COVID-19 changing regulatory picture around medical devices and technology in healthcare

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The COVID-19 pandemic has changed the regulatory picture around medical devices and technology in healthcare, and the way in which those technologies are reimbursed. Take telehealth, for example, which has seen greater reimbursement flexibility from the Centers for Medicare and Medicaid Services.

Some of these changes have presented opportunities for entrepreneurs and product developers, and policymakers have taken note and learned lessons that may help grease the wheels for future product development and the regulatory structure that surrounds them.

In broad strokes, this is the topic that will be covered in the HIMSS21 Digital session, "Regulations and Reimbursement: How to Navigate Compliance in an Uncertain World," which premieres on Aug. 10. Speaking at the session are Amy Abernethy, former principal deputy commissioner and acting chief information officer at the U.S. Food and Drug Administration; Deven McGraw, chief regulatory officer at Citizen; and Kim Brandt, partner at Tarplin, Downs and Young and former principal deputy administrator for operations and policy for the Centers for Medicare and Medicaid Services.

According to Abernethy, emergency regulations allowed the FDA to enact regulatory flexibilities, which allowed the agency to approve products much more quickly, thereby providing some measure of guidance for the industry as a whole. It allowed the industry to pressure-test what it would look like when the FDA and the federal government are working in more nimble ways.

The FDA, she said, could be more flexible with respect to digital health solutions and how they're used in everyday life. Clinical trials have allowed companies to use real-world data to fill in data sets when, say, a patient was unable to travel to a clinic. That set up a space in which the agency could evaluate what real-world data sharing does in terms of creating clinical trials for the future.

Companies, for instance, could use remote monitoring similar to telehealth to track patients' health at home, a practice that could continue after the pandemic, said Abernethy.

A similar transformation occurred at CMS, with that federal agency moving in ways it never had before, doing things like establishing practice locations in parking lots or unused office space. They also had to come up with a hospital-at-home model to have services performed inside the home.

According to Brandt, the Office of Civil Rights issued guidance on enforcement discretion to enable healthcare providers to take off-the-shelf telehealth solutions – and deploy them quickly.

More will be covered as their session debuts on Tuesday.