Congressional Panels Hold Hearings on Mobile Health
Mobile health technology is taking center stage this week with three House Energy and Commerce subcommittees holding hearings on how wireless innovation should be regulated and how it benefits patient safety.
The Communications and Technology Subcommittee started off Tuesday with members of the Republican majority blasting the 2.3% medical device excise tax and he possible implications for the mobile app industry.
The “wireless economy represents a tempting target for the 2.3 percent excise tax that the president’s health care law placed on medical devices,” said Rep. Greg Walden, R-OR, who chairs the subcommittee, in his prepared remarks.
Rep. Henry Waxman, D-CA, scoffed at the idea, saying most medical apps will fall under the Internal Revenue Service’s “retail exemption,” as they are readily available for purchase by regular consumers. Furthermore, “allegations that ordinary smartphones and tablets could be subject to added red tape or new taxes under Obamacare are absolute myths.”
Although lawmakers disputed over whether the tax could apply to smartphones and apps, there was general agreement that the U.S. Food and Drug Administration (FDA) needs to hurry up and issue final guidance on mobile medical applications (MMA). Witness Robert Jarrin, senior director of government affairs at Qualcomm, noted that the FDA issued the MMA draft guidance in July 2011, and the lack of a final word has only created uncertainty in industry.
He offered several steps the FDA could take in addition to finalizing the draft guidance, including having an office within the agency dedicated to mobile health.
Bradley Merrill Thompson, who was representing the mHealth Regulatory Coalition, a group that includes medical device manufacturers, smartphone healthcare application developers, cellular handset manufacturers, and network operators, agreed, adding that the agency could issue final guidance and expand it in the future. The FDA almost seems to be delaying until it has a complete, definitive guidance, he said in prepared remarks, something that is not possible in the rapidly changing mobile health environment.
In addition, the FDA should work with the Federal Communications Commission, the Office of the National Coordinator for Health Information Technology, and the Federal Trade Commission “to build a clearer and more predictable regulatory environment for these medical devices,” Thompson said. “Those agencies all have a certain expertise regarding wireless health technology and the healthcare sector will benefit from these agencies sharing their expertise with FDA.”
The other witnesses appearing in front of the committee were Ben Chodor, CEO of Happtique, which offers an app certification program; Jonathan Spalter, chairman of Mobile Future, T. Forcht Dagi, MD, partner at HLM Venture Partners, and George Ford, chief economist at the Phoenix Center for Advanced Legal and Economic Public Policy Studies.
Wednesday’s hearing, which took place in front of the House Energy and Commerce Committee’s Subcommittee on Health, addressed how health information technology (IT) can benefit patients. It featured A. Jacqueline Mitus, MD, senior vice president of development and strategy at McKesson Health Solutions, who argued in her prepared remarks that the current regulatory framework for devices is not well-suited for health IT. Medical devices and software are different, as the safety of the former depends upon how it was manufactured. With health IT, safety is dependent on how the software is designed and how it is deployed.
Furthermore, medical devices “are directly involved in the treatment of a patient, with little if any opportunity for a clinician to intervene. The majority of medical software does not directly or independently act upon a patient, but rather provides data and guidance,” Mitus noted.
Jim Bialick, executive director of the Newborn Coalition, which focuses on the development and use of technology in newborn and infant health, said his group was “surprised” that the 2011 draft guidance wanted to regulate apps as devices.
Furthermore, he said that while the FDA "has a legitimate role to play in maintaining patient safety for the highest risk products, it is readily apparent that Congress can and should adopt a more flexible model for products that simply manage information.” He also questioned whether the agency has the resources and expertise to evaluate mobile apps, adding that there’s concern over whether the regulatory science has been fully developed to regulate the market.
David Classen, MD, chief medical information officer at Pascal Metrics, who is scheduled to speak at the 23rd Annual AAMI/FDA International Conference on Medical Device Standards and Regulation Thursday, discussed ensuring patient safety with health IT, basing his presentation on the Institute of Medicine’s Health IT and Patient Safety: Building Safer Systems For Better Care report. Classen also spoke last October at the AAMI/FDA Interoperability Summit.
On Thursday, National Coordinator for Health Information Technology Farzad Mostashari and Christy Foreman, director of the Office of Device Evaluation at the Center for Devices and Radiological Health, will testify on regulation and innovation in front of the Subcommittee on Oversight and Investigations.
Posted: March 20, 2013