Healthcare organizations protect some of the most sensitive personal data in any sector — and they do it under a regulatory regime where a single breach can trigger federal investigation, multi-million dollar penalties, and lasting reputational damage. Whether you operate a hospital system, a clinical research organization, a digital health platform, or a healthcare technology vendor, your compliance program must protect Protected Health Information (PHI) at every point in its lifecycle.
Cleared Systems helps healthcare organizations design HIPAA-aligned security programs, conduct the risk analyses required by the Security Rule, and prepare for state-level regulators and federal auditors. For organizations supporting federal healthcare contracts — VA, DoD, HHS — we extend that work into NIST 800-171 and FedRAMP-aligned controls.
Key Compliance Challenges
- HIPAA Security and Privacy Rule alignment: Conducting the required Security Risk Analysis, documenting safeguards, and managing Business Associate Agreements across a sprawling vendor footprint.
- State privacy law convergence: Navigating Texas HB 300, California CMIA, New York SHIELD Act, and emerging state-level patient data protection rules on top of HIPAA.
- Connected device and EHR security: Securing electronic health record systems, medical IoT, and the integrations between them — often involving legacy systems with limited patching cadence.
- Federal healthcare contracts: Meeting CUI handling requirements when supporting VA, DoD, or HHS programs, including alignment to NIST 800-171.
Regulatory Frameworks
- HIPAA Security Rule (45 CFR Part 164, Subpart C) — Administrative, physical, and technical safeguards
- HIPAA Privacy Rule (45 CFR Part 164, Subpart E) — Use and disclosure of PHI
- HITECH Act — Breach notification, enforcement, audits
- State patient privacy laws — TX HB 300, CA CMIA, NY SHIELD, others
- NIST SP 800-66 — HIPAA Security Rule implementation guide
- NIST SP 800-171 — For federal healthcare contracts handling CUI
How We Help
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We work with Healthcare organizations to navigate their unique regulatory landscape.
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