The project CONFORMHEALTH it is a initiative of Soltel for the development of a comprehensive consent management tool for health data and regulatory compliancedesigned for European healthcare facilities. 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).

The goal of the project consists of developing a advanced digital platform that allows citizens manage your consent for the exchange and use of health data, both in the primary (healthcare) and secondary (R&D&I) spheres, within the framework of MyHealth@EU and HealthData@EU, ensuring regulatory compliance (GDPR, IA Act, Data Act), as well as the security, privacy and interoperability, promoting a reliable and efficient data ecosystem in Europe.

To achieve this, the project proposes the development of a modular tool encompassing regulatory compliance, data security, interoperability with European systems, anonymization and pseudonymization, monitoring and auditing, and consent management. The platform aims to foster research and innovation in the health sector while empowering citizens and giving them greater control over their health data, thereby creating a reliable and efficient health data ecosystem in Europe.

This platform combines consent management and regulatory compliance to facilitate the ethical, safe, and efficient use of health data in national and European settings. The solution will offer an intuitive interface for users to grant or revoke consent, integrating advanced features for monitoring regulatory compliance and governance that ensures the trust of patients, researchers, and regulators.

The solution will be structured into different modules: Granular consent management, Security through anonymization and pseudonymization, Interoperability with MyHealth@EU and HealthData@EU, Compliance with European regulations, Third-party representation and authorization, and Monitoring and audits to ensure transparency. Interoperability is a key pillar, enabling the effective sharing and use of data across different platforms and entities within the EHDS.