National health information technology (HIT) standards have been fast-tracked by the American Recovery and Reinvestment Act of 2009 (ARRA)—the $787 billion economic stimulus package that became law on February 17, 2009. ARRA expands and expedites the processes for developing and implementing national HIT standards. It establishes a public-private framework for the rapid identification of HIT standards to set the foundation for the national health information infrastructure. It provides congressional endorsement of the Office of the National Coordinator of Health Information Technology (ONCHIT) as a unit of the Department of Health and Human Services (DHHS) to shepherd adoption and implementation of HIT standards. ARRA also creates a federal council to coordinate and advance comparative effectiveness research to improve the quality of health care.
Federal Framework for HIT Standards Development and Adoption
Executive Order 13335, issued April 27, 2004, created ONCHIT to advance the prior President’s goal for a “majority of Americans to have access to electronic health records (EHRs) by 2014.” On June 3, 2008, ONCHIT issued “The ONC-Coordinated Federal Health IT Strategic Plan” to lay a framework for achieving that goal. On January 16, 2009, DHHS recognized as national HIT standards six interoperability specifications adopted by the Healthcare Information Technology Standards Panel (HITSP), a public-private cooperative body established to set standards that enable and support interoperability among healthcare software applications.
ARRA accelerates the process for adopting national HIT standards and resets the goal as “the utilization of an electronic health record for each person in the United States by 2014.” ARRA directs ONCHIT, in consultation with other federal agencies, to update “The ONC-Coordinated Federal Health IT Strategic Plan.” ARRA further directs DHHS to set by rulemaking not later than December 31, 2009 an “initial set of standards, implementation specifications, and certification criteria” for national interoperability HIT standards. DHHS may use any existing national interoperability HIT standards that DHHS has already recognized, such as the six HITSP interoperability specifications, in meeting its December 31, 2009 rulemaking deadline.
Public-Private Collaboration for HIT Standards Development
HIT Policy Committee. ARRA establishes a HIT Policy Committee as a federal advisory committee “to make policy recommendations” regarding implementation of the national HIT infrastructure. The HIT Policy Committee is to be led by the ONCHIT National Coordinator and is to have a membership drawn from DHHS, other federal agencies, Congress, and a broad range of private sector health care stakeholders. ARRA directs the HIT Policy Committee to ensure “the participation in [its] activities . . . of outside advisors, including individuals with expertise in the development of policies for the electronic exchange and use of health information, including in the areas of health information privacy and security.”
HIT Standards Committee. ARRA establishes a HIT Standards Committee as a federal advisory committee to recommend “standards, implementation specifications, and certification criteria for the electronic exchange and use of health information.” The HIT Standards Committee is also to be led by the ONCHIT National Coordinator and is to have a membership that reflects “providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and individuals with technical expertise on health care quality, privacy and security, and on the electronic exchange and use of health information.” As with the HIT Policy Committee, ARRA directs the HIT Standards Committee to ensure “the participation in [its] activities . . . of outside advisors, including individuals with expertise in the development of standards for the electronic exchange and use of health information, including in the areas of health information privacy and security.”
National eHealth Collaborative. ARRA allows the National eHealth Collaborative—the non-government successor of the DHHS advisory committee, the American Health Information Community—to be recognized by DHHS as either the HIT Policy Committee or the HIT Standards Committee.
Federal Implementation for Adopted HIT Standards
As federal agencies acquire, implement or upgrade HIT systems used for the direct exchange of individually-identifiable health information between the federal agencies and with non-federal organizations, the federal agencies will be required to use, as available, HIT systems and products “that meet standards and implementation specifications” adopted by DHHS through the public-private collaboration process established by ARRA.
Federal agencies involved with “promoting quality and efficient health care in Federal government administered or sponsored health care programs” must include in their contracts with health care providers and health plans requirements that, as the providers and health plans acquire, implement or upgrade their HIT systems, they use, as available, HIT systems and products that meet the HIT standards and implementation specifications adopted by DHHS. ARRA makes clear these requirements do not apply to these health care providers and health plans with respect to their private, non-federal business activities.
Federal Support for Comparative Effectiveness Research
Comparative effectiveness research examines clinical evidence to determine which medical procedures, medications and technologies are most effective. ARRA establishes the Federal Coordinating Council for Comparative Effectiveness Research to “foster optimum coordination of comparative effectiveness and related health services research conducted or supported” by federal agencies, including DHHS, the Department of Veterans Affairs and the Department of Defense. The goal of this coordination is to “reduc[e] duplicative effort and encourag[e] coordinated and complementary use of resources.” ARRA tasks the Council with advising the President and Congress on “strategies [for] the infrastructure needs of comparative effectiveness research within the Federal Government” and the “expenditures for comparative effectiveness research by relevant Federal departments and agencies.” ARRA restricts the Council from “mandat[ing] coverage, reimbursement, or other policies for any public or private payer.”
The Council is to consist of up to 15 federal officials with responsibility for health-related programs. Its membership must include representation from each of the following federal agencies: (i) the Agency for Healthcare Research and Quality, (ii) the Centers for Medicare and Medicaid Services, (iii) the National Institutes of Health, (iv) ONCHIT, (v) the Food and Drug Administration, (vi) the Veterans Health Administration, and (vii) the office that manages the Department of Defense Military Health Care System. At least half of the Council’s membership must be physicians or others “with clinical expertise.” The Council is to be chaired by the Secretary of DHHS. The Council’s first report—to contain descriptions of federal activities on comparative effectiveness research and recommendations for comparative effectiveness research to be “conducted or supported” with federal funds—is due to the President and Congress by June 30, 2009.