Spain Moves to Regulate Interoperable Digital Health Records

Spain introduces a new law to regulate interoperable digital health records.

    Key details

  • • Spain's Ministry of Health proposes legislation for interoperable digital health records.
  • • The law aims to unify health data systems across the EU.
  • • Strong data security measures and ethical AI guidelines are included.
  • • Public consultation is encouraged as the proposal moves forward.

On September 22, 2025, Spain's Ministry of Health announced the introduction of new legislation aimed at establishing a framework for interoperable digital health records within the country and across the European Union. This initiative is part of a broader effort to unify health data systems in Europe and aims to integrate advanced technologies, including artificial intelligence, into health care practices, ensuring data security and accessibility for patients and providers alike.

The proposed law seeks to create a standard for digital health records that would allow seamless sharing of patient information among healthcare providers across EU countries. This is especially significant as the EU has been working towards digitalization in healthcare for years, signaling an important step forward in establishing common protocols and standards. According to reports, the Ministry asserts that such interoperability is crucial for enhancing patient outcomes and streamlining healthcare processes.

Key points of the legislation include the establishment of unified protocols for data exchange, as well as strong security measures to protect patients’ data privacy. "The goal is to ensure that health care professionals have immediate access to pertinent patient data regardless of where they are in the EU," stated a representative from the Ministry of Health. This approach not only promises to improve efficiencies in treatment but also aims to empower patients by giving them more control over their health information.

Furthermore, the legislative proposal aligns with the European Commission's vision outlined in recent discussions on digital health, which underscores the necessity of cohesive cross-border health data policies. Alongside the digital health record agenda, the law will also regulate technologies such as AI in healthcare, setting strict guidelines to ensure their ethical implementation.

As this legislation proceeds, stakeholders are calling for thorough public consultation to address any concerns regarding data protection and ethical AI usage in healthcare. The Ministry is expected to unveil further details in the coming months, standing as a pivotal moment for Spain’s healthcare system and its integration into the European digital health landscape.