Compliance & Regulations/North America/HIPAA
Healthcare · United States — healthcare covered entities and business associates

HIPAA / HITECH

Privacy, security, and breach notification rules for Protected Health Information (PHI) in the United States.

Regulator
US Department of Health and Human Services (HHS) — Office for Civil Rights
Jurisdiction
United States — healthcare covered entities and business associates
Status
Active — HHS proposed Security Rule update in January 2025 with phased compliance through 2027.
In force since
April 2003 (Privacy Rule); April 2005 (Security Rule); 2009 HITECH Breach Notification.
Regulator's source
Who it applies to

Covered entities (providers, health plans, clearinghouses) and their Business Associates.

Audit / certification status

Safeguard is itself a Business Associate; HIPAA assurance package available under NDA.

What it requires

What HIPAA actually requires.

These are the obligations a regulated entity owes — the things an assessor or supervisor will ask about.

01

Administrative, physical, and technical safeguards per the Security Rule (164.308 / 164.310 / 164.312).

02

Business Associate Agreements (BAA) before sharing PHI with vendors.

03

Risk analysis and management documented per 164.308(a)(1)(ii)(A).

04

Breach notification within 60 days of discovery; HHS portal notice for breaches affecting 500+.

05

Encryption or addressable equivalent for PHI at rest and in transit.

06

Workforce access controls with role-based scoping and termination revocation.

How Safeguard maps to it

Pre-mapped controls. Continuous evidence.

Each requirement above is bound to live telemetry — not screenshots. The mapping below is what your auditor or regulator sees.

Continuous mapping of every Safeguard-collected PHI flow to the Security Rule control set.

BAAs templated and signed for every Safeguard customer touching PHI.

Encryption-at-rest and TLS 1.3 in transit with HSM-backed key management as default.

Access reviews exportable on demand with role and PHI-scope visibility.

Breach timeline reconstruction tooling for the 60-day window — auto-generated incident summary.

Evidence we produce

Artifacts your auditor accepts.

Each evidence artifact is signed and timestamped. Auditors can verify integrity without trusting Safeguard.

Risk analysis document (164.308(a)(1)(ii)(A)) generated quarterly.

BAA registry with active counterparties.

PHI access audit logs with quarterly review attestations.

Encryption posture report by data classification.

Breach-readiness tabletop exercise records.

Ready for HIPAA?

Bring the framework. We'll walk the controls with you — section by section, evidence packet by evidence packet, with the regulators you actually have to answer to.

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