Developing a Responsible Disclosure Policy Challenge The FDA is putting increased emphasis on responsible disclosure policies as part of aftermarket cybersecurity guidelines. At the same time, medical device buyers are becoming more aware of potential cybersecurity risks and creating their own purchasing guidelines related to device security. Increasingly, medical device companies are finding that having a responsible disclosure policy in place is a competitive advantage as well as a regulatory requirement. However, most responsible disclosure programs were designed by and for the software industry and do not properly address the legal and regulatory requirements, data confidentiality issues and potential for patient harm that medical device manufacturers must account for. An infusion pump

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