consider notifying your malpractice carrier or facility’s legal department if a review suggests a patient or family might initiate legal action against you or the facility.¹ You might consider pursuing legal action if an online review is defamatory, but such claims often are difficult to prove in court.¹ Even if you win, such a case could later be repeatedly mentioned in articles and journals, thus creating a permanent record of the negative review in the literature.¹

Enlist help with your online image. If financially feasible, hire a professional service to help improve your online image or assist in responding to negative reviews.¹ Build your profile on review web sites to help frame your online image, and include information that mentions the pertinent steps you are taking to address any legitimate concerns your patients raise in their reviews. Encourage your patients to post reviews because that could produce a more equitable sample and paint a more accurate picture of your practice.

Lobby professional medical organizations to take action to protect psychiatrists from negative online reviews by creating legislation that holds web sites accountable for their content.¹

Stay positive. Unfounded or not, negative online reviews are an inevitable part of a psychiatrist’s professional life.² One negative review (or even several) is not going to destroy your reputation or career. Do not feel alone if you receive a negative review. Seek advice from colleagues who have received negative reviews; in addition to offering advice, they can also provide a listening ear.²

Online reviews have become a popular method for patients to rate their psychiatrists. Patients’ online reviews can help other patients make more informed decisions about pursuing treatment, offer us valuable feedback on our performance, and help improve standards of care.¹ However, during the course of our careers, we may receive negative online reviews. These reviews may range from mild dissatisfaction to abusive comments, and they could have adverse personal and professional consequences.² For example, online discussions might make current patients question your practices or consider ending their treatment with you.² Also, potential patients might decide to not inquire about your services.² Here I offer suggestions for approaching negative online reviews, and point out some potential pitfalls of responding to them.

Remain professional. You might become upset or frazzled after reading online criticisms about your performance, particularly if the information is erroneous or deceptive. As much as you would like to immediately respond, a public tit-for-tat could prolong or fuel a conflict, or make you come across as angry.²

There may be occasions, however, when it would be appropriate to respond. If you choose to respond to a negative online review, you need to have a methodical plan. Avoid reacting in a knee-jerk manner because this is usually unproductive. In addition, ensure that your response is professional and polite, because an intemperate response could undermine the public’s confidence in our profession.²

Maintain patient confidentiality. Although patients are free to post anything they desire, psychiatrists must maintain confidentiality. The Health Insurance Portability and Accountability Act (HIPAA) applies to online reviews, which prevents us from disclosing information about patients without their permission, including even acknowledging that someone is our patient.³ Your patients’ disclosures are not permission to disclose their health information. Potential patients might avoid us or existing patients may end their treatment with us if they believe their personal information could be disclosed online without their consent. To avoid such concerns, reply to online reviews with generic comments about your practice’s general policies without violating confidentiality. Also, to avoid violating HIPAA rules, you may want to contact your malpractice carrier or your facility’s legal department before replying.¹

Invite patients to discuss their grievances. If your patients identify themselves in a review, or if you are able to identify them, consider inviting them to discuss their concerns with you (over the phone, face-to-face, or via video conferencing). During such conversations, thank the patient for their review, and do not ask them to delete it.² Focus on addressing their concerns and resolving any problems they experienced during treatment; doing so can help improve your practice. This approach also might lead a patient to remove their negative review or to write a review that lets other patients know that you are listening to them.

Even if you choose not to invite your patients to air their concerns, do not entirely dismiss negative reviews. Instead, try to step back from your emotions and take an objective look at such reviews so you can determine what steps to take to improve your practices. Improving your communication with patients could decrease the likelihood that they will write negative reviews in the first place.

Take action on fake reviews. If a negative review is fake (not written by one of your patients) or blatantly untrue, contact the web site administrator and provide evidence to support having the review deleted, especially if it violates the site’s terms of service.¹ However, this approach may not be fruitful. Web sites can be manipulated, and many do not require users to authenticate that they are actual patients.¹ Although most web sites would not want their reputation damaged by users posting fake reviews, more dramatic reviews could help lead to increased traffic, which lowers an administrator’s incentive to remove negative reviews.¹

Continue to: Consider legal repercussions

Consider legal repercussions. Stay up-to-date with online reviews about you by conducting internet searches once every 3 months.¹ Consider notifying your malpractice carrier or facility’s legal department if a review suggests a patient or family might initiate legal action against you or the facility.¹ You might consider pursuing legal action if an online review is defamatory, but such claims often are difficult to prove in court.¹ Even if you win, such a case could later be repeatedly mentioned in articles and journals, thus creating a permanent record of the negative review in the literature.¹

Enlist help with your online image. If financially feasible, hire a professional service to help improve your online image or assist in responding to negative reviews.¹ Build your profile on review web sites to help frame your online image, and include information that mentions the pertinent steps you are taking to address any legitimate concerns your patients raise in their reviews. Encourage your patients to post reviews because that could produce a more equitable sample and paint a more accurate picture of your practice.

Lobby professional medical organizations to take action to protect psychiatrists from negative online reviews by creating legislation that holds web sites accountable for their content.¹

Stay positive. Unfounded or not, negative online reviews are an inevitable part of a psychiatrist’s professional life.² One negative review (or even several) is not going to destroy your reputation or career. Do not feel alone if you receive a negative review. Seek advice from colleagues who have received negative reviews; in addition to offering advice, they can also provide a listening ear.²

Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.¹ Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.²

In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).^1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.¹

With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.

FDA-approved treatments

To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):

Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.^1,4 There are no other FDA-approved medications that contain CBD.

Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.¹

Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.¹

Continue to: Questionable claims about CBD

Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.¹ The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.⁵

Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.¹ Cannabidiol products cannot be sold as dietary supplements.¹ In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.¹ Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.¹ Also, CBD products can affect the therapeutic effectiveness of prescription medications.

Discuss CBD with your patients

Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.

Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.¹ Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.²

In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).^1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.¹

With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.

FDA-approved treatments

To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):

Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.^1,4 There are no other FDA-approved medications that contain CBD.

Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.¹

Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.¹

Continue to: Questionable claims about CBD

Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.¹ The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.⁵

Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.¹ Cannabidiol products cannot be sold as dietary supplements.¹ In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.¹ Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.¹ Also, CBD products can affect the therapeutic effectiveness of prescription medications.

Discuss CBD with your patients

Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.

Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.¹ Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.²

In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).^1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.¹

With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.

FDA-approved treatments

To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):

Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.^1,4 There are no other FDA-approved medications that contain CBD.

Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.¹

Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.¹

Continue to: Questionable claims about CBD

Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.¹ The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.⁵

Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.¹ Cannabidiol products cannot be sold as dietary supplements.¹ In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.¹ Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.¹ Also, CBD products can affect the therapeutic effectiveness of prescription medications.

Discuss CBD with your patients

Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.

The FDA defines “off-label” prescribing as prescribing an FDA-approved medication for an unapproved use, such as for an unapproved clinical indication, for a higher-than-approved dose, or for a patient who is not part of the FDA-approved population (eg, children or geriatric patients).¹ Off-label prescribing is common in psychiatry; approximately 13% of psychiatry patients are prescribed off-label psychotropic medications.² The American Psychiatric Association strongly supports “the autonomous clinical decision-making authority of a physician” and “a physician’s lawful use of an FDA-approved drug product or medical device for an off-label indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment.”³ Because many psychiatric diagnoses have no FDA-approved medications, off-label prescribing often may be a psychiatrist’s only pharmacologic option.

Unfortunately, off-label prescribing can increase a psychiatrist’s risk for liability when treatment falls short of patients’ expectations, or when patients allege that they were injured by the use of an off-label medication. Off-label prescribing does not automatically lead to losing a malpractice suit because the FDA states that physicians can prescribe approved medications for any scientifically supported use, including off-label.¹ Medical malpractice lawsuits alleging negligence in prescribing practices, such as off-label prescribing, typically include allegations against the psychiatrist for failure to⁴:

• adequately assess the patient
• consult the patient’s medical records
• obtain informed consent from the patient
• appropriately prescribe a medication for the clinical indication, dosage, patient’s age, etc.
• monitor for adverse effects and therapeutic effectiveness.

Steps to minimize your risk

When prescribing a medication off-label, the following approaches can help reduce your liability risk:

Conduct a comprehensive clinical assess­ment. This should include requesting and reviewing your patient’s medical records.

Explain your motivation. Explain to your patient how prescribing an off-label medication can directly benefit him/her. Make it clear that you are not conducting experimental research by prescribing off-label because some patients might perceive this as a covert form of research.

Know the medications you prescribe. Although this sounds obvious, psychiatrists should thoroughly understand how each medication they prescribe is likely to clinically affect their patient. This information is available from many sources, including the FDA’s medication information sheets and the manufacturer’s medication package inserts. If possible, make sure that your off-label prescribing is supported by reputable, peer-reviewed literature.

Obtain informed consent. Tell your patient that the medication you are recommending is being prescribed off-label. Discuss the medication’s risks, benefits, adverse effects, associated “black-box” warnings, off-label uses, and alternatives to the off-label medication.⁴ Allow time for the patient to ask questions about these treatments.

Continue to: Document all steps

Document all steps. There is an adage in medicine that “If it’s not written, it wasn’t done.” To help reduce your liability risk when prescribing off-label, be sure to document the following⁴:

• your clinical assessment
• information you gleaned from the patient’s medical records
• your review of information regarding both therapeutic and adverse effects of the medication you want to prescribe
• your discussion of informed consent, including documentation that the patient is aware that the medication is being prescribed off-label
• your clinical rationale for why the off-label medication is in the patient’s best interest.

Also, document the steps you take to monitor for adverse events and therapeutic effectiveness.⁴ Overall, the goal of documentation should be to support the adequate continuing care of our patients.

The FDA defines “off-label” prescribing as prescribing an FDA-approved medication for an unapproved use, such as for an unapproved clinical indication, for a higher-than-approved dose, or for a patient who is not part of the FDA-approved population (eg, children or geriatric patients).¹ Off-label prescribing is common in psychiatry; approximately 13% of psychiatry patients are prescribed off-label psychotropic medications.² The American Psychiatric Association strongly supports “the autonomous clinical decision-making authority of a physician” and “a physician’s lawful use of an FDA-approved drug product or medical device for an off-label indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment.”³ Because many psychiatric diagnoses have no FDA-approved medications, off-label prescribing often may be a psychiatrist’s only pharmacologic option.

Unfortunately, off-label prescribing can increase a psychiatrist’s risk for liability when treatment falls short of patients’ expectations, or when patients allege that they were injured by the use of an off-label medication. Off-label prescribing does not automatically lead to losing a malpractice suit because the FDA states that physicians can prescribe approved medications for any scientifically supported use, including off-label.¹ Medical malpractice lawsuits alleging negligence in prescribing practices, such as off-label prescribing, typically include allegations against the psychiatrist for failure to⁴:

• adequately assess the patient
• consult the patient’s medical records
• obtain informed consent from the patient
• appropriately prescribe a medication for the clinical indication, dosage, patient’s age, etc.
• monitor for adverse effects and therapeutic effectiveness.

Steps to minimize your risk

When prescribing a medication off-label, the following approaches can help reduce your liability risk:

Conduct a comprehensive clinical assess­ment. This should include requesting and reviewing your patient’s medical records.

Explain your motivation. Explain to your patient how prescribing an off-label medication can directly benefit him/her. Make it clear that you are not conducting experimental research by prescribing off-label because some patients might perceive this as a covert form of research.

Know the medications you prescribe. Although this sounds obvious, psychiatrists should thoroughly understand how each medication they prescribe is likely to clinically affect their patient. This information is available from many sources, including the FDA’s medication information sheets and the manufacturer’s medication package inserts. If possible, make sure that your off-label prescribing is supported by reputable, peer-reviewed literature.

Obtain informed consent. Tell your patient that the medication you are recommending is being prescribed off-label. Discuss the medication’s risks, benefits, adverse effects, associated “black-box” warnings, off-label uses, and alternatives to the off-label medication.⁴ Allow time for the patient to ask questions about these treatments.

Continue to: Document all steps

Document all steps. There is an adage in medicine that “If it’s not written, it wasn’t done.” To help reduce your liability risk when prescribing off-label, be sure to document the following⁴:

• your clinical assessment
• information you gleaned from the patient’s medical records
• your review of information regarding both therapeutic and adverse effects of the medication you want to prescribe
• your discussion of informed consent, including documentation that the patient is aware that the medication is being prescribed off-label
• your clinical rationale for why the off-label medication is in the patient’s best interest.

Also, document the steps you take to monitor for adverse events and therapeutic effectiveness.⁴ Overall, the goal of documentation should be to support the adequate continuing care of our patients.

The FDA defines “off-label” prescribing as prescribing an FDA-approved medication for an unapproved use, such as for an unapproved clinical indication, for a higher-than-approved dose, or for a patient who is not part of the FDA-approved population (eg, children or geriatric patients).¹ Off-label prescribing is common in psychiatry; approximately 13% of psychiatry patients are prescribed off-label psychotropic medications.² The American Psychiatric Association strongly supports “the autonomous clinical decision-making authority of a physician” and “a physician’s lawful use of an FDA-approved drug product or medical device for an off-label indication when such use is based upon sound scientific evidence in conjunction with sound medical judgment.”³ Because many psychiatric diagnoses have no FDA-approved medications, off-label prescribing often may be a psychiatrist’s only pharmacologic option.

Unfortunately, off-label prescribing can increase a psychiatrist’s risk for liability when treatment falls short of patients’ expectations, or when patients allege that they were injured by the use of an off-label medication. Off-label prescribing does not automatically lead to losing a malpractice suit because the FDA states that physicians can prescribe approved medications for any scientifically supported use, including off-label.¹ Medical malpractice lawsuits alleging negligence in prescribing practices, such as off-label prescribing, typically include allegations against the psychiatrist for failure to⁴:

• adequately assess the patient
• consult the patient’s medical records
• obtain informed consent from the patient
• appropriately prescribe a medication for the clinical indication, dosage, patient’s age, etc.
• monitor for adverse effects and therapeutic effectiveness.

Steps to minimize your risk

When prescribing a medication off-label, the following approaches can help reduce your liability risk:

Conduct a comprehensive clinical assess­ment. This should include requesting and reviewing your patient’s medical records.

Explain your motivation. Explain to your patient how prescribing an off-label medication can directly benefit him/her. Make it clear that you are not conducting experimental research by prescribing off-label because some patients might perceive this as a covert form of research.

Know the medications you prescribe. Although this sounds obvious, psychiatrists should thoroughly understand how each medication they prescribe is likely to clinically affect their patient. This information is available from many sources, including the FDA’s medication information sheets and the manufacturer’s medication package inserts. If possible, make sure that your off-label prescribing is supported by reputable, peer-reviewed literature.

Obtain informed consent. Tell your patient that the medication you are recommending is being prescribed off-label. Discuss the medication’s risks, benefits, adverse effects, associated “black-box” warnings, off-label uses, and alternatives to the off-label medication.⁴ Allow time for the patient to ask questions about these treatments.

Continue to: Document all steps

Document all steps. There is an adage in medicine that “If it’s not written, it wasn’t done.” To help reduce your liability risk when prescribing off-label, be sure to document the following⁴:

• your clinical assessment
• information you gleaned from the patient’s medical records
• your review of information regarding both therapeutic and adverse effects of the medication you want to prescribe
• your discussion of informed consent, including documentation that the patient is aware that the medication is being prescribed off-label
• your clinical rationale for why the off-label medication is in the patient’s best interest.

Also, document the steps you take to monitor for adverse events and therapeutic effectiveness.⁴ Overall, the goal of documentation should be to support the adequate continuing care of our patients.

As psychiatrists, we are increasingly using digital technology, such as e-mail, video conferencing, social media, and text messaging, to communicate with and even treat our patients.¹ The benefits of using digital technology for treating patients include, but are not limited to, enhancing access to psychiatric services that are unavailable due to a patient’s geographical location and/or physical disability; providing more cost‐effective delivery of services; and creating more ways for patients to communicate with their physicians.¹ While there are benefits to using digital technology, there are also possible repercussions, such as breaches of confidentiality or boundary violations.² Although there is no evidence-based guidance about how to best use digital technology in patient care,³ the following approaches can help you protect your patients and minimize your liability.

Assess competence. Determine how familiar and comfortable both you and your patient are with the specific software and/or devices you intend to use. Confirm that your patient can access the technology, and inform them of the benefits and risks of using digital technology in their care.¹

Create a written policy about your use of digital technology, and review it with all patients to explain how it will be used in their treatment.¹ This policy should include a back-up plan in the event of technology failures.¹ It should clearly explain that the information gathered with this technology can become part of the patient’s medical record. It should also prohibit patients from using their devices to record other patients in the waiting room or other areas. Such a policy could enhance the protection of private information and help maintain clear boundaries.¹ Review and update your policy as often as needed.

Obtain your patients’ written consent to use digital technology. If you want to post information about your patients on social media, obtain their written consent to do so, and mutually agree as to what information would be posted. This should not include their identity or confidential information.¹

Do not accept friend requests or contact requests from current or former patients on any social networking platform. Do not follow your patients’ blogs, Twitter accounts, or any other accounts. Be aware that if you and your patients share the same “friend” network on social media, this may create boundary confusion, inappropriate dual relationships, and potential conflicts of interest.¹ Keep personal and professional accounts separate to maintain appropriate boundaries and minimize compromising patient confidentiality. Do not post private information on professional practice accounts, and do not link/sync your personal accounts with professional accounts.

Do not store patient information on your personal electronic devices because these devices could be lost or hacked. Avoid contacting your patients via non-secured platforms because doing so could compromise patient confidentiality. Use encrypted software and firewalls for communicating with your patients and storing their information.¹ Also, periodically assess your confidentiality policies and procedures to ensure compliance with appropriate statutes and laws.¹

As psychiatrists, we are increasingly using digital technology, such as e-mail, video conferencing, social media, and text messaging, to communicate with and even treat our patients.¹ The benefits of using digital technology for treating patients include, but are not limited to, enhancing access to psychiatric services that are unavailable due to a patient’s geographical location and/or physical disability; providing more cost‐effective delivery of services; and creating more ways for patients to communicate with their physicians.¹ While there are benefits to using digital technology, there are also possible repercussions, such as breaches of confidentiality or boundary violations.² Although there is no evidence-based guidance about how to best use digital technology in patient care,³ the following approaches can help you protect your patients and minimize your liability.

Assess competence. Determine how familiar and comfortable both you and your patient are with the specific software and/or devices you intend to use. Confirm that your patient can access the technology, and inform them of the benefits and risks of using digital technology in their care.¹

Create a written policy about your use of digital technology, and review it with all patients to explain how it will be used in their treatment.¹ This policy should include a back-up plan in the event of technology failures.¹ It should clearly explain that the information gathered with this technology can become part of the patient’s medical record. It should also prohibit patients from using their devices to record other patients in the waiting room or other areas. Such a policy could enhance the protection of private information and help maintain clear boundaries.¹ Review and update your policy as often as needed.

Obtain your patients’ written consent to use digital technology. If you want to post information about your patients on social media, obtain their written consent to do so, and mutually agree as to what information would be posted. This should not include their identity or confidential information.¹

Do not accept friend requests or contact requests from current or former patients on any social networking platform. Do not follow your patients’ blogs, Twitter accounts, or any other accounts. Be aware that if you and your patients share the same “friend” network on social media, this may create boundary confusion, inappropriate dual relationships, and potential conflicts of interest.¹ Keep personal and professional accounts separate to maintain appropriate boundaries and minimize compromising patient confidentiality. Do not post private information on professional practice accounts, and do not link/sync your personal accounts with professional accounts.

Do not store patient information on your personal electronic devices because these devices could be lost or hacked. Avoid contacting your patients via non-secured platforms because doing so could compromise patient confidentiality. Use encrypted software and firewalls for communicating with your patients and storing their information.¹ Also, periodically assess your confidentiality policies and procedures to ensure compliance with appropriate statutes and laws.¹

As psychiatrists, we are increasingly using digital technology, such as e-mail, video conferencing, social media, and text messaging, to communicate with and even treat our patients.¹ The benefits of using digital technology for treating patients include, but are not limited to, enhancing access to psychiatric services that are unavailable due to a patient’s geographical location and/or physical disability; providing more cost‐effective delivery of services; and creating more ways for patients to communicate with their physicians.¹ While there are benefits to using digital technology, there are also possible repercussions, such as breaches of confidentiality or boundary violations.² Although there is no evidence-based guidance about how to best use digital technology in patient care,³ the following approaches can help you protect your patients and minimize your liability.

Assess competence. Determine how familiar and comfortable both you and your patient are with the specific software and/or devices you intend to use. Confirm that your patient can access the technology, and inform them of the benefits and risks of using digital technology in their care.¹

Create a written policy about your use of digital technology, and review it with all patients to explain how it will be used in their treatment.¹ This policy should include a back-up plan in the event of technology failures.¹ It should clearly explain that the information gathered with this technology can become part of the patient’s medical record. It should also prohibit patients from using their devices to record other patients in the waiting room or other areas. Such a policy could enhance the protection of private information and help maintain clear boundaries.¹ Review and update your policy as often as needed.

Obtain your patients’ written consent to use digital technology. If you want to post information about your patients on social media, obtain their written consent to do so, and mutually agree as to what information would be posted. This should not include their identity or confidential information.¹

Do not accept friend requests or contact requests from current or former patients on any social networking platform. Do not follow your patients’ blogs, Twitter accounts, or any other accounts. Be aware that if you and your patients share the same “friend” network on social media, this may create boundary confusion, inappropriate dual relationships, and potential conflicts of interest.¹ Keep personal and professional accounts separate to maintain appropriate boundaries and minimize compromising patient confidentiality. Do not post private information on professional practice accounts, and do not link/sync your personal accounts with professional accounts.

Do not store patient information on your personal electronic devices because these devices could be lost or hacked. Avoid contacting your patients via non-secured platforms because doing so could compromise patient confidentiality. Use encrypted software and firewalls for communicating with your patients and storing their information.¹ Also, periodically assess your confidentiality policies and procedures to ensure compliance with appropriate statutes and laws.¹