The Spanish Association of Orphan and Ultra Orphan Drug Laboratories(AELMHU) has presented its contributions to the Draft Bill on Digital Health, which adapts national legislation to Regulation (EU) 2025/327 and regulates the national interoperable digital health record and the use of digital technologies in healthcare.
From AELMHU, we believe that this draft bill represents an important opportunity to strengthen Spain's position as a benchmark in digital health, especially in the field of rare diseases.
First, we believe that this standard should incorporate robust and verifiable measures to ensure the protection of clinical data, especially in the context of rare and ultra-rare diseases. Information relating to the electronic medical record, because of its particularly sensitive nature, requires a comprehensive approach combining technical, organizational and legal safeguards.
This access to the electronic medical record must be patient-centered, guaranteeing both continuity of care and the protection of patient rights. Therefore, we believe that such access should be framed within an interoperable, secure model that respects patient autonomy, under an approach that reinforces the quality of care, promotes equity in access to health information and contributes to a transparent and collaborative relationship between patients, administration, professionals and providers.
We also propose that the electronic medical record should be configured around a minimum set of essential clinical data, accessible homogeneously and securely throughout the healthcare system. This standardization is key to guaranteeing continuity of care, interoperability between levels and territories, and the effective exercise of patients' rights.
On the other hand, we consider it essential to move towards a specific and robust regulation of the use of digital technologies in healthcare, since the digital transformation of the healthcare system must be guided by a clear legal framework that guarantees the protection of fundamental rights, technical interoperability and transparency in the use of digital tools applied to clinical practice.
This regulation should include services such as interoperable medical records, remote monitoring, clinical data platforms and mobile applications linked to care protocols. We also advocate the use of artificial intelligence tools applied to anonymized clinical data that can facilitate the generation of new research hypotheses, anticipate possible diagnoses in early stages and improve the clinical management of patients, especially in low-prevalence pathologies where phenotypic variability and the scarcity of evidence make decision-making difficult.
These technologies, when applied under ethical supervision and in secure processing environments, can help reduce clinical uncertainty, accelerate access to innovative therapies and strengthen equity of care. In the field of rare diseases, these tools are key to accelerating diagnosis, improving continuity of care and facilitating access to innovative therapies.
