ARRA Updates—Week of August 16

A flurry of ARRA-related activity this week, in part driven by some August 18 deadlines for the data breach notification provisions.

The Federal Trade Commission and the Department of Health and Human Services both have final breach notification rules in hand, though neither has been published in the Federal Register. Publication is expected in the coming days, possibly as soon as tomorrow.

The HHS regulations apply to covered entities under HIPAA. The FTC rule addresses noncovered entities, in particular, vendors of personal health records.

Both rules stick close to the programs as described in ARRA. In time FTC is expected to turn over its responsibilities to HHS, but until then the industry will have to navigate both regulations. (Look for full analysis once the rules are published

HHS had a second deadline this week to issue final guidance on securing protected health information. The guidance relates to the data breach regulations, specifying the methods that render PHI unusable, unreadable, or indecipherable to unauthorized individuals. HHS issued a proposed rule in April, with final guidance to come.

The Health IT Policy Committee, created under ARRA to advise HHS’s Office of the National Coordinator for Health IT, accepted a subcommittee recommendation that multiple bodies be authorized to certify health IT products as part of the ARRA “meaningful use” adoption incentives. The full committee in turn made the recommendation to the Office of the National Coordinator, which in coordination with the Centers for Medicare and Medicaid Services, will ultimately determine the details of the program this fall. The committee recommended that the Certification Commission for Healthcare Information Technology, the only current certifying body, serve solo in the near-term.

Today HHS secretary Kathleen Sebelius and vice president Joseph Biden held a press event highlighting the $1.2 billion in ARRA provisions for regional health IT centers and a nationwide health information exchange network.

On Tuesday, the Agency for Healthcare Research and Quality announced it will publish grant and contract solicitations for comparative effectiveness research this fall. ARRA appropriated $300 million for the program.

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