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NIST AI RMF 1.0: A 5-Step Starter
for Healthcare & SaaS

AI Risk is real and so is the need for governance.

Whether you’re a digital health startup, an SaaS platform, or a compliance-minded covered entity, chances are your teams are already using AI. From patient intake chatbots to marketing copy generators, Shadow AI is already at work inside your systems.

But what happens when AI touches Protected Health Information (PHI), Personally Identifiable Information (PII), or regulated operations? Customers and auditors alike now expect visible governance and not just a vague AI policy, but clear processes that map to security and privacy standards.

That’s where the NIST AI Risk Management Framework (AI RMF 1.0) comes in. It’s a flexible, non-binding framework but more importantly, it’s practical. You don’t need a massive compliance team or a six-month roadmap. You just need lightweight, auditable practices that fit into what you’re already doing.

Here’s how to make it real this Cybersecurity Awareness Month.

The 5-Step RMF Starter

The full NIST RMF includes four major functions: Map, Measure, Manage, and Govern. We’ve expanded it into five practical steps you can apply right now to strengthen AI governance in your organization without slowing your team down.

1. Govern — Write the 1-Page AI Policy

Start with a lean, living document that defines:

• Where AI is allowed (departments, systems, data)

• Who approves AI tools

• Who owns risk (compliance, legal, security)

• How changes are managed (approvals, reviews)

Then train your staff with a quick “Do / Don’t” prompt guide to set boundaries: No PHI in ChatGPT. No synthetic data in production. Simple, clear, repeatable.

2. Map — Inventory AI Use

List where and how AI is used today:

• Tools: Custom models, third-party APIs, automation tools

• Data Touched: PHI, PII, customer records, internal docs

• Impact Scope: Patients, clients, business operations

This doesn’t need to be perfect. It needs to be visible.

3. Measure — Define Risks and Success

Set metrics for both risk and performance:

• Risk Dimensions: Privacy exposure, fairness/bias, output integrity, cybersecurity

• Success Metrics: Accuracy, cost savings, turnaround time, user satisfaction

This helps you prioritize controls based on actual business impact.

4. Manage — Enforce and Monitor Controls

Don’t just write it, control it. Focus on:

• Approved tools list (+ Business Associate Agreements if PHI is involved)

• Access controls with MFA for all users

• Prompt sanitization: Avoid PHI, misleading phrasing, or exposed credentials

• Audit trails: Log access and prompt activity where possible

• Review cadence: Quarterly mini-reviews of AI use and controls

5. Prove — Keep Lightweight Evidence

You don’t need a binder, just a credible pack:

• 📝 Most recent policy version

• ✅ Approved tools list (dated + reviewed)

• 💬 3–5 sample prompts with PHI-sanitization applied

• 📓 Review log (1–2 lines per entry: what changed, who approved)

This is the kind of evidence auditors love. It’s lean. It’s trackable. It proves your intent and your action.

Framework Mapping 

Want to show that your AI use aligns with existing frameworks? Here’s how this maps:
NIST AI RMF Step → HIPAA → SOC 2 → ISO/IEC 27001:2022

• Govern
  HIPAA: §164.308(a)(1) Security Management Process; §164.316(b) Documentation
  SOC 2: CC1 (Control Environment), CC2 (Communication)
  ISO 27001: Clause 5 (Leadership & Policy), Clause 7.5 (Documented Info)

• Map
  HIPAA: §164.308(a)(1)(ii)(A–B) Risk Analysis & Risk Management
  SOC 2: CC3 (Risk Assessment)
  ISO 27001: Clause 6.1 (Risk assessment/treatment), Annex A.5/A.15 (supplier/org controls) as applicable

• Measure
  HIPAA: §164.308(a)(8) Evaluation; §164.308(a)(1)(ii)(D) Activity Review
  SOC 2: CC4 (Monitoring Activities)
  ISO 27001: Clause 9.1–9.2 (Monitoring/Measurement & Internal Audit)

• Manage
  HIPAA: §164.312 (Technical Safeguards: Access, Integrity, Transmission); §164.308(a)(3–6) (Workforce security, Access mgmt, Awareness/Training, Incident response)
  SOC 2: CC6 (Logical/Physical Access), CC7 (System Ops), CC8 (Change Mgmt), CC9 (Risk/Vendors)
  ISO 27001: Annex A.8 (Technological controls incl. Identity/Access A.8.2, Authn A.8.3, Monitoring A.8.16), Annex A.5 (Org controls incl. supplier)

• Prove
  HIPAA: §164.316(b) Documentation Requirements
  SOC 2: Evidence of design/operating effectiveness across CC1–CC9 (reports, logs, reviews)
  ISO 27001: Clause 7.5 (Documented Info), Clause 9.3 (Management Review), Clause 10 (Improvement)

VRC: Your Partner in Smart, Scalable AI Governance

You don’t need complex programs or expensive tooling to start. You need a practical framework, consistent controls, and credible evidence that proves you’re in control of your AI.

That’s what VanRein Compliance delivers. We help you:

• Draft your first AI policy and usage inventory.

• Establish access, prompt, and tool controls.

• Build a small-but-mighty evidence pack that auditors and clients trust.

We help you govern the AI you’re already using with proof, not paperwork.

Turn AI into Trust

AI risk isn’t a future concern—it’s already here. From shadow-AI tools to unchecked data exposure, your team’s use of AI demands real oversight. The good news? You don’t need to reinvent your compliance program. With a few focused controls and repeatable proof points, you can meet today’s expectations with tomorrow’s scalability in mind.

Smart AI governance sets your team up to move faster, safer, and more credibly.

Ready to move from AI guesswork to defensible governance?

👉 Book a Discovery Call Today with VanRein Compliance and take the first step toward a practical, audit-ready AI program. We’ll walk you through our RMF QuickStart and show you how to turn policy into proof—without bureaucracy.

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ISO/IEC 42001: The Management
System for Responsible AI

AI governance is now a frontline requirement. Customers want assurance that models are reliable and fair. Regulators expect privacy and security to be built in. Boards want transparency and control. ISO/IEC 42001 answers that pressure with a management-system approach for AI—policy, roles, risk, controls, monitoring, and continual improvement so organizations can operate AI responsibly and prove it.

Strategic Value That Compounds

• Trust acceleration. A recognized standard signals discipline around bias, security, and privacy—shortening sales cycles and easing due diligence.

• Control over AI sprawl. A single operating cadence (policy → inventory → risk → control → review) reduces one-off exceptions and shadow tools.

• Synergy with existing programs. ISO 42001 layers onto ISO 27001 and SOC 2 evidence you already keep (access reviews, logging, vendor due diligence).

• Audit-ready habits. Small, repeatable artifacts—versioned policies, owner sign-offs, review logs—turn intent into defensible proof.

Readiness Checklist You Can Maintain

Use this as a practical, light-weight starter aligned to ISO/IEC 42001. Keep artifacts short, dated, and owned.

AI Policy and Named Roles

• One-page policy defining purpose, scope, allowed tools, prohibited uses, and escalation.

• Named Owner, Approver, Reviewer with contact paths and substitution rules.

Use-Case and Data Inventory

• Register each AI use case: purpose, business owner, model/provider, inputs/outputs, PHI/PII flags, user population, downstream impact.

• Note deployment state (pilot/production), last review date, and planned changes.

Risk Criteria and Approval Gates

• Criteria covering privacy exposure, security, accuracy/robustness, bias/fairness, and explainability where applicable.

• Pre-go-live and change gates: when a material update, new data type, or new audience requires re-approval.

Controls You Can Prove

• Approved tools list; Business Associate Agreements when PHI is in scope.

• Identity and access with MFA, least privilege; admin action logging.

• Prompt/data hygiene standards (PHI sanitization patterns; no secrets/keys).

• Monitoring for drift, incident capture, and vendor health (SLAs, security notices).

• Vendor governance: DPAs/BAAs, no-training attestations, retention limits, regional storage declarations.

Continuous Improvement Loop

• Quarterly mini-review per use case: metrics snapshot, incidents, corrective actions, retire/scale decisions.

• One-page management review summary for leadership.

Evidence That Travels Across Audits

Keep the pack lean and consistent so it works for privacy, security, and customer assessments alike:

• Latest AI policy (version/date/owner).

• Approved tools and use-case inventory exports (with owners and flags).

• Three to five sanitized prompt/output examples that show policy in practice.

• A review log entry (what changed, risk notes, approvals).

• Vendor attestations/BAAs or a short rationale when not applicable.

Alignment With Your Existing Frameworks

• HIPAA Security Rule: access controls, audit controls, integrity, transmission security, documentation.

• SOC 2: CC6 (Access), CC7 (Change & Monitoring), CC8 (Change Mgmt), CC9 (Risk & Vendors).

• ISO/IEC 27001:2022: A.5 Identity & Access, A.8 Logging/Monitoring, A.15 Supplier Relationships, A.5.23 Secure Development.

VRC: Your ISO 42001 Readiness Partner

VanRein Compliance helps you adopt ISO/IEC 42001 in a way that’s practical, scalable, and defensible without drowning the team in paperwork, supporting you all the way through certification.

• 42001 Readiness Map
  Current-state review of AI use, evidence, and controls; prioritized gap list with owners and due dates.

• AI Policy and Roles Pack
  One-page policy, RACI for Owner/Approver/Reviewer, and change-control templates.

• Inventory and Risk Tooling
  Simple registers for use cases, data types, risk ratings, and approval checkpoints you can actually keep up.

• Control Implementation Support
  Approved-tools process, BAA/DPA reviews, PHI-sanitization standards, access/MFA guardrails, and logging practices.

• Quarterly Review Cadence
  Facilitation of your first two mini-reviews; handoff of a repeatable checklist and leadership summary template.

• Audit and Client-Assurance Package
  Curated artifacts (policy, inventories, logs, vendor attestations) aligned to ISO 42001 and cross-mapped to HIPAA/SOC 2/ISO 27001.

• End-to-End Certification Support
  Internal audit, management review facilitation, corrective action guidance, Stage 1/Stage 2 audit preparation until your ISO/IEC 42001 certificate is in hand.

Bottom Line

Responsible AI isn’t a memo; it’s a rhythm. ISO/IEC 42001 turns governance into a working cadence with short policy, clear owners, visible inventory, measured risk, enforceable controls, and a documented review loop. Organizations that operationalize these basics earn trust faster, scale AI with fewer surprises, and walk into audits with proof instead of promises.

Partner with VanRein Compliance today so you can skip the theory and move straight to readiness and certification. We’ll provide a concise policy template, an inventory/risk register, a quarterly review checklist, and a plan to reach Stage 1 and Stage 2 with confidence.

👉 Reply “ISO-42001” to kick off your ISO/IEC 42001 certification program.

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