The Food and Drug Administration, in collaboration with the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology, will soon publish a proposed strategy and recommendations on a risk-based regulatory framework for health IT, FDA Commissioner Margaret Hamburg, M.D., told a Senate committee hearing this morning. The report, mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA), was due to Congress by January but has been delayed.
"Implementing FDASIA is a considerable undertaking, requiring detailed planning to integrate these tasks with the rest of FDAs workload. All told, the 140-page law called for multiple deliverables of all types, including more than 30 proposed and final rules, more than 40 draft and final guidance documents, more than 20 reports to Congress, and many other additional reports," according to Hamburg's testimony before the Senate Health, Education, Labor and Pensions Committee.
At HIMSS14, a panel of FDA, FCC and ONC officials indicated that the agencies' goal is to issue the health IT report to Congress by the end of March.
Hamburg said that the FDA, working with the FCC and ONC, convened a working group of external stakeholders and experts under ONCs Health IT Policy Committee to provide input on the strategy and recommendations for the report to Congress, and that the committee adopted in full the working groups recommendations. When completed, the risk-based regulatory framework for health IT will "promote innovation, protect patient safety, and avoid duplicative regulation," she said, and will include mobile medical applications.
"Complementary to the FDASIA section 618 report in development, on September 25, 2013, FDA published its final guidance on mobile medical applications," Hamburg testified before the Senate committee. "FDA issued the mobile medical apps guidance to provide clarity and predictability for manufacturers of mobile apps. This guidance informs manufacturers, distributors, and other entities about how FDA intends to apply its regulatory authorities to software applications intended for use on mobile devices that perform the same functions as traditional medical devices."
Nevertheless, one technology area that wasn't covered in the FDA's September 2013 final guidance on mobile medical apps but will be addressed in the FDASIA-mandated report to Congress is clinical decision support software.
Congress, however, could reduce FDAs authority over health IT in coming months if proposed legislation becomes law. In October 2013, a bipartisan bill called the SOFTWARE Act was introduced in the House of Representatives to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA's regulatory authority over mobile medical apps. Last month, the PROTECT Act, a companion bill, was introduced in the Senate. Both the SOFTWARE Act and the PROTECT Act would exempt so-called "health software" and "clinical software" from FDA oversight.
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