ICS Medical Advisory
CISA's official vulnerability advisories for medical devices, the public record of disclosed device cybersecurity issues, indexed as ICSMA-YY-DDD-NN.
Definition
ICS Medical Advisories (ICSMAs) are official cybersecurity advisories published by CISA for medical devices, distinct from the more general ICS-Advisory (ICSA) series for industrial control systems. Each ICSMA describes affected products, vulnerability details (CVE IDs, CVSS scores), risk evaluation, mitigations, and the responsible manufacturer's coordinated disclosure timeline. ICSMAs are the public artifact of FDA-coordinated and H-ISAC-coordinated vulnerability disclosures and are referenced by hospital procurement, HDOs, and insurers when evaluating device cyber risk.What this means in practice
Receiving an ICSMA is a defining moment for a medical device manufacturer's post-market cybersecurity program. The advisory triggers customer notifications, board-level reporting, often FDA Form 3500A scrutiny if patient harm is plausible, and a measurable test of the manufacturer's CVD and post-market plan. Manufacturers should map their disclosure SOPs explicitly to the ICSMA process and know who at CISA, FDA, and H-ISAC their coordination contacts are before an incident.- •Discovering ICSMA process for the first time during an incident, pre-establish CISA and FDA contacts and run a tabletop.
- •Treating ICSMAs as marketing damage to be minimized, incomplete or evasive advisories destroy trust with hospital customers far more than the underlying vulnerability.
- •Ignoring competitor ICSMAs, they are the best public signal of what credible attacks against your product class look like.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsCISA's authoritative list of CVEs with confirmed in-the-wild exploitation, with mandatory federal remediation deadlines.
A globally unique identifier for a publicly disclosed cybersecurity vulnerability.
An industry-standard 0–10 score that quantifies the severity of a software vulnerability.
A documented process for receiving, triaging, and responsibly disclosing security vulnerabilities reported by external researchers.
More in Cybersecurity
· Same categoryMember-driven nonprofit that operates the trusted sharing community for cyber and physical threat intelligence across the healthcare sector.
The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.
The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.
A machine-readable statement that explains whether a known vulnerability is actually exploitable in a specific product.
Primary references
3 sources- 1
CISA Coordinated Vulnerability Disclosure ProcessVerifiedCISAcisa.gov
- 2
MDCG Cybersecurity GuidanceVerifiedMDCGhealth.ec.europa.eu
- 3
HSCC - Health Sector Coordinating CouncilVerifiedHSCChealthsectorcouncil.org
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