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.”
