HIPAA (USA)  ·  GDPR (EU)  ·  PHIPA (Ontario)  ·  PIPEDA (Canada)  ·  EU AI Act (EU)  ·  NIST AI RMF  ·  FDA AI/ML  ·  SOC 2  ·  ISO/IEC 42001  ·  ISO/IEC 27001  ·  OECD AI Principles

ISO/IEC 42001

Artificial Intelligence Management System

Updated: September 26, 2025 

ISO/IEC 42001 in General

ISO/IEC 42001, published in 2023, is the first international standard for Artificial Intelligence Management Systems (AIMS). It provides a governance framework to help organizations build, deploy, and monitor AI responsibly, with an emphasis on safety, transparency, and continual improvement. While it applies to all industries, it is especially critical in healthcare, where AI directly impacts patient safety and privacy.

History and overview

  • Publication: Released by ISO and IEC in December 2023.
  • Purpose: Establishes a management system for AI governance, similar to ISO/IEC 27001 (security) or ISO 9001 (quality).
  • Scope: Covers the full AI lifecycle, from design and development to deployment, monitoring, and retirement.
  • Certification: Organizations can undergo audits to demonstrate compliance with the standard. Formal accredited certification programs are still in the early stages of rollout by national and international accreditation bodies.

 

 

How it applies to AI in healthcare

ISO/IEC 42001 is highly relevant in healthcare settings, where AI tools must meet strict safety, privacy, and accountability standards. The framework helps ensure that AI-enabled clinical systems are trustworthy, explainable, and aligned with patient protection obligations.

Healthcare-specific obligations and requirements

  • AI-specific policies: Define organizational commitments for safe and ethical use of AI in clinical workflows.
  • Risk-based lifecycle management: Apply structured risk assessments to AI models handling protected health information (PHI) or influencing medical decisions.
  • Clinical safety monitoring: Continuously track AI performance for reliability, bias, and unintended clinical consequences.
  • Transparency and documentation: Maintain clear records explaining how AI systems use patient data and how clinical decisions are supported.
  • Human oversight: Ensure clinicians remain accountable for final decisions when AI tools are used in diagnosis, triage, or treatment planning.

Documentation and governance requirements in healthcare

  • AI project inventory: Catalog of all AI systems used in healthcare delivery, noting datasets, intended use, and risk classification.
  • Clinical impact assessments: Structured reviews of potential risks to patient safety, similar to Data Protection Impact Assessments (DPIAs).
  • Audit logs and version control: Track training data, algorithms, and model versions used in patient care for accountability and audits.
  • Ethics and review boards: Oversight committees that evaluate fairness, bias, and safety implications of clinical AI deployments.
  • Integration with ISMS: Link ISO/IEC 42001 processes with ISO/IEC 27001 security controls for PHI protection.

Best practices for healthcare AI

  • Align ISO/IEC 42001 with HIPAA safeguards to ensure patient privacy and secure data handling.
  • Adopt Privacy by Design in AI system development, minimizing PHI use where possible.
  • Conduct regular clinical validation and independent testing of AI tools before and during deployment.
  • Establish model drift detection to ensure AI systems remain accurate and safe over time.
  • Use ISO/IEC 42001 to prepare for cross-border compliance, such as EU AI Act obligations for high-risk healthcare AI systems.

Future developments in healthcare AI governance

  • Integration with the EU AI Act for high-risk systems used in medical decision-making.
  • Increased demand for ISO/IEC 42001 certification in healthcare vendor procurement and investor due diligence.
  • Growing use of algorithmic impact assessments as part of medical device approvals and audits.
  • Expansion of healthcare-specific annexes to address unique risks such as bias in diagnostic models or safety in adaptive learning systems.

 

Overlapping laws and frameworks

  • HIPAA (U.S.): Ensures PHI security and privacy alongside ISO/IEC 42001 governance.
  • GDPR, PHIPA, PIPEDA: Overlapping privacy obligations for patient data in healthcare AI.
  • ISO/IEC 27001: Provides foundational security controls that complement ISO/IEC 42001 for healthcare systems.
  • NIST AI RMF: Supports risk management for AI systems, aligning with ISO/IEC 42001 in medical contexts.
  • FDA AI/ML SaMD Guidance: Regulates AI tools classified as medical devices, often requiring governance supported by ISO/IEC 42001 processes.

References and official sources

ISO/IEC 42001:2023 — Information technology — Artificial intelligence — Management system: https://www.iso.org/standard/42001

ISO/IEC 42001: Artificial Intelligence Management Systems … (ANSI blog): https://blog.ansi.org/anab/iso-iec-42001-ai-management-systems/

ISO/IEC 42001 — Microsoft overview: https://learn.microsoft.com/en-us/compliance/regulatory/offering-iso-42001

ISO/IEC 42001 — BSI page: https://www.bsigroup.com/en-US/products-and-services/standards/iso-42001-ai-management-system/