Thursday, August 11, 2011

FDA Mobile Health Application Regulations

Right now there are an estimated 17,000 medical apps in use. By 2015, the FDA expects that 500 million smartphone users around the world will be using some kind of healthcare app.

Those are staggering numbers. It is understandable that the FDA sees the need to assert a degree of regulatory guidance over what the agency calls ‘mobile medical applications,’ and has proposed a set of guidelines to do just that.

Our first solution, AirStrip OB, was cleared by the FDA back in late 2005 and first marketed in 2006. It was also the first FDA-cleared app to be made available in the App Store. In reviewing the proposed guidelines, it appears AirStrip’s compliance activities have blazed a trail for other mobile apps to follow.

We knew from the start that we wanted to work closely with the FDA to ensure a high level of quality compliance, due to the innovative intended use of AirStrip Technologies applications. AirStrip gladly chose to do this at the time and will continue to do so. 

The proposed FDA guidelines mirror the compliance efforts AirStrip Technologies has engaged in since its inception. AirStrip has benefited greatly from committing to rigorous quality compliance. An excellent safety record and growing market share tell the industry that AirStrip’s leadership in this regard is hard-earned and well-deserved.

While all AirStrip applications - including CARDIOLOGY and PATIENT MONITORING - are FDA cleared, many other apps in the marketplace are not.

The FDA is indicating that medical apps that do not adhere to agency standards will fall under increased scrutiny for non-compliance. Those app creators will now be expected to offer a level of documentation that they are likely not used to providing, and this will surely alter the mobile medical app landscape. At the same time, true innovation that shows a commitment to quality compliance in the interests of patient safety should have ample room to flourish.

The FDA is now seeking comments online or in writing. The public comment period ends October 19, 2011. You can find more information about the FDA action here.


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  3. Bradley Merrill Thompson, an FDA medical device regulation expert and lawyer with EpsteinBecker, has penned a series of very popular articles on mobile health (mHealth) regulation for MobiHealthNews during the past year. Thompson’s FDA regulation series pulled from FDA workshop meetings, political speeches, questions posed by mHealth luminaries, and his own vast wealth of knowledge regarding FDA policies.automateandvalidate

  4. That’s about to change. The agency is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape they’ll encounter in the future, but they’re also nervous that overly broad rules will stifle innovation. 
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