Debate: European Health Data Space
Date: TUESDAY, 12 DECEMBER 2023
Speaker: Stella Kyriakides
Language: EN

The European Health Data Space aims to empower citizens to have control of their own health data. It also allows the use of this data for research, innovation and policymaking, but under very strict conditions. So, I want to start by firstly thanking the two co-rapporteurs – Members Sokol and Tardino – for putting so much work into this proposal. Now, we have stressed from the very beginning – and we have been the voices together with you – that in order for this to work, citizens’ trust is indispensable. We also need to be aware that the digital divide in our societies today will become the health inequalities of tomorrow. Many citizens face difficulties in accessing their own health data and in exercising their rights as citizens, their rights as patients. Too often, patients cannot benefit from innovative treatments, because we cannot yet properly harness the potential of health data. So we all discussed the importance of innovation, the importance of innovation in Europe. But if patients cannot benefit from these innovative treatments, because we cannot harness the potential of health data, then we’re really not working towards this important objective. I’m very happy to see that your report supports the objectives of our proposal. Now we need to be pragmatic when it comes to the certification of electronic health record systems, because the trust of the citizens will not be served if these requirements are too burdensome to work in practice. Now, honourable Members, you have called for the introduction of an opt-out for the reuse of health data and an opt-in for genetic data. I will share with you the view – and I fully agree that patients need to be at the centre of all our health policies, at the centre of the European Health Union, and I fully support what has already been said, the need to protect patients’ data. But we can achieve this goal if we put in very strong safeguards. We will ensure the anonymisation or pseudonymisation of data. We will require that the data is processed only in secure environments with the highest standards of privacy and cybersecurity, and we will provide for strict rules for permits with a clear list of prohibited uses. Having an opt-out can introduce bias into the data, because in particular, minority groups could be negatively affected by this if they are not represented in the data set, as we all know from research, new treatments or health applications, on which they need, they will not have their data into this. So we need to be very mindful of this when we are discussing the need for opt-out. We should also be mindful of our international obligations, without, of course, jeopardising security and data protection. The General Data Protection Regulation imposes very strict conditions on international data transfers. This should be our backstop here. So, dear Members, in ending – and I will have the opportunity in my closing remarks to discuss many of the points that I’m sure you will put forward – I believe that the European Health Data Space can really push forward for new, life-saving treatments. I firmly believe that it can facilitate progress on personalised medicine and AI. I believe that it can help researchers for a lot of time and effort. Last but not least, it will give citizens and patients access and control of their own data in a very easy way. So thank you very much and I look forward to the discussion.