How are Fitness Wearables Regulated in the US?
Fitness wearables have come a long way from the Manpo-Kei or “ten thousand steps” pedometer, which debuted in Tokyo in 1965 as the first-ever wearable health device and the forefather of the personal fitness tracking or ‘biohacking’ industry. Today, the global wearable technology market size is valued at USD 92.9 billion in 2025 and is […]
Who Owns Neural Data?
As Neuralink-style brain implants, consumer neurotechnology, and AI-driven neural devices move closer to mainstream adoption, lawmakers are beginning to wonder: who controls the data generated by our brains, and how far should companies be permitted to go in collecting, analysing, and commercialising it? Regulators in the US are grappling with the reality that neural data […]
The FDA’s Crackdown on Wearables
Two recent actions involving the United States Food and Drug Administration (FDA), in July 2025 – one, a FDA warning letter to WHOOP and the other, a Class I recall by Dexcom – are instructive in understanding the FDA’s evolving approach to Software as a Medical Device (SaMD) and connected health products. FDA’s oversight is […]
How Does the FDA Regulate Clinical Decision Software in the US?
The regulatory landscape for clinical decision support (“CDS”) software is shifting. On January 29, 2026, the FDA issued the guidance on CDS software (“Revised Guidelines”) that changed how certain risk factors in healthcare software are regulated. Understanding these new rules is critical for anyone developing tools that support clinical decision-making. Is Clinical Decision Support Software […]
Is Your Watch a Medical Device: How the US and EU Regulate Fitness Wearables
An Apple Watch, an Oura Ring, or a Whoop band sits at the centre of a long-running regulatory question: when does a lifestyle gadget that becomes a regulated medical device? In 2025 and 2026, both the United States and the European Union sharpened their answers, and the two systems are moving in noticeably different directions […]
How Does Saudi Arabia Regulate Healthtech and SAMDS?
When the Saudi Food and Drug Authority (SFDA) published MDS-G027, its Guidance on Digital Health Products, on 11 August 2025, it marked an important consolidation of the Kingdom’s regulatory thinking on one of healthcare’s fastest-moving areas. The document should be read alongside earlier SFDA instruments that have gradually built Saudi Arabia’s digital health regulatory architecture […]
UAE Private Wealth: Structuring Your Legacy
The United Arab Emirates has rapidly evolved from a tax-efficient residency destination into one of the world’s most sophisticated jurisdictions for private wealth structuring. Through the legal infrastructure of the Dubai International Financial Centre (DIFC) and Abu Dhabi Global Market (ADGM), wealthy families, founders, family businesses and private investors now have access to institutional-grade structures […]
Securing Health Data: Does your Data Protection Policy Comply with the UAE’s Technical Data Security Requirements?
For healthcare companies, healthtech platforms, and clinical service providers operating in the UAE, data protection compliance operates across two distinct but interconnected layers: the legal principles that govern how health data must be handled, and the technical security measures that operationalise those principles in practice. The distinction matters more than it might appear. The principles […]
Inside Vara’s Big Move on Crypto Derivatives in Dubai
On 31 March 2026, Dubai’s Virtual Assets Regulatory Authority (VARA) essentially overhauled the crypto regulatory regime. It introduced Version 2.1 of the Exchange Services Rulebook, moving crypto derivatives in Dubai out of the grey zone and into a clearly regulated framework for exchanges operating in the emirate. That means futures, options, CFDs, and perpetual-style products […]
UAE R&D Tax Credit Reforms
On March 18, the UAE Ministry of Finance issued Ministerial Decision No. 24 of 2026, which puts into effect the first phase of the UAE’s Research and Development (R&D) Tax Incentives Programme (the “Programme”). The Programme was originally introduced under Cabinet Decision No. 215 of 2025. It applies to tax periods starting on or after […]
