ISRAEL Law and Practice Contributed by: Alexandra Cohen and Eran Bareket, Gilat, Bareket & Co., Reinhold Cohn Group
2. Legal Framework 2.1 Definition of Digital Healthcare There are no regulatory definitions of digital health and digital medicine. There are several circulars of the Ministry of Health addressing certain aspects of these activities. The main body of regulation that is not health-specific but that applies to digital healthcare is the Israeli Pri- The digital transformation of the healthcare industry is unfolding rapidly, but the develop- ment of a comprehensive and detailed digital healthcare regulatory scheme is lagging behind. The government published a national digital transformation plan, and the Ministry of Health followed suit with its own digital health pro- gramme. However, the primary legislation was not amended. vacy Protection Authority (PPA). 2.2 Laws and Regulations As it stands, the main regulatory documents that have been published to date are circulars of the general manager of the Ministry of Health that concern: • certain aspects of the secondary use and sharing of health data; • the use of digital means in 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 information in computerised systems in the healthcare system; • the rules of ethics for remote care of the Israel Medical Association, etc.
The circulars are intended to be binding for health maintenance organisations and hospi- tals, although this is partially disputed by certain health maintenance organisations. Their author- ity over the private sector remains uncertain, yet considerable control over conduct is largely maintained due to the private sector’s reliance on healthcare institution data. In early 2023, a draft bill proposing a health data portability law was introduced. The objective of this bill is to provide the necessary regula- tory infrastructure to ensure that patient health information is available and reviewable when and where it is needed, all the while maintaining patient privacy and information security. To realise the vision of quality information in the Israeli healthcare system and to facilitate and improve co-operation between the authorities, a medical nomenclature project was launched. This project promotes the use of documentation and data coding in the Israeli healthcare system, with the first phase involving the implementation of SNOMED-CT for uniform medical terminology to document medical operations and diagnoses. At the data protection and privacy level, the PPA has published various publications covering the different aspects of data protection, including a document that: • delves into the different remote medical ser- vices available in Israel; • evaluates the privacy risks to patients; • outlines the relevant legal regulations and guidelines; and • provides specific recommendations for the utilisation of health and fitness applications.
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