Israel's Innovation Authority and the Ministry of Health announced on July 13, 2026 the selection of three companies for the country's first regulatory sandbox for artificial intelligence in healthcare. The program will test highly autonomous AI systems-technologies that can perform clinical tasks without direct physician oversight-in real hospital settings, guiding the creation of regulations for a new generation of medical tools.
The sandbox, supported by the Israel Innovation Authority's Pilot Fund, is a controlled framework that lets companies evaluate technologies that do not fit existing rules. Rather than waiting for legislation, participants work under the supervision of regulators to identify barriers, assess safety, and build the evidence needed for domestic and international adoption. The program aims to establish regulatory pathways for autonomous AI, a growing area of AI for Healthcare.
Moshe Bar Siman-Tov, Director General of the Ministry of Health, said: "Artificial intelligence is no longer a theoretical concept; it is already transforming many sectors, including healthcare. The role of modern regulation is not only to establish safeguards but also to enable innovation to reach patients safely and responsibly. The regulatory sandbox will allow us to work alongside industry to determine the most appropriate regulatory framework for the next generation of medical technologies while maintaining the highest standards of quality and patient safety. It will also strengthen the position of Israel's healthcare system as a global leader."
Dr. Alon Stopel, Chairman of the Israel Innovation Authority, said: "Artificial intelligence is transforming healthcare at an unprecedented pace, and Israel is uniquely positioned to lead both the development of these technologies and the regulatory environment that will enable the adoption of these innovative solutions. The combination of an advanced healthcare system, a world-class healthtech industry, and forward-looking regulation represents a strategic advantage for Israel. The regulatory sandbox program will help Israeli companies develop the next generation of medical solutions, evaluate them under real-world conditions, and accelerate their path to international markets."
Three companies in the first cohort
- Pulsenmore Ltd. will pilot an autonomous AI system for analyzing at-home ultrasound scans by pregnant women at Rabin Medical Center. The goal is a regulatory pathway that allows the system to make clinical decisions without a physician reviewing every routine exam.
- Cordio Medical Ltd. will test an AI system at Tel Aviv Sourasky Medical Center's Heart Failure Clinic that uses voice analysis, questionnaires, smartwatch data, and electronic records to detect early deterioration in heart failure patients and recommend medication adjustments per a predefined protocol.
- Simahook Ltd. will evaluate real-time AI guidance for fetal weight assessments at two Hadassah hospitals, examining how regulations can expand ultrasound use beyond specialists while maintaining safety and accuracy.
Why this matters for healthcare professionals
These pilots will generate the first practical evidence on how autonomous AI systems perform in clinical settings and what safety frameworks are needed. For clinicians, the results could redefine professional accountability, risk management, and the division of labor between AI and human providers. The sandbox's regulatory outcomes will likely influence international standards, so healthcare professionals should watch how these experiments shape the rules for AI tools that may soon work alongside them-or, in some cases, independently.
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