00:00:00:00 - 00:00:26:07 Unknown Without the patient citizens data, there is no future for research. There is no development of medicines. There is no future for health care or health care systems to exist or evolve. If patients or citizens data are not there. 00:00:26:09 - 00:00:53:05 Unknown Welcome to this latest episode of the BBMRI-ERIC Podcast. My name is Eleanor Shember, Head of Outreach, Education and Communications here at BBMRI. You just heard Gözde who, was speaking about the role of patients and citizens in EHDS. More from her later. That’s because I’m taking you to a workshop on information points for citizens under the EHDS. EHDS stands for European Health Data Space. 00:00:53:06 - 00:01:27:15 Unknown This workshop is jointly organised under the EHDS2Pilot project by BBMRI-ERIC’s ethical, legal and societal implications team and the Spanish Research Council in Brussels – CSIC where the workshop is being held. First, I’ll explain what the project is about. It brings together 17 partners including health data access bodies, health data sharing infrastructures and European agencies with the aim to build a pilot version of the European Health Data Space (EHDS) infrastructure for the secondary use of health data 00:01:27:21 - 00:01:56:08 Unknown known as “HealthData@EU” - which will serve research, innovation, policy making and regulatory purposes. The project connects data platforms in a network infrastructure and develops services supporting the user journey for research projects using health data from various EU Member States. It will also provide guidelines for data standards, data quality, data security and data transfer to support this cross-border infrastructure 00:01:56:10 - 00:02:19:02 Unknown The outcome is for the consortium to collaborate closely with the European Commission and their team working on developing the central services for secondary use of health data. Why does this matter? Well, under EHDS, citizens will have an opt out right in Europe so they need to be made aware their data may be used outside the immediate healthcare context. 00:02:19:04 - 00:02:42:07 Unknown EHDS has provisions for individual control of data. How much should you make citizens aware of the use of their data and opt out rights? This is a major topic that is being debated in political spaces and across European health communities. That’s because, if you care about how your health data might be used for research, EHDS is relevant to you. 00:02:42:09 - 00:03:05:21 Unknown Meanwhile, here in Brussels, the aim of the workshop is to explore how best to communicate with citizens that their rights are taken seriously, that they can keep in control of their data and its use, and to fulfil the legal obligations under the EHDS regulation. Over two days, patient organisations, experts and policy makers are discussing the varied concepts that exist in the EU 00:03:05:23 - 00:03:33:07 Unknown no one has a uniform approach. By sharing successful initiatives for informing the public about ongoing data sharing activities, as well as understanding past communication failures, the intention is this will help foster the implementation of the upcoming EHDS Regulation. Irene Schluender is a member of the BBMRI ELSI Service and Research unit as a legal expert, particularly on EU data protection law. 00:03:33:09 - 00:04:10:06 Unknown She is here to explain a little more and what, as one of the organisers of the workshop, she hopes it will achieve. We are leading as people in my AI the work package, but also dealing with citizens information, citizens rights and therefore we thought it would be a nice idea to come together and, have a look into what member states already have done in that respect to have a very sound basis to develop an aligned or harmonised strategy across Europe. 00:04:10:08 - 00:04:37:22 Unknown And I hope that we will really discuss and not only, let's say, advertise what we already have, but also learn from each other and also describe and explain the failures, not only the success factors, so that on the basis of workshop, we learn from each other in order to achieve improvement. And do you expect this to be these improvements to be implemented in some way as part of. 00:04:37:24 - 00:05:12:06 Unknown Yes. Yes. There is even an obligation under each. Yes to inform citizens in a way that is easily accessible and is updated about all the projects that have been granted access to the data of the citizens. But I'm deeply convinced that we should not go for the low hanging fruit in terms of just observing the legal obligations, but also try to really get people on board, because on the one hand, I think it's just our duty to do that. 00:05:12:08 - 00:05:43:24 Unknown On the other hand, it's so important in order to avoid a massive opt out. There have been opt out campaigns in some member states already in the past, and we are facing massive campaigning in social media for a variety of purposes. And I think we need it really urgently to adapt our communication strategies to this, because ultimately, an engaged and trustful citizen is an opted in citizen. 00:05:44:01 - 00:06:21:14 Unknown Yeah, and I can reveal my background. I'm from Germany and Germany is, as everybody knows, consent country. So we appreciate to have again the decision of every single citizen and not just a law saying you are obliged to provide your data, but really to get people on board so that they are convinced that it's for their health service, for the improvement of therapies, of health services, and not something that is there, you know, to make companies even richer or politicians even more powerful. 00:06:21:16 - 00:06:52:01 Unknown But it's for their sake too. Health data would not exist without patients and citizens so it’s right to hear early on from a representative here at the workshop. Gözde Soosoozloo (Briggs) is from the European Patients’ Forum who can talk about the role of patients and citizens when it comes to the governance of EHDS. I asked her, why should citizens and patients be asked in the first place? Without the patient citizens data, there is no future for research. 00:06:52:07 - 00:07:19:21 Unknown There is no development of medicines. There is no future for healthcare or healthcare systems to exist or evolve if patients or citizens data are not there. So it's something we need to consider is how are we going to engage them more so they actually are actively participating and their involvement are credited in the society much more. Very important thing is we keep on talking about is trust can only be built with knowledge. 00:07:19:23 - 00:07:52:18 Unknown And education is one of the key aspects for trust to be gained community societies, citizens, patients. They would only trust the system and be actively involved and be part of it. If they understand the concepts, if they understand the value of their input or their sharing of their data in this sense. So for us, it's very important for us, when they're in the implementation phase that day to bring the educational part of the the whole concept so that they run parallel together. 00:07:52:20 - 00:08:20:11 Unknown Having placed the citizen at the centre, it’s helpful to explore the evolving learning on citizen engagement when it comes to health data. It’s not all plain sailing so, what happens when communication fails? Franz Leisch spoke about working on ELGA – a digital system for storing health data when they faced a negative campaign during 2014 led by Austrian doctors‘ chamber against electronic health records. 00:08:20:13 - 00:08:48:24 Unknown Doctors and clinicians are those closest to patients so, if they’re not on board with digital health changes – especially during crises like the COVID-19 pandemic, it’s a problem. Related fears to ELGA were around bureaucracy and possibile liability for malpractice due to everything being digitally recorded. The risk is a lack of knowledge and greater fear means patients won’t sign up to digital initiatives like EHDS. 00:08:49:01 - 00:09:30:12 Unknown This makes future secondary health research more tricky. It’s this relationship with doctors and clinicians I wanted to ask Franz about. Forming a positive relationship to get them on board is vital for the success of EHDS. What did he learn from his experience? My advice for implementing the European health data space is to prevent, like negative campaigning, and I think you have to analyse and manage all the stakeholders, identify the groups, talk with them, involve them and hear what their concerns are, and you have to provide solutions tailor made. 00:09:30:14 - 00:10:04:18 Unknown And of course, the issue of data misuse can be justified associated with the mandatory vaccination in Austria. So you really have to prevent that. Silly stuff like that is happening again. The resistance that you met most strongly was in those healthcare providers. Yes, I think that that might be because you really changing the life of those people. And I think that, you know, if the change is not his free will, but is coming from the government, you find opposition. 00:10:04:20 - 00:10:31:12 Unknown So and I don't think you need to campaign, but you really have to talk to those stakeholder groups to find out what their problem might be or could be prevented. So I don't think you should let it come to campaigning through. You should do that like professionally before. Maybe you could call it lobbying in the group. Maybe you could lobby among the doctors and you could lobby among the software, whether the patients really have to fight it out professionally. 00:10:31:14 - 00:10:58:11 Unknown And I think there was so many already examples and experience in the European Union that you should collect it and give the responsible people a kind of toolkit which they can use and, to prevent such campaigning. So a toolkit, is that your biggest piece of advice in the implementation of the European health data space? My biggest one has yet to use all the knowledge and provided to those people who are responsible for implementing. 00:10:58:13 - 00:11:18:14 Unknown And of course, I think the thing you should provide is like there is not one solution. There's not a hammer. Like for every problem, you really have to make it tailor made. I see that every country special and every group in every country might be special. It really has to be a hard work and professionally done and not go in the problems, if at all, and don't care about it. 00:11:18:14 - 00:11:38:11 Unknown It really should be aware of that. And my experience problem is that the politicians very often do not have I don't know, they don't see the problems because they are not specialists. They don't provide the money for the things that's unnecessary. And this is the typical risk. Even if you know what you have to do, you cannot do it because you don't get funded. 00:11:38:13 - 00:12:00:17 Unknown This was one of my main problems, and you can augment it with, research. You can document with all the things you should do. But as soon as anything costs more than €100,000, you really have to lobby yourself through the politicians, because most of them, they won't take a serious. Even if you have a toolkit. What we know to do, we also have to bring the politicians on the side to that. 00:12:00:17 - 00:12:26:09 Unknown This is a risk of opposition and you really have to invest professional power and professional power also means budget. This is might be one of the big problems we had in Algo, because we had all the bad blood for the technical implementation and for the campaigning. It was only for TV ads or newspaper ads, but it would be much more sophisticated stakeholder analytics and and quasi preventive measures against campaigning. 00:12:26:09 - 00:12:48:13 Unknown And not only like PR measures, like making small satellites in the internet or newspaper articles or something, that public relations should be understanding the stakeholders, understanding their fear, and provide tailor made solutions, which can be from a toolkit, but it still needs to be tailor made for any group. I think in every country these folks are in. 00:12:48:15 - 00:13:14:22 Unknown Thank you, Franz, for your frank and open responses. Audra Diers-Lawson, Kristiania University, who you can hear presenting, spoke straight after Franz to give a sense of the learning possible from citizen engagement fails. I asked her, particularly with the challenge of mis and disinformation, what should data-sharing communications strategies contain for the realisation of a successful European health data space? 00:13:14:24 - 00:13:59:13 Unknown People? I think one of the most important things is to focus on what are the potential objections, who might be objecting, what their interests are in the objections, and then to craft information that pre-empts that, so that you give people a sense of what the objections could be and the answers to those questions that they would have. It's called inoculation theory, and it gives people a really good sense of what should happen, what can happen, and mostly how to respond to that when they're confronted with information that might be bad actor information, or simply information that is incomplete or counter to what the public health authorities would like them to hear and understand. 00:13:59:15 - 00:14:48:14 Unknown He used an acronym called Epic. Can you just describe that? Sure. Epic is a research based approach that focuses on engaged, positive, informative communication. So making sure that when we're talking with citizens about their health and about issues regarding their health, that we're having a two way conversation with them, that the nature of the communication is informative. It's really important that we're not just trying to persuade them, but we're trying to explain what they should be doing and why they should be doing it, that it's generally positive in nature and that we're really thinking in terms of what is the core of getting information out there is how we interact with each other. 00:14:48:16 - 00:15:16:23 Unknown To look at the ideal relationship with doctors, let’s look at what doctors actually want, need from and think about the European Health Data Space. Sara Roda is from CPME and has been presenting the European Doctors’ perspective on the implementation of the EHDS. Sara will summarise the key points she wanted to get across today. For the moment, how the idea being implemented is still, very unclear for the doctors. 00:15:16:23 - 00:15:45:07 Unknown We do have many questions. And in particular, what would be their role in the communication for citizens. They are seen, even if we don't want and we assign responsibilities of communication to other entities, they might still be the primary contact point from patients. So in that regard, in our view, we believe that they have to be engaged from the beginning on how to communicate and how all the each yes will be implemented because they are the end users. 00:15:45:07 - 00:16:12:14 Unknown And we need to ensure that there is clinical, usability from the electronic health record system and how to bridge this with the secondary use. So we need to make sure that the communication they agree with, with that communication, and they feel part on how to communicate properly the secondary use for patients. So the first point would be indeed to have more or less of a standard of information decided in advance with them on what should be communicated. 00:16:12:16 - 00:16:33:23 Unknown We have also to be mindful, who would have the official competencies to communicate to these informations to the patient what to if there would be any conflicting interests. So we don't want people that are impartial and want to have access to the data. And without informing properly the patients of the risks and the problems and all the consequences. 00:16:34:00 - 00:17:14:17 Unknown So we have to be mindful of those conflict of interests. And of course, if it is the doctor, the this will imply more time during consultations or consultations can be delayed and and there can be more administrative burdens on documents that patients would have to sign or, other information that they would have to look out for. So there is also the question of time management, and funding and compensation for these additional tasks that they were not foreseen because as the primary role of the doctor is to treat patients, and not so much these data management activities that, the yes, sir would imply in the secondary use regime. 00:17:14:19 - 00:17:40:10 Unknown And of course, and finally, and not least in the the, the most principal one is how we make sure that we maintain the patient. Doctor relationship healthy and robust. So we have to make sure that the patient continues to trust in their doctor, that there are no tensions that are brought up with the fear that the patients would have in not sharing information with the doctor, because this would be shared with third parties with commercial interests or even the government. 00:17:40:14 - 00:17:50:17 Unknown So that would be some of the issues that I wanted to come across. 00:17:50:19 - 00:17:56:05 Unknown So. 00:17:56:07 - 00:18:23:17 Unknown This all feeds into the shaping of policy and coordinating that across the European Union is quite a challenge. In the mix are industry and trade voices. Aneta Tash-kev-itsch is from the European Federation of Pharmaceutical Industries and Associations, a Brussels based trade and lobbying collective. Aneta was speaking on the implementation of ethical and regulatory provisions - how to build and maintain trust in data sharing for clinical trials. 00:18:23:19 - 00:19:10:12 Unknown I wanted to hear about her concerns on the implementaton of the EHDS. When it comes to my main concerns on maybe aspects that should be addressed, once the FDA's is being implemented, are some of those related to secondary research, because we've mainly, focus on the secondary purposes, of the use of the data, are related to provide a greater clarity to a data holder and the data user when it comes to the key provisions that shall be addressed, is those that related to sharing of the data containing intellectual property and commercial sensitive information with trust that without, data holder having a right to have a say when such data is 00:19:10:13 - 00:19:35:09 Unknown being requested, a burden can be created on the healthcare systems. When the head of data access bodies will be obliged to, handle such data without having prior experience in that. On top of that, to a trust that the data categories shall be better defined in order to make sure what type of data shall be disclosed. If that doesn't happened, it can create actually, confusion around the data holders. 00:19:35:09 - 00:19:59:13 Unknown And they might have a different reputation about which data types shall be shared. The third aspect is certainly an opt out, which in our opinion has to be some extent harmonised to not create sort of, divergent approaches across Europe. And it's also applications on the different types of data, such as, key coded aggregated data and offering an opt out retrospectively. 00:19:59:19 - 00:20:25:02 Unknown Would be also the further discussions of how that actually can be even feasible is required. But last but not least, it's certainly all of the provisions related to the scope of the European health data space, which is not well-defined. We are uncertain whether the US has extraterritorial scope, whether the entities established outside of the EU are obliged to comply with the rules, whether those that are established in the EU but hold the data of non-EU citizens are obliged to comply. 00:20:25:04 - 00:20:47:13 Unknown And last but not least, certain provisions related to sharing the data outside of the EU, specifically referring to the member States right to impose additional layers of protection if personal data shall be shared outside of the EU. Thus adds again to another sort of level of complexity to the system that is already kind of rather challenging for the researchers to operate in. 00:20:47:15 - 00:21:19:24 Unknown For the purpose of this workshop is to explore a lot of those issues, thinking about things more positively as well, because that's a big list of of challenges that implementation of places is thinking about what you are also presenting about, which is how you can take some of the experiences that you've garnered with the clinical trials into supporting any ideas that engages and builds trust with citizens. 00:21:20:01 - 00:21:43:07 Unknown How would you respond thinking about what you presented today? Yeah, thank you very much. So first and foremost, the European health data spends the long awaited, regulation that holds a great potential to, accelerate research, to improve patient outcomes, to pave the way to a learning healthcare environment. It's a key component of the innovation friendly ecosystem. Hence, that's the reason why we want to make sure that we actually succeed. 00:21:43:07 - 00:22:03:15 Unknown And the US delivers on its promise. From our perspective, it's really a paramount that we also engage with all of the stakeholders, including specifically patients, citizens. We are, from the start, clear about the value of data sharing via, for example, the national campaigns. We are looking at the different also transparency mechanism and how the data is currently shared. 00:22:03:15 - 00:22:24:10 Unknown And we measure it's actually impact on the public health, on the public perception of a data sharing. And also we need to build on already a well-functioning existing solutions to not reinvent the wheel, but to make sure that we are already kind of trying to scale up these solutions that were tested and developed in a co-created together with stakeholders. 00:22:24:12 - 00:22:43:18 Unknown And last but not least, make the most of the stakeholder forum that will be advising the dashboard. This would be really the main mechanism where the stakeholders can share the solutions, can also present the challenges that they face and the clarity they would need on some key provisions. Although again, we cannot really afford that that to fail. So we are in it together. 00:22:43:18 - 00:23:08:12 Unknown And it's a really, I would say, unprecedented moment to create a single market for data and to exploit further the great potential of the health data that is generated every day in the healthcare systems. I mean, ideally, we should stop saying that, in the EU we have the ocean of data, but the desert of analyses, we need to start finding the solution of how to turn that data into reliable evidence to inform our decisions. 00:23:08:14 - 00:23:32:01 Unknown And those decisions all centred on the patient. Yes, absolutely. I mean, these decisions, I mean healthcare, I think all they are eventually, related to the patient. Right? So, I mean, I think but for the patient, this is a great, actually opportunity, right. Because, we can have a greater, sort of perspective on what's the patient experience of care is patient can be more involved also in the clinical trials. 00:23:32:01 - 00:24:01:02 Unknown So there are also this is a way for a more innovative approaches in clinical trials. This is specifically relevant for the underserved population. Also for the people with rare diseases without specifically this kind of solutions, that allows us to capitalise on the amount of data generated in healthcare and turn it again into fill, maybe the gaps in our knowledge, in this area where the therapeutic options are not or not satisfactory, I mean, we will not succeed without having to function. 00:24:01:02 - 00:24:32:21 Unknown So it's all actually about patients and their needs. From a broader industry perspective is Gianluca Violante at Digital Europe, a trade association shaping industry digital policy positions. I asked him, why health data sharing matters and how the perspectives shared today feed into conversations with and interests of Digital Europe’s members? Health data sharing is, of course, a crucial for for innovation, for, you know, improving patient outcomes, improving health care systems. 00:24:32:21 - 00:24:58:09 Unknown And our members are at the forefront of that digital transformation. And, we we want to make sure that we are part of those conversations. So today is, is just one example of how how that, you know, exchange of views and productive conversations can take place. So we're very happy to be here and engaging with patients, healthcare professionals, other industry partners, and the broad health care ecosystem. 00:24:58:11 - 00:25:24:08 Unknown I think key takeaway for today is, you know, we need clear communication, with the broad health ecosystem so that applies to to patients, healthcare professionals, industry, and, and everybody who participates in this, in this healthcare system and are going to be important stakeholders in the implementation of of the regulation. And we all want it to to happen in the right way. 00:25:24:10 - 00:25:51:10 Unknown So I think for, for today, what I go, as a key takeaway is, you know, cooperates with all members, with all partners and engaging with, you know, regulators and policymakers early on to, to make sure we all represent our views. And, we got the PhDs right in both primary and secondary use of data for for the benefit of patients and innovations in Europe. 00:25:51:12 - 00:26:19:03 Unknown The workshop showcases various examples of existing patient portal initiatives. These are the French Public Register, the FINDATA and their citizen information portal, the German Medical Informatics Initiative, MyGenome Portal from Estonian Biobank, 1+ Million Genomes approach to informing citizens on secondary health data use, and lastly, the multi-layered citizen communication approach from HDL which you’ll hear about shortly. 00:26:19:05 - 00:26:54:07 Unknown Wiebke Lesch and Sophie Haderer, who both work in communications for The TMF, this stands for research, networking and digitisation in medicine in Germany. They discussed the lessons learned from their portal of the Medical Informatics Initative. I asked Wiebke and Sophie to begin by describing the initiative and how their portal works. So the medical informatics Initiative gathers routine data from German university hospitals to make it available for secondary use for research purposes. 00:26:54:09 - 00:27:26:00 Unknown It is funded by the German government, with €500 million from 2016 to 2026. So quite a lot of money so researchers can apply at the transparency portal to get routine medical data for research purposes, to create better research, better knowledge about diseases, and help treat patients better in the future. So that sounds like a certain high degree of consent must be given by participants. 00:27:26:02 - 00:27:58:10 Unknown Sophie, can you just describe that consent that is being used? So, the legal basis for the medical informatics initiative is the so-called broad consent. This is the legal basis for the sharing of pseudonymous patient data for research. And it is harmonised nationwide with all data protection authorities in Germany. And it is GDPR compliant. So that's great with broad consent for secondary use for research PhDs is on the horizon. 00:27:58:12 - 00:28:25:18 Unknown There's going to be some implications that will impact the portal and how you deal with the data. You can't answer what sort of changes you'll have to make, but what are you aware of that especially the ministry who've invested so much will have to be thinking about people come to you. So from our perspective, it is really important to involve patients early to integrate their perspectives. 00:28:25:20 - 00:28:59:14 Unknown And when you set up a transparency portal and inform citizens early on about the health data usage that we are well-prepared for, you know, to deal with the public opinion. And I would like to add that it would be really helpful that if we had requirements for patient information and patient involvement regarding the European health data space, in order to build one harmonised information infrastructure for the patients and the citizens, we have. To see the portal that Weibke 00:28:59:14 - 00:29:28:08 Unknown and Sophie discussed, check the show notes where links from today are shared. Someone with a track record of getting it right when it comes to effective relationship building and communications with citizens when it comes to health data sharing is Rebecca Alvarado from HDL. She spoke today about multi-layered citizen communication – from portals to press. She’ll summarise her key points now including the why, how, what method. 00:29:28:10 - 00:29:51:20 Unknown So citizen communication is a very complicated topic because citizens are huge audience and there's so many different ways to talk to them. Actually. So one important point is to actually know who you're talking to. Figure out the different distinct groups in your citizens group. Large group. The other thing is also to think about how you're actually going to communicate with your citizens. 00:29:51:22 - 00:30:14:02 Unknown And for this, I always borrow a concept from Simon Sinek called The Golden Circle to always start with your purpose. So when you're speaking to citizens, always focus on why you're doing what you're doing first, and then you can explain all the details and the complicated stuff later. So those are the two main principles that I love to work with when talking about citizen communication with why? 00:30:14:02 - 00:30:37:09 Unknown How what? One of the the examples that I use today, because it's just so easy to understand, is lately we've had a lot of journalists ask us because the electronic health record is coming to Germany. So there's a lot to explain. And with that, we had a journalist that had absolutely no digital health background. Ask how what an SP is and how it works. 00:30:37:11 - 00:30:59:17 Unknown And I was so proud of the people that I have trained to interview because they didn't start with explaining the SP, which is very complicated. They started with why we have space and why we have space is to make sure that we're not transferring data to other people. We want to keep it secure in one place, but we still want to optimise usage. 00:30:59:19 - 00:31:21:03 Unknown And he explained that first, and then he explained what an SP was and what got printed. The reason why we have SP. So of course not. What an actual spurs. So using that principle is so powerful even on a small level. So if you're writing the texts in your information portal or just talking to a journalist, it's the perfect principle to use everywhere. 00:31:21:05 - 00:31:48:16 Unknown Not everyone attending was there to present. Like Gianluca who you heard from earlier, representatives from health authorities were listening to the case studies to see what learning they could take home. I spoke with Marie, one such person, during the coffee break. Hi, Eleanor! My name is Marie Higgins and I'm a program manager in the Health Information Division of the Health Information and Quality Authority, and we are a, an agency of the Irish Department of Health. 00:31:48:18 - 00:32:18:24 Unknown And. Well, I'm delighted to be here because it's great opportunity for her to come to meet our European colleagues and to see what is going on in other European countries around the development of the European health data space. And I think I have learned an awful lot. I know I've learned an awful lot, and also it's great as well to see the different levels that different countries are at and where, where and where Ireland can learn from other countries experiences. 00:32:18:24 - 00:32:39:09 Unknown And also it's kind of comforting as well to know that, you know, some countries are really advanced and some countries are at the same level as others, and that we will hopefully work together to improve well, develop the European health data space. And then I suppose Hitchcock's ultimate aim is to create it's for safer services and better care for all. 00:32:39:14 - 00:32:48:13 Unknown So that's really what our ultimate aim is and hopefully the aim of the PhD as well. So thank you very much. 00:32:48:15 - 00:32:54:12 Unknown For. 00:32:54:14 - 00:33:28:09 Unknown Before we summarise the key points from the closing panel session, let’s meet Mélodie Bernaux who is from the EU Commission. As we have heard, in a fragmentory block of 27 countries, there are so many different approaches to health data and buiding trust. Melodie brings sensitivity to these issues learned from her medical background into her role in the EHDS project. She talks about the European Health Data Space’s approach to transparency and citizen trust when it comes to heath data re-use. 00:33:28:11 - 00:33:53:10 Unknown The pilot project is, of course, the first step towards full implementation. They will provide full rights recommendations which will inform the work of the Commission on Implementing Acts. So building new technical specifications and guidelines, for secondary use of health data and especially when it comes to building citizen trust, like today we are discussing, we need to workshop. 00:33:53:10 - 00:34:22:18 Unknown We need to gather input from different stakeholders, patient associations, healthcare providers, industry, researchers. Of course, all of this is super important to understand how what are the mistakes that were done in the past. And we know from the Covid experience that there were a lot of mistakes about the use of health data and how to use to build trust and to make everyone feel confident that we can share the data and we use it for the better good. 00:34:22:20 - 00:34:51:14 Unknown Some current approaches for engaging citizens are traditional with advertising campaigns and outreach frequently delegated to PR firms. The final session sought to explore different approaches and next steps towards engaged, informed and empowered participants - that’s you and I. The discussion was framed as ‘legal compliance versus best practice communication and further opportunities: manage opt-out, citizen forum and fostering citizen literacy’. 00:34:51:16 - 00:35:16:10 Unknown It included all participants and covered many issues including building trust and the inclusion of healthcare professionals and patients in the EHDS implementation, on choice for patients with different needs throughout the process, how to measure value from the use of data to demonstrate usefulness for patients and managing access to data via data access bodies who have limited capacities. 00:35:16:12 - 00:35:40:18 Unknown Closing the day, and this podcast, is Dr Michaela Th. Mayhofer who is one of the co-organisers and is Head of Ethical, Legal and Societal Implications at BBMRI-ERIC. After such a packed couple of days that brought up so many issues in the implementation of the European Health Data Space, I asked her, did the event achieve what she hoped and where next? 00:35:40:20 - 00:36:11:00 Unknown I think we have achieved beautifully what we've meant to do with the workshop. That is to have a dialogue between different stakeholders from the commission, from industry, from patient representatives, from research, also doctors to discuss openly about each us what it means for us. What are the fears, expectations, concerns, challenges, opportunities. And the viewpoints are as different that as they are positive and outlook. 00:36:11:03 - 00:36:37:21 Unknown That is, we want this to happen. We want digitalisation in the health care sector. Link it for research and there is a lack where we all agree in what the responsibilities are, who has to do what when we focus too much in how we get there, with which tools, rather than defining the clear goal and who has the task in carrying what load. 00:36:37:23 - 00:37:01:24 Unknown And having started that conversation with this diverse group of stakeholders is one of the first steps to really realise, in the long run. Thank you to everyone who took part in this podcast over the last few days. They’ve given you a sense of the issues at hand, examples of when data sharing activities really connect with citizens but also, when they fall flat. 00:37:02:01 - 00:37:25:02 Unknown This learning is critical for the implementation of the European Health Data Space. This podcast is brought to you by the ELSI team at BBMRI-ERIC who support the biobanking and biomolecular resources community. To learn more about how ELSI works, access the ELSI knowledge base, read research papers and reports from our ELSI experts, visit the BBMRI-ERIC website 00:37:25:08 - 00:37:59:20 Unknown at www.bbmri-eric.eu. There’s a newsletter sign up form there too so you can be kept updated on ELSI and EHDS, activity. If you enjoyed this podcast, do share it with interested friends and colleagues, and leave us a review on whichever platform you listened via – it helps us to reach new listeners. Watch out for our next podcast episode via our @BBMRI-ERIC socials on Twitter and LinkedIn, and thank you for listening. 00:37:59:22 - 00:38:11:20 Unknown