Do you want the Food and Drug Administration (FDA) to regulate your smartphone? Many in the booming digital health industry are indifferent to the risks of the FDA regulating apps as medical devices. As I noted in a recent Health Alert, the FDA’s current doctrine is to allow most new apps onto the market without regulation. However, this openness is defined only in rules written by the FDA itself, not legislation. Rep. Marsha Blackburn and others in Congress have proposed to amend the law to prevent the FDA from overreaching.
Entrepreneurs and patients who think that the FDA’s current posture is eternal should be aware of a campaign to regulate apps for health. Here’s a recent article from Mother Jones:
Online retailers like iTunes and Amazon offer thousands of apps promising all kinds of real-time information about your body — they can measure blood pressure, take your pulse, track your menstrual cycle, and tell you how well your lungs are working. Mobile health is one of the fastest-growing app categories: According to the consulting firm research2guidance, there are 100,000 mobile health apps on the market, double the number available two and a half years ago. The industry is worth some $4 billion today, and analysts predict that it will reach $26.5 billion by 2017.
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