(meta-data) “TAG, You-Are-It” (ONC, CMS, DHHS) !
This December 2010, the President’s Council of Advisors on Science and Technology (“PCAST”) released its Report titled “Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward,” and, boy, it makes meaningful use look like a walk in the park!
The Report notes, among many other things, that the current structure of available health IT systems is inadequate, resulting in user difficulty, unavailability of relevant information, such as best practices, limited capability for sharing data across systems, patient concerns regarding improper access, and the inability to search or aggregate and de-aggregate data where necessary for research, public health, quality improvement, or patient safety. In essence, current health IT systems cannot easily support the desired outcomes. The Report identifies key legislation and regulations responsible for moving the development of health IT forward, namely, HITECH and the “meaningful use” EHR Incentive Program, as well as demonstration projects to develop experience and the necessary conditions for progress. However, the Report stresses the urgency of accelerating and redirecting much needed federal groundwork for HIE.
The Report notes the successes of early adopters of integrated EHR systems (i.e., Kaiser Permanente and VHA), while recognizing areas of functionality still in dire need of improvement, such as interoperability. It finds data exchange and aggregation central to accomplishing potential health IT benefits yet rejects current HIE models as being “ill-suited” as the basis for a national health information infrastructure due to durability and interoperability concerns. PCAST considers new technologies, such as “cloud-based” EHR products, patient personal health records, and data aggregation “middleware” products for interoperability that have potential to remove barriers and create solutions, as well as other promising models for data exchange.
PCAST rejects standardized health record formats and service-oriented architecture (SOA) in favor of metadata-tagged data elements and data-element access services (DEAS), the advantages of which the Report describes in detail. Such “tags” are small pieces of information accompanied by a larger “megadata tag” which groups them by attributes as well as required privacy and security protection.
The Report argues that a universal exchange language based upon tagged dataelements (i.e., DEAS and metadata-tagged data) is more sophisticated and better for privacy and security.
For example, DEAS would require authentication of an individual into the system and allow only access to information based upon the role he or she is assigned. To obtain access to encrypted tagged data elements, based upon a patient’s privacy choices, the individual would have to have the proper credentials and role. It is also crucial to note that the Report rejects that such a system would require “universal patient identifiers” or create a central repository of patient information.
Furthermore, the Report explores how HIPAA is ill-equipped, and possibly detrimental to medical research and care, to handle the changes in health IT and how HITECH both partially remedies and exacerbates this situation, such as accounting of disclosures which will “stifle innovation”.
Finally, the Report argues that federal leadership is necessary to combat economic concerns and incentivize information exchange and development of health IT systems. Adopting standardized metadata, aligning economic incentives (such as through “meaningful use”), encouraging technological innovation and competition, supporting development of network infrastructures through appropriately designed pilot projects, and developing a regulatory health IT structure along with regulatory oversight all are suggested by the Report as necessary.
PCAST detail several layers and roadmaps for government agencies to progress towards the realization of a national health IT infrastructure. It also recommends guidelines for transitioning from existing EHRs and information exchange systems to the new tagged data element model advocated by the Report, and addresses generation of necessary early design choices by ONC and the Report’s vision for future CMS meaningful use requirements. The Report concludes with specific short and mid-term recommendations for ONC, DHHS, CMS, and other agencies in order to realize the objectives outlined in the Report towards establishment of a national health IT infrastructure. In response, ONC, for one, appears to have already set up a PCAST Report Workgroup, and the first meeting is scheduled for January 14, 2011.
To review PCAST’s summary of Recommendations of who should do what next, click Continue Reading below.
FOLLOWING RECOMMENDATIONS REPRINTED FROM PCAST REPORT (PP 77-79):
The Chief Technology Officer of the United States should:
- In coordination with the Office of Management and Budget (OMB) and the Secretary of HHS, and using technical expertise within ONC, develop within 12 months a set of metrics that measure progress toward an operational, universal, national health IT infrastructure. Research, prototype, and pilot efforts should not be included in this metric of operational progress.
- Annually, assess the Nation’s progress in health IT by the metrics developed, and make recom-mendations to OMB and the Secretary of HHS on how to make more rapid progress.
The Office of the National Coordinator should:
- Move more boldly to ensure that the Nation has electronic health systems that are able to exchange health data in a universal manner based on metadata-tagged data elements. In particular, ONC should signal now that systems will need to have this capability by 2013 in order to be deemed as making “meaningful use” of electronic health information under the HITECH Act.
- Act to establish initial minimal standards for the metadata associated with tagged data elements, and develop a roadmap for more complete standards over time.
- Facilitate the rapid mapping of existing semantic taxonomies into tagged data elements, while continuing to encourage the longer-term harmonization of these taxonomies by vendors and other stakeholders.
- Support the development of reference implementations for the use of tagged data elements in products. Certification of individual products should focus on interoperability with the reference implementations.
- Set standards for the necessary data element access services (specifically, indexing and access control) and formulate a strategic plan for bringing such services into operation in an interoperable and intercommunicating manner. Immediate priority should be given to those services needed to locate data relating to an individual patient.
- Facilitate, with the Small Business Administration, the emergence of competitive companies that would provide small or under-resourced physician practices, community-based long-term care facilities, and hospitals with a range of cloud-based services.
- Ensure that research funded through the SHARP (Strategic Health IT Advanced Research Projects) program on data security include the use of metadata to enable data security.
The Centers for Medicare & Medicaid Services should:
- Redirect the focus of meaningful use measures as rapidly as possible from data collection of specified lists of health measures to higher levels of data exchange and the increased use of clinical decision supports.
- Direct its efforts under the Patient Protection and Affordable Care Act toward the ability to receive and use data from multiple sources and formats.
- In parallel with (i.e., without waiting for) the NRC study on IT modernization, begin to develop options for the modernization and full integration of its information systems platforms using modern technologies, and with the necessary transparency to build confidence with Congress and other stakeholders.
- When informed by the preliminary and final NRC study reports, move rapidly to implement one or more of the options already formulated, or formulate new options as appropriate, with the goal of making substantial progress by 2013 and completing implementation by 2014. CMS must transition into a modern information technology organization, allowing integration of multiple components and consistent use of standards and processes across all the provider sectors and programs it manages.
- Exercise its influence as the Nation’s largest healthcare payer to accelerate the implementation of health information exchange using tagged data elements. By 2013, meaningful use criteria should include data submitted through reference implementation processes, either directly to CMS or (if CMS modernization is not sufficiently advanced) through private entities authorized to serve this purpose.
- By 2013, provide incentives for hospitals and eligible professionals to submit meaningful use clinical measures that are calculated from computable data. By 2015, encourage or require that quality measures under all of its reporting programs (the Physician Quality Reporting Initiative, hospitals, Medicare Advantage plans, nursing homes, etc.) be able to be collected in a tagged data element model.
The Department of Health and Human Services should:
- Develop a strategic plan for rapid action that integrates and aligns information systems through the government’s public health agencies (including FDA, CDC, NIH, and AHRQ) and benefits payment systems (CMS and VA).
- Convene a high-level task force to align data standards, and population research data, between private and public sector payers.
- Convene a high-level task force to develop specific recommendations on national standards that enable patient access, data exchange, and de-identified data aggregation for research purposes, in a model based on tagged data elements that embed privacy rules, policies and applicable patient preferences in the metadata traveling with each data element.
- As the necessary counterpart to technical security measures, propose an appropriate structure of administrative, civil, and criminal penalties for the misuse of a national health IT infrastructure and individual patient records, wherever such data may reside.
- Appoint a working group of diverse expert stakeholders to develop policies and standards for the appropriate secondary uses of healthcare data. This could be tasked to the Interagency Coordinating Council for Comparative Effectiveness Research.
- With FDA, bring about the creation of a trusted third-party notification service that would iden¬tify and implement methods for re-identification of individuals when data analysis produces important new findings.
Other or multiple agencies:
- AHRQ should be funded to develop a test network for comparative effectiveness research. The FDA, and also other HHS public health agencies, should enable medical researchers to gain access to de-identified, aggregated, near-real-time medical data by using data element access services.
- HHS should coordinate ONC activities with CDC, FDA, and any other entities developing adverse event and syndromic surveillance networks.
- The Department of Defense and the Department of Veteran Affairs should engage with ONC and help to drive the development of standards for universal data exchange of which they can become early adopters
