Program governance and risk management

The HITRUST program governance and risk management requirement expects you to define clear governance ownership and risk processes that are explicitly tied to your assurance objectives, then prove they operate. Operationalize it by assigning accountable owners, documenting risk decisions and exceptions, running a repeatable risk assessment and reporting cadence, and retaining audit-ready evidence of oversight. ¹

Key takeaways:

• Document who owns security and compliance decisions, how decisions are made, and how risk is accepted or remediated.
• Align risk processes to assurance objectives, then show routine operation through minutes, risk registers, and approvals.
• Evidence quality is a primary failure mode; build an artifact list and retention routine from day one.

For HITRUST work, “program governance and risk management” is less about writing a policy and more about proving control of the program: who is accountable, how risk is identified and treated, and how leadership knows whether assurance objectives are being met. Assessors and internal audit teams usually focus on two things: (1) decision rights and escalation paths, and (2) evidence that the risk process runs on a predictable cadence and produces decisions that change outcomes.

This requirement is commonly under-implemented in fast-growing healthcare organizations and service providers because ownership is informal (“security handles it”) and risk decisions happen in chat threads, not in auditable records. The result is a program that might function day-to-day but cannot demonstrate governance in an assessment.

This page gives requirement-level implementation guidance you can execute quickly: a practical operating model, step-by-step build instructions, the exact artifacts to retain, and the audit questions you should pre-answer in your documentation. The only cited source provided for this requirement is a HITRUST public framework overview; it informs the intent but does not replace the licensed HITRUST standard text. ¹

Program governance and risk management requirement (HITRUST): plain-English meaning

You must define and operate governance and risk processes aligned to assurance objectives. In practice, this means:

• Governance: named owners, defined decision rights, and a documented forum (or set of forums) that oversees the assurance program.
• Risk management: a repeatable method to identify, analyze, treat, and monitor risk, with explicit links to what you are assuring (e.g., confidentiality, integrity, availability, privacy obligations, customer commitments).
• Proof: evidence that decisions were made, tracked, and revisited. “We would do it if needed” will not pass.

The fastest path is to treat governance as an operating system: roles + meeting cadence + inputs/outputs + retention.

Regulatory text

Provided excerpt (summary-level, not licensed standard text): “Baseline implementation-intent summary derived from publicly available framework overviews; licensed standard text is not reproduced in this record.”
Implementation intent summary: “Define governance and risk processes aligned to assurance objectives.”
Reference: HITRUST-01 ¹

What an operator must do with this text

• Convert “define” into approved, version-controlled documentation: a governance charter (or equivalent), a risk management procedure, and named accountability.
• Convert “aligned to assurance objectives” into a mapping that shows how your risk process prioritizes what you claim you assure (for HITRUST, that is typically scoped systems and data types in your assessment boundary).
• Convert “processes” into repeatable routines with outputs: risk register updates, exception decisions, and management reporting.

Who it applies to (entity + operational context)

This requirement applies to organizations pursuing HITRUST assurance, including:

• Healthcare organizations (providers, payers, digital health, health IT teams inside larger enterprises).
• Service providers that handle healthcare data or provide in-scope services to healthcare clients. ¹

Operationally, it applies wherever you have:

• An assurance objective to meet (HITRUST assessment scope, customer security requirements, internal security goals).
• Material risk decisions (accepting vulnerabilities, delaying remediation, onboarding third parties, changing architectures, scoping systems).

If your organization is multi-entity or multi-product, define governance at two levels: enterprise (policy, risk appetite, oversight) and in-scope environment (control owners, scoped risk register, scoped reporting).

What you actually need to do (step-by-step)

Step 1: Establish governance ownership (RACI + decision rights)

1. Name an executive sponsor for the assurance program (often the CISO, CIO, CTO, or COO depending on structure).
2. Assign control-domain owners (security, privacy, IT ops, engineering, product, HR, legal, procurement) with written responsibilities.
3. Document decision rights:
   • Who can accept risk?
   • Who can approve compensating controls?
   • Who can approve scope changes?
4. Create an escalation path for overdue remediation and high-risk exceptions.

Deliverable: a one-page Governance RACI and Decision Rights document, approved and version-controlled.

Step 2: Define the governance forums and cadence

1. Stand up a Security & Risk Steering Committee (or equivalent) with a written charter.
2. Define:
   • Attendees (roles, not just names)
   • Meeting cadence
   • Required inputs (risk register, exception log, KRIs, audit issues, third-party risk items)
   • Required outputs (decisions, assignments, due dates)
3. Add a lightweight operational risk review (security team + IT/engineering) to keep the register current between steering meetings.

Deliverables: committee charter, agenda template, minutes template, and a standing artifact list.

Step 3: Implement a repeatable risk management process (method + workflow)

You need a procedure that answers, consistently, these operator questions:

• What counts as a risk event or risk condition?
• How do you score it (likelihood/impact or equivalent)?
• What treatment options exist (remediate, mitigate, transfer, accept, avoid)?
• What evidence is required to accept risk?

Minimum viable workflow:

1. Intake: risks enter via vulnerability management, audits, incidents, architecture reviews, third-party assessments, and change management.
2. Assessment: assign risk owner, scope, affected assets, and scoring.
3. Treatment plan: remediation tasks with owners and dates, or formal risk acceptance with rationale and compensating controls.
4. Approval: risk acceptance and exceptions require documented approval at the right level.
5. Monitoring: periodic review, re-scoring after changes, closure criteria.

Deliverables: risk management procedure, risk scoring rubric, and a risk register with required fields.

Step 4: Align risk work to assurance objectives (mapping that an assessor can follow)

Make alignment explicit using a mapping table:

• Assurance objective (for example: protect ePHI confidentiality in the in-scope platform)
• Primary risk categories (identity and access, logging/monitoring, third-party exposure, data handling)
• Where evidence lives (risk register entries, meeting minutes, exception decisions)

Deliverable: Assurance Objectives-to-Risk Mapping (table format) tied to your HITRUST scope statement.

Step 5: Document risk decisions and exceptions (audit-ready)

Create a controlled risk decision record for:

• Risk acceptances
• Policy exceptions
• Compensating controls
• Deferred remediation (when you knowingly carry risk)

Each record should include: description, affected scope, justification, compensating controls, approver, expiry/review date, and closure criteria.

Deliverables: exception log, risk acceptance forms/records, and approval evidence (ticket approvals or signed memos).

Step 6: Prove ongoing oversight (reporting and follow-through)

1. Define a small set of governance reporting outputs: risk register summary, top risks, overdue actions, open exceptions, and audit findings.
2. Tie each action item to a system of record (ticketing, GRC tool, or controlled spreadsheet with change history).
3. Retain evidence that actions close: tickets, change records, test results, and follow-up minutes.

Deliverables: monthly/quarterly risk report, action tracker, and closure evidence.

Required evidence and artifacts to retain (what auditors ask for)

Keep these artifacts in a controlled repository with version history:

• Governance charter(s) and meeting cadence definition
• RACI / ownership matrix and role descriptions
• Risk management policy/procedure and scoring rubric
• Risk register (including status history)
• Exception log and risk acceptance records with approvals
• Steering committee agendas, minutes, attendance, and decision logs
• Evidence of remediation tracking (tickets, change approvals, validation results)
• Scope statement for the HITRUST boundary and the assurance-objectives mapping ¹

Retention rule of thumb: keep artifacts long enough to cover your assessment period and show continuity across changes in leadership or tooling.

Common exam/audit questions and hangups

Auditors and HITRUST assessors commonly press on:

• “Who can accept risk?” If you cannot show a consistent approval authority, expect a finding.
• “Show me the last few risk decisions.” They will look for completeness (rationale, compensating controls, expiry) and not just a list.
• “How do you know governance meetings are effective?” Minutes should show decisions and follow-through, not status-only discussions.
• “How do risks from third parties enter the register?” If third-party risk is separate, show the linkage and escalation.
• “How does this connect to scope?” Unscoped registers and generic objectives make the alignment claim hard to support. ¹

Frequent implementation mistakes (and how to avoid them)

1. Ownership is implied, not documented.
   Fix: publish a RACI and decision-rights matrix; reference it in the risk procedure.

2. Risk register exists, but exceptions live elsewhere.
   Fix: define a single source of truth and require cross-references (risk ID in tickets, exception ID in minutes).

3. Approvals are buried in email/chat.
   Fix: require approvals through a controlled workflow (ticket approval, e-signature, or documented minutes with named approver).

4. No expiry dates for accepted risk.
   Fix: require review triggers (time-based expiry, material change, incident, new vulnerability).

5. Governance meetings produce no measurable outputs.
   Fix: enforce a decision log and an action log with due dates and owners; review overdue items first.

Enforcement context and risk implications

No public enforcement cases were provided in the source catalog for this requirement, so this page does not cite specific actions. Practically, weak governance and undocumented risk acceptance increase the likelihood that a security incident, audit failure, or customer escalation turns into a control deficiency you cannot defend with evidence. HITRUST assessments are evidence-driven; gaps are often less about intent and more about missing documentation and inconsistent operation. ¹

Practical 30/60/90-day execution plan

Days 1–30: Stand up minimum viable governance and records

• Assign executive sponsor, program owner, and domain owners; publish RACI and decision rights.
• Draft and approve the governance charter and risk management procedure.
• Create the risk register and exception log (even if in a controlled spreadsheet).
• Run the first steering committee meeting; produce minutes with decisions and action items.

Days 31–60: Populate and normalize the risk workflow

• Pull in risk inputs: vulnerability backlog, audit issues, incident learnings, third-party findings, major system changes.
• Run recurring operational risk reviews; update scoring and owners.
• Start formal risk acceptances for deferred remediation; require compensating controls and expiries.
• Produce the first management risk report and document distribution.

Days 61–90: Make it assessment-ready and sustainable

• Validate evidence quality: sample risk items end-to-end (intake → decision → action → closure).
• Tune the scoring rubric and approval thresholds based on what leaders actually decide.
• Document scope alignment: map assurance objectives to top risk categories and to register entries.
• If you use Daydream, configure workflows to enforce required fields, approvals, and retention so evidence is generated as work happens, not reconstructed at audit time.

Frequently Asked Questions

Do we need a dedicated risk committee to meet the program governance and risk management requirement?

You need documented oversight and decision-making. A dedicated committee is common, but a combined security/IT governance forum can work if it has a charter, defined attendees, and retains minutes and decision logs. ¹

What is the minimum evidence set an assessor will expect?

Expect to show ownership, a documented risk process, a living risk register, and proof of operation through minutes, approvals, and remediation tracking. If you can’t show risk acceptance decisions with rationale and approver, that is a common failure point. ¹

Can we keep the risk register in a spreadsheet?

Yes, if it is controlled (access limits, change history, version control) and you can tie entries to tickets, exceptions, and meeting decisions. Many teams later move to a GRC tool when volume or audit pressure increases.

How do we define “assurance objectives” in a way that is defensible?

Start from what your HITRUST scope covers (systems, data types, services) and write objectives that match those boundaries. Then map risks and controls back to those objectives so an assessor can trace why a risk mattered and how it was treated. ¹

What should trigger a risk re-review?

Use triggers you can enforce: a material system change, a new vulnerability affecting in-scope assets, a security incident, a change in third-party service scope, or an upcoming exception expiry. Document the triggers in your risk procedure.

How should third-party risk fit into this governance model?

Treat third-party risk as a feeder into the enterprise or scoped risk register. High-risk third-party issues should have owners, treatment plans, and steering committee visibility the same way internal risks do.

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Footnotes

1. HITRUST certification overview