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E PCAST Report Recommendations 1 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 in- frastructure. 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 recommendations 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 man- ner 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. 1 Excerpted from: PCAST (President’s Council of Advisors on Science and Technology). 2010. Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward. ostp/pcast-health-it-report.pdf. 281

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282 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM • Act to establish initial minimal standards for the metadata associ- ated 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 indi- vidual products should focus on interoperability with the reference implementations. • Set standards for the necessary data element access services (specifi- cally, 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-re- sourced physician practices, community-based long-term care fa- cilities, 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 pos- sible 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 confi- dence 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 implemen-

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283 APPENDIX E tation by 2014. CMS must transition into a modern information technology organization, allowing integration of multiple compo- nents 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 ac- celerate the implementation of health information exchange using tagged data elements. By 2013, meaningful use criteria should in- clude 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 profession- als 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 agen- cies (including FDA, CDC, NIH, and AHRQ) and benefits payment systems (CMS and VA). • Convene a high-level task force to align data standards, and popu- lation research data, between private and public sector payers. • Convene a high-level task force to develop specific recommenda- tions on national standards that enable patient access, data ex- change, 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 travel- ing with each data element. • As the necessary counterpart to technical security measures, pro- pose 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 health- care 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 noti- fication service that would identify and implement methods for re- identification of individuals when data analysis produces important new findings.

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284 DIGITAL INFRASTRUCTURE FOR THE LEARNING HEALTH SYSTEM Other or multiple agencies • AHRQ should be funded to develop a test network for compara- tive 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.