Despite FDA moves, push continues for Congress to act on mobile health
Apple, Intel and other digital health companies are winning their war against old-school medical device regulation. The industry that stands to make millions from mobile health tech has Food and Drug Administration regulations locked down, and it has the support of Congress, too. With the governmentâs approval, wearable monitors and health apps on iPhones are proliferating; the wearable electronic market is predicted to be valued at $11.6 billion by 2020. Story Continued Below A sustained lobbying campaign by tech companies that will profit from selling digital health has been successful so far. In recent weeks FDA has promised not to regulate technologies that receive, transmit, store or display data from medical devices, and announced it will keep its regulatory paws off most mobile medication applications as well. But thatâs not enough for the industry or members of Congress who say FDA promises, in the form of agency guidances, arenât enough. They want laws that assure industry it can innovate and sell its products without federal meddling. Rep. Marsha Blackburn (R-Tenn.), whose SOFTWARE Act is part of the House Energy and Commerce Committeeâs recently released 21st Century Cures draft legislation, said FDAâs guidance wasnât enough. Her bill, like a Senate version from Orrin Hatch (R-Utah) and Sen. Michael Benet (D-Colo.), would establish firm limits on the kinds of technology FDA could regulate. âIt is clear from the recent guidance documents released by the FDA that they intend to maintain regulatory discretion â that is, they can change the rules whenever they want. Guidance is not the way to go,â Blackburn said. âMy legislation will provide the clarity and transparency needed as well as codifying the proper authorities of the FDA.â Blackburn is working âwith stakeholders and the FDAâ on a draft of the bill that could appear soon, she said. In the meantime, with the FDAâs blessing, developers no longer have to make sure most medical data-displaying products are FDA-compliant, and most medical app developers wonât have to wait for the FDAâs approval before marketing an application. When the Apple Watch comes out this April, for example, it will contain an app â unreviewed by FDA â that allows a diabetic user to see information from a continuous glucose monitor. FDA wonât regulate the app because itâs an accessory to a device. Most health mobile app makers can release their products without pre-market submission to the FDA. Even apps that perform medical device functions will be regulated only if FDA determines they pose a potentially serious risk to a patientâs safety. âThe myriad of systems that record, share and use personal and health data have become a significant help for many of us by putting information at our fingertips to use when and where we think it might help promote a healthy lifestyle,â wrote Bakul Patel and Jeffrey Shuren of the FDAâs Center for Devices and Radiological Health in a blog post elaborating on the guidances. âThrough such smart regulation we can better facilitate innovation and at the same time protect patients.â The FDAâs guidances followed increased lobbying by the tech sector, including giant Intel, which purchased wearable technology manufacturer Basis Science last fall, and builds the chips that fuel health and all other kinds of IT. Intel last year spent at least $1.5 million lobbying on telehealth wearables, remote patient monitoring, the use of patient-generated data for meaningful use Stage 3 and other health IT issues. Appleâs lobbying has also surged. According to disclosure forms, the tech giant spent $1.2 million lobbying in the fourth quarter of 2014, including on issues related to health data and mobile devices and health. Apple declined requests for comment for this article. The FDA has been saying it would be relatively hands-off when it comes to digital health innovations, and the finalized guidance was a breath of fresh air for mobile health advocates. The guidances âprovide much needed ârules of the roadâ for e-health veterans and for start-ups,â said Alice Borrelli, director of global health policy at Intel. âFDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software,â said Bradley Merrill Thompson, general counsel of the mHealth Regulatory Coalition, which lobbied Congress on FDA mobile medical app guidance and regulation. âItâs exciting, because it means that innovation in this space can truly flourish.â FDA guidances have been influential and effective spurs to development, notes Josh Sharfstein, former deputy FDA commissioner and associate dean of the Johns Hopkins School of Public Health. âGuidance can be a pathway to help industry understand whatâs necessary for approval. A lot of action happens from guidance.â Yet the call for congressional action continues, although ostensibly industry has gotten what it wanted from the FDA. âWhile it is good to see the FDA acknowledging the types of low-risk technology where its oversight is not necessary, the guidance â¦ ultimately underscores the need [for] legislation like the SOFTWARE and MEDTECH Acts to give the industry certainty and clarity,â said Stephanie Zaremba of electronic health records vendor athenahealth. The Health IT Now coalition recently suggested that Blackburnâs SOFTWARE Act needs to be sharpened so even more software is exempt from FDA regulation. âCurrent regulatory uncertainty stifles healthcare innovation â¦ we believe Congress must act,â wrote Health IT Now Director Joel White. Rock Health, a seed fund, and Startup Health, a digital health âincubator,â which have funded and coached hundreds of digital health startups, applauded the FDA moves. Guidance on medical device data systems âlowers the barrier to entry dramatically,â said Malay Gandhi of Rock Health. âClarity and guidance like this from regulators makes it more likely that the worldâs best talent will keep investing time and resources into transforming health care,â said Unity Stoakes of StartUp Health, a group whose partners include Mark Cuban, AARP, the Robert Wood Johnson Foundation and Pfizer. While wearables may have won the hearts of lobbyists, investors and lawmakers, other regulators are sounding alarms. The Federal Trade Commission is wary of wearablesâ role in the Internet of Things, and digital health was central to the agencyâs report on the issue earlier this month. FTC Commissioner Julie Brill said recently the proliferation of mobile health apps and connected devices adds to the need for a Consumer Privacy Bill of Rights.