News Feature | April 14, 2014

Federal mHealth Report Released

Katie Wike

By Katie Wike, contributing writer

Federal mHealth Report

Federal law requires FDA, ONC, and FCC to release annual report containing proposed strategy, recommendations for Health IT - especially mobile

As required by a 2012 law, the FDA recently released its report on the state of HIT - the FDASIA Health IT Report. With the help of the FCC and ONC, the report contains proposed strategy and recommendations for the future of national HIT.

“Health information technology (HIT) presents tremendous benefits to the American public, including greater prevention of medical errors, improved efficiency and health care quality, reduced costs, and increased consumer engagement However, if HIT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients,” explains the FDA.

“The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius in a press release. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.”

According to mHealth News, this widely anticipated report also makes final how health technology, specifically mHealth, will be regulated. "I think it implies that many of the functionalities found in HIT software and related products that may currently warrant regulation may no longer do so," Robert Jarrin, senior director for government affairs for Qualcomm and a member of the FDASIA External Working Group, told mHealth News. "If that is the case, developers of HIT software and products such as CDS can rest assured that they will not run afoul of FDA regulation.”

“I think all of those are good ideas, and frankly I think it shows that people in industry, on Capitol Hill, and in the agencies are largely in agreement,” said Bradley Merrill Thompson, an attorney with Epstein Becker & Green, P.C. “Indeed, it seems that all three sectors are saying about 90 percent the same things. The bottom line is that HHS, and the three agencies, are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for all of the HIT developers producing wonderful, important, cutting-edge new technologies.”

“This proposed strategy will facilitate innovation, protect patients and support FDA’s focused oversight on higher risk technology, similar to medical devices that are currently regulated,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “FDA looks forward to additional stakeholder feedback on the proposed framework in this draft report.”