Interactive control overlap matrix: FDA Cybersecurity ↔ HIPAA ↔ SOC 2 ↔ IEC 81001-5-1
Identify which security controls satisfy multiple compliance frameworks simultaneously. Eliminate redundant work by building a unified control set with multi-framework traceability.
One implementation, multiple compliance credits. ~60–70% of controls overlap across FDA, HIPAA, and SOC 2 — implement once and document for all three.
Filter to "Gaps Only" to see controls required by one framework but not others. These are your framework-specific obligations that need dedicated attention.
Export the mapping as CSV for inclusion in your Design History File, HIPAA audit evidence binder, or SOC 2 readiness documentation.
Premarket submission requirements
ePHI safeguard requirements
Trust Services Criteria guide
Health software security lifecycle
Device-to-cloud compliance
Reference architecture for backends
33
Total Controls
22
Covered by All Selected
11
Gaps (≥1 framework missing)
| Control | FDA | HIPAA | SOC 2 | IEC 81001 |
|---|---|---|---|---|
Unique User Identification Every user has a unique identifier; no shared accounts | SPDF — Access Control | § 164.312(a)(2)(i) | CC6.1 | Clause 5.3.2 |
Role-Based Access Control (RBAC) Access permissions based on job role with least privilege | SPDF — Least Privilege | § 164.312(a)(1) | CC6.1, CC6.3 | Clause 5.3.2 |
Multi-Factor Authentication (MFA) Two or more authentication factors required | SPDF — Authentication | § 164.312(d) | CC6.1 | Clause 5.3.2 |
Automatic Session Timeout Sessions terminated after inactivity period | SPDF — Session Mgmt | § 164.312(a)(2)(iii) | CC6.1 | N/A |
Emergency Access Procedure Documented procedure for emergency system access | N/A | § 164.312(a)(2)(ii) | CC6.1 | N/A |
Access Review and Recertification Periodic review of access rights (quarterly recommended) | N/A | § 164.308(a)(4) | CC6.2 | Clause 5.3.3 |
| Control | FDA | HIPAA | SOC 2 | IEC 81001 |
|---|---|---|---|---|
Encryption at Rest (AES-256) All sensitive data encrypted in storage | SPDF — Data Protection | § 164.312(a)(2)(iv) | CC6.7 | Clause 5.3.4 |
Encryption in Transit (TLS 1.2+/1.3) All data encrypted during transmission | SPDF — Communication Security | § 164.312(e)(1) | CC6.6, CC6.7 | Clause 5.3.4 |
Key Management (KMS/HSM) Cryptographic key lifecycle management | SPDF — Crypto Mgmt | § 164.312(a)(2)(iv) | CC6.7 | Clause 5.3.4 |
Data Integrity Verification Checksums, HMAC, or digital signatures for data integrity | SPDF — Data Integrity | § 164.312(c)(1) | PI1.1 | Clause 5.3.5 |
Secure Data Disposal Secure erasure per NIST SP 800-88 on decommission | N/A | § 164.310(d)(2)(i) | CC6.5 | Clause 5.7 |
Data Classification Classification scheme for data sensitivity levels | N/A | § 164.312(a)(1) | CC6.7, C1.1 | Clause 5.3.1 |
| Control | FDA | HIPAA | SOC 2 | IEC 81001 |
|---|---|---|---|---|
Audit Logging Record of security-relevant events with timestamps | SPDF — Audit Trail | § 164.312(b) | CC7.2 | Clause 5.3.6 |
Log Protection and Retention Tamper-proof log storage with retention policy | SPDF — Log Integrity | § 164.316(b)(2) | CC7.2 | Clause 5.3.6 |
Security Monitoring (SIEM) Real-time security event detection and correlation | Post-market monitoring | § 164.308(a)(1)(ii)(D) | CC7.2, CC7.3 | Clause 5.6 |
Anomaly Detection Automated detection of unusual access or behavior patterns | SPDF — Anomaly Detection | § 164.308(a)(1)(ii)(D) | CC7.3 | Clause 5.6 |
| Control | FDA | HIPAA | SOC 2 | IEC 81001 |
|---|---|---|---|---|
Cybersecurity Risk Assessment Formal exploitability-based risk evaluation | SPDF — Risk Assessment | § 164.308(a)(1)(ii)(A) | CC3.2 | Clause 5.2 |
Threat Modeling Systematic threat identification using STRIDE/PASTA | SPDF — Threat Model | § 164.308(a)(1)(ii)(A) | CC3.2 | Clause 5.2.2 |
SBOM Management Software Bill of Materials with CVE monitoring | Section 524B SBOM | N/A | CC3.2 | Clause 5.4 |
Residual Risk Acceptance Formal acceptance process for remaining risks | SPDF — Risk Acceptance | § 164.308(a)(1)(ii)(B) | CC3.4 | Clause 5.2.5 |
| Control | FDA | HIPAA | SOC 2 | IEC 81001 |
|---|---|---|---|---|
Vulnerability Scanning Regular automated vulnerability scanning | SPDF — Security Testing | § 164.308(a)(8) | CC7.1 | Clause 5.5 |
Patch Management Process Timely deployment of security patches | Section 524B Patching | § 164.308(a)(5)(ii)(B) | CC7.1 | Clause 5.6.2 |
Coordinated Vulnerability Disclosure Public process for reporting and addressing vulnerabilities | Section 524B CVD | N/A | CC7.4 | Clause 5.6.3 |
Penetration Testing Annual third-party security assessment | SPDF — Pen Testing | § 164.308(a)(8) | CC7.1 | Clause 5.5 |
| Control | FDA | HIPAA | SOC 2 | IEC 81001 |
|---|---|---|---|---|
Incident Response Plan Documented procedure for security incident handling | SPDF — Incident Mgmt | § 164.308(a)(6) | CC7.3, CC7.4 | Clause 5.6.1 |
Breach Notification Process for notifying affected parties after a breach | MDR (21 CFR 803) | § 164.400-414 | CC7.4 | N/A |
Disaster Recovery Plan Procedures for system recovery after major incidents | N/A | § 164.308(a)(7)(ii)(B) | A1.2 | N/A |
Data Backup Regular backup of critical data with verification | N/A | § 164.308(a)(7)(ii)(A) | A1.2 | N/A |
| Control | FDA | HIPAA | SOC 2 | IEC 81001 |
|---|---|---|---|---|
Security Policies and Procedures Documented security policies reviewed annually | SPDF — Security Policy | § 164.316(a) | CC1.1, CC1.2 | Clause 5.1 |
Change Management Process Formal change control for production systems | Design Controls (820.30) | § 164.316(b)(2)(iii) | CC8.1 | Clause 5.4.3 |
Security Training Program Role-based security awareness training | SPDF — Training | § 164.308(a)(5) | CC1.4 | Clause 5.1.2 |
Vendor/Third-Party Risk Management Security assessment of vendors and suppliers | SPDF — Supply Chain | § 164.314(a) | CC9.2 | Clause 5.4.2 |
Business Associate Agreements Contractual HIPAA flow-down to vendors | N/A | § 164.314(a) | CC9.2 | N/A |