Cloud EHR migration
RA-1 procedures require an updated risk analysis before cutover, covering tenant configs, BA subprocessors, and identity federation.
Risk Assessment Policy and Procedures
Critical Risk
Moderate
Low Cost
RA-1 requires risk assessment policy and procedures addressing purpose, scope, roles, management commitment, coordination, and compliance, plus procedures to implement the Risk Assessment family. For covered entities and BAs, RA-1 formalizes the HIPAA-required security risk analysis and ongoing risk assessment cadence across EHR, devices, vendors, and facilities.
Control Objective
Maintain policy and procedures that ensure risks to ePHI confidentiality, integrity, and availability are systematically identified, assessed, documented, and kept current.
Implementation Guidance
- Publish RA-1 policy defining scope (all ePHI systems, locations, and key BAs).
- Assign risk assessment ownership (security/privacy) and leadership acceptance of results.
- Require enterprise risk analysis at defined frequency and upon significant changes.
- Define methodology (threats, vulnerabilities, likelihood, impact) appropriate to healthcare.
- Mandate risk register updates and linkage to remediation / risk acceptance.
- Include third-party and medical device risk inputs.
- Review policy annually and after OCR guidance or major incidents.
- Align with RA-3 assessments and PM risk management strategy.
Real-World Use Cases
How this control shows up in healthcare and HIPAA-covered environments.
New research data lake
Policy triggers assessment of de-identification quality, access paths, and residual re-identification risk before datasets land.
Post-ransomware peer hospital event
Organization reassesses backup exposure and remote access risks under RA-1-driven out-of-cycle analysis.
Best Practices
- Written methodology and scope.
- Change-triggered assessments, not only annual.
- Leadership sign-off on residual risk.
- BA and device risks included.
- Risk register integrated with CAPA tracking.
- Evidence retained ≥6 years.
Common Gaps & Violations
- One risk analysis from years ago never updated.
- IT asset risks only; clinics and paper processes ignored.
- Findings with no treatment decisions.
- Vendor risks excluded.
- Methodology undocumented.
Required Documentation
- Risk assessment policy (RA-1)
- Risk analysis methodology
- Roles and acceptance authorities
- Cadence and trigger definitions
- Policy review records
How to Test & Validate
- Verify RA-1 policy currency and scope includes ePHI.
- Confirm last enterprise assessment meets cadence.
- Sample a major change for triggered reassessment.
- Trace findings to risk responses.
- Interview leadership on residual risk acceptance.
Audit Considerations
OCR frequently cites failure to conduct an accurate and thorough risk analysis. RA-1 shows the analysis is a governed program, not a one-off binder.
HIPAA Mapping
How this NIST control supports HIPAA Security Rule expectations.
- 164.308(a)(1)(ii)(A) Risk Analysis — conduct an accurate and thorough assessment of potential risks and vulnerabilities to ePHI.
- 164.308(a)(1)(ii)(B) Risk Management — implement security measures sufficient to reduce risks to an appropriate level.
- 164.306 Security standards general rules — flexibility balanced with documented risk-based decisions.
- 164.316 Policies and procedures — maintain risk assessment policy documentation.
Compliance Tips
- Schedule RA updates alongside EHR major releases and new BA onboarding.
- Keep an executive one-pager of top ePHI risks for board reporting.
- Use the same register for security and privacy risks where possible.
Frequently Asked Questions
Is a vulnerability scan the same as RA-1 risk assessment?
No. Scans feed assessments; RA-1 requires policy for broader risk analysis including administrative and physical factors.
How often must risk analysis occur?
HIPAA expects ongoing risk analysis; define annual minimum plus triggers for significant changes in RA-1 policy.
How does RA-1 relate to RA-3?
RA-1 is policy/procedures; RA-3 is performing risk assessments under that policy.
References & Resources
- NIST SP 800-53 Rev. 5 — RA-1
- NIST SP 800-30
- HHS Security Risk Assessment guidance
- Related controls: RA-3, RA-5, PM-9, CA-2
Related Guidelines
Related controls that commonly accompany RA-1.
Need Help Implementing RA-1?
Our auditors map NIST SP 800-53 controls to your HIPAA Security Rule program — policies, technical evidence, and audit readiness.