Soltel has completed the project CONFORM-HEALTH, a technological solution aimed at facilitating the management of consent and preferences for the use of health data, in a granular and dynamic way, within the framework of the European Health Data Area (EHDS).
The project addresses one of the main challenges of digital health: making it possible for health data to be used safely, interoperably and responsibly, while ensuring that people maintain control over their data and the purposes for which it can be used.
The tool allows for granular and dynamic management of citizens' preferences, including granting, modifying, and revoking consent, as well as exercising the right to opt out of certain secondary uses. Each person's decisions about how and why their data is used become automatic rules that the system applies whenever someone requests access to or exchanges that data.
CONFORM-HEALTH, which features a simple and intuitive interface, incorporates capabilities geared towards:
- Clearly inform about the possible uses of health data.
- Manage consents according to the purpose, type of data or scope of application and do so dynamically.
- Register and version decisions and revocations.
- Facilitate the traceability of access and uses.
- Contribute to anonymization and pseudonymization.
- Promote interoperability with European ecosystems.
- Provide evidence for audit and compliance.
The solution has been designed with a modular and scalable approach, aligned with the principles of sovereignty, transparency, and interoperability promoted in European data spaces. It also envisions integration with processes associated with the primary and secondary use of health information, supporting both patient care and research and innovation activities.
Furthermore, CONFORM-HEALTH contributes to legal compliance by helping institutions and entities in the healthcare sector align with the European Health Data Spaces Regulation (EHDS) and other key regulations (GDPR, Data Act, IA Act), providing mechanisms to manage consent, record evidence of compliance, and facilitate auditing and supervision by competent authorities.
In this way, CONFORM-HEALTH contributes to strengthening the trust of citizens, patients, healthcare professionals, data providers and researchers.
For promoters and managers of data spaces, the tool offers a common framework for applying citizen preferences, reducing the operational burden, and improving consistency between regulatory obligations and their technical implementation.
The project represents a step forward towards more transparent, secure and people-centered health data spaces, ready to drive collaboration and innovation in the field of digital health.
Going forward, the plan includes the operational consolidation of the solution, its continuous improvement to adapt to the regulatory and technical evolution of healthcare data spaces, and the exploration of collaborations that facilitate its adoption in digital health initiatives.
This project has the financial support of the European Union through the Next Generation EU funds within the framework of the 2024 call for the granting of aid, in the field of digitalization, for the digital transformation of strategic productive sectors through the development of technological products and services for Data Spaces, of the State Secretariat for Digitalization and Artificial Intelligence (Ministry of Digital Transformation and Public Function).
