HealthExec July 6, 2018
Government regulation can’t keep up with innovation in healthcare technology, especially when dealing with mobile medical applications—and those in charge of developing regulatory framework know it, according to top officials at the FDA in a July 2 viewpoint in JAMA.
The piece—penned by FDA Director Scott Gottlieb, MD; Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health at the FDA; and Bakul Patel, MS, MBA, associate director of digital health at the FDA—argued that efficiency in regulation can encourage development and utilization of mobile medical apps.
“[T]he regulatory framework enacted by Congress in 1976, and incrementally improved since then, is not well suited for software-based technologies, including mobile apps, what FDA and other regulators call ‘software...
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