Israel tests autonomous medical AI in clinical sandbox

Israel’s Innovation Authority and Ministry of Health have launched a healthcare AI regulatory sandbox focused on systems that can perform defined clinical tasks with a degree of autonomy. The first cohort includes three Israeli health technology companies working on pregnancy care, heart failure management and fetal ultrasound assessment in real clinical settings.

The programme targets a shift beyond decision-support tools toward AI that may independently handle parts of a clinical workflow, make recommendations under predefined protocols or reduce routine physician review. Pulsenmore will test at-home pregnancy ultrasound analysis with Rabin Medical Center’s Beilinson Hospital, building on a platform it says has supported more than 250,000 home ultrasound scans. Cordio Medical will pilot heart failure monitoring with Tel Aviv Sourasky Medical Center using voice analysis, questionnaires, smartphone data, smartwatch data and medical records to detect deterioration and recommend medication changes under physician-defined protocols. Simahook will work with Hadassah medical centres on AI-guided fetal weight assessment.

The sandbox reflects wider regulatory pressure as health systems weigh automation against safety, accountability, bias, cybersecurity, model drift and clinical validation. Canada’s machine learning-enabled medical device guidance and the EU AI Act, which entered into force in 2024, point toward lifecycle regulation rather than one-time approval for adaptive medical software.