Government Healthcare Policy, Business and Technology

Medical Device Cybersecurity Needs Enforceable Regulations, Not Just Suggestions, ICIT Says

Healthcare Informatics: The Institute for Critical Infrastructure Technology (ICIT) this week released a critical analysis of the U.S. Food and Drug Administration’s (FDA) guidance on medical device cybersecurity and argues that “subtle suggestions” are not enough.

ICIT is a non-partisan organization that acts as a conduit between the private sector, federal agencies and legislative community with the goal of supporting and protecting the country’s technology infrastructures. The report, “Assessing the FDA’s Cybersecurity Guidelines for Medical Device Manufacturers: Why Subtle ‘Suggestions’ May Not Be Enough,” criticizes the agency for falling short on implementing enforceable regulations over medical device manufacturers.

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