Israel’s Health Ministry and Innovation Authority have launched a first-of-its-kind regulatory “sandbox” to test advanced artificial intelligence systems in healthcare, naming three companies to lead initial pilots, Health Ministry Spokesperson Shira Solomon said on Thursday.
The program will allow Plessanmore, Cordio Medical and Simhawk to trial high-autonomy AI technologies in real clinical settings while regulators develop safety and approval frameworks. The initiative is designed to accelerate adoption of next-generation medical tools that can perform some clinical tasks independently, beyond traditional decision-support systems.
Plessanmore will pilot an at-home ultrasound platform at Beilinson Medical Center aimed at enabling autonomous analysis of routine pregnancy scans. Cordio Medical will test a home-based heart failure management system at Tel Aviv Sourasky Medical Center (Ichilov Hospital), combining voice analysis and patient data to detect deterioration and guide treatment adjustments under preset protocols. Simhawk will run trials at Hadassah hospitals in Jerusalem on AI-guided fetal weight assessment, including use by non-specialist staff.
“The regulatory sandbox will allow us to learn together with the industry how to properly regulate the next generation of medical technologies, while maintaining the quality and safety of treatment, and will strengthen the position of the Israeli health system as a world leader,” said Health Ministry Director-General Moshe Bar Siman Tov.
Innovation Authority Chairman Alon Stoppel said it could help position Israel as a leader in both medical AI development and regulation.
Regulatory sandboxes allow companies to operate under supervision in areas not yet covered by existing rules, helping authorities address issues such as liability, safety and clinical responsibility. Solomon said insights from the pilots are expected to inform future regulation in Israel and abroad.
