Stay Up to Date with Medical AI Regulations

Get the latest news and updates about AI regulations, all in one place.

  • Regulations

    Microsoft’s new Medical AI Diagnostic Orchestrator (MAI DxO) claims 85 % accuracy on 304 of the New England Journal of Medicine’s hardest cases—four times better than experienced clinicians and at lower simulated cost. The supporting pre print lays out a rigorous, sequential diagnosis benchmark (SDBench) that mimics real clinical decision making. The bar for “state of the art” in Healthcare AI just moved; so did regulators’ and investors’ expectations

    https://images.ctfassets.net/84ucdbqgjpl5/NNrmH7n6UqgDaWDM5Mwsx/cac2a7039975cf6042cff9d03ae3a048/enes.jpeg

    Enes HOSGOR

    CEO at Gesund.ai

    Jul 2, 2025

    · 8 min read

  • Regulations

    The American Medical Association, in partnership with Manatt Health, released a first-of-its-kind AI Governance Framework for Healthcare Providers; a free, interactive toolkit designed to help health systems, clinics, and provider groups implement AI in a safe, ethical, and operationally sound manner.

    https://images.ctfassets.net/84ucdbqgjpl5/NNrmH7n6UqgDaWDM5Mwsx/cac2a7039975cf6042cff9d03ae3a048/enes.jpeg

    Enes HOSGOR

    CEO at Gesund.ai

    Jun 25, 2025

    · 9 min read

FDA Ends Animal Testing: It’s not Just Ethical, It’s Strategic. Here’s What Comes Next for Pharma and AI

Regulations

In a transformative shift, the FDA announced plans to phase out animal testing requirements for mono...

https://images.ctfassets.net/84ucdbqgjpl5/NNrmH7n6UqgDaWDM5Mwsx/cac2a7039975cf6042cff9d03ae3a048/enes.jpeg

Enes HOSGOR

CEO at Gesund.ai

Jun 20, 2025

· 8 min read

The FDA Is Now Using Generative AI to Review Drugs and Devices. Here’s What That Means for You.

Regulations

In a bold move that underscores how seriously it takes artificial intelligence, FDA is rolling out a...

https://images.ctfassets.net/84ucdbqgjpl5/NNrmH7n6UqgDaWDM5Mwsx/cac2a7039975cf6042cff9d03ae3a048/enes.jpeg

Enes HOSGOR

CEO at Gesund.ai

Jun 10, 2025

· 7 min read

Biden and AI Governance: The Case for a Hub-and-Spoke Framework in Model Validation

Regulations

Amid rapid AI adoption across critical sectors, the U.S. government is taking steps.....

https://images.ctfassets.net/84ucdbqgjpl5/NNrmH7n6UqgDaWDM5Mwsx/cac2a7039975cf6042cff9d03ae3a048/enes.jpeg

Enes HOSGOR

CEO at Gesund.ai

Jan 3, 2024

· 8 min read

The New Section 1557 Rule: AI Compliance in Healthcare Just Became a Strategic Imperative

Regulations

As of May 1, 2025, hospitals and health plans must comply with the revised Section 1557... ...

https://images.ctfassets.net/84ucdbqgjpl5/48XpA29EmZQDjM8GxyJ98R/41f17acc7462c6e811670c523cf4da69/Frame_38747.svg

Gesund.ai

May 18, 2025

· 10 min read

Walking The Walk: Gesund Achieves SOC 2 - Type II Compliance, The Highest Standard for Data and IT Security

Regulations

Gesund.ai is proud to announce that we’ve received a clean SOC 2 - Type II attestation report. ...

https://images.ctfassets.net/84ucdbqgjpl5/48XpA29EmZQDjM8GxyJ98R/41f17acc7462c6e811670c523cf4da69/Frame_38747.svg

Gesund.ai

May 30, 2023

· 3 min read