The argument raging over the U.S. Food and Drug Administration’s final take on mHealth regulations can be boiled down to whether laws or guidance from the agency will more effectively stoke innovation while protecting patients.
Some members of Congress are pushing legislation to codify the FDA’s mobile medical apps guidance to give the industry predictability for innovation. Those opposed argue that guidance is more flexible, can better protect patients and can adapt to a changing market.
Both sides were bandied about during a November 19 hearing before the House Committee on Energy and Commerce’s Subcommittee on Health.
At the forefront was a bill proposed on October 22, dubbed the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, which would amend the Food and Drug Cosmetic Act by providing what the bill authors say is regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records and other healthcare-related software.
[See also: Legal questions arising as mHealth outpaces regulations.]
“This bipartisan legislation is an important and necessary step toward establishing a new regulatory framework for health IT that recognizes the different categories of health IT solutions and focuses FDA oversight on the technology that poses a potential risk to patient safety,” said Michael Marchlik, vice president of quality assurance and regulatory affairs at McKesson Technology Solutions, testifying before the committee.
Supporters of the bill are concerned that without legislation, the FDA could change direction at any time in the ways it enforces its guidance and may stifle the rapid increase in the development of medical apps for smartphones, a number that is expected to grow to 500 million by 2015.
But Jeffrey E. Shuren, MD, a physician and attorney who directs the FDA's Center for Devices and Radiological Health, testified in support of guidance over legislation, saying guidance can be made more clear but also is more easily changed over time. Legislation is “set in stone,” he said.
Even so, he said, FDA guidance is not easily changed. He also pointed out that the FDA’s most recent guidance on mobile apps has set a deregulatory tone by only regulating apps that can cause patient harm.
Shuren urged Congress to first observe how the industry moves forward with the 40-page guidance, issued on September 23 by the FDA, to see how effectively it supports innovation before passing any legislation – as well as to wait for a forthcoming report from the Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup sometime in February 2014. The workgroup is charged with providing expert input on issues and concepts identified by the FDA, the Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC) that can be used to create a regulatory framework – or a starting point – for teasing out what mobile health regulation should look like.
Whereas the SOFTWARE Act is “a logical step forward,” Marchlik said “applying a four-decade-old approach to mobile and cloud-based technologies that did not exist even four years ago is ill advised.”
The SOFTWARE Act was proposed by Reps. Marsha Blackburn (R-Tenn.), Gene Green (D-Texas), Phil Gingrey (R-Ga.), Diana DeGette (D-Colo.), Greg Walden (R-Ore.) and G. K. Butterfield (D-N.C.).
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