Spain's Sandbox IA — the EU's First National AI Regulatory Sandbox Under the AI Act
Spain
Under Royal Decree 817/2023, Spain became the first EU country to run a live AI Act regulatory sandbox: a 2025 …
Israel · Jerusalem · See the Israel profile
Israel's Health Ministry and Innovation Authority launched a regulatory sandbox on 9 July 2026, naming three companies — including Pulsenmore and Cordio Medical — to pilot high-autonomy clinical AI in real hospitals while regulators co-develop approval rules.
On 9 July 2026, Israel's Ministry of Health and the Israel Innovation Authority launched a national regulatory sandbox for high-autonomy healthcare AI, letting companies trial systems that perform some clinical tasks independently while regulators observe and build approval frameworks in parallel.
Let high-autonomy clinical AI systems be trialled in real hospital settings while regulators co-develop approval rules for autonomy and clinical risk in parallel, rather than adopting rules before any real-world evidence exists.
Three companies were named to the first cohort: Pulsenmore, selected for an approximately $1 million project developing autonomous AI analysis of at-home pregnancy ultrasound scans with Beilinson Medical Center (Clalit Health Services); Cordio Medical, piloting voice-analysis-based home heart-failure monitoring with Tel Aviv Sourasky Medical Center (Ichilov Hospital); and a third participant trialling AI-assisted fetal-weight assessment with Hadassah's hospitals in Jerusalem.
The program is only weeks old at the time of this evaluation - no clinical outcome or accuracy data has yet been published, and its value here is the regulatory design (named ministries, defined clinical partners, budgeted pilots) rather than demonstrated results.
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Ireland
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