FDA recognizes ANSI/AAMI medical device standard to enhance cybersecurity

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 very helpful for hospitals and health systems. These measures provide clearly defined and consistent security standards to help evaluate possible cyber risk associated with new medical devices and emerging technology among vendors. The standards also highlight the need for manufactures to communicate and coordinate with health care delivery organizations to assist in the identification and management of security risks. It is recommended that hospital and health system clinical engineering and cybersecurity teams conduct a coordinated review of the defined consensus standard to ensure that newly purchased medical devices and technology, subject to these standards, are in compliance.”
 
For more information on this or other cyber and risk issues contact Riggi at jriggi@aha.org. For additional cyber and risk resources and threat information, visit www.aha.org/cybersecurity.