More delay on FDA guidance on mobile medical apps? (US)

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It sure looks like it. S.3187, proposed by Sen. Tom Harkin of Iowa, holds up health IT and mobile medical guidance by wrapping it up into a reauthorization of the user fee programs that fund the FDA’s reviews of prescription drugs and medical devices. In fact, Harkin’s bill demands, according to a post on the HIMSS website, a review process that could take over 18 months after passage of the act. In the post, the Harkin bill proposes:

The Secretary of Health and Human Services “may issue final guidance on medical mobile applications” only after submitting to the Senate, “Not later than 18 months after the date of enactment of this Act…a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to medical device regulation and health information technology software, including mobile applications, that promotes innovation and protects patient safety…the Secretary shall convene a working group of external stakeholders and experts to provide appropriate input on the strategy and recommendations required for the report.”

FierceMobileHealthcare spoke with Bradley Thompson of Epstein Becker Green, who has been a guiding force in moving FDA forward on mobile health issues: ‘He and other proponents are “actively talking with Senate staff” about the FDA’s timeline, and pushing for the guidance “not to be held up.”‘ Based on the proposed legislation, it’s beginning to feel like 2014–and what should move forward quickly becomes a political football.