Pharmeca.cz

The European Health Data Space should lead to the empowerment of citizens and support for research and innovation.

EU residents will have more control over their health data, being able to access it electronically and share it across borders. This is particularly beneficial for cross-border healthcare, allowing individuals to access medical records and receive care seamlessly throughout the EU.

The EHDS promotes the secondary use of health data for research, innovation, and policy-making. Researchers and innovators will be able to access health data more easily and securely, which could drive the development of new treatments, medical devices, and AI applications.

The main objectives of the European Health Data Space (source: excerpt from the Communication from the Commission to the European Parliament and the Council: The European Health Data Space: Harnessing the power of health data for people, patients, and innovation):  

EHDS - main points:

• 3 May 2022 – European Commission launched the EHDS regulation proposal to easier exchange and access health data at EU level.
• 6 December 2023 – The EU Council approved the regulation proposal.
• 15 March 2024 – After five tripartite meetings between Parliament, the Council and the Commission, so called “trialogue”, an agreement on provisional proposal was reached between the European Parliament and the EU Council. The compromised text contains e.g. a right to opt-out of the system, an electronic health records system assessment, a data localisation and some specific timelines of implementation.
• 24 April 2024 - The European Parliament formally approved EHDS regulation proposal. After the end of the legislative process, the European Parliament and the Council will adopt the final text of the new Regulation. 
• The proposal is currently in its first reading procedure, document identifier COM(2022)0197. The European Parliament is expected to decide on the proposed amendments by the end of December 2024. 

EHDS general information:

One key feature of the EHDS is the introduction of common standards for electronic health record (EHR) systems across the EU, fostering interoperability and creating a single market for these systems. This includes a mandatory self-assessment for systems to ensure secure data storage and transfer.

The regulation also establishes an opt-out system where individuals can choose to restrict access to their data for secondary purposes, such as research, while still allowing essential data sharing for healthcare delivery. Member States will manage access requests for health data and may implement stricter rules for sensitive information like genetic data.

The EHDS framework is expected to enhance patient care by reducing unnecessary testing and improving evidence-based decision-making. It also strengthens privacy protections while enabling the reuse of health data for public health and research purposes.

CTIS was established by pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and will completely replace the previous system for clinical trials EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) after 30th January 2025. CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.

CTIS is guaranteed by European Medicines agency (EMA) and works in a secured workspace.

The important milestones for clinical trials:

• CT starts after 30^th January 2023 – the submission must be completed through CTIS
• CT ends before 30^th January 2025 – CT is maintained in EudraCT or national systems
• CT is expected to continue after 30^th January 2025 – transition from the EudraCT or national systems to the CTIS is necessary.

Although the deadline is still 11 months away, according to the EMA's recommendations, the transition process should begin without delay. There are a few tricky points in the transition process that are worth noting.

• The transition should take 2 months (according to the EMA methodology) but be prepared for a longer period. Once the process is complete, all information and data are processed through CTIS.
• The new country should be included in clinical trial after the transition in all current clinical trial countries is complete.
• The national language especially with special characters, can be a problem. You must provide labels in the national language.
• Relation in workspace can be unstable, in which case the submission may not complete successfully and a resession may be required. 

Because the system is not intuitive and not easy to use (experience), there are guidance and Q&As from EMA (link) as well as webinars (link) for users and sponsors. 

EMA has also published an interesting video to improve awareness of the regulation of the clinical trials system: https://youtu.be/0nQ2ABHa9L0?feature=shared 

In the next video, EMA introduces CTIS workspaces and common system functionalities to users: https://youtu.be/NSQmVtqhmWo?feature=shared 

EMA publishes CTIS statistics weekly (link). Last published data from 6th to 12th February 2024:

Despite difficulties, until now there are 2473 successful submissions. However, there are also many CTs that must go through the transition either. 

If this is also the case with your CT, don't delay any longer and go for the submission. Good luck, you'll make it.