A tool in medical device cybersecurity - MedCrypt

As cybersecurity threats against connected medical devices continue to rise, both regulators and manufacturers face the challenge of balancing process-driven oversight with product-level technical safeguards.This whitepaper examines postmarket cybersecurity disclosures through the lens of the FDA Postmarket Management Guidance and NIST Cybersecurity Framework (NIST-CSF), revealing how many vulnerabilities remain unaddressed — and how MedCrypt’s technology could mitigate the majority of them. Using real-world data from the ICS-CERT advisory database, the paper quantifies MedCrypt’s impact on reducing vulnerability exposure and supporting proactive threat detection across the medical device ecosystem.

FDA guidance now expects manufacturers to not only design secure products but also manage risk throughout the device lifecycle.
Yet, between 2013 and 2018, only a small fraction of the NIST-CSF cybersecurity subcategories were referenced in medical device vulnerability disclosures. The findings highlight a critical gap: while 72% of the FDA’s recommendations address process interventions, 28% require product solutions — areas where software-based tools like MedCrypt can have the most direct impact.

This whitepaper helps medical device leaders understand:

• Where current postmarket cybersecurity efforts fall short
• How FDA and NIST-CSF frameworks intersect
• Which vulnerabilities can be technically mitigated through embedded security solutions

• Engineering and product development teams seeking to strengthen postmarket cybersecurity posture
• Regulatory and QA/RA professionals aligning with FDA postmarket and 524B requirements
• CISOs and cybersecurity program leaders evaluating secure design and detection frameworks
• Executives and compliance officers driving organizational readiness and market trust

• Only 12% of NIST-CSF cybersecurity subcategories have been represented in historical vulnerability disclosures — leaving major blind spots.
• MedCrypt’s capabilities address 80% of the technical subcategories and could have prevented 76% of known vulnerabilities.
• FDA’s focus on both process and product interventions underscores the need for embedded, proactive cybersecurity solutions.
• Threat sharing, forensic monitoring, and data encryption are becoming regulatory expectations, not optional features.

1. Introduction: Cybersecurity as a Tool, Not an Afterthought
   
   1. How prior MedCrypt whitepapers established the landscape
   2. Objectives of this postmarket assessment
2. Section I: State of the Industry — Where We Stand Today
   
   1. Overview of FDA and NIST-CSF alignment
   2. Analysis of disclosed vulnerabilities (2013–2018)
   3. The 12% problem: missing vulnerabilities across 88% of NIST-CSF categories
   4. Process vs. Product interventions and their real-world implications
   5. Security stack limitations for healthcare delivery organizations (HDOs)
3. Section II: MedCrypt Coverage — How Embedded Security Solves the Gaps
   
   1. MedCrypt’s software library and cryptographic functions
   2. Implementation of encryption, authentication, and threat monitoring
   3. Coverage statistics:
      
      1. 80% of NIST-CSF technical subcategories addressed
      2. 76% of historical vulnerabilities mitigated through MedCrypt functionality
   4. Real-world examples:
      
      1. How MedCrypt supports forensic logging and intrusion detection
      2. Use of metadata for anomaly detection and threat sharing
4. Section III: Hypotheses & Predictions — The Road Ahead
   
   1. Global regulatory influence (e.g., GDPR, emerging regional frameworks)
   2. Expected FDA enforcement and increased public scrutiny during 510(k) reviews
   3. The growing role of security researchers and third-party partnerships
   4. The evolution from exploit-based hacking to deliberate disruption
   5. The role of MedCrypt and industry collaboration in proactive risk reduction
5. Appendix A: Vulnerability Mapping and NIST-CSF Crosswalk
   
   1. Summary of ICS-CERT data and MedCrypt coverage
   2. Mapped examples of how cryptographic, monitoring, and authentication features mitigate specific risks