ISRAEL Law and Practice Contributed by: Alexandra Cohen and Eran Bareket, Gilat, Bareket & Co., Reinhold Cohn Group
ucts Liability Law. However, other areas – such as AI, SaMD and telehealth – lack dedicated leg- islation or formal enforcement mechanisms, and are primarily addressed through general legal principles or non-binding guidelines. That said, individuals and entities can always seek redress by filing a lawsuit, relying on gener- al legal frameworks such as tort, contract, prod- uct liability, constitutional rights under the Basic Law: Human Dignity and Liberty, administrative law, consumer protection law, etc, depending on the nature of the harm or dispute. 4.3 Defences There are several mechanisms to mitigate or defend against the legal exposures discussed in 4.1 Legal Risks of Digital Healthcare . In Israel, entities can reduce risk by aligning with Ministry of Health circulars on digital health, such as those addressing secondary use of data, cloud computing and patient access to personal records, which, while not always binding, reflect regulatory expectations and accepted standards of practice. Implementing robust data protection measures in accordance with the Protection of Privacy Regulations (Data Security) 5777-2017, and aligning with documents published by the PPA and guidance generally consistent with the GDPR, can further support claims of regulatory compliance. Obtaining prior approval from the Helsinki Committee for research involving health data, and participating in national initiatives such as the SNOMED-CT-based medical nomencla- ture project, also help demonstrate responsible conduct. In commercial contexts, contracts should allo- cate risk clearly through indemnities, warranties and data use provisions. In the AI context, adopt- ing bias mitigation and transparency measures,
alongside maintaining detailed documentation of compliance efforts, strengthens the ability to defend against liability claims, especially in neg- ligence or data misuse scenarios. 5. Emerging Legal Issues and Reform 5.1 Emerging Legal Issues in Digital Healthcare In 2024, the Medical Information Mobility Law (5784–2024) was enacted, replacing earlier draft proposals. As part of its implementation, the Ministry of Health published a new plan to establish the infrastructure for adopting the FHIR standard, enabling the interoperable, secure exchange of health data across the system. The law is designed to facilitate the smooth trans- fer of medical information between healthcare organisations in Israel, addressing not only the shared infrastructure and data transmission standards (FHIR) but also the use of standard- ised terminology. To support this, Israel established a national medical terminology framework aimed at creat- ing a unified language across the healthcare sys- tem. This standardisation effort helps to ensure consistent, accurate data usage and improves overall co-ordination in digital healthcare. 5.2 Recent or Imminent Reform While recent legislative and policy develop- ments in Israel address certain aspects of digital healthcare, they do not constitute a comprehen- sive or sector-specific regulatory framework. The Medical Information Mobility Law (5784–2024) promotes patient access to and the portability of health data and is expected to support digital infrastructure, but it does not directly regulate digital health technologies, services or provid-
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