The FDA’s Updated Approach to Wellness Tech: A Closer Look
The U.S. Food and Drug Administration (FDA) released its 2026 guidance on Low-Risk General Wellness Devices on January 6, replacing the 2019 version and bringing much-needed clarity to how wellness technologies should be designed and marketed in today’s digital health ecosystem. The document is short, but its implications stretch across fitness bands, smartwatches, health apps, […]
UAE Health-tech Platforms: How to Ensure Ongoing Compliance
Summary Upon incorporation of a HealthTech platform in the UAE, ongoing legal, regulatory and technical obligations begin immediately. HealthTech is one of the UAE’s most tightly supervised sectors, with regulators such as the Dubai Health Authority (DHA), Ministry of Health and Prevention (MOHAP) and Emirates Drug Establishment (EDE) requiring consistent compliance. Post-incorporation compliance is not […]
The EU Digital Omnibus on AI: All You Need to Know About The Proposed Amendments to the EU AI Act
Summary On 19 November 2025, the European Commission (the “Commission”) published its Digital Omnibus on AI, a legislative proposal to streamline implementation of the EU Artificial Intelligence Act (the “Act”). The proposal addresses delays in harmonized standards and guidance while adjusting compliance timelines and reducing administrative burdens. Key points: High-risk AI system compliance deadlines extended, […]
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, […]
Getty Images v Stability AI: Another Legal Win for AI Against Copyright Holders
On 4 November 2025, the High Court in London delivered judgment in Getty Images (US) Inc & Ors v Stability AI Ltd. Summary The dispute centred on Getty Images’ claims that Stability AI’s generative model, Stable Diffusion, had unlawfully used its copyrighted material and trade marks. The judgment delivered mixed outcomes: Getty secured limited trade […]
How Does India Regulate AI? 10 Things You Need to Know
1. What are the India AI Governance Guidelines? On November 5, 2025, the Ministry of Electronics and Information Technology (MeitY) released the India AI Governance Guidelines under the India AI Mission. Unlike prescriptive regulatory models adopted elsewhere, India has chosen to leverage existing legal frameworks rather than creating new standalone AI legislation. The Guidelines address […]
OpenEvidence V Doximity: A Closer Look
Two of the biggest AI-driven healthcare players are locked in an escalating legal battle. OpenEvidence, a clinical decision support platform widely used as a medical search engine among clinicians, sued Doximity, medical networking platform that provides communication channels for clinicians and patients in June 2025, alleging that the $13 billion company impersonated doctors to misappropriate […]
Google’s Antitrust Woes Continue: A Closer Look
In the span of a few days, Google has faced two landmark rulings on opposite sides of the Atlantic. The first, on September 2, 2025, in the United States of America et al., v. Google LLC, (the “U.S. Case”), saw Judge Amit P. Mehta stop short of breaking up Google’s search business, instead directing measures […]
