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LEGISLATION | Digital Health Law
On 22 September, the Ministry of Health launched a preliminary public consultation on the Draft Digital Health Act, which adapts Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space to national law, and amending Directive 2011/24/EU and Regulation (EU) 2024/284 and regulating the national interoperable digital health record and the use of digital technologies in healthcare (European Health Data Space Regulation).
The purpose of the draft bill is to adapt Spanish law to the European Health Data Space Regulation, which establishes a common legal framework for the interoperability and ethical and secure use of health data within the European Union. The instrument will thus regulate the use of digital and emerging technologies in the healthcare sector, as well as the ethical and secure processing of clinical data for scientific purposes.
The challenges facing the regulation are:
- Ensuring that citizens can exercise their rights in relation to their electronic health data.
- Defining the governance of the primary use of health data.
- Defining the governance of the secondary use of health data.
- Extending interoperable medical records to the private sector.
- Regulating the conditions for the use of digital technologies, including AI, in healthcare.
- Setting conditions for the incorporation of digital health products into the basic portfolio of NHS services and for their financing.
- Systematise the legal framework for the processing of personal health data available in the NHS.
The deadline for submitting comments is 20 October 2025.
New features of the PMS system and extension of deadlines for marketing authorisation holders to submit data
The Spanish Agency of Medicines and Medical Devices (AEMPS) has announced that the European Medicines Agency (EMA) Product Management Service (PMS) system has incorporated new features. These will enable marketing authorisation holders (MAHs) to modify and submit information on their non-authorised medicines through a centralised procedure (whether by mutual recognition, decentralised or national) more quickly and efficiently. To do so, they can use the Product User Interface (PUI), available on the EMA's Product Lifecycle Management (PLM) portal.
In addition, the EMA has extended the deadlines for data submission. For medicines included in the Union's list of critical medicines, the new deadline will be June 2026, instead of December 2025. For other medicines authorised through a non-centralised procedure, the deadline is extended to June 2027, instead of December 2026.
LEGISLATION | Draft Royal Decree regulating the recognition and control of the right to health protection and healthcare
Last Friday, the Ministry of Health published for public consultation and information the Draft Royal Decree regulating the recognition and control of the right to health protection and healthcare funded by public funds in the cases provided for in Article 3 ter of Law 16/2003 of 28 May on the cohesion and quality of the National Health System.
In 2018, Royal Decree-Law 7/2018 of 27 July on universal access to the National Health System, establishing a system for recognising the right to healthcare based on the criterion of citizenship and recognising the right to health protection and healthcare for persons not registered or authorised as residents in Spain under the same conditions as persons with Spanish nationality. However, after its publication, situations of inconsistency in the application of the rule throughout Spain continued to be detected, as well as the presence of administrative barriers.
Now, the main objective of this Royal Decree is to ensure the consistent application of the principle of universality throughout Spain and to facilitate the procedure for recognising the right to healthcare for this population group. To this end, this new text introduces the following new features:
- Accreditation of the right to healthcare
- Vulnerability report for temporary stays
- Extension of coverage to Spaniards abroad and their families
- Equalisation of orthopaedic co-payments
The deadline for contributions is 7 October 2025.