Digital health appears to be making its way onto the national stage. Yesterday, FDA Commissioner Scott Gottlieb gave the field a shout-out in his remarks to the US House Subcommittee on Agriculture, Rural Development concerning the Fiscal Year 2019 budget request for the FDA.
“The Budget requests new resources for the FDA to make significant investments in advancing critical areas of science, domestic technology and public health,” Gottlieb said to the subcommittee. “Among these efforts, we're seeking to advance a new paradigm in the regulation of digital health technology that I believe will allow us to grow this promising field more quickly.”
The President’s Fiscal Year 2019 budget request asks for a total of $5.8 billion for the FDA, which means an increase of $663 million or 13 percent more than the FY 2018 Annualized Continuing Resolution, according to Gottlieb.
It was a busy day for Gottlieb, who also announced a new effort to enhance and modernize the FDA’s approach to medical device safety and innovation.
“We’re considering what more we can do inside the FDA to better protect patients, while at the same time working closely with patients, providers, and device developers to better understand and address device risk and make sure that we’re appropriately balancing risk and benefit,” Gottlieb wrote in his statement on the medical device plan. “I believe that the work in this area has made dramatic differences to the millions of Americans whose lives have been saved or vastly improved by these technologies.”
In all, the initiative outlines five key areas of focus. These areas include: establishing a robust medical device patient safety net in the US, exploring regulator options to streamline and modernize timely implementation of postmarked mitigation, spurring innovation towards safer medical devices, advancing medical device cybersecurity, and integrating CDRH’s premarket and postmaket offices and activities to advance the use of Total Product Life Cycle (TPLC) approach to device safety.
Perhaps most relevant to digital health companies is the cybersecurity component.
“Exploitation of device vulnerabilities could threaten the health and safety of patients,” Gottlieb wrote.
His plan proposes the department seek more authority and funding under Congress to work on combating cybersecurity vulnerabilities and exploits. He also said the department hopes to form a CyberMed Safety (Expert) Analysis Board, which will be a public-private partnership. The board would serve as a resource for device makers as well as working to complement existing device vulnerability coordinations, according to the statement.
“Medical device safety is a key priority for the FDA,” Gottlieb wrote. “We’re committed to protecting American patients by minimizing avoidable risks and advancing device technologies that are delivering growing benefits.”
Recently the FDA has been focusing on medical devices and software. For example, at the end of last quarter the FDA released their new CDS draft guidances, which outlined forms of the CDS which won’t be regulated based on the degree of human involvement instead of based on risk.
The FDA is also looking to change the way devices are FDA approved. Last summer, the FDA began talks around implementing a new Pre-Cert program that would allow for certain companies that the FDA has deemed responsible and safe in their development to build products without undergoing the FDA clearance or approval process for each new device. In the fall, a pilot began to test the plan.