A TECH-THEMED TO-DO LIST: Twenty months into the pandemic, the FDA remains consumed with vital decisions on coronavirus vaccines and treatments. But it’s also facing key questions on the future of medical software that can help make clinical decisions, deliver virtual care and chart a course for the post-pandemic world.
The agency’s digital health portfolio is getting more attention with President Joe Biden’s continuing search for a permanent FDA chief and acting commissioner Janet Woodcock’s term due to expire on Nov. 15. The top candidate for the job is Robert Califf, who helmed the agency for a year in the Obama administration and has been leading medical strategy and policy at Alphabet, Google’s parent company.
Health tech watchers identify several areas that will loom large for the next commissioner:
Preserving the balance: The FDA has a “dual role,” said Brian Scarpelli, senior global policy counsel at ACT | The App Association, a group representing small app developers. On one hand, the agency partners with software developers to find new applications for technology. But it’s also the cop on the health tech beat, exercising its traditional regulatory powers.
Some industry observers think a nominee like Califf would be perfectly positioned. Califf’s experience in the digital health world will likely make him open to policies fostering innovation, while still addressing the safety of new devices, said Jodi Daniel, partner in Crowell & Moring’s health care group.
Others worry he’ll be too cozy with the industry he regulates. The Revolving Door Project, a watchdog group, pointed to Califf’s support for data to bolster health care as a sign that he can’t be expected to “scrutinize health-tech’s data privacy, anonymization, or security practices.”
Adapting to new products: Software that triages or diagnoses patients can save lives in a crisis and theoretically gets better as new data rolls in. But that poses tricky problems for regulators: If they approve version 1.0 of an AI-driven product, how do they track the developments that lead to versions 1.1, 1.2 and beyond?
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It’s a conundrum that’s been around for years. Scarpelli and others are hoping the agency provides some guidance soon. Added clarity could spur developers to introduce more products that evolve as more data flows in about their performance.
Making the post-pandemic transition: At the beginning of the pandemic, the FDA relaxed regulations on products that helped facilitate virtual care, like apps that offer cognitive behavioral therapy. Medical device makers could make tweaks to their products …….