mHIMSS executives say FDA regulation won't hold back app innovation

“Venture funding for healthcare start-ups is at an all-time high.”
By Diana Manos
10:27 AM

Q: One of the panel members said something about Congress taking charge of app regulation. Do you see this ever happening?

A: The hearings highlighted the need for predictable and timely regulation. Both congress and the executive branches should work together. The FDA continues to exert restrained regulatory oversight and noted that the timeframe for a formal medical device review is within its congressionally mandated limits of 90 days (average time is 67 days for the review of a medical device submission). The more interesting discussion that did go unnoticed is the role of providing outreach to the development community. HIMTA, introduced in the 112th Congress, was a potential stepping stone to further assist the development community. In addition, the emerging role of the FDA Safety Innovation Workgroup was largely ignored by the committee in favor of focusing on the taxation issue, which was largely addressed by Congressman Waxman and Ms. Foreman.

Q: What so you think about the healthcare app market as a whole. Any predictions for the future?

A: Valuations of these innovative companies will continue to grow. The breadth and depth of patient engagement will also continue to grow with these apps. 

[See also: Where is the 'fine line' between safety and free rein for mobile development?

[See also: Healthcare apps: ripe for the picking?]

 

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