EHDS ready through structured governance and documented responsibility

Medtora includes a dedicated EHDS module that enables companies to document and manage their preparedness for the European Health Data Space in a structured and compliant manner. Within the platform, the company can define key roles, procedures and policies required to support future EHDS compliance.

The company designates a responsible person with overall accountability for EHDS, including data access and data sharing, communication with Health Data Access Bodies (HDABs), and approval of requests for secondary use of health data. This ensures clear ownership and governance aligned with EHDS expectations.

Medtora allows the company to document its governance procedures for handling electronic health data in accordance with EHDS. This includes procedures for data storage, access control, consent management and documentation. While Medtora provides a structured framework and suggested content, the company remains responsible for ensuring that the documented procedures are accurate, complete and legally sufficient.

The platform also supports documentation of collaboration with Health Data Access Bodies. Companies can describe how requests are received, assessed and approved, and how data is shared in compliance with applicable legislation and participant consent.

In addition, Medtora enables documentation of internal policies for opt-out and data sharing restrictions. Companies can define how withdrawal of consent is handled, how participant rights are respected, and how the system ensures that data is not used after consent has been withdrawn.

By providing a structured framework for EHDS roles, governance and documentation, Medtora enables organizations to prepare for EHDS compliance and future regulatory requirements while maintaining control, transparency and accountability across clinical and healthcare projects.