On March 29, 2023, the FDA has issued a new final guidance on the Refuse to Accept (RTA) policy relating to cybersecurity in medical devices, specifically for “Cyber Devices” as defined in the newly-amended FD&C Act (Section 524B). In mapping its guidance to the new statutory authority, the FDA specifies what is expected when a submission is provided to the agency for review.
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On Dec 29, President Biden signed into law a $1.7 trillion omnibus spending bill that has significant implications for healthcare as well as for how security for medical devices are regulated and enforced. Manufacturers must now include evidence of security controls and security testing, as well as plans to maintain device’s security posture through updates and patches, all supported by documented evidence, e.g., a software bill of materials for commercial, open-source, and off-the-shelf software components.
Cybersecurity used to be seen as a compliance initiative in healthcare but has become a patient safety and business imperative in recent years. For MDMs, tying market delays and metrics to a lack of security will inspire faster action. For HDOs, assessing strategies for incoming devices can start to shift the tide in how risks expand.
Healthcare is a cyber criminal’s dream. It presents the intersection of a data treasure trove, weak security posture, limited resources, complicated supply chain, and patient care delivery. Originally published at https://hitconsultant.net on February 24, 2022.