March 18, 2013, 2:14 PM — U.S. House lawmakers plan to hold a three-day series of hearings to determine how the U.S. Food and Drug Administration should regulate mobile health applications.
The House Energy and Commerce Committee plans to begin the hearings Tuesday, amid concerns that FDA regulations may stifle application programming innovation.
On March 1, 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 they said could harm innovation and the economic benefits of the U.S. mobile marketplace.
The FDA has yet to issue final guidance about how it plans to regulate mobile applications, but its draft guidance stated that regulations would apply only to those technologies that are marketed for medical uses.
David Collins, senior director of mobile at the Healthcare Information and Management Systems Society (mHIMSS), said the FDA is expected to come out with its regulatory guidance within the next six months.
"For regulations, we need to have a long-term safety net for predictable regulation guidance that helps developers balance innovation with safety and security. Maintaining the integrity and trust between providers, patients and technology developers is key to engaging patients in their care with their providers," Collins said.
Collins said there will be benefits if the taxes and regulations under consideration can help fund innovation and support mobile health initiatives.
"For instance, take a look at the enhanced 911 surcharge, everyone is paying that fee and it's so clearly a win-win for everyone. If an mHealth app tax is proposed that has a similar end goal, then that's great," he said.
In 2011, the FDA proposed regulating mobile medical apps under either one of two conditions: That the apps were used as an accessory to a medical device already regulated by the FDA, or to transform a mobile device into a regulated medical device by using attachments, sensors, or other devices, presuming the manufacturer marketed the product for medical use.
The hearings will focus on how future FDA regulations could affect developers, physicians and patients.