27 autumn 2025 “These fields are essential for enabling personalised medicine,” Dr Liners points out. However, having good digital health tools is not enough to make it happen. “We must consider the readiness and willingness of health- care professionals and patients to use, adopt and find such technologies useful, including those that AI fuels. This is essentially a matter of trust.” Navigating new EU regulations To ensure that digital health tools can be trusted and that personal data is handled with care, the European Union has recently adopted several new regulatory frameworks complementing general legislation on personal data pro- tection. Those impacting healthtech innovators include: European Health Data Space (EHDS) Set up to create a secure and harmonised frame- work for the exchange and use of electronic health data across EU member states. It facili- tates the primary use of health data for better individual healthcare, as well as the secondary use for research, innovation and policy-making. AI Act The AI Act provides compliance requirements for AI applications depending on their risk levels. AI-enabled medical devices, which are considered “high-risk”, need to comply with additional requirements for transparency, data management, ethics and human oversight. Medical Device and In Vitro Diagnostics regulations also set rules and processes to ensure that digital health technologies or products with a medical purpose are safe and effective for patients. From compliance to competitive advantage Navigating the regulatory landscape may be complex, but it is necessary for businesses targeting the Euro- pean market. “My recommendation is to embrace the regulations and understand that compliance provides value and helps build user trust,” says Dr Liners. Lux- embourg has implemented several measures to help healthtech companies achieve compliance with regu- lations from the outset. DIGITAL HEALTHTECH © Luxinnovation/Capsule Jean-Philippe Arié and Françoise Liners