American Hospital Association November 8, 2023
The Food and Drug Administration has recognized a consensus standard to help medical device makers address cybersecurity concerns. The agency said the SW96:2023 standard for medical device security and security risk management, published by the American National Standards Institute and Association for the Advancement of Medical Instrumentation, aligns with existing international safety risk management standards and quality systems defined by ISO 14971, and provides direction to sponsors on how to address cybersecurity risks in device design and development.
“We encourage the use of this new standard to enhance quality and support product performance,” the agency said.
John Riggi, AHA’s national advisor for cybersecurity and risk, said, “From an operational perspective, the recognized and defined medical device security consensus standards are...
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