25/02/2026
2025 was a defining year for digital health. Reading this piece, I am struck by how clearly 2026 will test whether data driven health businesses can balance innovation and regulation.
On one hand, hyper personalisation is no longer aspirational. AI driven decision support is moving tailored care into the mainstream. The direction of travel is obvious. Patients increasingly expect proactive, personalised and seamless digital services.
On the other hand, the regulatory environment is crystallising fast. The European Health Data Space Regulation, the EU AI Act, updated ICO guidance, and the UK Data Use and Access Act 2025 all signal the same message. AI in health is welcome, but only with robust governance, interoperability standards, clear lawful bases, and demonstrable operational readiness.
What I find particularly interesting is the growing clarity around pseudonymisation and secondary use. The relative approach confirmed by the CJEU, alongside updated UK guidance, opens meaningful opportunities for research and AI training. But it also raises the bar on governance. Claims that data is no longer personal must be backed by rigorous risk assessment and technical safeguards.
The tension is clear. Data is the engine of hyper personalised care and scalable AI. Yet it is also the primary source of legal, ethical and reputational risk. Competitive advantage in 2026 will not come from AI capability alone. It will come from embedding compliance, transparency and interoperability into product design from day one.
For digital health leaders, the question is no longer whether to invest in AI and data infrastructure. It is whether their governance models are mature enough to sustain trust at scale.
https://www.osborneclarke.com/insights/data-driven-digital-health-businesses-challenged-balancing-ai-advances-and-tighter