Industry observers have expressed concerns that when the U.S. Food and Drug Administration releases final guidance later this year, mobile medical application developers will be subjected to the same slow, burdensome approval process that medical devices must go through.
Not so, says a prominent Silicon Valley lawyer quoted in a Jan. 30 Wall Street Journal blog.
The financial newspaper quotes Mavis Yee, a partner at Silicon Valley law firm Nixon Peabody, who believes the regulatory environment for mobile medical apps--for which the FDA issued a Draft Guidance for Industry on MMAs in July 2011--could be more benign than many industry observers fear. According to the draft guidance, the FDA has little interest in regulating the vast majority of the 40,000 or more mobile medical apps that currently are available for mobile devices, said Yee, whose firm has a dedicated health-technology legal practice.
Yee believes the FDA will only scrutinize those companies looking to develop wireless accessories for existing medical devices, as well as those that turn a smartphone or computer tablet into a clinical medical device. She asserts that the vast majority of downloadable mHealth apps are diet and exercise trackers, reference tools for doctors and consumers, programs that help to digitize patient records, and consumer social-networking tools that will not fall under the FDA's purview.
Yee is also encouraged by the recent bill submitted to Congress by Rep. Mike Honda (D-Calif.) that calls for the creation of an Office of Wireless Health at the FDA, and also mandates the creation of a prize program to incentivize innovators to take risks when developing mHealth technologies.
"I'm trying to ascertain the status of this bill, and to ask how technology companies and Silicon Valley groups can have input" on the possible formation of the new FDA office, Yee said. Honda's bill was submitted to Congress in December, too recently for the FDA to have formally responded to the idea, she said.
An article published recently on the mHIMSS website by attorneys at Arent Fox law firm in Washington, D.C. reviewed regulatory issues that made mHealth news in 2012 that they believe also will spill over into 2013. At the top of the lawyers' list was the FDA's ongoing efforts to finalize guidance for industry regulating certain mobile medical apps as medical devices.
To learn more:
- read the WSJ blog