The COVID-19 pandemic has accelerated the adoption of digital health for about 20 months, but the FDA's health IT agenda has remained largely untouched, Politico reported Nov. 10.
Five things to know:
- The FDA is facing several questions on the future of medical software and how this technology plays a role in telehealth and clinical decision-making moving forward, Politico reported.
- At the start of the pandemic, the FDA relaxed regulations on products that helped deliver virtual care. Yet once the public health emergency comes to an end, there isn't a clear path as to what happens with these technologies, according to the report.
- The health IT industry is also looking for signs from the FDA on how it will regulate clinical decision support software. There also is a lack of clarity on how the FDA approval process will affect software updates in products. For example, if version 1.0 of a product is approved, it's unclear if FDA approval will be needed for future versions of the software or how it will be tracked, Politico reported.
- President Joe Biden is searching for an FDA head as the interim chief's term expires Nov. 15. The top candidate for the role is Robert Califf, who leads medical strategy and policy at Google parent company Alphabet. Mr. Califf also led the FDA for one year during the Obama administration.
- Some health IT experts said Mr. Calif is the perfect fit for the role, Politico reported. His experience in digital health would leave him open to the innovation potential medical technology brings while also tamping down security concerns. Other industry experts expressed concern that he will be unable to properly regulate healthcare tech if he has close ties to it, according to the report.