UAE – Abu Dhabi Global Market publishes Healthcare Regulations 2022

Now onshore healthcare legislation applies also to ADGM entities

On 11th January 2023, the ADGM published the news (on its official website) about the new ADGM Healthcare Regulations 2022. These Healthcare Regulations adopt the Abu Dhabi onshore healthcare legislation, including the regulations and circulars that the DoH (Department of Health) issued into ADGM’s legislative framework.

Key Points of the Healthcare Regulations 2022

• With the issuance of the Healthcare Regulations, the purview of the onshore health sector (applicable in Abu Dhabi) will extend to all ADGM-licensed entities.
• Only licensed entities have permission to practice in/from the ADGM healthcare sector.
• The process to obtain a license involves a few stages. The initial stage involves the ADGM Registration Authority, followed by the DoH, which will provide technical pre-approval. Next, the ADGM Registrar will come into the picture to finalize the application process and grant the commercial license.
• After the ADGM Registrar grants the license, companies must obtain a final license from the DoH.
• The DoH has the power to monitor, inspect and review the compliance of licensed entities under the health sector regulations.
• The ADGM Registration Authority and the DoH have the authority to set, apply and collect the respective fees payable on the activities the applicant performs during the license application process.

Detailed Analysis

The Healthcare Regulations have introduced a framework that helps ADGM-licensed entities and healthcare professionals to comply with the onshore health sector legislation. Additionally, the Healthcare Regulations also provide valuable guidance to handle potential conflicts or inconsistencies between the onshore and offshore legal requirements.

According to the Healthcare Regulations, entities other than licensed health professionals or firms (as defined in the Healthcare Regulations) do not have permission to conduct health-related activities in/from the ADGM.

Moreover, the Healthcare Regulations also state that entities must possess the following to conduct regulated health-related activities from the ADGM:

• Commercial license from the ADGM Registration Authority
• Valid license from the DoH

Applicants must also pay administrative fees to the ADGM Registration Authority, and the DoH for the health-related activities they conduct during the application process. The Healthcare Regulations have outlined procedures companies must follow to obtain a commercial license.

This commercial license will allow entities to conduct health-related activities in the ADGM, which are as below:

The Healthcare Regulations also introduce new rights to the DoH. These rights will allow the DoH to monitor, inspect and review licensed entities to check if they comply with the established standards, requirements, conditions, and procedures.

The new Healthcare Regulations create a more structured legal framework within the healthcare sector throughout Abu Dhabi. At the same time, the regulations provide more clarity for licensed entities as to which legal requirements apply to their activities.

Moreover, the new regulations will indirectly affect healthcare service providers because they will have to comply with the Abu Dhabi standards for Health Information Security and Cyber Security Standards as per the Circular No. 147 of 2022 (issued by DoH).

Additionally, the circular stipulates that licensed entities must exercise stricter cybersecurity controls. These controls include the steps below:

• Healthcare-related information must not lead outside of the UAE.
• Stopping the use of cloud-based services that store health-related information (regardless of whether the solution is hosted inside/outside the UAE).

ADGM has always been proactive in strengthening mutual strategic cooperation and institutional integration between government bodies in Abu Dhabi to achieve the Abu Dhabi Economic Vision 2030. As a part of the initiative to achieve the above objectives, the ADGM has signed an agreement with the Department of Health in Abu Dhabi to benefit from their experience in regulating and monitoring health, medical, and pharmaceutical entities operating within the AGDM’s.

Healthcare, medical, and pharmaceutical companies feel confident upon adopting the healthcare legislation. It assures that the ADGM and Abu Dhabi (in general) work actively to comply with the authorities in regulating the healthcare industry.

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