UAE Law and Practice Contributed by: Haykel Hajjaji, Julie Teperow, Robin Blaney and Winsome Cheung, Covington & Burling LLP
except in cases involving the compassionate use of pharmaceuticals and medical devices. For interventional clinical trials, approvals must be obtained from both the EDE and the Ethics Commit- tee, and an import permit for the medical product is required. For non‑interventional clinical trials, approval from an Ethics Committee is necessary, and the EDE must be notified. Clinical trials may also be conducted by submitting an application through the DHA or DoH. 2.3 Public Availability of the Conduct of a Clinical Trial There is currently no comprehensive database for clin- ical trials in the UAE. However, the UAE has launched the UAE Health Research Portal (“Health Portal”), which provides access to data and information from clinical trials as well as health and biomedical research publications conducted in the UAE. It is not yet clear, though, whether the portal offers complete or fully comprehensive coverage of all such research activi- ties. 2.4 Use of Online Tools to Support Clinical Trials There are no restrictions for using online tools to sup- port clinical trials in the UAE. 2.5 Use of Data From Clinical Trials Health data in the UAE is governed by Federal Law No 2 of 2019 Concerning the Use of Information and Communications Technology in Health Fields (“Health Information Law”) and Ministerial Decision No 51 of 2021 (“Health Data Transfer Regulation”). Under the Health Information Law, health data – including data resulting from clinical trials – must comply with the following requirements. • Health data must be kept confidential and may not be shared unless permitted. • Health data may not be stored, transferred, or pro- cessed outside the UAE.
• Any circulation or transfer of health data must preserve patient confidentiality and may only be used for health‑related purposes unless the patient provides approval. The Health Data Transfer Regulation outlines the cir- cumstances under which health data may be stored or transferred outside the UAE as exceptions to the restrictions set out in the Health Information Law. One of these exceptions includes data used for approved scientific research. Data transferred under the scientific research excep- tion must be encrypted and anonymised, and it may only be used for the purposes of that specific scien- tific research. Such data may only be shared with the relevant entity. In practice, approval from the health authority of the relevant emirate may be required before transferring health data. Under the UAE Personal Data Protection Law (PDPL), biometric and health data (including genetic data and healthcare‑related data) are considered sensitive per- sonal data. Under the PDPL, any transfer of personal data must rely on a lawful basis, one of which is consent. Data necessary for scientific studies is listed as an exception under the PDPL, meaning it may be pro- cessed without consent. This exception, however, remains subject to the requirements of the Health Information Law and the Health Data Transfer Regu- lation. Additionally, the Department of Health, under its Healthcare Data Privacy Standard, and the Dubai Health Authority, under its Policy for Health Data and Information Sharing, prohibit the transfer of patient health data unless expressly authorised by the DOH or DHA. 2.6 Personal or Sensitive Data Personal and sensitive data will be subject to the PDPL, the Health Information Law, and the Health Data Transfer Regulation.
368 CHAMBERS.COM
Powered by FlippingBook