A single ransomware incident at a healthcare organization can trigger OCR investigation, breach notification obligations, and civil monetary penalties — regardless of whether a HIPAA Security Rule audit was ever conducted. The OCR audit protocol maps directly to what Pistos produces.
The HIPAA Security Rule requires an ongoing, documented security management process — not a point-in-time assessment. OCR audits evaluate whether the program has been maintained continuously, not whether it looked good on the day it was built.
45 CFR Parts 160 and 164 — HHS / OCR
Requires covered entities and business associates to implement administrative, physical, and technical safeguards to protect ePHI. The Security Rule maps to 54 implementation specifications — required and addressable — that OCR evaluates in audit protocol examinations.
Health Information Technology for Economic and Clinical Health
Expanded HIPAA obligations to business associates, increased civil monetary penalties, and established the breach notification rule requiring notification to OCR, affected individuals, and — for breaches affecting 500 or more — prominent media outlets.
Office for Civil Rights — HHS
OCR conducts Phase 2 audits using a structured protocol covering privacy, security, and breach notification rules. The security audit protocol maps directly to the CIS Controls domains that Skopein assesses and Sentinel tracks — risk analysis, workforce training, access controls, audit logging.
Medical Device Manufacturers
The FDA requires medical device manufacturers to submit cybersecurity documentation with premarket submissions and maintain a Software Bill of Materials. Post-market surveillance must address vulnerabilities identified after market release.
OCR Phase 2 security audits follow a structured protocol. Every audit request has a corresponding Pistos output — documented, dated, and already organized when the request arrives.
OCR requires a thorough and accurate assessment of the potential risks to ePHI confidentiality, integrity, and availability.
Sentinel produces a complete annual risk assessment with control scores, inherent risk ratings, and remediation roadmap.
Covered entities must train all workforce members on policies and procedures and document training completion.
Manthesis produces dated completion records and phishing simulation results for every staff member.
Technical policies and procedures for electronic information systems must restrict access to authorized users only.
Skopein reads actual access control configuration — MFA state, privileged account enumeration, dormant account detection.
Covered entities must implement hardware, software, or procedural mechanisms that record and examine system activity.
Sentinel tracks audit log management controls with evidence of review procedures and retention policy documentation.
Encryption of ePHI in transit and at rest — addressable specification requiring documented rationale for any alternative measure.
Skopein verifies actual encryption state — BitLocker enforcement, TLS version, email encryption posture.
Covered entities must have executed BAAs with all business associates who handle ePHI on their behalf.
Sentinel tracks BAA status for every vendor relationship with documented review dates and evidence uploads.
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