mHealth Needs Evidence, Evaluation
By Katie Wike, contributing writer
FDA Commissioner explained at the recent mHealth summit in Washington DC just what mHealth needs to be scientific rather than trendy
FDA Commissioner Margaret Hamburg said in her keynote speech at the mHealth summit held recently in Washington, DC, “Each of the new medical products we approve and usher to the market involves a balancing of risks and benefits, which is based on study and evaluation of hard data and the best available science. It is a huge responsibility that FDA is charged with, nowhere more so than when dealing with unfolding technologies that offer enormous potential - but also may present real risks for people and their health.”
Hamburg said, earlier in her speech, “I strongly believe our focus can’t be just be on, as the author Michael Lewis termed it, the latest ‘New, New Thing’ – no matter how jazzy those technological developments may be.”
FierceHealth IT, which notes Hamburg admitted she bought her first iPhone only two weeks before, further quotes her as saying, "I may be a late adopter, but I recognize that the world is transforming. Certainly, the FDA has understood the value of scientific computation to support our mission and the advancement of health."
FierceHealth IT writes of Hamburg’s comments, “The FDA must ensure healthcare apps are safe, effective and reliable. The recently-released final medical app guidance makes clear that if a mobile platform is a medical device, the FDA will continue to regulate it. It's about the functionality, not the platform, and for the many mobile apps that are less risky for consumers to use, such as weight trackers, the FDA will exercise discretion.”
Hamburg believes it is the FDA’s responsibility to ensure that mobile medical apps are reliable, safe, and effective. The FDA released guidelines in September which regulate apps, specifically those which the agency has designated as having the most risk due to misuse. Apps which pose a low risk or simply help with disease management will be regulated with the FDA’s discretion.
Hamburg said, "Medicine alone without proper context, thought and appropriate care will fall short," adding, "It's up to all of us to make sure [mobile health technology] is used appropriately"
Still, there is work to be done. SearchHealthIT quotes Robert Jarrin, mHIMSS advisory council chair, who testified before Congress in November on mHealth regulation, as saying, “Despite the FDA's guidance, there's still a struggle on Capitol Hill to find the balance between promoting patient safety and inadvertently stifling innovation through regulation.”
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