Navigate the new EU regulatory framework for health data exchange. Ensure interoperability, cybersecurity, and patient control over their clinical information.
The European Health Data Space (EHDS) is a key regulation designed to empower EU citizens regarding their health data and foster a single market for digital health services.
Unlike HIPAA, which focuses on privacy in the U.S., EHDS sets strict rules on primary use (direct care) and secondary use (research and public policy) of medical data.
Organizations must implement technical interoperability standards and comply with Electronic Health Record (EHR) system certification requirements under a reinforced cybersecurity framework.
Right to immediate access and portability of clinical data between member states.
Secure access to anonymized data for research, innovation, and public health.
Mandatory certification for EHR systems and connected medical devices.
Creation of national Health Data Access Bodies (HDAB).
Transitioning to a federated health data ecosystem requires overcoming complex technical and legal barriers.
Adapting current systems to the European Electronic Health Record Exchange Format (EEHRxF) to allow data to flow seamlessly between countries.
Managing patient rights to object to secondary use of their data without affecting the quality of primary healthcare services.
Integrating securely with national contact points and complying with the requirements of the European health network.
We support health providers, pharmaceutical companies, and software developers in achieving regulatory compliance.
Specific security testing on FHIR APIs, PACS/DICOM systems (medical imaging), and connected medical devices.
Facilitating the exploitation of health data for research purposes ('Secondary Use') by implementing robust security architectures.
Monitoring and continuous improvement services to maintain compliance as regulations evolve and your business changes.
We know how to harmonize General Data Protection Regulation with new EHDS uses.
We integrate Medical Informatics specialists into our projects.
Expert convergence between healthcare, regulation, and cybersecurity for risk-free deployment.
Structured and proven framework for EHDS compliance.