Health Affairs: IFR needs more specification, Halamka says
The government needs to play a stronger role in establishing a firm foundation for meaningful use for commercial interests to flourish, according to John D. Halamka, MD, CIO at Beth Israel Deaconess Medical Center in Boston, in an opinion article in the April edition of Health Affairs.
“With stimulus funds as a powerful carrot, the Interim Final Rule (IFR) should be extended in the near term to include greater specificity for content, vocabulary, transmission, security and quality standards,” wrote Halamka in an article that sought to identify gaps in and additions to the regulations in the American Recovery and Reinvestment Act of 2009 (ARRA) that would support more rapid progress.
Content standards should be more specific and include implementation guides
According to Halamka, the Office of the National Coordinator for Health IT (ONC) did not want to provide too much specificity on meaningful use that would require changing the regulation in the future as technology and other factors evolve, leading to a lack of specificity on lab and clinical summary standards. “This ambiguity could result in a virtual Tower of Babel,” wrote Halamka, who also is the dean for technology at Harvard Medical School in Boston. ONC, according to Halamka, needs to enhance the IFR including specificity in areas such as these, with well-developed implementation guides.
“In the long term, the total cost of implementing and maintaining standards is reduced when all participants in data exchange use the same content standards,” wrote Halamka. “With more data flowing, care will be better coordinated, and data can be used for multiple purposes such as population health, personal health records and clinical research.”
Vocabulary subsets should be required
The IFR currently specifies vocabulary laboratory, problem lists, medication names, allergies and units of measure but does not provide specific lists of vocabulary subsets that should be used by all stakeholders, Halamka wrote. “The implication of this is that data recorded in different systems may use different, incompatible vocabulary terms,” he said.
The National Library of Medicine provides a problem-list subset using the most common terms from several leading U.S. institutions and has also developed a list of the most commonly ordered lab tests—the top 98 percent of all tests ordered in the country—whose use would ease implementation of lab interfaces for every provider and hospital by ensuring uniformity of lab-naming conventions.
In addition, Halamka recommended that the IFR include changes to the current ICD-10 “migration” plan, although he acknowledged that this recommendation is controversial.
Transmission approaches should be specific
The IFR currently provides no specific guidance as to how data should be sent from place to place, according to Halamka. “ARRA and the proposed regulations on meaningful use require care coordination…[but] without a specific architecture or reference implementation for submission of immunization or syndromic surveillance data or public health reporting, these will be challenging to implement,” he wrote.
One option is to provide very specific guidance as a starting point, to ensure that any stimulus dollars spent on healthcare information exchange are used to create data flows that are consistent in each locality. “Once this basic data exchange is in place, innovation can flourish,” Halamka noted.
Security and privacy should be enhanced with specific consent standards
As the definitions of meaningful use evolve, areas of new work will include greater engagement of patient, leveraging data for comparative effectiveness and clinical research, and better management of the knowledge base for clinical decision support, according to Halamka. “All of these uses will require new polices, novel technologies and new architectural models ... a consistent mechanism for recording patient consent for disclosure and reuse of health data is foundational to this future work."
Quality reporting should have a more specific, less burdensome path forward
“Careful consideration should be given to the appropriate level of reporting requirements. More measures may not translate into more meaningful use of health IT, and increased burden may deter participation,” wrote Halamka. Halamka recommended that the IFR require reporting consistent with existing Centers for Medicare and Medicaid requirements at the time of reporting citing that “[r]equiring hospitals to adopt a new standard in one year and potentially replacing it in the next year will add confusion and could jeopardize adoption of the subsequent standard.”
“We need to extend the [IFR] in several areas, given the once-in-a-lifetime opportunity to accelerate change with stimulus funds,” concluded Halamka. “We can then incorporate further lessons learned from the market as EHRs are implemented.”
“With stimulus funds as a powerful carrot, the Interim Final Rule (IFR) should be extended in the near term to include greater specificity for content, vocabulary, transmission, security and quality standards,” wrote Halamka in an article that sought to identify gaps in and additions to the regulations in the American Recovery and Reinvestment Act of 2009 (ARRA) that would support more rapid progress.
Content standards should be more specific and include implementation guides
According to Halamka, the Office of the National Coordinator for Health IT (ONC) did not want to provide too much specificity on meaningful use that would require changing the regulation in the future as technology and other factors evolve, leading to a lack of specificity on lab and clinical summary standards. “This ambiguity could result in a virtual Tower of Babel,” wrote Halamka, who also is the dean for technology at Harvard Medical School in Boston. ONC, according to Halamka, needs to enhance the IFR including specificity in areas such as these, with well-developed implementation guides.
“In the long term, the total cost of implementing and maintaining standards is reduced when all participants in data exchange use the same content standards,” wrote Halamka. “With more data flowing, care will be better coordinated, and data can be used for multiple purposes such as population health, personal health records and clinical research.”
Vocabulary subsets should be required
The IFR currently specifies vocabulary laboratory, problem lists, medication names, allergies and units of measure but does not provide specific lists of vocabulary subsets that should be used by all stakeholders, Halamka wrote. “The implication of this is that data recorded in different systems may use different, incompatible vocabulary terms,” he said.
The National Library of Medicine provides a problem-list subset using the most common terms from several leading U.S. institutions and has also developed a list of the most commonly ordered lab tests—the top 98 percent of all tests ordered in the country—whose use would ease implementation of lab interfaces for every provider and hospital by ensuring uniformity of lab-naming conventions.
In addition, Halamka recommended that the IFR include changes to the current ICD-10 “migration” plan, although he acknowledged that this recommendation is controversial.
Transmission approaches should be specific
The IFR currently provides no specific guidance as to how data should be sent from place to place, according to Halamka. “ARRA and the proposed regulations on meaningful use require care coordination…[but] without a specific architecture or reference implementation for submission of immunization or syndromic surveillance data or public health reporting, these will be challenging to implement,” he wrote.
One option is to provide very specific guidance as a starting point, to ensure that any stimulus dollars spent on healthcare information exchange are used to create data flows that are consistent in each locality. “Once this basic data exchange is in place, innovation can flourish,” Halamka noted.
Security and privacy should be enhanced with specific consent standards
As the definitions of meaningful use evolve, areas of new work will include greater engagement of patient, leveraging data for comparative effectiveness and clinical research, and better management of the knowledge base for clinical decision support, according to Halamka. “All of these uses will require new polices, novel technologies and new architectural models ... a consistent mechanism for recording patient consent for disclosure and reuse of health data is foundational to this future work."
Quality reporting should have a more specific, less burdensome path forward
“Careful consideration should be given to the appropriate level of reporting requirements. More measures may not translate into more meaningful use of health IT, and increased burden may deter participation,” wrote Halamka. Halamka recommended that the IFR require reporting consistent with existing Centers for Medicare and Medicaid requirements at the time of reporting citing that “[r]equiring hospitals to adopt a new standard in one year and potentially replacing it in the next year will add confusion and could jeopardize adoption of the subsequent standard.”
“We need to extend the [IFR] in several areas, given the once-in-a-lifetime opportunity to accelerate change with stimulus funds,” concluded Halamka. “We can then incorporate further lessons learned from the market as EHRs are implemented.”