ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
feree must be a corporation under the control of a database owner that has assured the protection of privacy after the transfer. Two MoH circulars from 2018 relate to sec- ondary uses of health data and collaborations based on such data. The circulars include vari- ous measures to protect the data, such as de- identification, requirements for approvals, and security measures. 2.6 Databases Containing Personal or Sensitive Data If the data in the database is identifying, then the database should be subject to the provisions of the Protection of Privacy Law of 1981 and its regulations, including those described in 2.5 Use of Data Resulting From Clinical Trials . This may require registration of the database if sensitive information such as health conditions are includ- ed, more than 10,000 persons are included in the database, or for other reasons defined in the law. Such inclusion may also require the implemen- tation of adequate security measures stipulated in the Protection of Privacy Regulations (Data Security) of 2017. Amendment No 14 of the Pri- vacy Protection Law of 1981 – currently under legislative procedure – seeks to revise the defini- tion of “sensitive data” to encompass, inter alia, medical data as defined in the Patients’ Rights Law of 1996 and genetic data as defined in the Genetics Information Law of 2000. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices According to the Pharmacists Ordinance of 1981, “preparation” or “medicinal drug” is any
form of substance that has properties for curing or preventing a disease or for the treatment of a disease – or that is presented as having such features that cause (or is given for the purpose of causing, restoring, replacing, repairing or chang- ing) a physiological action in the body through pharmacological, immunological or metabolic action – and is given (or can be given) for medi- cal diagnosis. The Medical Device Law of 2012 excludes preparations (see 1.3 Different Categories of Pharmaceuticals and Medical Devices ) from the definition of “medical device” but includes any of the following: • a device used for medical treatment, as well as a device or computer software required for operating such a device – for this purpose, “device” includes an accessory, chemical substance, biological product, or biotechno- logical product; • contact lenses; and • an electrical device that emits ionising or non- ionising radiation used for cosmetic treat- ment. Additionally, in 2002 (a decade before the Medi- cal Device Law of 2912 was enacted), the MoH issued a guideline classifying medical products that combine preparations and medical devices or whose classification is unclear/disputed (MoH Guideline 47). The guideline includes rules on how to classify the product, as well as the clas- sifications of specific products (such as bandag- es containing medical material, biological glue, ultrasound gels, condoms, and more). Requests for early designation may be filed with the medical assistant at the Preparations Registration Department or AMAR in the MoH.
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