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Breaking Digital Health News: Congress Permits FDA to Proceed with its Mobile Medical Apps Guidance

June 20, 2012

I sent the following announcement to 11,350 Digital Health group members on June 19, 2012:

Dear group members,

I heard some great news yesterday from the mHealth Regulatory Coalition’s Brad Thompson and Jason Brooke

Here is a note from Brad, which he sent to me for the purpose of sharing with the group:


Last night the mobile health industry avoided a big stumbling block with the help of Congress.

Over the last several weeks, a debate has been raging on Capitol Hill regarding whether Congress should step in and slow down the FDA process for clarifying the scope of the agency’s regulation of mobile apps. On the one side, those who oppose FDA regulation were seeking a delay in the FDA guidance, pending a substantial review by a variety of stake holders including other agencies and the Congress itself. On the other side, those who acknowledge that FDA has a legitimate role to play wanted to avoid any delay, in the desire to get needed clarity around the scope of FDA regulation so that industry and investors could move forward. In the end, in section 618 of FDA Safety and Innovation Act released last night, Congress directed that FDA and other stakeholders would study the issue further, but did not prevent FDA from finalizing its guidance in the meantime. Many in industry breathed a sigh of relief.

The legislation had passed both the House and Senate and had been undergoing a reconciliation between the two versions for a couple of weeks. In producing the final legislation, the House and Senate Conferees blended the two different bills to produce section 618, which requires HHS to produce a report, with input from FDA, ONC, and FCC, on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.” It (is) pretty hard to argue with that.

HHS may, if it wants to, convene a working group to aid in the development of that report. That working group would include folks outside government with a stake in the issue, such as venture capital investors, HIT vendors, small business owners, and the like. This should be interesting to watch.

Brad Thompson
General Counsel, mHealth Regulatory Coalition


For background, here are a few previous group discussions on the topic:

More one-sided bashing of FDA: While healthcare apps are on the rise, the FDA threatens to stifle innovation in the U.S.
Senate passes MDUFA bill with moratorium on FDA’s draft guidance of mobile medical apps
Mr. Sonnier goes to Washington
MRC Releases Proposed mHealth Guidance for FDA, Requests Comment from Other Stakeholders
FDA (finally) announces draft regulations for mobile medical apps
The mHealth Regulatory Coalition met with FDA to present the Coalition’s paper on: “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth”

Best regards,
Paul Sonnier

Founder, 11,000+ member Digital Health group on LinkedIn
Head of Digital Health Strategy, Popper and Company
Mentor, Blueprint Health
Twitter: @Paul_Sonnier


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  1. Am not totally sure if this is a good or a bad thing. Hopefully, it will be something that will speed up the regulatory process while at the same time protecting the public.

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