New mHealth Regulatory Bill To Be Proposed This Week

10-14-2013 4-29-20 PM

Despite the FDA’s recent and long overdue publication on mobile health app regulation, Senator Marsha Blackburn of Tennessee has drafted a bill she plans to introduce this week that grants the FDA more authority and resources to address mobile health app regulation.

Speaking at a Telecommunications Industry Association event, she said  the bill “will provide the FDA with the tools it needs to effectively protect consumers from the high-risk technologies.” She goes on saying that the bill “will encourage the development of new technologies to improve healthcare … and create new jobs.”

Citing the 97,000 health-related mobile apps in the App store, Blackburn says her bill works to establish regulatory standards that protect consumers without subjecting low tech health apps to unnecessary oversight or complex regulatory processes. Its not clear at this point what her bill would address that is not already covered by the FDA’s new mHealth regulatory guidelines. It also seems unlikely that Congress would consider a bill like this in the midst of a government shutdown, so she’ll likely have to wait until that issue is resolved before she will be able to move her bill forward.

Blackburn is no stranger to health IT regulation. In 2012, she sent a letter to the FDA and FCC expressing concern that "complex regulatory framework" could "inhibit future growth and innovation in the market, and could preclude tools that help patients better manage their care." This past March during a subcommittee meeting on health, she further defined her position, saying of mHealth regulation that, "It’s up to Congress to decide what FDA’s role should be." In July, she proposed legislation that would amend the Food, Drug, and Cosmetic Act – which gives the FDA its authority – to include a definition of “medical health technology.”

Blackburn is not the only congressional representative pursuing regulatory changes for the mHealth market. Silicon Valley Representative Mike Honda proposed HR 6626, the Health Care Innovation and Marketplace Technologies Act. Honda’s bill preserves both the FDA and FCC’s regulatory authority in the mHealth market and goes on to authorize an mHealth development office within the Department of Health and Human Services.

Honda’s bill was referred to the House Small Business committee, the House Ways and Means committee, and the House Energy and Commerce committee for further evaluation nearly a year ago. His bill has no co-sponsors, a key predictor of how likely a bill is to come out of committee and eventually pass. Marsha Blackburn has not introduced her bill yet so there is no news on who, if anyone, will co-sponsor the bill with her, or which committees it will ultimately be referred to. If the bill is proposed without co-sponsors, it will very likely die in committee as most bills do.

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