Proactive Healthcare Cybersecurity — The Missing Link Between Vulnerabilities and Patches

This whitepaper explores a critical blind spot in medical device cybersecurity — the lack of correlation between vulnerability severity and patch availability.
Analyzing data from the ICS-CERT advisory database (2013–2019), MedCrypt found that despite a 400% increase in vulnerability disclosures since FDA issued its postmarket cybersecurity guidance (2016), patching practices remain inconsistent across the industry.

The paper reveals that while patch frequency has increased by 46.5%, the CVSS score of a vulnerability has no statistical relationship with whether it gets patched. The findings emphasize the need for proactive, security-by-design architectures and continuous vulnerability management to reduce reliance on reactive patching.

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Medical device security cannot depend on patching alone.
For devices embedded in critical care environments or implanted in patients, patching can introduce new risks — downtime, data loss, or interference with clinical workflows.
Yet, FDA guidance explicitly requires manufacturers to design devices that “anticipate software patches” and support secure, rapid updates.

This whitepaper helps manufacturers and regulators understand:

• Why traditional patching models are insufficient for connected medical devices
• How proactive design and secure architectures mitigate risk
• Why patch frequency and vulnerability severity remain misaligned
• How industry transparency through ICS-CERT reporting reflects maturity in security managemen

• Medical device manufacturers (MDMs): engineers, cybersecurity teams, and regulatory professionals
• Healthcare delivery organizations (HDOs): IT, biomedical, and clinical security leaders
• Regulatory and standards bodies: professionals involved in FDA, NIST, and ISO security frameworks
• Product security officers and executives: developing lifecycle vulnerability management programs

• 46.5% increase in patch frequency since FDA’s postmarket guidance (2016).
• No correlation between CVSS severity and whether a patch is issued.
• Patching remains concentrated among large vendors and high-visibility devices.
• Security researcher collaboration increases patch likelihood and disclosure transparency.
• Future resilience depends on proactive design and continuous monitoring, not reactive patching.

1. Introduction: Why Patching Is Not Enough
   
   1. Overview of the FDA’s Postmarket Cybersecurity Guidance (2016)
   2. ICS-CERT’s role in medical device vulnerability transparency
   3. The myth of patching as a complete mitigation strategy
2. Section I: Medical Device Patching 101
   
   1. Defining patching in medical versus IT systems
   2. Why patching is uniquely challenging for embedded or life-sustaining devices
   3. Clinical, operational, and regulatory considerations in patch deployment
3. Section II: Data Analysis — What the Numbers Reveal
   
   1. Review of 68 ICS-CERT advisories and 154 vulnerabilities (2013–2019)
   2. Key finding: 46.5% increase in patched vulnerabilities after FDA guidance
      
   3. Vendor participation 400% increase in coordinated disclosures
   4. Patching frequency by vulnerability type and device class (infusion pumps, imaging, diagnostics)
   5. No correlation between CVSS scores and patch frequency
4. Section III: Observations and Influencing Factors
   
   1. Role of security researchers in increasing patch frequency (69.5% correlation)
   2. Network monitoring as a mitigation when patching is impractical
   3. Case examples: vendor maturity and proactive disclosure programs
   4. Why medium CVSS vulnerabilities are least frequently patched
5. Section IV: Hypotheses and Predictions
   
   1. Patching will increase but remain concentrated among industry leaders
   2. Security researchers will lower the “bar for patching,” driving volume
   3. Vendors will eventually compete on patch transparency and speed
   4. The industry will evolve toward proactive, secure-by-design architectures
6. Section V: Broader Implications and Future Direction
   
   1. Limitations of patching for embedded and implantable devices
   2. Call for vulnerability-scoring frameworks incorporating patient safety and clinical impact
   3. The path forward: continuous monitoring, automated updates, and ecosystem collaboration
7. Appendices
   
   1. Appendix A: CVSS v2 vs. v3 scoring analysis and distribution changes
   2. Appendix B: Vulnerability root cause categories (code defect, encryption, configuration, authentication, OS, third-party, misc.)