On the heels of the FDA issuing its final guidance on mobile medical applications, a Congresswoman is gearing up legislation that would arm the agency with more authority and resources to that end.
Rep. Marsha Blackburn (R-Tenn.) said at the Telecommunications Industry Association conference held Oct. 8-10 here that she will introduce a bill that would require the FDA to regulate mobile health-related applications, though she did not say when exactly she would propose 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,” Blackburn is quoted as saying in a HIMSS news update.
Blackburn’s bill would provide FDA with the authority and resources to protect consumers from “high-risk technologies” without regulating low-risk health related mobile apps, and would attempt to avoid stifling innovation, HIMSS reports. Blackburn also indicated she would be conscious of not creating an overly expensive and time consuming regulatory process.
Blackburn added that she wants to encourage the new technologies to improve healthcare and create fresh jobs.
[See also: 3 types of mHealth apps the FDA will regulate.]
Blackburn’s announcement follows the Sept. 23 release of the Food and Drug Administration’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 Sept. 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 use a smartphone as an ECG to detect abnormal heart rhythms).
[See also: 6 types of mHealth apps for which the FDA will 'exercise enforcement discretion'.]
In the past, Blackburn has issued a number of other health-related bills, including HR 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, hopefully with a downward impact on prices.
She has also introduced H.R.1468, Strengthening and Enhancing Cybersecurity by Using Research, Education, Information, and Technology Act of 2013 (SECURE IT) 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.
This article originally appeared on mHealthNews.com.
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