U.S. Rep. Marsha Blackburn (R-Tenn.) intends to introduce a bill that would require the U.S. Food and Drug Administration to regulate mobile health-related applications.
Blackburn made the announcement at the Telecommunications Industry Association conference on Oct. 8-10 in Washington, D.C. – though she didn't say when she would submit the bill.
“There are 97,000 health-related mobile apps in the Apple App store, and health providers and patients are turning to mobile devices more and more,” she said in a HIMSS news update.
According to HIMSS, Blackburn proposes to provide the FDA with the authority and resources to protect consumers from “high-risk technologies” without regulating low-risk health-related mobile apps, and would do so without stifling innovation. She also said she doesn't want to create an expensive or time-consuming regulatory process.
Blackburn said she wants to encourage new technologies to improve healthcare and create fresh jobs.
Blackburn’s announcement follows the September 23 release of the FDA's final guidance for mobile medical application developers, which promised limited regulation for most health and wellness apps while applying risk-based standards to diagnostic and quasi-medical device apps.
The FDA will exercise “enforcement discretion,” under the Federal Food, Drug & Cosmetic Act, for the majority of mobile apps “as they pose minimal risk to consumers,” FDA officials said in a September 23 news release. Among those are apps helping patients self-manage their disease or conditions “without providing specific treatment or treatment suggestions,” such as for tracking exercise and diet, automating health tasks or communicating with providers via EMRs.
Instead, the FDA will focus “on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended,” such as apps designed to detect melanoma. The FDA generally categorizes medical apps it will regulate into those intended for use as a medical device accessory (like an app that lets clinicians view medical images on a smartphone or tablet) and those using mobile platforms as a medical device (like an app that uses a smartphone as an ECG to detect abnormal heart rhythms).
Blackburn has issued a number of other health-related bills, including H.R. 762, The Health Care Choice Act, to allow Americans to buy insurance policies across state lines. The bill’s intent is to allow insurance companies to more effectively compete for business regionally and nationally, with an anticipated downward impact on prices.
She has also introduced H.R.1468, The Strengthening and Enhancing Cybersecurity by Using Research, Education, Information and Technology Act of 2013 (SECURE IT), designed to authorize private entities to develop and employ countermeasures and cybersecurity systems. H.R.1468 would allow private entities, including nonfederal government agencies, or state, tribal or local governments to voluntarily disclose cyber threat information to designated cybersecurity centers to prevent and mitigating threats to information security.
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