United Arab Emirates – In Case You Missed It: Key UAE Healthcare Legislative and Regulatory Developments of 2024
Healthcare & Life Sciences Focus
Andrea TithecottPartner, Head of Healthcare & Life Sciences
Clive DSouzaAssociate,Corporate Commercial
Soha Wahid Paralegal,Corporate Commercial
The year 2024 witnessed profound changes in the UAE's healthcare regulatory framework, marked by the introduction of new laws and amendments that underscore the nation’s commitment to improving healthcare standards and safeguarding patient rights. This article highlights key legislative advancements, including the creation of the Emirates Drug Establishment (‘EDE’), along with updated regulations for allied healthcare professionals issued by the Department of Health Abu Dhabi (‘DOH’) and the Dubai Health Authority (‘DHA’), and the implementation of laws governing genomic data use and mental health services. These measures are designed to elevate the UAE’s position as a frontrunner in healthcare innovation, aligning with broader national goals – such as advancing public health, boosting domestic pharmaceutical production, and ensuring patient safety.
Beyond these critical updates, the article also explores the new regulations for home healthcare services and the introduction of ethical guidelines for healthcare professionals, paving the way for continued progress in the sector. Here are some of the key highlights:
Federal Law No. 28 of 2023 has established the Emirates Drug Establishment, a new federal institution to license and regulate medical products in the UAE. The EDE aims to improve public health, promote research and development, strengthen local industrial capacity, and ensure medicine security. It will oversee pharmaceuticals, medical equipment, healthcare products, cosmetics, veterinary products, fertilizers, pesticides, and GMOs. The EDE will take responsibility for certain laws currently under the Ministry of Health and Prevention (‘MOHAP’) that will transition over to EDE, that will also develop policies, oversee pharmacological research, approve and register medical products, issue licenses, and manage marketing approvals. Healthcare companies must comply with EDE's regulations for licensing, testing, approval, pricing, and pharmacovigilance.
Federal Law No. 11 of 2023 amends certain provisions of Federal Law No. 8 of 2019 concerning medical products, the pharmacy profession, and pharmaceutical establishments. The revised law simplifies the process for 'Marketing Authorization Holders' to obtain licenses to market multiple products and allows specific entities to market medical products without additional authorization. It also introduces new requirements for importing and marketing activities, mandating at least two pharmaceutical establishments for these activities. There is a requirement to appoint at least one distributor and at least two importers of pharmaceutical products.
Federal Law No. 49 of 2023 regulates the use of the human genome in the UAE. The law aims to ensure the safe and ethical use of the human genome, protect public health, prevent genetic diseases, and promote scientific research. Key provisions include regulating consent requirements, establishing a national genomic database, banning genome alteration and human cloning, and outlining penalties for violations. Healthcare providers must obtain informed consent before genomic screening, provide genetic counselling, adhere to data compliance standards, and obtain a license to offer genomic services.
Federal Law No. 6 of 2023 regulates the licensing and practice of allied healthcare professionals in the UAE. The law covers fields such as nursing, physiotherapy, aesthetics, radiology, anesthesia, and laboratories. Key provisions include licensing requirements, ethical standards, prohibitions on unlicensed practice, and the establishment of a national medical register. Penalties for violations include warnings, fines, license suspension/revocation, and criminal penalties.
Federal Law No. 10 of 2023 regulates relationships between psychiatric patients and healthcare providers, ensuring quality healthcare and protecting the rights and dignity of psychiatric patients. The law applies to all mental health activities, patients, facilities, and workers in the UAE. It outlines licensing requirements for mental health services, oversight and follow-up procedures, and patient rights. The law also details procedures for voluntary, compulsory, and emergency admissions, and includes penalties for non-compliance.
MOHAP Resolution No. 40 of 2024 establishes national standards for home healthcare services to ensure high-quality, safe, and accessible care. The resolution applies to all healthcare facilities and professionals licensed to provide home healthcare services. Key points include registration and licensure requirements, staffing, policies and procedures, patient-centered care, safety and rights, infection control, emergency protocols, and the use of remote monitoring equipment.
Version 2 of the DOH Standard for Provision of Home Healthcare Services, effective June 2024, outlines duties, requirements, and responsibilities for home healthcare providers in Abu Dhabi. Key changes include licensing requirements, staffing, accreditation, quality metrics, referrals, care plans, documentation, and discharge procedures. The standard mandates integration with the Malaffi electronic medical system.
Adopted by MOHAP, DOH, and Sharjah Health Authority in May 2024, these guidelines provide ethical guidance for healthcare professionals across diverse clinical scenarios. Topics include autonomy, informed consent, privacy, digital health, conflicts of interest, emergency care, palliative care, women's health, mental health, organ donation, medical tourism, research, and innovation. The guidelines emphasize patient-centered care, shared decision-making, cultural sensitivity, and respect for patient rights.
Effective September 2023, this manual ensures high-quality patient care and safety in all DHA-licensed health facilities. Key objectives include enhancing quality and safety, ensuring compliance, promoting patient-centered care, and fostering continuous improvement. The framework includes components such as clinical leadership, clinical effectiveness, clinical audit, training and education, staffing, risk management, and patient and public involvement.
Effective April 2024, these new standards aim to enhance quality improvement, governance, risk management, patient care, and safety protocols in healthcare services. The standards are organized into five chapters covering organizational management, patient-centered care, safety, clinical support services, and clinical services. The assessment process involves peer reviewers and an expert panel to endorse accreditation awards.
Effective 29 June 2024, this policy applies to DHA-licensed healthcare professionals and hospitals with ICUs. It aligns with Federal Decree Law No. 4 of 2016 concerning Medical Liability and Ministerial Decision No. 19 of 2022 concerning the Standards of Death Determination. The policy outlines conditions for ‘Do Not Resuscitate’ orders, patient rights, activation and communication procedures, documentation requirements, and conflict resolution.
Published in May 2024 and effective August 2024, this version 2 of ADHICS aims to protect the confidentiality, integrity, and availability of health information and manage security risks in Abu Dhabi healthcare entities. The standard defines requirements for health information security governance, risk management, and compliance. It includes 11 domains and 131 controls, covering areas such as human resources security, asset management, access control, communications and operations management, system acquisition, development and maintenance, information security incident management, business continuity management, compliance, physical and environmental security, cloud security, and data privacy.
Issued on 10 August 2024 and effective 10 November 2024, this policy outlines requirements for sharing and protecting personal health information in line with UAE laws and DHA regulations. It defines the roles and responsibilities of data controllers and processors, data subjects/patients, and third parties. The policy covers consent methods, anonymizing or pseudonymizing data, data sharing agreements, and breach reporting.
Effective July 2024, this policy establishes a framework for ethical and standardized biobanking in Abu Dhabi. It applies to all stakeholders, including healthcare providers, researchers, and donors. The policy defines requirements for biobank licensure, facility setup, governance, ethical, legal, and social considerations, data protection, consent, and stakeholder relations.
The updated ADHICS standard enhances health information security by addressing governance, risk management, compliance, and data privacy.
Effective February 2024, these guidelines provide guidance for responsible genomic research and clinical translation. They apply to healthcare providers, researchers, payers, and other stakeholders. The guidelines emphasize integrity, patient primacy, respect, transparency, social and distributive justice, and adherence to DOH standards for data privacy.
Effective August 2024, these guidelines ensure safe, ethical, and effective stem cell research and clinical use. They apply to healthcare providers, laboratories, academic institutes, payers, and stakeholders involved in stem cell activities. The guidelines outline ethical principles, research categories, intervention types, safety and efficacy requirements, and encourage education and collaboration.
Effective July 2024, this new standard emphasizes lifelong learning and competency for healthcare professionals. It applies to all DOH-licensed healthcare providers, professionals, and providers. The standard outlines continuing professional development (‘CPD’) for CPD activities, CPD providers' requirements, and the CPD cycle, which includes defining needs, planning activities, completing CPD, and assessing outcomes. Healthcare providers must support workforce development, facilitate enrolment, monitor progress, and evaluate outcomes.
Looking forward to 2025, several pivotal legislative changes are expected to significantly influence the UAE's healthcare landscape. Moreover, the rapid growth of digital health will continue to accelerate, supported by regulatory frameworks that encourage the expansion of telemedicine and electronic health records, driving innovation in patient care. Additionally, updated regulations for health data protection and cybersecurity will be crucial in addressing emerging challenges related to healthcare technologies. Simultaneously, the EDE is set to become fully functional as the primary regulatory authority for pharmaceuticals and clinical trials. Currently transitioning responsibilities from MOHAP, the EDE will issue comprehensive guidelines and regulations once this handover is completed, streamlining oversight of pharmaceuticals and clinical research. Together, these developments will continue to strengthen the UAE’s reputation as a global leader in healthcare innovation and regulatory standards, improving both public health outcomes and industry practices. We look forward to keeping you up to date on all developments in the coming year.
For further information,please contact Andrea Tithecott and Clive DSouza.
Published in January 2025
