ISRAEL Law and Practice Contributed by: Alexandra Cohen and Eran Bareket, Gilat, Bareket & Co., Reinhold Cohn Group
test and iterate new products more rapidly, with- out the delays often associated with rigid com- pliance or sector-specific regulatory approvals. It also encourages greater experimentation with emerging technologies in clinical settings, as the absence of overly prescriptive rules permits a broader range of pilot programmes and adap- tive development cycles. This environment has helped to position Israel as a global hub for digi- tal health innovation, attracting both local entre- preneurs and international investment. 3. Regulatory Oversight 3.1 Oversight of Digital Healthcare In Israel, digital healthcare falls under the over- sight of several regulatory bodies, each tasked with specific roles. The Ministry of Health serves as the central authority for digital healthcare regulation. It han- dles the registration and marketing approvals for medical devices and digital health technologies, and is responsible for regulating clinical trials. It also supervises the secondary use of health data and oversees data-sharing collaborations. It publishes circulars addressing topics such as telehealth implementation, cloud infrastruc- ture and patient access to electronic medical records. PPA is the leading body responsible for data protection and cybersecurity within the digital health landscape. It regulates how databases containing personal and health data are man- aged, and ensures compliance with the Protec- tion of Privacy Law. The PPA has the authority to enforce regulations in cases of unauthorised data use and conducts routine supervisory inspections. In 2024, the PPA released a supervi- sory report assessing digital health providers on
organisational controls, data management and cybersecurity, revealing a generally high level of compliance. The judicial system also plays an important role in digital health governance. Israeli courts have jurisdiction over regulatory disputes and enforcement matters. 3.2 Non-Healthcare Regulatory Bodies As explained in 3.1 Oversight of Digital Health- care , the PPA is a non-healthcare regulatory agency responsible for enforcing the privacy and data protection legislative scheme in Israel. It is primarily concerned with issues such as: • the way data is collected; • the way data is shared; • preserving the confidentiality of private data, including health data; • protecting against data breaches; • managing medical terminology; and • preventing cyber-attacks, amongst others. Government participation is also manifested through the Authority for Innovation, which offers financial support for digital medicine projects Privacy and data protection are the most strong- ly enforced areas, largely because Israel has a dedicated legal framework for privacy, and the PPA includes a dedicated enforcement depart- ment that supervises organisations, conducts audits and makes sure companies, public bod- ies and non-governmental organisations com- ply with data protection rules. In 2024, the PPA published a supervision report evaluating digital health providers on governance, data manage- ment and security. Most showed high compli- across various fields. 3.3 Enforcement
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