President Barack Obama signed the bipartisan Food and Drug Administration Safety and Innovation Act (S.3187) last week after being approved by Congress last month.[1]
The bill will allow the FDA to move forward with plans to regulate mobile medical apps. Meanwhile, the Department of Health and Human Services will develop a report on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regular duplication.”
The USDA plans to release guidelines by the end of the year as to how it would oversee certain mobile medical apps.
Joel White, executive director of Health IT Now, commented about mobile medical apps, “Congress should have a role in helping develop a framework that makes sense for mobile health technologies as they exist today, but is flexible enough to evolve with the market.”
Previous versions of the bill planned to stall or possibly stop the FDA’s plans for mobile medical apps while the HHS drafted its report. However, legislators agreed to amend the bill so the FDA could continue without HHS action.
In addition, the law initiates a new fee for generic drug sellers and reinstates user fees that the FDA gathers from the drug and medical device industries. It will also amend FDA policy and increase the agency’s safety regulation oversight.
“The entire mobile health ecosystem is developing inherently low-risk technologies to extend care beyond offices and hospitals, and these novel, low-risk devices and integrated solutions can be expedited via these changes to the FDA’s de novo pathway,” said Joseph Smith in a press release. He is the chief medical and science officer of the San Diego-based independent non-profit West Wireless Health Institute.
“It’s great to see our region’s healthcare innovation community work together with our elected officials on this legislation that speeds medical device innovation and lowers costs in the healthcare system, benefitting patients through common sense policies that safely expedite approvals,” Smith continued.
[1] Wicklund, Eric. “Obama paves way for FDA’s mobile app guidelines.” Healthcare IT News. Web. 12 July 2012.
