Fiona Maini, principal, global compliance and strategy at Medidata, discusses the main advantages of the European Health Data Space potential challenges/hurdles to overcome, particularly in terms of data protection and IT security.
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Data concept
The EU wants to create a European Health Data Space. In your opinion, what are the key benefits of such an initiative?
The creation of a European Health Data Space (EHDS) has a huge range of benefits for both individuals and the healthcare industry. For individuals, the key benefit is the ease of access to their health data and for it to be shared between health systems in different member states. For example, if you are travelling between European member states, healthcare professionals in any country would be able to access your health records quickly and easily should you have a medical emergency; or access your prescription data should you need more medication whilst travelling.
For the industry more broadly, the new system would facilitate the use of data for medical insights, providing researchers with access to a much broader pool of data, extending their ability to make meaningful discoveries which could accelerate the development of new medicines. Currently, most heath data exists in siloes and a lot of data is duplicated across various clinical trials, reducing its potential and resulting in inefficiencies. The EHDS would promote collaboration within the clinical trial industry, leading to increased innovation and better patient outcomes. Another benefit of the timely and secure exchange of data that the EHDS would bring is that it would enable health bodies to monitor trends and disease outbreaks, allowing them to respond to public health emergencies in a faster and more effective way.
How do you assess the different preconditions in the various European countries / UK?
With regards to the sharing and using health data, several EU member states have made significant progress in facilitating this process within their own countries. However, other countries are still in the process of implementing necessary measures, such as patient summaries and e-prescription services, with 11 countries still relying on paper printouts for prescriptions. In addition, there are currently only a limited number of countries who allow health data to be transmitted across borders, which is obviously a key element of the EHDS.
If we think about the preparedness of individual countries, some would be more ready that others to integrate a unified data platform such as the EHDS. For example the UK (although no longer part of the EU) already has a huge unified data repository through the NHS, and other countries have established Health Data Access bodies, such as France’s Findata and Germany’s Forschungsdatenzentren. Consequently, these countries would be able to integrate another platform quicker than countries with disparate systems or no single national health database.
Which technical hurdles have to be overcome for a common health data space?
In terms of data management, the main challenge will be the integration of a huge number of data sources from individual health systems, and standardising language across all these sources to ensure it can all be interpreted and analysed in the same manner. In addition, countries who are still more reliant on paper health records would have to undertake a significant digitalisation effort to be able to access the EHDS.
What challenges do you see, especially in terms of data protection and IT security?
Obviously, it will be vital to ensure that patient’s data is protected in a manner that is compliant with existing data protection regulations, such as the General Data Protection Regulation (GDPR), to ensure that patient’s data is stored securely. Furthermore, given that health data is highly sensitive, there will need to be an extremely reliable system to anonymise patient data before it is shared for secondary uses, such as clinical research. This will all require close collaboration with data protection and cybersecurity leaders across Europe.
From a patient perspective, it’s important to ensure that data privacy processes are transparent, meaning that individuals understand how their data is being used, who has access to it, and for what purposes. When people trust that their data is being handled securely, ethically, and lawfully, they are more likely to participate in these sorts of data sharing efforts.
In your perspective, what should definitely be included in a regulatory/legal framework - and what not?
One question that remains around the EHDS is at what point data from clinical trials and research should be integrated into the system, and how much data should be incorporated. Likewise, it remains to be seen whether data would be uploaded both to individual, in-country or country-specific systems, and the EHDS, which could become a laborious task, or whether data from these systems could be automatically pulled across to the EHDS. Linked to this, robust mechanisms need to be in place to allow any erroneous data to be removed, and for data to be changed if required.
Going back to the potential challenges around data security and data protection, there would also need to be detailed frameworks around how requests to access data stored in the EHDS are evaluated, and specific requirements that data holders and users would have to meet before being granted access to this data. It will also be important to ensure that the EHDS is aligned with other legalisation, such as GDPR, EU MDR, and the AI Act, to ensure consistency across the EU.
Fiona Maini will be participating in a panel session Day One of Med-Tech Innovation Expo on 7th June titled: The Latest in the MedTech Regulatory Landscape. Register for FREE at www.med-techexpo.com
