Legacy Device Cybersecurity
Cybersecurity considerations for medical devices that cannot be reasonably protected against current threats.
Definition
A legacy medical device is one that cannot be reasonably protected against current cybersecurity threats - typically because the underlying OS or platform is unsupported (e.g., Windows XP/7, embedded RTOS without update path), the device cannot accept patches, or the manufacturer has ended support. IMDRF/CYBER WG/N73 (2023) defines the term and frames a shared-responsibility model among manufacturers, healthcare delivery organizations (HDOs), and other stakeholders.What this means in practice
Legacy devices are ubiquitous in hospitals - imaging systems, infusion pumps, lab analyzers - and are repeatedly implicated in ransomware incidents. The right response is a documented end-of-life plan, transparent communication to operators, and a path to a supported replacement, not silent obsolescence.Examples
- An X-ray machine running on an outdated operating system like Windows XP is considered a legacy device, as it can no longer receive security updates to protect against modern cyber threats.
- Many older infusion pumps lack the ability to be patched or updated with current security protocols, making them vulnerable to network-based attacks that could disrupt patient care.
- A laboratory analyzer, though still functionally sound for its intended medical purpose, may be deemed a legacy device if its manufacturer has ceased support and no security mitigations are available for newly discovered vulnerabilities.
- •Letting devices age into legacy status without notifying operators or providing compensating-control guidance.
- •Assuming HDO network segmentation alone substitutes for manufacturer responsibility.
- •Continuing to sell new units of a device that can no longer be patched.
Frequently asked questions
Cross-references
See also
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsAn industry-developed reference framework from the Healthcare Sector Coordinating Council for end-to-end MedTech cybersecurity.
International harmonized guidance on medical-device cybersecurity from the IMDRF Cybersecurity Working Group.
The designed-in ability to deploy security updates to a fielded medical device in a timely, controlled, and verifiable manner.
FDA's framework for ongoing vulnerability monitoring, risk assessment, and remediation of medical device cybersecurity issues after a device is on the market.
More in Cybersecurity
· Same categoryAAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle.
AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management.
AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57.
Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient.
Where this term appears across MedTech Terms.
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1IMDRF/CYBER WG/N73 (2023)Tier 2 VerifiedIMDRFimdrf.org
- 2FDA Cybersecurity Guidance (Sept 2023)Tier 2 VerifiedFDAfda.gov
- 3HSCC - Health Sector Coordinating CouncilTier 4 VerifiedHSCChealthsectorcouncil.org
Inline markers like [1] jump to the matching reference above.