Committee Leaders Concerned Regulations Could Harm Innovation and Increase Costs for Consumers
WASHINGTON, DC – The Energy and Commerce Committee today announced the Subcommittees on Communications and Technology, Health, and Oversight and Investigations will hold a “Health Information Technology” hearing series March 19-21 to discuss the critical role of technology in the health care industry and how federal regulations could threaten patient safety and innovation and increase costs for consumers. On March 1, 2013, committee leaders wrote to FDA Commissioner Margaret Hamburg seeking more information on possible FDA regulation of smartphones, tablets, and mobile apps through Obamacare’s medical device tax, which could harm the innovation and economic benefits of the U.S. mobile marketplace.
On Tuesday, March 19, the Communications and Technology Subcommittee, chaired by Rep. Greg Walden (R-OR), will explore how FDA regulations and taxes could impact innovation in mobile applications and devices. On Wednesday, March 20, the Health Subcommittee, chaired by Rep. Joe Pitts (R-PA), will discuss how technological advancements benefit patients and discuss ways to ensure that innovation continues. On Thursday, March 21, the Oversight and Investigations Subcommittee, chaired by Rep. Tim Murphy (R-PA), will hear directly from FDA and HHS to obtain more information on the Obama administration’s perspective and future plans. More information will be posted here as it available.
“Most Americans have no idea that their smartphone, tablet or the mobile apps that have become part of their daily lives could be subject to added red tape or a new tax under Obamacare. Over a three day span next week, we will explore how regulation would affect growth and innovation and look to hear directly from innovators, doctors, patients, and government witnesses who are considering the new tax,” said Energy and Commerce Committee Chairman Fred Upton (R-MI).
House lawmakers to examine regulation of medical apps
By Hayley Tsukayama
House lawmakers said Tuesday that they will conduct a three-day series of hearings next week to look at how the Food and Drug Administration should regulate medical applications on smartphones and tablets. Lawmakers from the House Energy and Commerce committee will look specifically at how regulation affects patients, physicians and developers looking to capitalize on the growing field of mobile health and medical apps.
The hearings follow a letter the committee sent to the FDA earlier this month, in which lawmakers questioned whether the Patient Protection and Affordable Care Act could allow the FDA to define smartphones and tablets with health-related apps as “medical devices” — and levy new taxes on developers and smartphone makers under the health-care law.
That’s been a concern for developers, who often operate with very narrow margins, said Rep. Marsha Blackburn (R-Tenn.), the committee’s vice chairman. Blackburn said she’s concerned that the possibility of these taxes could discourage developers from making health-related apps.
“We don’t want to see their research and development restricted” by new taxes, she said. 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.”
When asked for comment on the committee’s letter, FDA spokeswoman Synim Rivers confirmed the agency will respond to the letter, but declined further comment.
The market for health-related apps is already growing quickly. The market for mHealth app services will reach $26 billion by 2017, up from $718 million in 2011, according to a study from the consulting firm Research2Guidance.
In a best-case scenario, patients could use these apps to track valuable information, such as blood sugar levels or heart rates, which could help them work with their physicians to monitor their long-term health. But having apps collect all of that sensitive data also raises privacy concerns about how developers can use and repurpose that information.
The FDA has been mulling these issues for a couple of years, having been charged to devise a strategy that balances both innovation and privacy concerns.
In 2012, Congress gave the FDA the green light to define which medical apps would require its attention. The agency has asked for comment on a proposal that would give it regulation authority over accessories to existing medical devices, such as apps that show MRI scans, as well as apps and accessories that transform mobile devices into regulated medical devices, such as attachments or apps that turn smartphones into heart monitors. But the agency has yet to issue final guidance on the matter.
Blackburn said that lawmakers will be asking the FDA as well as the Department of Health and Human Services for clear guidance on the matter in the hearings next week.
On Tuesday, the committee’s subpanel on technology will speak with developers to look at how consumers are using existing health and fitness apps. The following day, the subcommittee on health will examine how health-care practitioners and patients use these kinds of apps for diagnoses. The series will wrap on Thursday, when the subcommittee on oversight and investigation hears testimony from the FDA and HHS officials.
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