Product Security & Engineering
A vulnerability report needs its own process.
Section 524B requires it
For cyber devices, Section 524B requires a plan to monitor, identify, and address postmarket vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures. A disclosure program is part of the submission, not an afterthought.
Coordinated with the person who found it
A published policy tells researchers, customers, and suppliers where to report. Coordination means agreeing with the reporter on what is published and when, so users get accurate information alongside a fix or mitigation, as ISO/IEC 29147 and 30111 describe.
Shared with the sector
A disclosure ends in an advisory: affected products, the risk, and what users should do. Sharing it through an ISAO reaches other manufacturers and healthcare organizations that rely on the same components.
MedISAO
Disclose through an FDA MOU partner.
MedISAO is an information sharing and analysis organization for medical device manufacturers, and part of Medcrypt Security Intelligence (MSI). With MSI, you get a working coordinated disclosure program, including the policy and procedure documents FDA expects in postmarket, plus device-specific vulnerability alerts and training.
In September 2018, FDA’s Center for Devices and Radiological Health signed a Memorandum of Understanding with MedISAO and H-ISAC to share information about medical device vulnerabilities and threats. FDA’s postmarket cybersecurity guidance also counts active ISAO participation as one of the conditions for its Part 806 reporting policy on certain uncontrolled-risk vulnerabilities.
2018
FDA CDRH signs MOU 225-18-028 with MedISAO and H-ISAC for sharing medical device vulnerability and threat information.
Read the MOU on fda.govDisclosure · not incident response
A disclosure starts with a reported vulnerability, often before anyone has exploited it. Incident response starts with a security event and runs on your incident response plan. An incident may call for notifying customers, but that notice is not a coordinated disclosure.