ISO/IEC 42001 vendors for Healthcare
Vendors that support ISO/IEC 42001:2023 AI Management System and explicitly serve healthcare customers. Listings verified April 28, 2026.
| Vendor | HQ | Founded | Size | Pricing | Last verified |
|---|---|---|---|---|---|
| 2021.AI | Copenhagen, DK | 2016 | 51-200 | Contact for pricing | Apr 27, 2026 |
| Lasso Security | Tel Aviv, IL | 2023 | 11-50 | Enterprise pricing only. Not publicly listed. | Apr 27, 2026 |
| Naaia | Louveciennes, FR | 2021 | 11-50 | No public pricing tiers; demo and quote requested via website. | Apr 27, 2026 |
| Prompt Security | Tel Aviv, Israel | 2023 | 11-50 | Now part of SentinelOne Singularity Platform. Continues as a standalone product. Enterprise pricing only; contact sales or SentinelOne. | Apr 22, 2026 |
| Fairly AI | Kitchener, Canada | 2020 | 11-50 | On-premises or private-cloud deployments; quote-based. | Apr 21, 2026 |
| OneTrust AI Governance | Atlanta, United States | 2016 | 1000+ | Enterprise platform; contact sales for quote, no public pricing listed | Apr 23, 2026 |
| Enzai | Belfast, United Kingdom | 2021 | 2-10 | SaaS platform, enterprise subscription. No public pricing listed. Contact sales via enz.ai. | Apr 22, 2026 |
| ModelOp | Chicago, United States | 2018 | 11-50 | No public pricing listed; contact sales for enterprise quotes. | Apr 23, 2026 |
| Collibra AI Governance | New York, United States | 2008 | 1000+ | Enterprise subscription; contact sales for custom quote based on users, assets, modules. | Apr 23, 2026 |
| Trustible | Arlington, United States | 2023 | 11-50 | Contact sales for enterprise pricing; no public plans listed | Apr 23, 2026 |
| Scrut Automation | Palo Alto, US | 2021 | 51-200 | Contact for pricing | Apr 24, 2026 |
| Drata | San Francisco, US | 2020 | 501-1000 | Contact for pricing | Apr 24, 2026 |
| Credo AI | Palo Alto, US | 2020 | 51-200 | Contact sales for enterprise subscription quote. Credo AI homepage | Apr 26, 2026 |
About ISO/IEC 42001
ISO/IEC 42001:2023 is the first international management-system standard for artificial intelligence, published in December 2023 jointly by ISO and IEC. It specifies requirements for establishing, implementing, maintaining, and continually improving an AI management system (AIMS) within an organisation. The standard follows the harmonised high-level structure used by ISO 27001 and ISO 9001, making integration with existing management systems straightforward. ISO 42001 is voluntary but is the most credible signal a vendor or operator can provide that AI risk is governed at the management-system level. Certification is granted by accredited third-party certification bodies (the ISO/IEC body itself does not issue certificates) and follows a typical 3-year cycle with annual surveillance audits.
Read framework guide →About Healthcare
Hospitals, payers, and digital health companies using AI for clinical decision support, imaging, coding, prior authorization, and patient engagement. Regulated by FDA SaMD, HIPAA, and HHS Section 1557 non-discrimination rules in addition to AI-specific laws.
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