Congress To Hold Additional Hearings On Medical App Regulation and Security

6-24-2013 9-53-36 PM

On Thursday, the House Subcommittee on Health and Technology will hold a hearing titled “Mobile Medical App Entrepreneurs: Changing the Face of Health Care,” during which members will hear testimony from AirStrip CEO Alan Portela, Ideomed CEO Keith Brophy, and University of Buffalo systems engineering PhD candidate Sabrina Casucci.

The sessions are expected to focus on the challenges that medical app developers are facing, the need for increased security standards in the mHealth market, and federal regulation.

AirStrip CEO Alan Portela is in good position to weight in on security standards in the mHealth market, as he just led his company through the US Air Force’s strict DIACAP certification process, which validates security standards used in an application and authorizes their use on DoD networks. As a result, AirStrip is now the only mHealth app approved for use within the DoD’s network.

Federal regulation is also likely to be a hot topic as the industry at large waits for the FDA to publish its final regulatory framework for the medical app market. The FDA promised to publish its regulations as soon as possible following Congressional hearings this past March. After three months of inaction, the industry pushed back this week when the mHealth Regulatory Coalition sent a letter to HHS Secretary Kathleen Sebelius calling for the regulations to be published as soon as possible.

"The MRC believes the timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community. Guidance is needed by industry and will help unlock investment in the mHealth market. Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear." – Bradley Merrill Thompson, attorney representing mHealth Regulatory Coalition.

The letter goes on to suggest that investors are incorrectly assuming that the FDA will take an overly assertive approach to regulating the market, and that once regulations are made public investors will feel reassured and entrepreneurs will start to see renewed access to much needed capital.

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