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Nerve Transplantations and Transfers Can Restore Function
Although nerve transplantations are rarely performed, they can provide an alternative to amputation, and some surgeons say they should be considered for seriously injured patients.
Surgeons interviewed for this article identified a total of nine neurosurgeons and plastic surgeons, including themselves, who have transplanted nerves from living donors for more than 10 years.
The surgeons believe that thousands of patients—including soldiers returning from Iraq—could benefit from transplantations and similar procedures. Soldiers who suffer blunt injuries to an isolated spot of nerve would be especially good candidates, said Dr. Andrew Elkwood in an interview.
Dr. Susan Mackinnon, a plastic surgeon at Washington University in St. Louis, performed the first nerve transplantation from a live donor in 1989 in Canada. Transplantation is used as a last resort if patients do not have enough of their own nerve tissue for a graft, she said.
Grafts of patients' own nerve tissues have been around for years, said Dr. Elkwood, a plastic surgeon who practices in New Jersey.
Both surgeons prefer live donors over cadavers for transplantations because family members usually are willing to donate nerve tissue immediately and such tissue is less likely to be rejected than cadaver tissue. It can take several months to find an appropriate cadaver, they added.
The ideal time for a transplantation is 3 months after injury, according to Dr. Elkwood.
In November, Dr. Allan Belzberg, a neurosurgeon at Johns Hopkins University, performed his first allograft transplantation of nerves from a 40-year-old mother to her 19-year-old son, to restore the use of his hand 1 year after an automobile accident left him with left leg amputation and 14-cm gaps in the median and ulnar nerves of the left arm going to the hand.
Dr. Belzberg opted against an autologous graft of expendable leg nerves because the patient had already lost one leg and the other had been broken in seven places. Nor did he want to remove nerves from the patient's one good arm.
Dr. Belzberg harvested nerves from the mother's legs and arms.
Within 3 months, Dr. Belzberg should know if the patient's nerves have regenerated. If all goes well, he will regain motion in his fingers within 8 months and, within 2 years, bend his elbow, grasp with his fingers, and feel protective sensations such as pain, cold, and heat, Dr. Belzberg said. He estimated the chances of achieving these outcomes as 50%–75%.
The patient will take the immunosuppression drug tacrolimus (FK 506) for about 2 years. One side effect of the drug is nerve growth, but Dr. Belzberg said he and a team of other doctors believe the drug is unlikely to spur tumor formation.
Dr. Mackinnon and other surgeons are now using another technique, nerve transfer, to treat patients in whom part of the brachial plexus has been torn. Nerve transfer consists of sacrificing the function of expendable portions of a patient's healthy nerves to revive function in a seriously injured, more crucial nerve.
Bundles of a healthy nerve near the motor end plate of the damaged muscle are teased apart and redirected to revive function in the recipient nerve and muscle. No grafting is necessary.
The technique changes the nerve injury from a proximal injury to a distal one, so nerves—which regenerate only about an inch a month—have less distance to grow, Dr. Mackinnon said.
For example, an injury to the ulnar nerve in the upper arm can require 2 years of recovery after grafting. But “stealing” nerve fibers from the pronator quadratus would require only a few months of recovery, Dr. Mackinnon said.
“There's a strong need for these procedures [transplantations and transfers],” Dr. Elkwood said, adding that too many physicians are unaware they are being done successfully. “We need massive education [about these procedures]. They need to become more mainstream in the lay and medical communities,” he said.
Although nerve transplantations are rarely performed, they can provide an alternative to amputation, and some surgeons say they should be considered for seriously injured patients.
Surgeons interviewed for this article identified a total of nine neurosurgeons and plastic surgeons, including themselves, who have transplanted nerves from living donors for more than 10 years.
The surgeons believe that thousands of patients—including soldiers returning from Iraq—could benefit from transplantations and similar procedures. Soldiers who suffer blunt injuries to an isolated spot of nerve would be especially good candidates, said Dr. Andrew Elkwood in an interview.
Dr. Susan Mackinnon, a plastic surgeon at Washington University in St. Louis, performed the first nerve transplantation from a live donor in 1989 in Canada. Transplantation is used as a last resort if patients do not have enough of their own nerve tissue for a graft, she said.
Grafts of patients' own nerve tissues have been around for years, said Dr. Elkwood, a plastic surgeon who practices in New Jersey.
Both surgeons prefer live donors over cadavers for transplantations because family members usually are willing to donate nerve tissue immediately and such tissue is less likely to be rejected than cadaver tissue. It can take several months to find an appropriate cadaver, they added.
The ideal time for a transplantation is 3 months after injury, according to Dr. Elkwood.
In November, Dr. Allan Belzberg, a neurosurgeon at Johns Hopkins University, performed his first allograft transplantation of nerves from a 40-year-old mother to her 19-year-old son, to restore the use of his hand 1 year after an automobile accident left him with left leg amputation and 14-cm gaps in the median and ulnar nerves of the left arm going to the hand.
Dr. Belzberg opted against an autologous graft of expendable leg nerves because the patient had already lost one leg and the other had been broken in seven places. Nor did he want to remove nerves from the patient's one good arm.
Dr. Belzberg harvested nerves from the mother's legs and arms.
Within 3 months, Dr. Belzberg should know if the patient's nerves have regenerated. If all goes well, he will regain motion in his fingers within 8 months and, within 2 years, bend his elbow, grasp with his fingers, and feel protective sensations such as pain, cold, and heat, Dr. Belzberg said. He estimated the chances of achieving these outcomes as 50%–75%.
The patient will take the immunosuppression drug tacrolimus (FK 506) for about 2 years. One side effect of the drug is nerve growth, but Dr. Belzberg said he and a team of other doctors believe the drug is unlikely to spur tumor formation.
Dr. Mackinnon and other surgeons are now using another technique, nerve transfer, to treat patients in whom part of the brachial plexus has been torn. Nerve transfer consists of sacrificing the function of expendable portions of a patient's healthy nerves to revive function in a seriously injured, more crucial nerve.
Bundles of a healthy nerve near the motor end plate of the damaged muscle are teased apart and redirected to revive function in the recipient nerve and muscle. No grafting is necessary.
The technique changes the nerve injury from a proximal injury to a distal one, so nerves—which regenerate only about an inch a month—have less distance to grow, Dr. Mackinnon said.
For example, an injury to the ulnar nerve in the upper arm can require 2 years of recovery after grafting. But “stealing” nerve fibers from the pronator quadratus would require only a few months of recovery, Dr. Mackinnon said.
“There's a strong need for these procedures [transplantations and transfers],” Dr. Elkwood said, adding that too many physicians are unaware they are being done successfully. “We need massive education [about these procedures]. They need to become more mainstream in the lay and medical communities,” he said.
Although nerve transplantations are rarely performed, they can provide an alternative to amputation, and some surgeons say they should be considered for seriously injured patients.
Surgeons interviewed for this article identified a total of nine neurosurgeons and plastic surgeons, including themselves, who have transplanted nerves from living donors for more than 10 years.
The surgeons believe that thousands of patients—including soldiers returning from Iraq—could benefit from transplantations and similar procedures. Soldiers who suffer blunt injuries to an isolated spot of nerve would be especially good candidates, said Dr. Andrew Elkwood in an interview.
Dr. Susan Mackinnon, a plastic surgeon at Washington University in St. Louis, performed the first nerve transplantation from a live donor in 1989 in Canada. Transplantation is used as a last resort if patients do not have enough of their own nerve tissue for a graft, she said.
Grafts of patients' own nerve tissues have been around for years, said Dr. Elkwood, a plastic surgeon who practices in New Jersey.
Both surgeons prefer live donors over cadavers for transplantations because family members usually are willing to donate nerve tissue immediately and such tissue is less likely to be rejected than cadaver tissue. It can take several months to find an appropriate cadaver, they added.
The ideal time for a transplantation is 3 months after injury, according to Dr. Elkwood.
In November, Dr. Allan Belzberg, a neurosurgeon at Johns Hopkins University, performed his first allograft transplantation of nerves from a 40-year-old mother to her 19-year-old son, to restore the use of his hand 1 year after an automobile accident left him with left leg amputation and 14-cm gaps in the median and ulnar nerves of the left arm going to the hand.
Dr. Belzberg opted against an autologous graft of expendable leg nerves because the patient had already lost one leg and the other had been broken in seven places. Nor did he want to remove nerves from the patient's one good arm.
Dr. Belzberg harvested nerves from the mother's legs and arms.
Within 3 months, Dr. Belzberg should know if the patient's nerves have regenerated. If all goes well, he will regain motion in his fingers within 8 months and, within 2 years, bend his elbow, grasp with his fingers, and feel protective sensations such as pain, cold, and heat, Dr. Belzberg said. He estimated the chances of achieving these outcomes as 50%–75%.
The patient will take the immunosuppression drug tacrolimus (FK 506) for about 2 years. One side effect of the drug is nerve growth, but Dr. Belzberg said he and a team of other doctors believe the drug is unlikely to spur tumor formation.
Dr. Mackinnon and other surgeons are now using another technique, nerve transfer, to treat patients in whom part of the brachial plexus has been torn. Nerve transfer consists of sacrificing the function of expendable portions of a patient's healthy nerves to revive function in a seriously injured, more crucial nerve.
Bundles of a healthy nerve near the motor end plate of the damaged muscle are teased apart and redirected to revive function in the recipient nerve and muscle. No grafting is necessary.
The technique changes the nerve injury from a proximal injury to a distal one, so nerves—which regenerate only about an inch a month—have less distance to grow, Dr. Mackinnon said.
For example, an injury to the ulnar nerve in the upper arm can require 2 years of recovery after grafting. But “stealing” nerve fibers from the pronator quadratus would require only a few months of recovery, Dr. Mackinnon said.
“There's a strong need for these procedures [transplantations and transfers],” Dr. Elkwood said, adding that too many physicians are unaware they are being done successfully. “We need massive education [about these procedures]. They need to become more mainstream in the lay and medical communities,” he said.
Feds Push for Electronic Health Record System
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
The HHS focus on standards and on interoperability issues shows that Secretary Mike Leavitt “understands the connection between what physicians purchase and patients' ability to have view of their records,” said David Kibbe, M.D., director of the Center for Health Information Technology for the American Academy of Family Physicians. The announcement indicates an “accelerated pace” of progress on EHRs, Dr. Kibbe said.
While issuing the request for proposal, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by Mr. Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued in late July. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health information technology systems in part because they gave both clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use IT, proactive resolution of privacy issues, and adequate funding. Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
This month, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
The HHS focus on standards and on interoperability issues shows that Secretary Mike Leavitt “understands the connection between what physicians purchase and patients' ability to have view of their records,” said David Kibbe, M.D., director of the Center for Health Information Technology for the American Academy of Family Physicians. The announcement indicates an “accelerated pace” of progress on EHRs, Dr. Kibbe said.
While issuing the request for proposal, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by Mr. Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued in late July. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health information technology systems in part because they gave both clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use IT, proactive resolution of privacy issues, and adequate funding. Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
This month, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
The HHS focus on standards and on interoperability issues shows that Secretary Mike Leavitt “understands the connection between what physicians purchase and patients' ability to have view of their records,” said David Kibbe, M.D., director of the Center for Health Information Technology for the American Academy of Family Physicians. The announcement indicates an “accelerated pace” of progress on EHRs, Dr. Kibbe said.
While issuing the request for proposal, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by Mr. Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued in late July. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health information technology systems in part because they gave both clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use IT, proactive resolution of privacy issues, and adequate funding. Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
This month, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
Feds Push for National Electronic Record System
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
While issuing the request for proposals, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by HHS Secretary Mike Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and accountability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposals, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense and Department of Veterans Affairs, as well as Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement from top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health information technology systems, in part because they gave both clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' different phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use information technology, proactive resolution of privacy issues, and adequate funding.
Other countries' experiences suggest a strong central organization to lead the entire health information technology implementation process, and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer.
In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
While issuing the request for proposals, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by HHS Secretary Mike Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and accountability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposals, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense and Department of Veterans Affairs, as well as Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement from top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health information technology systems, in part because they gave both clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' different phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use information technology, proactive resolution of privacy issues, and adequate funding.
Other countries' experiences suggest a strong central organization to lead the entire health information technology implementation process, and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer.
In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
While issuing the request for proposals, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by HHS Secretary Mike Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and accountability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposals, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense and Department of Veterans Affairs, as well as Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement from top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health information technology systems, in part because they gave both clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' different phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use information technology, proactive resolution of privacy issues, and adequate funding.
Other countries' experiences suggest a strong central organization to lead the entire health information technology implementation process, and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer.
In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
FDA Delays Changes to Concerta Label Until 2006
ROCKVILLE, MD. — A Food and Drug Administration panel has decided to postpone changes to safety warnings in the label for Concerta, a stimulant widely prescribed for attention-deficit hyperactivity disorder.
The FDA's Pediatric Advisory Committee recommended that agency officials delay any possible changes until data on adverse events associated with all methylphenidates (including Ritalin, Methylin, and Metadate) have been analyzed. Some committee members said they were unsure whether certain events were caused by the drugs or by underlying conditions. That review probably won't be complete until early 2006, according to Anne Trontell, M.D., deputy director of the FDA's Office of Drug Safety.
The FDA's legally required 1-year postexclusivity data review for Concerta examined reports of adverse psychiatric and cardiovascular events, including hallucinations, suicidal ideation, psychotic behavior, hypertension, and arrhythmias.
Although FDA officials and members of the Pediatric Advisory Committee agreed that these reports don't give new or unusual information, most also noted that existing warnings about possible adverse events could be better presented on the Concerta label, which now includes information in seven different places.
The FDA wants to update safety information on the labels on Concerta and other methylphenidates because prescribing practices have changed drastically since the first such drug (Ritalin) entered the market in 1955, said Paul J. Andreason, M.D., of the FDA's division of neuropharmacological drug products.
Calling methylphenidates “remarkably effective,” Richard Gorman, M.D., representative for the American Academy of Pediatrics, noted the public perception that methylphenidates are dangerous.
“Nothing I've heard today about these medications makes me particularly concerned,” said pediatric epidemiologist Thomas B. Newman, M.D., of the University of California, San Francisco.
Most committee members also urged FDA officials to let physicians and the public know why the FDA is postponing changes to safety information on the Concerta label and that the FDA is continuing to monitor methylphenidate problems.
Michael E. Fant, M.D., a neonatologist and biochemist at the University of Texas, Houston, also suggested studying the drug's effects on younger children.
Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics, added that exclusivity trials showed differences in metabolism and clearance among 3- to 8-year-olds, and added that exclusivity studies did not involve younger children.
FDA committee members also considered information from a small study of Ritalin that suggests it is associated with chromosome aberrations in peripheral blood lymphocytes, an independent risk factor for cancer.
That study by Randa A. El-Zein, M.D., and colleagues, published earlier this year in Cancer Letters, was the topic of an on-site evaluation by officials at the FDA and other federal agencies. They determined the study had methodology flaws, including a lack of placebo controls and unusual data presentation, said David Jacobson-Kram, Ph.D., of the FDA's Office of New Drugs.
He added that researchers don't know how the drug can damage DNA.
The Texas researchers are seeking funding to perform a larger study, while the FDA, the National Institute of Child Health and Human Development, the National Institute of Environmental Health Sciences, and Duke University, Durham, N.C., are collaborating to replicate the study by Dr. El-Zein and colleagues, according to Dr. Jacobson-Kram.
“If these data are reproducible, it would be very concerning,” he said, adding that studies similar to Dr. El-Zein's won't yield results for at least a year.
ROCKVILLE, MD. — A Food and Drug Administration panel has decided to postpone changes to safety warnings in the label for Concerta, a stimulant widely prescribed for attention-deficit hyperactivity disorder.
The FDA's Pediatric Advisory Committee recommended that agency officials delay any possible changes until data on adverse events associated with all methylphenidates (including Ritalin, Methylin, and Metadate) have been analyzed. Some committee members said they were unsure whether certain events were caused by the drugs or by underlying conditions. That review probably won't be complete until early 2006, according to Anne Trontell, M.D., deputy director of the FDA's Office of Drug Safety.
The FDA's legally required 1-year postexclusivity data review for Concerta examined reports of adverse psychiatric and cardiovascular events, including hallucinations, suicidal ideation, psychotic behavior, hypertension, and arrhythmias.
Although FDA officials and members of the Pediatric Advisory Committee agreed that these reports don't give new or unusual information, most also noted that existing warnings about possible adverse events could be better presented on the Concerta label, which now includes information in seven different places.
The FDA wants to update safety information on the labels on Concerta and other methylphenidates because prescribing practices have changed drastically since the first such drug (Ritalin) entered the market in 1955, said Paul J. Andreason, M.D., of the FDA's division of neuropharmacological drug products.
Calling methylphenidates “remarkably effective,” Richard Gorman, M.D., representative for the American Academy of Pediatrics, noted the public perception that methylphenidates are dangerous.
“Nothing I've heard today about these medications makes me particularly concerned,” said pediatric epidemiologist Thomas B. Newman, M.D., of the University of California, San Francisco.
Most committee members also urged FDA officials to let physicians and the public know why the FDA is postponing changes to safety information on the Concerta label and that the FDA is continuing to monitor methylphenidate problems.
Michael E. Fant, M.D., a neonatologist and biochemist at the University of Texas, Houston, also suggested studying the drug's effects on younger children.
Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics, added that exclusivity trials showed differences in metabolism and clearance among 3- to 8-year-olds, and added that exclusivity studies did not involve younger children.
FDA committee members also considered information from a small study of Ritalin that suggests it is associated with chromosome aberrations in peripheral blood lymphocytes, an independent risk factor for cancer.
That study by Randa A. El-Zein, M.D., and colleagues, published earlier this year in Cancer Letters, was the topic of an on-site evaluation by officials at the FDA and other federal agencies. They determined the study had methodology flaws, including a lack of placebo controls and unusual data presentation, said David Jacobson-Kram, Ph.D., of the FDA's Office of New Drugs.
He added that researchers don't know how the drug can damage DNA.
The Texas researchers are seeking funding to perform a larger study, while the FDA, the National Institute of Child Health and Human Development, the National Institute of Environmental Health Sciences, and Duke University, Durham, N.C., are collaborating to replicate the study by Dr. El-Zein and colleagues, according to Dr. Jacobson-Kram.
“If these data are reproducible, it would be very concerning,” he said, adding that studies similar to Dr. El-Zein's won't yield results for at least a year.
ROCKVILLE, MD. — A Food and Drug Administration panel has decided to postpone changes to safety warnings in the label for Concerta, a stimulant widely prescribed for attention-deficit hyperactivity disorder.
The FDA's Pediatric Advisory Committee recommended that agency officials delay any possible changes until data on adverse events associated with all methylphenidates (including Ritalin, Methylin, and Metadate) have been analyzed. Some committee members said they were unsure whether certain events were caused by the drugs or by underlying conditions. That review probably won't be complete until early 2006, according to Anne Trontell, M.D., deputy director of the FDA's Office of Drug Safety.
The FDA's legally required 1-year postexclusivity data review for Concerta examined reports of adverse psychiatric and cardiovascular events, including hallucinations, suicidal ideation, psychotic behavior, hypertension, and arrhythmias.
Although FDA officials and members of the Pediatric Advisory Committee agreed that these reports don't give new or unusual information, most also noted that existing warnings about possible adverse events could be better presented on the Concerta label, which now includes information in seven different places.
The FDA wants to update safety information on the labels on Concerta and other methylphenidates because prescribing practices have changed drastically since the first such drug (Ritalin) entered the market in 1955, said Paul J. Andreason, M.D., of the FDA's division of neuropharmacological drug products.
Calling methylphenidates “remarkably effective,” Richard Gorman, M.D., representative for the American Academy of Pediatrics, noted the public perception that methylphenidates are dangerous.
“Nothing I've heard today about these medications makes me particularly concerned,” said pediatric epidemiologist Thomas B. Newman, M.D., of the University of California, San Francisco.
Most committee members also urged FDA officials to let physicians and the public know why the FDA is postponing changes to safety information on the Concerta label and that the FDA is continuing to monitor methylphenidate problems.
Michael E. Fant, M.D., a neonatologist and biochemist at the University of Texas, Houston, also suggested studying the drug's effects on younger children.
Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics, added that exclusivity trials showed differences in metabolism and clearance among 3- to 8-year-olds, and added that exclusivity studies did not involve younger children.
FDA committee members also considered information from a small study of Ritalin that suggests it is associated with chromosome aberrations in peripheral blood lymphocytes, an independent risk factor for cancer.
That study by Randa A. El-Zein, M.D., and colleagues, published earlier this year in Cancer Letters, was the topic of an on-site evaluation by officials at the FDA and other federal agencies. They determined the study had methodology flaws, including a lack of placebo controls and unusual data presentation, said David Jacobson-Kram, Ph.D., of the FDA's Office of New Drugs.
He added that researchers don't know how the drug can damage DNA.
The Texas researchers are seeking funding to perform a larger study, while the FDA, the National Institute of Child Health and Human Development, the National Institute of Environmental Health Sciences, and Duke University, Durham, N.C., are collaborating to replicate the study by Dr. El-Zein and colleagues, according to Dr. Jacobson-Kram.
“If these data are reproducible, it would be very concerning,” he said, adding that studies similar to Dr. El-Zein's won't yield results for at least a year.
Benefits of Exercise for Spinal Cord Repair Debated
BALTIMORE — Exercise provides health benefits to patients with spinal cord injuries, but whether exercise increases patients' sensation and ability to move, perhaps by stimulating repair of damaged nerves, is still an open question.
A new spinal cord injury center at Baltimore's Kennedy Krieger Institute offers an activity-based therapy plan for both children and adults with congenital, viral, or trauma-related spinal cord injury that emphasizes repetitive motion intended to awaken dormant nerves.
The centerpiece of activity-based therapy, sometimes called “advanced restoration” therapy, is a recumbent stationary bicycle. Patients pedal aided by electrodes attached to specific muscle groups. Some in-house patients also use a robotic walking machine known as Lokomat that operates the legs as the patient's upper body is suspended in a harness over a treadmill. All the equipment is designed to be adaptable for children.
Children may respond especially well to activity-based therapy because their central nervous systems are developing and their smaller, lighter bodies may be more receptive to any restorative or regenerative effects of these exercises, according to the center's director, neurologist John W. McDonald, M.D.
Although he thinks the therapy stimulates remyelinization, no trials have tested the process in humans. That's because no noninvasive imaging method has the necessary resolution for measuring cellular events, he explained.
Exercise was shown to improve the physical condition of the body, including such indicators as bone density, blood glucose level, muscle mass, and cardiovascular fitness, in 60 adults with spinal cord injuries who participated in a 3-year cohort study. These patients' spinal cord injuries were of at least 18 months' duration at the time of enrollment in the study, past the point when therapy is traditionally considered effective.
Dr. McDonald said the patients also experienced “useful improvement in movement and sensation” as a result of the exercise program.
He will present details of the data at the annual meeting of the American Neurological Association in San Diego in September. A prospective randomized trial examining activity-based therapy in children is underway at Philadelphia Shriners Hospital and Kennedy Krieger Institute and is about half completed, Dr. McDonald noted. He is planning a larger-scale prospective study in adults at Philadelphia Shriners Hospital, Shepherd Center in Atlanta, and Kennedy Krieger Institute.
Other researchers are less enthusiastic about repetitive motion therapy.
Traditional physical therapy is usually just as good, said Bruce H. Dobkin, M.D., program director of the neurologic rehabilitation and research program at the University of California, Los Angeles. His recent study at six sites across the United States and in Canada showed regular therapy yielded results similar to those of an experimental regimen of treadmill walking assisted by physical therapists.
Newer therapies may prove to be useful, according to Steven Kirshblum, M.D., of the Kessler Institute for Rehabilitation in West Orange, N.J.
Future effective treatments for patients with spinal cord injuries will probably combine drugs, surgery, exercise, and possibly stem cells, Dr. Kirshblum predicted.
BALTIMORE — Exercise provides health benefits to patients with spinal cord injuries, but whether exercise increases patients' sensation and ability to move, perhaps by stimulating repair of damaged nerves, is still an open question.
A new spinal cord injury center at Baltimore's Kennedy Krieger Institute offers an activity-based therapy plan for both children and adults with congenital, viral, or trauma-related spinal cord injury that emphasizes repetitive motion intended to awaken dormant nerves.
The centerpiece of activity-based therapy, sometimes called “advanced restoration” therapy, is a recumbent stationary bicycle. Patients pedal aided by electrodes attached to specific muscle groups. Some in-house patients also use a robotic walking machine known as Lokomat that operates the legs as the patient's upper body is suspended in a harness over a treadmill. All the equipment is designed to be adaptable for children.
Children may respond especially well to activity-based therapy because their central nervous systems are developing and their smaller, lighter bodies may be more receptive to any restorative or regenerative effects of these exercises, according to the center's director, neurologist John W. McDonald, M.D.
Although he thinks the therapy stimulates remyelinization, no trials have tested the process in humans. That's because no noninvasive imaging method has the necessary resolution for measuring cellular events, he explained.
Exercise was shown to improve the physical condition of the body, including such indicators as bone density, blood glucose level, muscle mass, and cardiovascular fitness, in 60 adults with spinal cord injuries who participated in a 3-year cohort study. These patients' spinal cord injuries were of at least 18 months' duration at the time of enrollment in the study, past the point when therapy is traditionally considered effective.
Dr. McDonald said the patients also experienced “useful improvement in movement and sensation” as a result of the exercise program.
He will present details of the data at the annual meeting of the American Neurological Association in San Diego in September. A prospective randomized trial examining activity-based therapy in children is underway at Philadelphia Shriners Hospital and Kennedy Krieger Institute and is about half completed, Dr. McDonald noted. He is planning a larger-scale prospective study in adults at Philadelphia Shriners Hospital, Shepherd Center in Atlanta, and Kennedy Krieger Institute.
Other researchers are less enthusiastic about repetitive motion therapy.
Traditional physical therapy is usually just as good, said Bruce H. Dobkin, M.D., program director of the neurologic rehabilitation and research program at the University of California, Los Angeles. His recent study at six sites across the United States and in Canada showed regular therapy yielded results similar to those of an experimental regimen of treadmill walking assisted by physical therapists.
Newer therapies may prove to be useful, according to Steven Kirshblum, M.D., of the Kessler Institute for Rehabilitation in West Orange, N.J.
Future effective treatments for patients with spinal cord injuries will probably combine drugs, surgery, exercise, and possibly stem cells, Dr. Kirshblum predicted.
BALTIMORE — Exercise provides health benefits to patients with spinal cord injuries, but whether exercise increases patients' sensation and ability to move, perhaps by stimulating repair of damaged nerves, is still an open question.
A new spinal cord injury center at Baltimore's Kennedy Krieger Institute offers an activity-based therapy plan for both children and adults with congenital, viral, or trauma-related spinal cord injury that emphasizes repetitive motion intended to awaken dormant nerves.
The centerpiece of activity-based therapy, sometimes called “advanced restoration” therapy, is a recumbent stationary bicycle. Patients pedal aided by electrodes attached to specific muscle groups. Some in-house patients also use a robotic walking machine known as Lokomat that operates the legs as the patient's upper body is suspended in a harness over a treadmill. All the equipment is designed to be adaptable for children.
Children may respond especially well to activity-based therapy because their central nervous systems are developing and their smaller, lighter bodies may be more receptive to any restorative or regenerative effects of these exercises, according to the center's director, neurologist John W. McDonald, M.D.
Although he thinks the therapy stimulates remyelinization, no trials have tested the process in humans. That's because no noninvasive imaging method has the necessary resolution for measuring cellular events, he explained.
Exercise was shown to improve the physical condition of the body, including such indicators as bone density, blood glucose level, muscle mass, and cardiovascular fitness, in 60 adults with spinal cord injuries who participated in a 3-year cohort study. These patients' spinal cord injuries were of at least 18 months' duration at the time of enrollment in the study, past the point when therapy is traditionally considered effective.
Dr. McDonald said the patients also experienced “useful improvement in movement and sensation” as a result of the exercise program.
He will present details of the data at the annual meeting of the American Neurological Association in San Diego in September. A prospective randomized trial examining activity-based therapy in children is underway at Philadelphia Shriners Hospital and Kennedy Krieger Institute and is about half completed, Dr. McDonald noted. He is planning a larger-scale prospective study in adults at Philadelphia Shriners Hospital, Shepherd Center in Atlanta, and Kennedy Krieger Institute.
Other researchers are less enthusiastic about repetitive motion therapy.
Traditional physical therapy is usually just as good, said Bruce H. Dobkin, M.D., program director of the neurologic rehabilitation and research program at the University of California, Los Angeles. His recent study at six sites across the United States and in Canada showed regular therapy yielded results similar to those of an experimental regimen of treadmill walking assisted by physical therapists.
Newer therapies may prove to be useful, according to Steven Kirshblum, M.D., of the Kessler Institute for Rehabilitation in West Orange, N.J.
Future effective treatments for patients with spinal cord injuries will probably combine drugs, surgery, exercise, and possibly stem cells, Dr. Kirshblum predicted.
Ready or Not, Feds Push Nationwide Health IT Forward
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
The HHS focus on standards and on interoperability issues shows that Secretary Mike Leavitt “understands the connection between what family physicians purchase and patients' ability to have view of their records,” said David Kibbe, M.D., director of the Center for Health Information Technology for the American Academy of Family Physicians.
The announcement indicates an “accelerated pace” of progress on EHRs, Dr. Kibbe said.
While issuing the request for proposals, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by Dr. Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies.
The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and accountability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month.
That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care IT.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health IT systems in part because they gave both clinicians and payers an early and influential role in health IT projects and kept them involved throughout the projects' phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use information technology, proactive resolution of privacy issues, and adequate funding.
Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process, as well as the integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report noted.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer.
In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
The HHS focus on standards and on interoperability issues shows that Secretary Mike Leavitt “understands the connection between what family physicians purchase and patients' ability to have view of their records,” said David Kibbe, M.D., director of the Center for Health Information Technology for the American Academy of Family Physicians.
The announcement indicates an “accelerated pace” of progress on EHRs, Dr. Kibbe said.
While issuing the request for proposals, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by Dr. Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies.
The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and accountability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month.
That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care IT.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health IT systems in part because they gave both clinicians and payers an early and influential role in health IT projects and kept them involved throughout the projects' phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use information technology, proactive resolution of privacy issues, and adequate funding.
Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process, as well as the integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report noted.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer.
In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
The HHS focus on standards and on interoperability issues shows that Secretary Mike Leavitt “understands the connection between what family physicians purchase and patients' ability to have view of their records,” said David Kibbe, M.D., director of the Center for Health Information Technology for the American Academy of Family Physicians.
The announcement indicates an “accelerated pace” of progress on EHRs, Dr. Kibbe said.
While issuing the request for proposals, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by Dr. Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report that endorses a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies.
The report summarizes public comments on how to move forward on a nationwide EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and accountability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month.
That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care IT.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD were successful at adopting health IT systems in part because they gave both clinicians and payers an early and influential role in health IT projects and kept them involved throughout the projects' phases.
VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time for the process to mature, assimilating lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use information technology, proactive resolution of privacy issues, and adequate funding.
Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process, as well as the integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report noted.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer.
In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
Is a Single Patient Identifier Key to EHR System?
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform.
Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last year, Markle and several health information technology organizations released a “road map” outlining a decentralized approach emphasizing patient privacy, interoperability, and community involvement within an established framework.
One solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he pointed out, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can play an important role in “eliminating barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve.”
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) introduced legislation aimed at speeding adoption of electronic health records by waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Similar legislation has been introduced in the Senate by Majority Leader Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.).
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform.
Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last year, Markle and several health information technology organizations released a “road map” outlining a decentralized approach emphasizing patient privacy, interoperability, and community involvement within an established framework.
One solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he pointed out, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can play an important role in “eliminating barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve.”
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) introduced legislation aimed at speeding adoption of electronic health records by waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Similar legislation has been introduced in the Senate by Majority Leader Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.).
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform.
Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last year, Markle and several health information technology organizations released a “road map” outlining a decentralized approach emphasizing patient privacy, interoperability, and community involvement within an established framework.
One solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he pointed out, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can play an important role in “eliminating barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve.”
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) introduced legislation aimed at speeding adoption of electronic health records by waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Similar legislation has been introduced in the Senate by Majority Leader Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.).
Feds Push Nationwide Electronic Record System Forward
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
While issuing the request for proposal, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by HHS Secretary Mike Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report endorsing a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on an EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and account-ability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD adopted health information technology systems in part because they gave clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' phases. VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time to assimilate lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use IT, proactive resolution of privacy issues, and adequate funding. Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer. In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
While issuing the request for proposal, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by HHS Secretary Mike Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report endorsing a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on an EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and account-ability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD adopted health information technology systems in part because they gave clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' phases. VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time to assimilate lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use IT, proactive resolution of privacy issues, and adequate funding. Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer. In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
The Department of Health and Human Services took more steps toward a nationwide electronic health record system when it issued requests for proposals for key system components and announced formation of an advisory committee.
The department said it is seeking vendors to create processes for setting data standards, certification, and architecture for a Web-based system and to assess patient privacy and security.
While issuing the request for proposal, HHS also announced formation of the American Health Information Community (AHIC), a 17-member public/private organization that will give the department input and recommendations on making health records digital, interoperable, and secure.
Headed by HHS Secretary Mike Leavitt, AHIC will include representatives of consumer groups, providers, payers, hospitals, vendors, and privacy interests.
These announcements came as HHS also issued a report endorsing a decentralized, Web-based system linked by uniform communications and a software framework of open standards and policies. The report summarizes public comments on how to move forward on an EHR system.
Dr. Leavitt called the report “first specs” for the system, which should include:
▸ Use of existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs.
▸ Regional implementation and harmonization.
▸ Incremental evolution with “appropriate” incentives, coordination, and account-ability.
▸ Focus on patients and sufficient privacy safeguards.
The report, request for proposal, and AHIC announcement follow several suggestions made by a Government Accountability Office report issued late last month. That report recommended deploying the national EHR system in small increments, building on what already works, and using common standards.
The report also pointed to lessons learned by the Department of Defense, Department of Veterans Affairs, Denmark, Canada, and New Zealand in setting up health care information technology.
Those lessons suggest the need to obtain full endorsement of top leadership in health organizations, including support for funding, according to the GAO.
The VA and DOD adopted health information technology systems in part because they gave clinicians and payers an early and influential role in health information technology projects and kept them involved throughout the projects' phases. VA and DOD experiences also highlight the need to limit initial deployment to a few test sites to allow time to assimilate lessons learned before full deployment, GAO said.
International lessons also include the need to focus on creating standards first, finding regional incentives to motivate physicians to use IT, proactive resolution of privacy issues, and adequate funding. Other countries' experiences suggest a strong central organization to lead the entire health IT implementation process and integration of federal efforts with hospitals before undertaking a larger national plan, the GAO report said.
The Certification Commission for Healthcare Information Technology is working with HHS on certification issues and is expected to define a basic process for EHRs in ambulatory settings this summer. In September, HHS plans to issue a first release of an information architecture that will allow data sharing across federal health organizations, some states, and some private entities, according to the GAO.
Electronic Health Records Spark Identifier Debate : Some say single, voluntary approach would reduce errors; others want to build on decentralized system.
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform. Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and otherwise improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last July, Markle and several health information technology organizations released a “road map” that outlines a decentralized approach emphasizing patient privacy, interoperability, and local community involvement within an established framework.
One technology solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate in a new system, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he pointed out, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three Massachusetts communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can play an important role in “eliminating barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve,” she added.
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
In May, Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) introduced legislation aimed at speeding adoption of electronic health records by, among other things, waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Sen. Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.) are expected to introduce similar legislation.
A recently passed Kentucky law authorizes creation of a single, statewide electronic health network that will let physicians, hospitals, and insurers exchange patient information electronically. The legislation provides $350,000 as start-up money for university endowments for experts to help create the system.
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform. Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and otherwise improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last July, Markle and several health information technology organizations released a “road map” that outlines a decentralized approach emphasizing patient privacy, interoperability, and local community involvement within an established framework.
One technology solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate in a new system, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he pointed out, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three Massachusetts communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can play an important role in “eliminating barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve,” she added.
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
In May, Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) introduced legislation aimed at speeding adoption of electronic health records by, among other things, waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Sen. Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.) are expected to introduce similar legislation.
A recently passed Kentucky law authorizes creation of a single, statewide electronic health network that will let physicians, hospitals, and insurers exchange patient information electronically. The legislation provides $350,000 as start-up money for university endowments for experts to help create the system.
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform. Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and otherwise improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last July, Markle and several health information technology organizations released a “road map” that outlines a decentralized approach emphasizing patient privacy, interoperability, and local community involvement within an established framework.
One technology solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate in a new system, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he pointed out, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three Massachusetts communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can play an important role in “eliminating barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve,” she added.
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
In May, Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) introduced legislation aimed at speeding adoption of electronic health records by, among other things, waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Sen. Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.) are expected to introduce similar legislation.
A recently passed Kentucky law authorizes creation of a single, statewide electronic health network that will let physicians, hospitals, and insurers exchange patient information electronically. The legislation provides $350,000 as start-up money for university endowments for experts to help create the system.
Do EHRs Need More Than One Patient Identifier?
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform. Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and otherwise improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last July, Markle and several health information technology organizations released a “road map” that outlines a decentralized approach emphasizing patient privacy, interoperability, and local community involvement within an established framework.
One technology solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate in a new system, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he said, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three Massachusetts communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can help eliminate “barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve,” she added.
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) have introduced legislation aimed at speeding adoption of electronic health records by, among other things, waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Sen. Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.) are expected to introduce similar legislation.
A Kentucky law authorizes creation of a single, statewide electronic health network that will let physicians, hospitals, and insurers exchange patient information electronically. The legislation provides $350,000 as start-up money for university endowments for experts to help create the system.
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform. Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and otherwise improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last July, Markle and several health information technology organizations released a “road map” that outlines a decentralized approach emphasizing patient privacy, interoperability, and local community involvement within an established framework.
One technology solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate in a new system, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he said, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three Massachusetts communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can help eliminate “barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve,” she added.
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) have introduced legislation aimed at speeding adoption of electronic health records by, among other things, waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Sen. Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.) are expected to introduce similar legislation.
A Kentucky law authorizes creation of a single, statewide electronic health network that will let physicians, hospitals, and insurers exchange patient information electronically. The legislation provides $350,000 as start-up money for university endowments for experts to help create the system.
WASHINGTON — One key to the widespread use of electronic health records is a single, voluntary identifier for each patient, Newt Gingrich said at a briefing sponsored by the Alliance for Health Reform. Most patients would embrace a comprehensive system based on single, voluntary individual health identifiers because of its potential to reduce medical errors and otherwise improve health care quality, said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.
But Carol Diamond, M.D., managing director of the health program at the Markle Foundation, a charity dedicated to using technology to improve the nation's health care and security, called for a system that can be accessed using multiple patient identifiers.
Any new system for electronic health records should build on what already exists, she said. “We have a decentralized [health care] system. That's been the premise of our approach,” Dr. Diamond explained. “We are never going to get to this giant database in the sky that's got everything that we need.”
Last July, Markle and several health information technology organizations released a “road map” that outlines a decentralized approach emphasizing patient privacy, interoperability, and local community involvement within an established framework.
One technology solution is unlikely to fit both a two-physician practice and a hospital with hundreds of beds, said Colin Evans, director of policy and standards for the digital health group at Intel. He added that a model that's based on people accessing decentralized data “may work generally” but would require aggregation of data.
He noted that the United Kingdom's National Health Service is developing a computerized medical records system based on a semiaggregated model.
Physicians and hospitals will need both financial and nonfinancial incentives to participate in a new system, noted Mickey Tripathi, president of the Massachusetts eHealth Collaborative. “For doctors in small practices, it's risky to invest $25,000–$50,000 for an [information technology] system,” he said, noting the marketplace currently provides no incentives to do so.
The organization is currently setting up pilot projects in three Massachusetts communities. The pilots will help Blue Cross Blue Shield of Massachusetts decide how to invest $50 million in a statewide electronic health infrastructure. Mr. Tripathi said the pilot projects allow local communities to determine their own needs and require minimal interoperability within their own area and a statewide grid.
Government can help eliminate “barriers to entry,” said Zoe Baird, Markle Foundation president. “We're all grappling with who will develop [interoperability] standards and what policy attributes they have to achieve,” she added.
Mr. Evans said a number of initiatives among both health and technology industry groups are “closing in” on interoperability standards for health care.
The Bush Administration has pledged to finance projects intended to spur adoption of computerized health records within the next 10 years. Last year, it appointed David J. Brailer, M.D., as the nation's first national health information technology coordinator. However, Congress in November declined to allocate $50 million Bush had requested for Dr. Brailer's office and pilot projects for fiscal year 2005. The administration has requested $125 million for fiscal year 2006, but no Congressional action is expected until fall.
Rep. Tim Murphy (R-Pa.) and Rep. Patrick Kennedy (D-R.I.) have introduced legislation aimed at speeding adoption of electronic health records by, among other things, waiving certain provisions of the Stark antikickback laws so that hospitals can provide information technology to physician practices, according to Rep. Murphy's staff. Sen. Bill Frist (R-Tenn.) and Sen. Hillary Rodham Clinton (D-N.Y.) are expected to introduce similar legislation.
A Kentucky law authorizes creation of a single, statewide electronic health network that will let physicians, hospitals, and insurers exchange patient information electronically. The legislation provides $350,000 as start-up money for university endowments for experts to help create the system.