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Preliminary bill for the Law on Digital Health open for consultation in Spain
On September 22, 2025, the Spanish Ministry of Health launched a prior public consultation on the preliminary bill for the Law on Digital Health, which will regulate the use of big data, digital technologies, and emerging tools (e.g., artificial intelligence, biometrics, neurotechnologies) in healthcare and research. The Law will:
- Ensure all citizens have an interoperable digital medical record accessible nationwide and across the EU, including private healthcare providers;
- Establish governance for the primary (clinical) and secondary (research, innovation, public health) use of health data, aligned with the EU's European Health Data Space (EEDS) Regulation;
- Define ethical, secure, and legally compliant processing of personal health data;
- Establish conditions for incorporating and financing digital health products: digital health products—such as apps, connected devices, or monitoring systems—are an increasingly important part of clinical practice. However, until now, there has been no clear legal framework regulating their inclusion in the Common Package of Benefits of the National Health System or their financing. The Law will establish the criteria these solutions must meet (such as interoperability and the contribution of data to the national information system) to ensure that their use provides value, safety, and equity in access.
Citizens and organizations can submit input via an online form until October 20, 2025. The consultation aims to gather opinions before drafting the law.
The full details in Spanish can be found here, here, and here.
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