During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients.
Today, that’s leaving the health care industry, and especially younger digital startups, in a tricky spot. Companies have benefited from the reduced regulatory burden of the pandemic — but it’s unclear how long they’ll get to ride the gravy train. “What’s going to happen is the regulatory agencies are required to essentially go back to the way it was before,” said Amy Abernethy, former deputy principal commissioner and acting CIO at the FDA. “But we don’t unlearn.”
In a wide-ranging conversation, three former agency officials including Abernethy spoke at the virtual portion of the HIMSS digital health conference on Tuesday about the impact that temporarily loosened restrictions might have in the long term. In particular, they focused on how a confluence of factors — years-long policy pushes, pandemic-aligned emergency measures, and the changing of the presidential administration — may impact how regulators adopt real world data.
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