Carmel, CA FDA Analyzing Mobile Health Apps Which Are Being Developed Fast And Furiouslyby Richard Kuehn on 07/04/12
Advances in technology continue to come at a rapid clip, and the Food and Drug Administration (FDA) is now scrambling to analyze the more than 40,000 medical apps which are available for smartphones, tablets and other devices. Although they offer myriad options to analyze your health, from monitoring blood pressure and sugar levels to analyzing Electrocardiam (EKG) Rhythyms via an interpretation guide, the apps haven't been through rigorous medical testing. Some worry that mistakes may be made if consumers rely too heavily on these apps. Until now, the market has been completely unregulated. But last year, the FDA began to draft guidelines that require developers that are making medical claims to apply for FDA approval, the same process the maker of a medical device would have to go through. Although this will not make many friends for the FDA in the mobile app development community--this process will be expensive and time consuming--it must be done when looking at important tests like an EKG. The latter app was designed for health care professionals but priced at just $0.99, it's likely being downloaded by consumers as well. One developer's reaction to a reporter at USA Today was, "The FDA's current regulatory process was created when the floppy disk was around," said Joel White, executive director of the Health IT Now Coalition. Alain Labrique, who directs a global initiative at Johns Hopkins University says the FDA program will delay some development but it's a needed consumer safeguard. He said many apps are a lot of hype with very little evidence. Although we want innovation in medical devices," we also want to protect the public and be sure that medical claims are supported by data assessment and some comparison to a gold standard," I agree. Mobile apps are appealing to a wider and wider demographic, with many seniors adopting smartphones. The last thing we need is someone relying on a mobile app for medical advice which hasn't been through rigorous testing. This could be extremely dangerous. I am, however, very bullish about devices that are used in conjunction with a physician. I wrote recently on my blog, for instance, about a secure handheld device where diabetics can check their blood sugar levels and the results are databased on a secure server where both the doctor and patient can analyze the tests. I hope more devices like these hit the market to monitor chronic diseases.