How The GCC Regulates AI In Healthcare?
AI is moving rapidly from pilots to everyday clinical reality in the Gulf Cooperation Council (GCC), and regulators are racing to make sure this transformation is safe, ethical, and legally sound. Across the UAE, Saudi Arabia, Qatar, Bahrain, Kuwait, and Oman, a clear message is emerging: healthcare AI is welcome, but only if it meets […]
Federal Decree Law No. 20 of 2025: All You Need to Know About The Latest Amendments to the UAE Companies Law
Summary On 1 October 2025, the UAE issued Federal Decree-Law No. (20) of 2025 (Amendment Law), introducing targeted amendments to Federal Decree-Law No. (32) of 2021 on Commercial Companies (CCL). Key points: Scope extended to foreign companies with UAE presence and clarifies free zone company operations outside designated zones Re-domiciliation framework established, allowing companies to […]
How Does the UAE Regulate Digital Health Platforms?
Summary The UAE’s healthcare and healthtech sectors operate under a multi-layered regulatory system split between federal and emirate-level authorities. Setting up a healthtech platform requires navigating jurisdictional choices, licensing requirements, and comprehensive compliance obligations including data protection, telemedicine standards, and cybersecurity measures. Key points: Three primary regulators govern healthcare: Ministry of Health and Prevention (MOHAP) […]
How is SaMD (Software as a Medical Device) Regulated in the UAE?
Summary Software as a Medical Device (SaMD) represents a rapidly growing segment of digital health innovation in the UAE. Under Federal Decree-Law No. 38 of 2024, which came into effect on January 2, 2025, SaMD is subject to comprehensive regulatory oversight by the Emirates Drug Establishment (EDE). Key points: Digital health tools that diagnose, treat, […]
The UK Streamlines Market Entry for Medical Devices: A Closer Look
In May last year, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published a policy statement regarding international recognition of regulatory approvals of medical devices. In July this year, MHRA announced it had reviewed feedback from stakeholders on its proposed policy from May and that it has decided to move forward with its proposal. […]
Health-Tech Regulations in UAE: What Every Startup Founder Must Know
In recent years, the UAE has rapidly evolved into a regional hub for health technology startups. With strong government support and a digitally inclined population, the ecosystem is ripe for innovation. From AI-powered diagnostic tools to remote patient monitoring and digital therapeutics, health-tech solutions are transforming healthcare access and delivery. However, with opportunity comes responsibility. […]
Healthtech Startups Take on Epic: A Closer Look
Particle Health and CureIS, two healthtech startups have recently filed lawsuits against Epic Systems, the largest provider of electronic health record (EHR) systems in the United States. Epic, known for supplying EHR software to major hospitals and healthcare providers across the country, is being accused of engaging in anticompetitive conduct that allegedly stifles innovation and […]
U.S. Tariffs vs Pharma: A Closer Look
As global trade tensions escalate under the second Trump administration, the U.S. pharmaceutical and clinical research industries are bracing for impact. A new wave of proposed tariffs threatens to raise the cost of critical components, from active pharmaceutical ingredients (APIs) and lab reagents to diagnostic devices, with potentially serious implications for R&D pipelines, drug pricing, […]
The Abu Dhabi Health Technology Assessment Guidelines: A Closer Look
In June 2025, the Department of Health – Abu Dhabi (DoH), introduced their new Health Technology Assessment (HTA) Guidelines, establishing a formal process that sets out how new health technologies will be reviewed before they can be accepted and funded in Abu Dhabi. The guidelines, now effective, are aimed at manufacturers, healthcare providers, pharmaceutical and […]
Is Secondary Use of Patient Data Permitted in the UAE? A Comparative Study
The secondary use of patient data refers to the use of health-related data for purposes other than the original intent for which it was collected (typically clinical care). In this tech-driven era where data is the backbone of many industries, the health records, data and other information gathered during patient care is proving valuable far […]
