Critical EHR module from a new ISV
Procurement cannot issue PO until SCRM tiering and security questionnaire complete under SR-1 procedures.
Supply Chain Risk Management Policy and Procedures
Medium Risk
Moderate
Low Cost
SR-1 requires developing, documenting, and disseminating a supply chain risk management policy and procedures, designating roles, and reviewing/updating on a defined frequency. Healthcare supply chains include EHR vendors, medical device manufacturers, cloud regions, open-source components, and staffing firms — compromises or failures upstream become ePHI incidents downstream. SR-1 establishes the policy backbone for managing those risks.
Control Objective
Establish and maintain an SCRM policy and procedures with clear roles so technology and service supply chain risks to ePHI systems are identified, assessed, and treated consistently.
Implementation Guidance
- Publish an SCRM policy covering acquisition, development, maintenance, and disposal of products/services affecting ePHI systems.
- Assign roles: SCRM lead, procurement, security, clinical engineering, and legal.
- Define procedures for vendor risk assessment, criticality tiering, and contract SCRM clauses.
- Include software Bill of Materials (SBOM) expectations for critical clinical applications where feasible.
- Address counterfeit, tampered, and unsupported components — especially for network and clinical devices.
- Integrate SCRM checkpoints into procurement before purchase orders for High-tier items.
- Review policy at least annually and after major supply disruptions or incidents.
- Align SR-1 with SA-9 oversight and PS-7 personnel requirements for continuity.
Real-World Use Cases
How this control shows up in healthcare and HIPAA-covered environments.
Infusion pump firmware from a questionable channel
Clinical engineering rejects gray-market parts; policy requires authorized distributor sourcing.
Open-source library CVE in a patient portal
SCRM procedures require dependency tracking and rapid patch coordination with the portal vendor.
Best Practices
- Written SCRM policy with owners.
- Criticality-based vendor tiers.
- Procurement gates for High tier.
- Authorized sources for devices/firmware.
- SBOM/dependency awareness for apps.
- Annual policy review.
Common Gaps & Violations
- No SCRM policy — only generic purchasing rules.
- Security engaged after contract signature.
- Gray-market clinical hardware.
- No ownership for supply chain incidents.
- Policy never reviewed after COVID-era vendor shifts.
Required Documentation
- SCRM policy
- SCRM procedures / playbooks
- Role designations
- Tiering criteria and examples
- Evidence of periodic policy review
How to Test & Validate
- Locate current SCRM policy and last review date.
- Verify roles are designated and known to procurement.
- Sample a High-tier purchase for SCRM gate evidence.
- Confirm clinical device sourcing rules exist.
- Trace alignment to SA-9 vendor oversight.
Audit Considerations
Supply chain questions increasingly appear in security assessments. A named SCRM policy with procurement integration is stronger than ad-hoc vendor reviews.
HIPAA Mapping
How this NIST control supports HIPAA Security Rule expectations.
- 164.308(a)(1) Risk Analysis — supply chain threats are relevant risks to ePHI.
- 164.308(a)(1)(ii)(B) Risk Management — manage risks introduced by vendors and components.
- 164.308(b) Business Associate Contracts — contractual SCRM expectations support BA assurances.
- 164.310(d) Device and Media Controls — provenance and integrity of devices/media matter for ePHI protection.
Compliance Tips
- Add an SCRM checkbox to the capital request form for clinical systems.
- Keep a 'top 20 critical suppliers' list reviewed by security quarterly.
- Do not bury SCRM only in IT — include clinical engineering and pharmacy automation vendors.
Frequently Asked Questions
Is SR-1 the same as vendor risk management?
Vendor risk is a major part; SCRM also covers components, manufacturers, logistics, and development supply chains.
How does SR-1 relate to SA-9?
SR-1 is the policy/procedure foundation; SA-9 operationalizes requirements and oversight for external system services.
Do we need SBOMs for everything?
Start with internet-facing and critical ePHI applications; expand as tooling matures.
References & Resources
- NIST SP 800-53 Rev. 5 — SR-1
- NIST SP 800-161 Supply Chain Risk Management Practices
- Related controls: SA-9, RA-3, PS-7, CM-8, SI-2
Related Guidelines
Related controls that commonly accompany SR-1.
Need Help Implementing SR-1?
Our auditors map NIST SP 800-53 controls to your HIPAA Security Rule program — policies, technical evidence, and audit readiness.