ISRAEL Law and Practice Contributed by: Alexandra Cohen and Eran Bareket, Gilat, Bareket & Co., Reinhold Cohn Group
Devices Law, 2012. These products are reg- istered through the Medical Accessories and Devices (MAD) division, even when they func- tion as standalone software solutions. For exam- ple, Insulin Insights is a clinical decision support software that helps diabetes patients monitor and optimise insulin use. Another example is the CoroFlow Cardiovascular Measurement System & Accessories, which include a soft- ware component that operates in conjunction with specialised hardware to measure coronary blood flow. More complex systems such as 3D medical image processing tools and neurosur- gical navigation software have also previously been registered as SaMDs. Although there is no specific statutory definition of SaMD in Israel, such products are treated as medical devices if their intended use falls within the scope of clini- cal diagnosis or treatment. Wearable Technologies Self-care, wellness and fitness IT products are generally not regulated as medical devices unless they make explicit health-related claims or provide clinical-level diagnostics or treatment. Wearable technologies used for general fitness and wellness purposes (eg, step counters, sleep monitors) are typically considered consumer products. Data Protection Cybersecurity and data protection in healthcare are governed primarily by the Protection of Pri- vacy Law, 5741-1981, and the accompanying Data Security Regulations, 2017. These laws apply across sectors but are particularly critical in healthcare due to the sensitivity of medical data. The Ministry of Health has issued circulars on cloud computing, patient data access and cyber protection in the health system. The PPA also plays an active enforcement role, and has
published sector-specific supervision reports addressing healthcare cybersecurity practices. AI There is currently no dedicated regulation addressing the use of AI or machine learning in healthcare, but AI/machine learning-pow- ered tools used in clinical settings are subject to general medical device regulations. In April 2023, the Ministry of Health published guiding principles for the development of AI-based tech- nologies in digital health, although these remain non-binding. These tools must still comply with existing regulatory frameworks, including those related to safety, efficacy and data protection. Telehealth Telehealth services are governed by a series of Ministry of Health circulars outlining, inter alia, patient accessibility, remote diagnostics and informed consent. These guidelines apply to health maintenance organisations and hospitals, and address both ethical and clinical considera- tions. Telehealth services became more main- stream following the COVID-19 pandemic and continue to be widely used, although no primary legislation has yet been enacted. Cross-border telehealth remains largely unregulated, with gen- eral licensing laws applying. 2.6 Sufficiency of Legislative Framework Israel’s current legal and regulatory framework provides oversight for digital healthcare, primar- ily through general laws and Ministry of Health circulars. However, significant gaps remain – particularly regarding the implementation of digital health technologies across various areas of healthcare, including AI and machine learn- ing. The relative lack of detailed legislation has created a flexible environment that can be con- ducive to entrepreneurial activity and innovation, enabling start-ups and technology developers to
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