Formal change management processes are required or recommended by several regulatory and compliance frameworks to ensure that modifications to information systems do not introduce security vulnerabilities or operational disruptions. The
Health Insurance Portability and Accountability Act (HIPAA) Security Rule requires covered entities to implement policies and procedures for making changes to information systems, as part of its administrative safeguards for
electronic protected health information (45 CFR 164.308(a)(8)). The December 2024
Notice of proposed rulemaking (NPRM) to overhaul the HIPAA Security Rule would strengthen change management requirements by mandating that regulated entities maintain a comprehensive technology asset inventory and notify relevant workforce members within 24 hours of any changes to a user's access to ePHI. The
Payment Card Industry Data Security Standard (PCI DSS) requires formal change control processes for all changes to system components in the cardholder data environment, including documentation of impact, authorized approval, functionality testing, and back-out procedures (Requirement 6.5.1).
ITIL formalizes change management as a core service management practice, classifying changes as standard, normal, or emergency and requiring a
change advisory board for risk assessment of significant changes. == See also ==