Israeli Ministry of Health’s Regulatory Updates
The following is a short summary of recent regulatory updates:
- Guiding Principles for the Development of Artificial Intelligence (AI) based Technologies
The Israeli Ministry of Health (“MOH”) published, in December 2022, draft guiding principles for the development of AI-based technologies (the “Principles Draft”). The MOH is now seeking feedback and suggestions with respect to the Principles Draft from health organizations and other parties within the health-tech and digital health ecosystem and from the general public.
The Principles Draft states that AI and machine learning (ML) technologies have the potential to change healthcare by deriving new and significant insights based on the vast amount of data generated by the local healthcare system. Accordingly, the Principles Draft sets 10 guiding principles which are intended to lay the foundation for developing a Good Machine Learning Practice, in a manner similar to the recent guiding principles published by foreign regulatory authorities such as the FDA, Health Canada and the MHRA.
The 10 guiding principles are as follows: (1) integrating multidisciplinary expertise throughout the applicable product’s life cycle; (2) using the best software engineering and data security tools in building models; (3) appropriate representation of the intended patients population within the clinical research participants and data sets; (4) use of independent databases for training and testing; (5) selection of reference data which was developed in the best methods; (6) building a model adapted to the data available, which model shall reflect the intended use of the applicable product; (7) focusing on the performance of the human-AI team; (8) the testing phase should demonstrate the product’s performance under clinically relevant conditions; (9) communicating essential information to users in a clear manner; and (10) monitoring the performance of the embedded models and managing the risks involved in retraining of the models.
The MOH intends to adopt these principles to assist those involved in the development of AI/ML technologies. Feedback and suggestions can be sent to the MOH until January 14, 2023.
- Food Importation Reform – Entry into Effect
The MOH’s food importation reform, designated to reduce regulation and to streamline the processes of importing food into Israel (the “Reform”) entered into effect on January 1, 2023. Under the Reform certain European standards were adopted. The Reform allows importers, who meet certain criteria, to be registered as “Proper Importers”, which would allow them a quick release from customs. The Reform deals with three main aspects: (i) uniform and advanced regulation on food as is performed in other countries, primarily the EU; (ii) an importer who meets the ‘proper importer’ standard is entitled to go through a “green route”, without having to obtain an import permit for each shipment; and (iii) implementation of a digital supervision system that enables monitoring of the route of the imported food. High-risk foods (e.g., baby formulas, health foundations, nutritional supplements,) are excluded from the Reform. An importer who will fail to meet the requirements may lose its status as a Proper Importer. The MOH is currently establishing an extensive administrative enforcement system, to monitor such activities.
- European Regulatory Approvals of Medical Devices – Extension of Pilot
The MOH announced a pilot program, in December 2021, broadening the scope of foreign marketing approvals that may be referenced when locally registering medical devices (the “Pilot”). See our previous legal update in the matter. In December 2022, the MOH announced that the Pilot has been extended and will remain in effect until June 2023.
- Guidelines for the Performance of Clinical Studies
The MOH issued, on June 1, 2021, following the cancelation of certain specific Covid-related guidelines for the performance of clinical studies, a pilot program which allowed for certain procedures in the performance of clinical studies in Israel. See our previous legal update in the matter. In December 2022, the MOH announced that due to its success, such pilot was extended and will remain in effect until further notice.
- Donation Reporting Obligation
The MOH issued, in December 2022, a notice to physicians, pharmacists, researchers, and healthcare companies with a reminder of the obligation to report donations to healthcare providers. Israeli law imposes a reporting obligation regarding donations, that are made within the healthcare field, on both the provider and the recipient of the applicable donation. Generally, a report on all donations received in the past year must be submitted by March 1st of each subsequent year, through an online form on the MOH website. The reporting should be done online and should be submitted by March 1, 2023.
We wish all of our clients and colleagues a happy new year!
We note that the above is merely a short summary of the subject matter, and does not cover all relevant provisions of the guidelines.
For additional information please contact Partner Hili Cohen, Head of Life Sciences Department (Hili@gkh-law.com), Partner Tami Fishman (Tamif@gkh-law.com), Adv. Ofir Goldstein (Ofirg@gkh-Law.Com) or Adv. Moran Oren Shoham (morans@gkh-law.com).
