Healthcare Configuration Management Policy

Healthcare Configuration Management Policy

Policy Metadata

Policy Number:

Effective Date:    Next Review Date:

Purpose and Scope

Purpose: This policy establishes requirements for identification, control, documentation, change management and auditing of configuration items that affect clinical systems, administrative information systems, medical devices, network infrastructure and related services that support patient care and protected health information.

Definitions

Configuration Item (CI): Any hardware, software, firmware, documentation, process, or service component that is subject to configuration control because its integrity is required for safe and effective operation.

Baseline: An agreed, formally recorded configuration of a set of CIs that serves as a basis for further activity and can only be changed through the change control process.

Policy Statements

All configuration items within scope must be identified, documented in the Configuration Management Database (CMDB) or equivalent inventory, and associated with defined owners and lifecycle status. Unauthorized changes that may affect system availability, patient safety, privacy, or regulatory compliance are prohibited.

Roles and Responsibilities

The Policy Owner is responsible for maintaining this policy, ensuring periodic review, and coordinating compliance activities. The Configuration Manager administers the CMDB, enforces change control procedures, and coordinates change advisory board (CAB) reviews. System owners are responsible for identifying CIs and approving changes that affect their systems.

Configuration Identification and Baselines

All CIs shall be uniquely identified, versioned, and associated with documentation that defines configuration attributes, interfaces, and dependencies. Baselines shall be established for production, test, and development environments and must be approved by the system owner and Configuration Manager prior to promotion.

Change Control Process

Changes to CIs shall be submitted and tracked as formal change requests. Each change request must include a description, justification, risk assessment, rollback plan, test plan, scheduled implementation window and approval of affected system owners. The CAB shall review non-emergency changes and authorize implementation consistent with patient safety and continuity of care obligations.

Emergency Changes

Emergency changes required to protect patient safety, restore critical services, or remediate active security incidents may be implemented prior to formal CAB approval if authorized by the Emergency Change Authority. All emergency changes must be documented, post-implemented review performed, and retroactively approved by the CAB within a defined timeframe.

Patch and Vulnerability Management

Security patches and updates shall be evaluated for impact and scheduled pursuant to change control. Critical vulnerabilities that present immediate risk to patient safety or protected information shall be mitigated following emergency change procedures if timely planned deployment is not feasible.

Configuration Management Database (CMDB)

The CMDB shall maintain authoritative records of CIs, relationships, versions and change history. Access to create or modify CMDB records shall be limited to authorized personnel and subject to audit logging. Reconciliation processes shall be performed regularly to ensure inventory accuracy.

Access Control and Separation of Duties

Changes to production configurations shall follow the principle of least privilege and separation of duties. Individuals who approve changes must not be the sole implementers for the same change when such separation reduces risk.

Monitoring, Audit and Compliance

Configuration activities shall be subject to periodic internal audit to confirm compliance with this policy, applicable laws, and regulatory obligations. Audit findings that indicate noncompliance must be remediated according to the organization's corrective action processes.

Training and Awareness

Personnel with configuration responsibilities must receive initial and periodic training on configuration management processes, change control procedures and safety requirements. Training completion records must be retained in accordance with records retention policies.

Noncompliance, Exceptions and Enforcement

Noncompliance with this policy may result in disciplinary action, suspension of system access, or other corrective measures. Requests for temporary or permanent exceptions must be submitted in writing and approved by the Policy Owner and Approving Executive. Exceptions must document compensating controls and expiration.

Records Retention

Records of configuration items, change requests, approvals, test results and audit logs shall be retained in accordance with organizational retention schedules and applicable legal or regulatory requirements.

Review and Approval

This policy will be reviewed at least annually or after any material change to systems or regulatory requirements. Revisions must be approved by the Approving Executive prior to publication.

Acknowledgment of Understanding

By signing below the Approving Executive attests that they have reviewed this policy, that it is consistent with organizational objectives for patient safety, data protection and operational continuity, and that the required resources for implementation have been identified.

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