Compliance Score
Covered
Partial
Missing
| Rule | Framework | Status | Confidence | Evidence |
|---|---|---|---|---|
|
Encryption of Personal Data in Transit GDPR-ART32-ENC-TRANS |
GDPR | MISSING | HIGH |
Protocol does not meet encryption requirements for data in transit Enable encryption with AES-128-GCM or stronger, minimum 128-bit keys, and ensure scope covers data in transit |
|
Mutual Authentication Between Entities GDPR-ART32-AUTH |
GDPR | COVERED | HIGH |
Protocol implements mutual authentication: device (ECDSA_P-256), server (X.509_certificate) Meets GDPR Article 32 mutual authentication requirement ✓ |
|
Data Integrity (MAC/Authentication Tags) GDPR-ART32-INTEGRITY |
GDPR | COVERED | HIGH |
Protocol uses AEAD cipher (AES-256-CCM) which provides data integrity Meets GDPR Article 32 data integrity requirement ✓ |
|
Comprehensive Audit Logging GDPR-ART32-LOGGING |
GDPR | PARTIAL | MEDIUM |
Protocol has logging enabled with 3 scope items Add missing scope items (authentication, key_rotation, data_access) and ensure minimum 30 days retention |
|
Encryption and Decryption for Data in Motion HIPAA-SEC-CRYPTO |
HIPAA | MISSING | HIGH |
Protocol does not meet HIPAA encryption requirements for data in motion Enable encryption with supported algorithms and implement ephemeral key exchange |
|
Access Controls (Authentication) HIPAA-SEC-ACCESS |
HIPAA | COVERED | HIGH |
Protocol uses mutual authentication with strong methods: ECDSA_P-256, X.509_certificate Meets HIPAA Security Rule access control requirement ✓ |
|
Firmware Must Be Digitally Signed HC-MED-FW-SIGN |
Health Canada | COVERED | HIGH |
Firmware updates are signed using ECDSA-P256 Meets Health Canada medical device firmware signing requirement ✓ |
|
Comprehensive Audit Trail (Authentication, Key Changes, Errors) HC-MED-AUDIT |
Health Canada | COVERED | HIGH |
Protocol has comprehensive medical audit logging with 90 days retention and cloud transmission Meets Health Canada medical device audit requirements ✓ |