AI in Healthcare February 6, 2024
It’s not easy to get patients, providers, payers, vendors and regulators to agree on any one aspect of healthcare delivery. But FDA’s Center for Devices and Radiological Health (CDRH) recently managed to get representatives of all five groups to settle on a working definition of transparency.
Admittedly, for the exercise, CDRH limited the term to one discrete context: as it applies to AI embedded in medical devices. But that doesn’t detract from the force of the consensus definition.
Transparency of AI in these settings, the groups concur, refers to the degree to which appropriate information about a device—including its intended use, development, performance and, when available, logic—is clearly communicated to stakeholders.
The meeting’s minutes are synopsized in a paper published...
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