Virtual wards and remote healthcare are reshaping the delivery of medical services. With the global telehealth market expected to reach $175.5 billion by 2026, both the UK and the EU are working to adapt their regulatory frameworks to keep pace with technological innovation and evolving patient needs. This article explores the current landscape, recent legal developments, and the direction of travel for virtual wards in both geographies.
The adoption of telehealth has accelerated dramatically in recent years. Online consultations in Europe have doubled between 2019 and 2024, now exceeding 116 million annually. In England, remote consultations account for about a third of all GP visits, and there are currently 20 virtual ward beds per 100,000 GP-registered people, a figure NHS England aims to double based on the NHS 10 year plan. Across the EU, telemedicine is available in 77% of countries, telepsychiatry in 51%, and teleradiology in 84%, reflecting a broad embrace of digital healthcare solutions.
UK position
The UK’s regulatory framework for virtual wards is shaped by a combination of general and sector-specific rules. Patient data is protected under UK GDPR and the Data Protection Act 2018, while digital health solutions must comply with the UK Medical Devices Regulations 2002 and the Medicines and Medical Devices Act 2021 to the extent that they are classified as “medical devices”. The Network and Information Systems (NIS) Regulations 2018 also apply to the extent the relevant service provision is classified as an essential service under those Regulations.
In addition to the general legislative frameworks, if providers of “virtual wards” solutions want to supply to the NHS, there will be NHS-specific standards which will need to be met. These include compliance with frameworks such as the Data Security and Protection Toolkit (DSPT), NHS Digital Clinical Safety Standards, and procurement frameworks. Registration with the Care Quality Commission (CQC) may also be required if the solution is a relevant regulated activity, and the Health and Care Professions Council (HCPC) sets standards for remote care for the relevant professionals involved.
Looking ahead, the UK is positioning itself as a leader in life sciences and digital health. The NHS 10 Year Plan promotes digital-first care, remote monitoring, and the safe deployment of AI. The Life Sciences Sector Plan introduces the ‘Innovator Passport’ to streamline NHS procurement for MedTech. Meanwhile, the MHRA’s Software Group is focused on assuring the safety of software and AI as medical devices. Despite these advances, however, challenges remain, particularly around the complexity of NHS procurement and the variable pace of technology adoption across regions.
EU view
The EU’s regulatory landscape is being shaped by harmonised legislation and recent case law. The Cross-Border Healthcare Directive (2011/24/EU) regulates reimbursement for patients receiving care in other EU countries, while the Medical Device Regulation (MDR, (EU) 2017/745) sets requirements for the approval and classification of medical devices, including software. The European Health Data Space Regulation ((EU) 2025/327) governs access to electronic health data.
Recent legal developments have provided further clarity. In September 2025, the European Court of Justice confirmed that telemedicine refers only to healthcare delivered remotely, without the simultaneous physical presence of patient and provider. Telemedicine services must comply with the legal rules of the provider’s home country, following the country-of-origin principle. For hybrid treatments, telemedicine and in-person elements are assessed separately under relevant legal provisions. In June 2024, the Hamburg Higher Regional Court confirmed that apps intended for medical purposes are classified as medical devices under the MDR. Software that provides information for diagnostic or therapeutic decisions is at least Class IIa and requires a conformity assessment with the involvement of a notified body, even if it does not perform its own diagnostic analysis.
As a rule of thumb, the EU’s AI Act classifies AI-based medical applications as high-risk, imposing strict requirements for conformity, supervision and transparency. Telemedicine continues to grow, building on established models including digital doctor contact, referral services, and information providers. Billing rules for telemedical services differ between statutory and private health insurance, with strict requirements for human oversight and decision-making.
Direction of travel
Artificial intelligence and wearable health devices are set to play a central role in diagnostics and remote monitoring. Seamless integration with electronic health records will be crucial for the success of virtual wards. Both the UK and EU are continuously adapting their regulatory frameworks to address emerging technologies and cross-border complexities, presenting an evolving regulatory landscape for innovators to navigate. Blended models of in-person and remote care are likely to become the norm, offering significant value in areas with limited access to specialist healthcare.
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