House hearings underway on mobile health regulations
Continuing to pressure the U.S. Food and Drug Administration on whether it intends to regulate smartphones, tablets and mHealth apps as medical devices under the Affordable Care Act, the House Energy and Commerce Committee will hold a three-day series of hearings beginning this morning to "look specifically at how regulation affects patients, physicians and developers looking to capitalize on the growing field of mobile health and medical apps," according to a Washington Post blog post.
The scheduling of the hearings follows a March 1 letter that six Republican committee members sent to the regulatory agency warning that if the FDA determines that certain smartphone, tablet, or mobile medical apps are devices under ACA, "it raises the possibility that they would also be subject to new taxes" that "could affect the growth and innovation" of the mHealth industry overall.
Rep. Marsha Blackburn (R-Tenn.), the committee's vice chairman, says she's concerned that the possibility of these taxes could discourage developers from making health-related apps, according to the Post.
"We don't want to see their research and development restricted" by new taxes, Blackburn said, according to the Post. "We're hearing from our innovators that they're concerned--not only with the what-ifs [such as] what are they going to begin to classify as a medical device, but also how intrusive is this going to be into the health care monitoring, disease maintenance and management."
Blackburn added that the committee members will be asking the FDA, as well as the U.S. Department of Health & Human Services, for "clear guidance" on the matter in the hearings.
Today, the committee's subpanel on technology will speak with developers to look at how consumers are using existing health and fitness apps. Tomorrow, the subcommittee on health will examine how health-care practitioners and patients use these kinds of apps for diagnoses. On Thursday, the subcommittee on oversight and investigation will hear testimony from FDA and U.S. Department of Health & Human Services officials.
To learn more:
- read the Washington Post blog
Legislation to call for creation of FDA Office of Mobile Health
Obama signs FDA safety bill, affirming agency's role in medical app guidance
FDA mobile medical app guidance faces delay to 2013