ICIT on FDA guidance: Regulatory enforcement needed on med device cybersecurity

From: FierceHealthIT

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Draft cybersecurity guidelines for devicemakers recently released by the U.S. Food and Drug Administration are too “subtle,” despite showing that security of medical devices is a priority, according to the Institute for Critical Infrastructure Technology (ICIT).

The FDA is offering suggestions at a stage where “regulatory enforcement is needed,” James Scott, senior fellow at ICIT, which advises decision makers on technology and cybersecurity trends, and Drew Spaniel, a visiting scholar at Carnegie Mellon University, write in an assessment of the guidelines.

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