The regulation harmonizes regulations on a European scale, which is a major issue in terms of the health of populations across Europe on the one hand, and in terms of innovation on the other.

The regulation creates, in very concrete terms, for example:

• An infrastructure enabling the sharing of health data contained in medical records, respecting the rights of individuals, for cross-border care of people during their travels in Europe;

• An infrastructure, procedures for accessing harmonized and regulated data in member states, and catalogs of data available to facilitate the secondary reuse of health data that has been previously anonymized or pseudonymized.

The regulation strengthens and harmonizes, in addition to the GDPR, the rights of individuals concerning health data: the right of direct access to medical records, the right to object to the processing of health data, settings for access to this data, enhanced information, and facilitation of the exercise of rights for individuals, and rules for data localization.It also provides for a robust framework of European and national governance for digital health. It requires the creation, in each member state, of national authorities competent to support and control the proper application of the regulation. It strengthens European governance of digital health by replacing the eHealth network, co-chaired by France, with a committee of the EHDS with a comitology involving all stakeholders in the decisions (patients, health professionals, researchers, industrialists, institutional representatives, etc.).

The European Commission will establish the central infrastructure and services supporting the EHDS.In the medium term, the regulation also provides for the possibility of connection for countries and organizations based outside the EU, under conditions of guaranteed security and data protection.Its implementation will be spread over the next 2 to 6 years and will require adjustments to existing regulations in France, particularly concerning the reuse of health data (secondary use).

Read more


Discover our latest articles

View All Blog Posts
April 29, 2024

FTC Completes Updates to Health Breach Notification Rule for Health Apps

The Federal Trade Commission announced it has finalized changes to the Health Breach Notification Rule (HBNR) that will strengthen and modernize the rule by clarifying its applicability to health apps and other similar technologies and expanding the information that covered entities must provide to consumers when notifying them of a breach of their health data.

April 23, 2024
No items found.

iliomad is deligthed to have supported the ICM - Institut du Cancer de Montpellier in their CNIL's authorization process

We are delighted to share that the ICM - Institut du Cancer de Montpellier was authorized by the French Data Protection Authority (CNIL) to conduct APAD-ECO study. The CNIL granted authorization to conduct a medico-economic study on the effects of physical activity in women treated for breast cancer on April, 19th. This groundbreaking study involves combining data from two clinical trials with that of the Caisse nationale de l’Assurance Maladie, covering the period from 2009 to 2022. The study aims to assess the long-term impacts of physical activity in patients who have undergone treatment for breast cancer. We are proud to have contributed to this project by providing the ICM - Institut du Cancer de Montpellier with a compliant Data Protection Impact Assessment (DPIA), a crucial step in obtaining CNIL approval.