CDRH Discussion Paper on Communicating Cybersecurity Issues

FDA is seeking feedback on a discussion paper entitled Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework. The paper provides best practices to consider when communicating with patients and caregivers about cybersecurity vulnerabilities. Feedback on the discussion paper, according to the agency, will help inform future efforts designed to improve cybersecurity safety communications, including the potential development of a cybersecurity communications framework.

The paper was developed based on input received at a 2019 Patient Engagement Advisory Committee meeting. It highlights important elements to include when developing safety communications for cybersecurity vulnerabilities, including interpretability, discussing risks and benefits, acknowledging and explaining the unknown, availability and findability of the information. On 10/22, FDA is holding its next advisory committee meeting to further discuss the best practices and elements to consider when developing the framework.