Regulatory pathway · all topics

HIPAA Security Rule (45 CFR Part 164 Subpart C)

The HIPAA Security Rule establishes administrative, physical, and technical safeguards required for ePHI. Required Implementation Specifications include access controls (164.312(a)), audit controls (164.312(b)), integrity controls (164.312(c)), authentication (164.312(d)), and transmission security (164.312(e)). Civil monetary penalties up to USD 1.5M per violation category per year. Risk analysis (164.308(a)(1)) is the foundational requirement. Covered Entities and Business Associates are subject. HHS OCR enforces.

Source

HHS, '45 CFR Part 164 Subpart C - Security Standards for the Protection of ePHI'

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-C

How MedTek OS handles this

Compass drafts the hipaa security rule (45 cfr part 164 subpart c) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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