From: FedScoop
There’s incredible diversity among medical device manufacturers, which raises some questions about what a cyber threat information sharing mechanism could look like, one expert said.
By Whitney Blair Wyckoff
The Food and Drug Administration in recent draft guidance urges medical device makers to join a group that would allow them to share information on cyberthreats, but big questions remain about what the structure of such a group — called an information sharing analysis organization, or ISAO — would be.
The draft, released last month, outlines recommendations to help manufacturers manage vulnerabilities of their devices once they hit the market. If device makers participate in an ISAO and meet a few other requirements, they wouldn’t have to undergo corrective actions, like a recall, if they uncover certain kinds of online vulnerabilities in their products.
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