The House Energy and Commerce’s Subcommittee on Commerce and Technology, Health, Oversight and Investigations held three days of hearings titled “Health Information Technology: Harnessing Wireless Innovation”. Potential regulations and taxes on smartphones, tablets, mobile apps, and federal regulations were discussed. In the three days, a number of witnesses expressed their viewpoints.
Robert Jarrin, Senior Director Government Affairs for Qualcomm Incorporated explained that on July 2011, the FDA issued a Draft Guidance on Mobile Medical Applications (MMA). Officials from FDA said that the final MMA guidance document would be de-regulatory. It is now March 2013, and the FDA has yet to release a final MMA guidance document. This has led to confusion, apprehension, and in some cases, reluctance by mobile health app developers to enter the market for fear of regulation
Representing the Newborn Coalition, Jim Bialick the Executive Director, told the Committee that medical apps are not medical devices so it was a surprise when the FDA issued their draft guidance to regulate mHealth apps as medical devices.
Benjamin M. Chodor, CEO, Happtique Inc., explained that unlike other aspects of the healthcare marketplace there is little to no barrier to entry into the health app market which means that basically anyone with an idea and programming skills can build a mobile health app but many are unaware of the regulatory landscape. What is needed is a balanced, risk-based approach to regulations.
Representing the mHealth Regulatory Coalition, Bradley Merril Thompson, General Counsel agreed that over regulating apps will negatively impact manufacturers and developers who have to comply with requirements that are disproportionate to the very low risk level of these products.
According to, Joseph M. Smith, MD, PhD, Chief Medical and Science Officer at West Health Institute, suggested “What is needed are streamlined, predictable, transparent, risk-based regulations, development of proactive regulations and reimbursement based on true functional interoperability, and development of a reimbursement policy that would align stakeholder’s incentives to drive the adoption of appropriate technology.”
After the multi-day hearing highlighted a great deal of uncertainty related to medical device taxes and regulations, FDA’s Christy Foreman, Director of the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH), informed the Committee members that FDA’s policy on mobile medical apps will not include the regulation of consumer’s smartphones or tablets.
She continued to say, “FDA is consulting with ONC and FCC and plans to prepare a report by January 2014 with a proposed strategy and recommendations for an appropriate risk-based regulatory framework for health IT that will include mobile medical apps.
Go to http://energycommerce.house.gov/hearing/health-information-technologies-harnessing-wireless-innovation for more information.