EHDS Compliance European Health Data Space
Navigate the new EU regulatory framework for health data exchange. Ensure interoperability, cybersecurity, and patient control over their clinical information.
What is EHDS?
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.
Regulation Pillars
Primary Use & Interoperability
Right to immediate access and portability of clinical data between member states.
Secondary Use (HealthData@EU)
Secure access to anonymized data for research, innovation, and public health.
Cybersecurity & Certification
Mandatory certification for EHR systems and connected medical devices.
Data Governance
Creation of national Health Data Access Bodies (HDAB).
Implementation Challenges
Transitioning to a federated health data ecosystem requires overcoming complex technical and legal barriers.
Technical Standardization
Adapting current systems to the European Electronic Health Record Exchange Format (EEHRxF) to allow data to flow seamlessly between countries.
"Opt-out" Rights
Managing patient rights to object to secondary use of their data without affecting the quality of primary healthcare services.
MyHealth@EU Infrastructure
Integrating securely with national contact points and complying with the requirements of the European health network.
Our EHDS Services
We support health providers, pharmaceutical companies, and software developers in achieving regulatory compliance.
Offensive Cybersecurity
Specific security testing on FHIR APIs, PACS/DICOM systems (medical imaging), and connected medical devices.
- Application Pentesting
- Cloud Pentesting
- Threat Simulation (Red Team)
Privacy & Secondary Data Use
Facilitating the exploitation of health data for research purposes ('Secondary Use') by implementing robust security architectures.
- Design and deployment of mandatory technical "bubbles" where researchers access data without extraction capabilities.
- Data Classification and Quality
- Semantic Interoperability Audit
Continuous Compliance
Monitoring and continuous improvement services to maintain compliance as regulations evolve and your business changes.
- Periodic compliance audits
- Regulatory change monitoring
- Technical conformity testing
Why choose SPSec for EHDS Compliance
GDPR + EHDS Convergence
We know how to harmonize General Data Protection Regulation with new EHDS uses.
Healthcare DNA
We integrate Medical Informatics specialists into our projects.
Knowledge Integration
Expert convergence between healthcare, regulation, and cybersecurity for risk-free deployment.
Proprietary Methodology
Structured and proven framework for EHDS compliance.