ISRAEL Law and Practice Contributed by: Alexandra Cohen and Eran Bareket, Gilat, Bareket & Co., Reinhold Cohn Group
The regulations were inspired by, and are gener- ally consistent with, the European General Data
standards, including mandatory de-identification protocols, access control mechanisms, secure data-sharing environments, and binding confi- dentiality obligations. Software as a Medical Device (SaMD) SaMDs are regulated under several medical device registration procedures. While most technical standards, such as those related to quality management and safety, apply broadly to all medical devices, SaMD is subject to a specific requirement to submit validation and verification documents demonstrating that the software performs its intended medical function reliably and safely (Ministry of Health Procedure No REG-2024/03). This requirement applies to SaMD classified as Class III under the FDA, or as Classes IIb and III under the EU, and only in cases where the software’s safety and per- formance are not adequately addressed in the risk management report, clinical evaluation or the summary of clinical trials. In addition, under Ministry of Health Procedure No REG-2024/08, software changes that affect the safety or perfor- mance of medical devices (in FDA Classes II–III or EU Classes IIa–III) are classified as material changes (for example, a software update that enables Wi-Fi functionality in an insulin pump). These require the submission of a formal change request to the Ministry of Health, along with sup- porting documents such as updated regulatory approvals and ISO 13485 certification. 2.5 Issue-Specific Legal Framework In Israel, various aspects of digital healthcare are regulated to different extents, often under general or adjacent legal frameworks rather than dedicated, standalone laws. SaMDs Software-based medical devices are regulated by the Ministry of Health under the Medical
Protection Regulation (GDPR). 2.3 Role of Policymakers
Israeli policymakers are keeping pace with technological developments in digital health- care through updated regulation and strategic national initiatives, making efforts to improve inter-agency collaboration. While comprehen- sive legislation is still evolving, the Ministry of Health has issued binding circulars regarding: • the process of obtaining informed consent; • the use of cloud computing in the Israeli healthcare system; • the criteria for operating telehealth medicine; • providing patients accessibility to personal health data (“healthcare in the palm of your hand”); • the protection of data in computerised sys- tems in the healthcare system; • the rules of ethics for remote care of the Israel Medical Association, etc. The PPA enforces data protection standards and has reviewed compliance across digital health providers. 2.4 Technical Standards Technical standards in Israel’s digital health sector are used to ensure interoperability, data consistency and security across healthcare systems. For example, the Ministry of Health is implementing the Fast Healthcare Interoper- ability Resources (FHIR) standard as part of the 2024 Medical Information Mobility Law, which aims to enable seamless and standardised data exchange between healthcare providers. Gener- ally, the Ministry of Health circulars concerning secondary uses of health data and data-sharing collaborations define technical and procedural
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