What the Medical Device Industry Can Learn From Past Cybersecurity Vulnerability Disclosures (ICS-CERT 2024 Report)

Since the FDA’s 2016 Postmarket Cybersecurity Guidance, the rate of ICS-CERT medical device advisories has grown 386%, signaling stronger transparency but also persistent cybersecurity weaknesses.
This 2025 update expands Medcrypt’s decade-long analysis of 2013–2024 ICS-CERT medical device advisories, revealing that while industry maturity has improved, vulnerability trends remain remarkably consistent.

Key findings:

• 59.8% of all vulnerabilities still stem from user authentication and code defects.
• Patch references decreased by 22% in 2024, despite new FDA Section 524B enforcement.
• Only 27 of the top 40 manufacturers maintain public vulnerability disclosure programs.
• Nearly half of all vulnerabilities (200/433) originated from just four vendors (Baxter, BD, Medtronic, Philips).

These data reveal that cybersecurity progress has plateaued — and that proactive risk management, not reactive disclosure, must define the next era of medical device security.

Even after eight years of formal postmarket expectations, many manufacturers continue to treat vulnerability management as reactive.
The FDA’s Section 524B now mandates timely updates and patching, but patch reference rates fell sharply in 2024.
This suggests that while manufacturers are more transparent, they remain resource-limited, compliance-driven, and dependent on legacy processes.

For regulators, manufacturers, and healthcare delivery organizations alike, these findings underscore an urgent need for:

Proactive, lifecycle-integrated security design rather than patch-based defense.

Collaborative vulnerability disclosure processes across vendors, researchers, and CISA.

Evidence-based security decisions rooted in longitudinal vulnerability data.

• Medical Device Manufacturers (MDMs): Product security and engineering leaders managing FDA and global compliance.
• Regulatory and Quality Professionals: Teams responsible for postmarket surveillance and 524B compliance evidence.
• Healthcare Delivery Organizations (HDOs): Security and IT staff managing device vulnerabilities and risk.
• Policy and Standards Bodies: Agencies and working groups (FDA, CISA, MDIC, AAMI, IEC) shaping next-generation disclosure policy.

• ICS-CERT advisories have increased 386% since FDA’s 2016 guidance — but vulnerability causes remain the same.
• Patch references dropped 22% year-over-year, despite legal obligations under 524B.
• Researchers are key contributors, now referenced in 68% of advisories.
• Disclosure transparency ≠ remediation; true maturity requires design-stage prevention and continuous monitoring.
• The industry must shift from compliance reporting to proactive risk reduction anchored in real-time intelligence.

1. Introduction: A Decade of ICS-CERT Medical Device Disclosures
   
   1. Study background, methodology, and data sources (2013–2024)
   2. Purpose: evidence-based assessment of disclosure trends and maturity
2. Section I: Data and Methodology
   
   1. Overview of the ICS-CERT database and inclusion criteria
      
   2. Link to raw dataset and methodology appendix
   3. Caveats in CVSS scoring and CWE classification
3. Section II: Observations From the Data
   
   1. Root causes haven’t changed — 59.8% from user authentication & code defects
   2. Device class trends: infusion pumps, imaging, diagnostics, and patient monitors
   3. Disparities in vulnerability reporting across vendors and device types
   4. FDA’s postmarket guidance as a pivot point for disclosure growth
4. Section III: 2024 Trends and Insights
   
   1. Record highs in global vulnerabilities (~50,000 submitted to NVD)
   2. 22% decline in patch references despite Section 524B
   3. No correlation between CVSS score and patch availability
   4. 68% of advisories referenced external researchers — up from 7% pre-guidance
5. Section IV: Comparative Analysis — ICS-CERT vs. NVD
   
   1. How ICS-CERT and NVD differ in purpose, audience, and scope
   2. NVD’s backlog and incomplete manufacturer tagging
   3. Case examples where CVSS scores differ between systems
   4. Why medical device advisories remain underrepresented in NVD
6. Section V: Root Cause Analysis
   
   1. Code defects, user authentication, and OS vulnerabilities dominate
   2. CVSS median severity across categories (5.9–7.9 range)
   3. Persistent over-reliance on third-party libraries without update mechanisms
7. Section VI: Role of Researchers
   
   1. Doubling of researcher attributions in 2024 advisories
   2. Researchers drive patch likelihood and industry accountability
   3. Evolving collaboration models between vendors, FDA, and academia
8. Section VII: Conclusions and Predictions
   
   1. Disclosure frequency plateauing post-2022
   2. Without stronger enforcement or incentives, maturity may stall
   3. Proactive vulnerability prevention must replace reactive patching
   4. FDA 524B enforcement will redefine expectations for “timely updates”
9. Appendices
   
   1. Appendix A: Advisory frequency by year and vendor participation
   2. Appendix B: CVSS severity mapping and transition to CVSS v4.0
   3. Appendix C: Root cause category definitions and CWE mapping
   4. Appendix D: ICS-CERT vs. NVD comparative framework