Israel launches first AI healthcare regulatory sandbox

Israel’s Innovation Authority and Ministry of Health have picked three healthtech companies for the country’s first regulatory sandbox for AI in healthcare. The pilots will test autonomous systems for pregnancy ultrasound, heart-failure management and fetal-weight assessment, while shaping the rules for future AI medical tools in Israel and abroad.

Why it matters: - Israel is creating a supervised path for autonomous AI medical systems that do more than support clinicians. - The pilots could help define how AI tools are approved for patient care, both in Israel and in international markets. - The program is intended to address real concerns around safety, accountability, workflow integration and workforce shortages.

What happened: - The Israel Innovation Authority and the Ministry of Health selected the first three companies for Israel’s new Regulatory Sandbox Program for artificial intelligence in healthcare. - The announcement was made on July 13, 2026. - The initiative is supported through the Israel Innovation Authority’s Pilot Fund. - The program is designed to let companies develop, evaluate and validate highly autonomous AI-powered medical technologies in a supervised regulatory setting.

The details: - Pulsenmore Ltd. will run a pilot at Rabin Medical Center’s Beilinson Hospital. - Pulsenmore is developing an autonomous AI system to analyze at-home ultrasound exams performed by pregnant women. - The goal is to create a regulatory pathway that would allow the system to make autonomous clinical decisions without a physician reviewing every routine scan. - Cordio Medical Ltd. will run a pilot at the Heart Failure Clinic at Tel Aviv Sourasky Medical Center, also known as Ichilov Hospital. - Cordio Medical is building an AI-powered home-management system for patients with heart failure. - The system uses voice analysis, medical questionnaires, smartphone data, smartwatch data and electronic medical record information. - The system is designed to detect early signs of clinical deterioration and recommend medication adjustments under a treatment protocol set by the treating physician. - The Cordio Medical pilot will also evaluate the regulatory framework for AI systems that can perform therapeutic interventions. - Simahook Ltd. will conduct a pilot at Hadassah Ein Kerem Medical Center and Hadassah Mount Scopus Medical Center. - Simahook is testing an AI system that helps healthcare professionals perform fetal weight assessments using real-time intelligent guidance. - The pilot will examine what regulatory changes are needed to let non-ultrasound specialists perform ultrasound exams while maintaining quality, safety and diagnostic accuracy. - The sandbox is a controlled environment for technologies that do not yet fit existing regulations. - Participating companies operate under guidance from the Ministry of Health and the Israel Innovation Authority. - The program is meant to identify regulatory barriers and establish adoption pathways for Israel’s health system and global markets. - The pilots will take place in real-world clinical settings with leading medical centers. - The companies will also receive Pilot Fund support to speed the move from development to commercialization. - The program is expected to generate clinical data and operational experience that could help with future discussions with international regulators.

Between the lines: - The program marks a shift from AI that advises clinicians to AI that can carry out defined clinical tasks. - That shift raises new questions about liability, patient safety and responsibility when a system acts on its own. - Israel is trying to set the rules early, before those questions are settled elsewhere. - The country is also using the sandbox to strengthen its healthtech sector by tying regulation to commercialization.

What’s next: - The selected companies will begin pilots with the relevant medical centers. - The Ministry of Health and the Israel Innovation Authority will use the pilots to test regulatory boundaries and refine oversight. - The results are expected to inform future Israeli regulation for autonomous AI medical systems. - The insights may also help Israeli companies move faster toward international approval and market entry.

The bottom line: - Israel is building one of the first dedicated regulatory frameworks for autonomous AI in healthcare, and these pilots are the first test of how that model will work in practice.