Lawmakers and mobile health advocates plan to address how the Food and Drug Administration should regulate mobile health technologies, such as smartphones and mobile medical apps that are increasingly being used for health-related reasons.
The House Energy and Commerce Committee plans to hold three subcommittee hearings
this week. The daily hearings, which begin Tuesday, will focus on the administration's perspective on mobile health innovation and regulation, how innovation benefits patients and wireless innovation in healthcare.
The investment community has called for more clarity around the regulation of mobile health technology, also called mHealth, which can range from an iPhone app that monitors diet to mobile or wireless technologies used in hospitals and home-care settings.
The FDA issued draft guidance in mid-2011
about how it plans to oversee mobile medical apps, but has yet to release the final guidance.
“We have a pressing need to solve the healthcare cost crisis,” Dr. Joseph Smith, chief medical officer and chief science officer for the West Health Institute, a not-for-profit that supports mobile health innovation. “These technologies afford such an opportunity.”
He noted that the unclear regulatory framework has led to pullback from some investors. Smith, who plans to provide testimony during Wednesday's hearing about the impact of mobile innovation on patients, said he will focus on the need for “predictable, transparent, risk-based regulation,” the value of interoperability, and reimbursement policy that aligns stakeholders.
Some lawmakers have expressed concern that FDA regulation of smartphones, tablets and apps could mean those technologies are subject to the medical device excise tax, a 2.3% tax on the sales of certain devices that went into effect in January. The tax is part of the Patient Protection and Affordable Care Act and is considered the device industry's contribution to financing healthcare reform.
In a March 1 letter to FDA Commissioner Dr. Margaret Hamburg (PDF)
, committee leadership asked the FDA to clarify whether the smartphones and mobile health apps will be subject to the tax.
It also requested that the agency provide information about when it plans to issue final guidance on how it plans to oversee mobile medical apps.
“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,” Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a news release.
Ben Chodor, CEO of Happtique, a mobile health apps marketplace owned by GNYHA Ventures, the for-profit arm of the Greater New York Hospital Association, is expected to testify at Tuesday's hearing
. In his prepared remarks, Chodor said the company developed a health app certification program
because it expects a large segment of the health app market to fall outside of FDA oversight.
The program, launched in February, is a “voluntary program borne out of the expressed need by many healthcare organizations and clinicians for a way to identify technically and substantively valid apps,” Chodor said in the remarks.
Oversight of mobile health technologies may also include other federal agencies. The Federal Communications Commission has partnered with the FDA
to regulate certain sectors, such as the development of medical body area networks and other wireless medical devices that use spectrum.
The two government agencies first announced plans to work together to regulate wireless medical devices in 2010.
A task force convened by the FCC released a report in September
that said federal agencies, such as the CMS, the FDA and the Office of the National Coordinator for Health Information Technology, should increase collaboration on mHealth as a way to “promote innovation, protect patient safety and avoid regulatory duplication.”