Digital Health

Digital health is rapidly transforming healthcare and life sciences. From smartphone applications and wearable technology used to track our sleeping patterns or fitness or technology which is used to diagnose and treat illnesses or injuries to social media communities supporting patients suffering from the same conditions, digital health is already changing our lives and disrupting existing business models.

Organisations used to operating along traditional sector lines and within recognised industry norms are rethinking their business models to tap into the seemingly limitless potential offered by digital health. We help clients turn this disruption into opportunities. Drawing on deep expertise in AI, data and connected technologies, we guide you through unfamiliar issues and complex, fast-evolving regulation across key markets. This ensures that legal, regulatory and other risks associated with this innovation are identified early and managed effectively.

Through our international, multi-disciplinary team, which combines deep healthcare and life sciences sector knowledge and understanding with leading capabilities in technology, data, IP and regulatory, we offer organisations what they need: the best business-focused legal and regulatory advice in a fast-changing healthcare environment. We act for regulators, pharmaceutical, medtech and biotech companies and digital health innovators, with our network of lawyers advising across the UK, Europe, the Middle East and Asia, supporting clients from concept to scale.

“When it comes to digital health issues, like IP, data protection, and related rules and legislation, Simmons & Simmons really know their stuff.”
Legal 500 2026

We advise on the full spectrum of digital health issues, including:

• AI in healthcare: We advise on AI governance and assurance, including EU AI Act readiness, ISO/IEC 42001, and NIST AI Risk Management Framework. We help clients address model risk, validation and explainability requirements for AI systems in healthcare.
• Data: Data underpins all digital health projects. We help clients to comply with data protection laws such as GDPR, Data Act, ePrivacy, Data Governance Act and the European Health Data Space (EHDS) and to develop strategies for cross-border transfers, secondary use, data commercialisation and protection, as well as handling data protection litigation.
• Collaborations, licensing and Intellectual Property: Healthcare and life sciences businesses have traditionally protected products and processes through patents, while technology companies rely on copyright and database rights to protect software and IT systems. With this increasing sector convergence, we assist you in addressing how IP rights apply to innovative technologies; advising on ownership and licensing of data, algorithms and software, including open-source compliance and brand protection.
• Consumer, e-commerce and digital marketing: Digital health offerings often sit at the intersection of consumer, healthcare and technology regulation. We advise on client-facing documentation and regulations relating to websites, apps and digital marketing towards healthcare professionals and patients, helping you to build trust with users while remaining compliant.
• Cybersecurity: Cyber-attacks present an increasing threat, particularly for health data. We advise on contracting around cybersecurity risks, implementing incident response processes and ensuring compliance with evolving standards such as NIS2. Security by design and incident readiness and response are central to our approach.
• Governance and operating models: We advise on the setup and operation of consortia, data trusts and multi-jurisdictional programmes, ensuring robust governance and compliance across borders.
• Regulatory compliance: You need to consider whether a digital product may be regulated as a medical device under the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) and, its likely classification for market access. We also advise on clinical and performance evaluation, UDI and vigilance, reimbursement strategies and can help you engage with regulators to guide their understanding.
• Product liability: Digital health collaborations present new challenges for product liability, given the nature of the technologies and the range of of parties who could be liable (data providers, software developers, hardware developers, physicians). We advise on safety regimes, recalls and supply-chain risk allocation.
• Tax: The creation of new intangible property, changes to business models and/or or the relocation of functions/assets have tax implications that need careful planning. Digitalisation may also create opportunities to improve your tax and transfer pricing structures for digital operating models.
• Transactions: Digital health collaborations, joint ventures, mergers and acquisitions, strategic partnerships and minority investments require a nimble approach. Our due diligence relies less on a desktop review and more on engaging with management teams on the risks above, underpinned with tailored warranties.