A system doubling down on trust, data mobility and responsible AI
Israel’s life sciences and healthcare ecosystem enters 2026 with a regulatory spine that stresses trustworthy data mobility, interoperable infrastructure and safe evaluation of AI-enabled interventions. The Government’s long-running National Digital Health Plan continues to frame health data as a growth and care-quality lever, while new implementation workstreams – most notably under the Medical Information Mobilization (Data Portability) Law, 2024 – move from principle to practice.
Market context and activity signals
Israel’s innovation policy keeps healthcare as a national priority, with public programs designed to help health organisations operationalise secure data-sharing and to catalyse pilot-ready environments for startups. At a macro level, official reporting shows a resilient high-tech sector – including medical devices and digital health – despite wider headwinds, with policy stakeholders framing healthcare data and interoperability as structural enablers of future growth.
Headline regulatory developments
1) Medical information mobility and interoperability
The Medical Information Mobilization Law, 2024 (commonly referred to as the Medical Data Portability Law) establishes individuals’ rights to mobilize their medical information, with the aim of improving care continuity, enabling personalised and preventive medicine, and fostering innovation, subject to patient consent and privacy safeguards. The law sets forth a staged commencement, alongside powers for the Ministry of Health (MOH) Director-General to set technical and security rules.
Implementation is being operationalised through the MOH’s Data Portability Certification Program, which provides FHIR-based technical profiles, authorization and consent flows, and a certification testing tool that organisations can run against their endpoints to evidence compliance and data-quality. The technical guidelines specify infrastructure, security, access control and performance requirements, giving the market a concrete blueprint for phased rollout.
What it means for market participants. Hospitals and HMOs should treat 2026 as a heavy preparation window: mapping data to MOH “information baskets,” hardening privacy/cyber controls, and aligning consent/user-interface patterns with MOH specifications. Vendors and startups benefit from clearer interoperability rails but should plan for robust conformance testing and data-minimisation by design.
2) Clinical trials governance — now with dedicated AI principles
Clinical research in Israel is governed by the Public Health Regulations (Clinical Trials in Humans) and associated MOH procedures, with institutional Helsinki Committees as the gateway and, for defined categories, MOH approval.
New for 2026, the MOH issued “Principles for the Evaluation of AI-Based Interventional Clinical Trials” – a guidance directed at ethics committees and sponsors whenever an AI tool may influence clinical decision-making. The principles emphasise patient safety, privacy, accountability, fairness, transparency/explainability, and appropriate human oversight, and they draw on international anchors such as SPIRIT-AI and good ML practice. Available in February 2026 (EN/HE), the guidance is structured as practical questions across four domains — AI system description, data governance, trial design and disclosures, with clarifications and examples to drive consistent, proportionate review.
Implications for developers/sponsors and institutions:
- Protocol design: Expect deeper diligence on dataset provenance/representativeness, prospective performance targets (including failure modes), model-update governance, and early stopping criteria.
- Risk & transparency: Budget for enhanced privacy/cyber documentation, error-handling and participant disclosures that an AI tool may influence decisions; committees are prompted to examine explainability and human-in-the-loop safeguards.
- Lifecycle thinking: The guidance encourages lifecycle-aware study designs (fixed vs adaptive models) and anticipates monitoring for drift and bias.
These principles do not replace existing law; they strengthen consistency and quality in ethics reviews where AI interventions are active, improving predictability for sponsors and host institutions.
3) Drug registration: accelerated routes and international reliance
In March 2025 the MOH unveiled an outline that materially shortens registration timelines for original, biosimilar and generic medicines – down to 70 or 120 business days where criteria are met. The framework prioritizes products addressing urgent population needs. The outline is being piloted in 2025–2026, signaling a durable shift toward reliance on trusted foreign approvals, combined with strong quality, safety and pharmacovigilance documentation.
4) Medical devices — AMAR’s role and maturing procedures
The MOH Medical Equipment Division (AMAR) remains pivotal for device registration, import/export permits and market supervision. AMAR practice is anchored in recognition of trusted foreign approvals and is standardising renewals and modifications through binding procedures and updated forms, moving the market toward predictable lifecycle management. Familiarity and compliance with AMAR’s procedures remains central for market access planning.
5) Digital health policy spine (recap)
The Cabinet-approved National Digital Health Plan (2018) still frames the system’s trajectory toward data-driven, interoperable care and innovation. That plan explicitly envisaged regulatory changes to enable data-based research and innovation – a trajectory now visible in the Health Mobilization Law and MOH’s certification work.
Opportunities for 2026
- Interoperability → scale: As FHIR-based certification matures, integrations into HMOs/hospitals should become more predictable, reducing one-off interfaces and accelerating pilot-to-production transitions for clinically-validated tools.
- Responsible AI clarity: The AI-interventional principles give committees and sponsors a shared checklist, which should shorten iteration cycles on protocol amendments for AI trials.
- Ecosystem momentum: Policy and reporting bodies continue to characterise digital health and medical devices as strategically important within Israel’s innovation economy, creating room for public-private collaboration.
Outlook
Regulatory efforts are converging on three pillars: (i) patient-centred data mobility with rigorous security and consent; (ii) interoperable standards backed by certification; and (iii) proportionate, principle-based oversight for AI that can affect care. Together, these should improve trust, reduce integration friction and raise evidence standards – conditions that reward compliance-by-design and close MOH engagement.
Short summary
Israel is shifting from policy to implementation. The Medical Information Mobilization Law (2024) and MOH’s FHIR-based certification program operationalise interoperability and patient-centred data-sharing; new MOH principles (Feb 2026) guide AI-based interventional trials around safety, privacy, fairness, transparency and human oversight. AMAR remains pivotal for device lifecycle access, and MOH maintains oversight of drug registration and clinical trials. The upshot is an ecosystem coupling innovation-friendly rails with clearer guardrails, supportive of personalised and preventive care.
