Check our recommendations for the European Commission !
Two years after its launch, the Healthy Data project is coming to an end. Over the last few months, our team has been working on our final deliverable within the TEHDAS project: 12 recommendations for the European Commission relaying citizens' key values about the second life of their data and their preferences on how to engage them in the future European Health Data Space. These recommendations were built on the nearly 6000 contributions you have shared on our platform and through our interactive quiz, as well as on other preliminary work and stakeholders’ inputs provided through 4 workshops conducted after the publication of the consultation’s results. They also took into account the current legislative proposal for a European Health Data Space, released by the European Commission last year. What are the recommendations in a nutshell? The first part of our recommendations builds on the premise that according to citizens, using data means using a part of their identity and history. Therefore, when using data for secondary purposes stakeholders have to bear in mind that they are entering a relationship between citizens and their data. This part expands then on how to develop and support the different elements constituting the relationship between data, citizens and stakeholders involved in the second life of data. The second part begins with reminding that citizens perceive data as having a certain power, to do good but also to do harm. This part then deals with citizen-supported mechanisms to ensure the balance between risk mitigation and benefit maximisation when using data. The third part of the recommendations develops on the necessity to bring together all of the above into a dynamic regulatory framework driven by citizens, taking into account the core ethical values they identify. A fourth part mirrors the values and principles which should guide the secondary use of health data according to citizens with the current proposal of the European Health Data Space. Read the one-pager here! Read the full report here! What happens next? Following the publication of this final report on the TEHDAS website, the European Commission will have knowledge of and access to this document. This is an opportunity to make the values of citizens heard at the genesis of the European Health Data Space. In parallel, our team will conduct a communication and dissemination campaign of the recommendations to all partners who have been involved at some point in the project, as well as to additional policy makers. You can always follow us on the channels shared below: Sciensano (Belgium): Twitter LinkedIn Health Data Hub (France): Twitter LinkedIn Understanding Patient Data (UK): Twitter Youtube Although our team members will no longer be directly involved in the TEHDAS project, we happily remain available to answer your questions and keep the dialogue open. Sciensano: firstname.lastname@example.org Health Data Hub: email@example.com NHS Confederation: James.Maddocks@nhsconfed.org
Our series of workshop ended
Our series of workshop ended: 150 European stakeholders came to help us build our final recommendations based on citizens' contributions Since the publication of our interim report outlining the 6,000 contributions collected from citizens, the Healthy Data team has organised a series of workshops to meet national and European stakeholders. Our aim was to discuss the secondary use of health data in-depth and to get their feedback on the citizens' contributions in order to better delineate the main areas to focus on and to clarify the best way to develop our future recommendations. More information on the national workshops is available here. The European workshop was organised in a hybrid format at the Hungarian Permanent Representation in Brussels. More than 50 stakeholders participated in the face-to-face workshop, and more than 100 followed us online. Once again, we would like to express our gratitude to the members of the Permanent Representation for hosting us, as well as to all stakeholders for participating in person and online. How did the workshop go? During the two-hour workshop, participants were given an overview of the European Commission's proposal for a European Health Data Space, the TEHDAS joint action and the process followed to conduct the Healthy Data consultation and its main outcomes. We then presented them with several statements from the citizens' contributions, organised under three main themes: benefits, conditions and citizens' engagement regarding the secondary use of health data. Both online and in person, participants were able to vote on the statements, write their comments in the chat room, or intervene directly if they were present. The discussion hold during the workshop was very fruitful, thanks to the multiple interventions and comments received from the audience. For more information: Find the slides here, Access the recording here Read the summary of the discussion here And now? We are now in the final phase of our project, and will start writing our final deliverable for the European Commission on how to raise awareness and engage citizens in the future European Health Data Space.
The national workshops are over! Discover our first results!
Over the last few days, the Healthy Data team has conducted three national workshops in the participating countries of the project, namely France, Belgium and the UK. On this occasion, we were able to present the main results of the consultation to the national stakeholders of the health data eco-system in each country, such as digital experts, health professionals, researchers, patient associations and civil society actors. In total, nearly one hundred stakeholders attended the three consecutive workshops. We would like to thank all the participants for taking the time to listen, discuss and contribute during the workshop. What did we discuss? We had the opportunity to discuss different major themes in order to feed our reflection on the recommendations we will elaborate for the European Commission on citizens' engagement in the future European Health Data Space. These main themes were the following: Conceptual framework: how can citizens' conceptions of health data influence the framework for their re-use? Collaboration: how to treat citizens as equal partners in the re-use of health data? What roles do different stakeholders play and how can we maximise collaboration? Trust and beneficence: how to foster trust and beneficence of citizens towards health data reuse (safeguards, actions, information...)? In order to have a more detailed idea of the content of the discussions held during these workshops, you can consult the summaries made for each workshop below: Workshop conducted in Belgium Workshop conducted in France Workshop conducted in the UK Where do we go from here? The results of our consultation and the points highlighted during these national workshops have been presented to European stakeholders during a hybrid European workshop organized at the Hungarian Permanent Representation in Brussels on 11 October. More information on the European workshop here.
From citizens' perspectives to policy recommendations
Next steps of the Healthy Data consultation Last month, we finally published our report with our analysis of the 6.000 contributions we gathered through the Healthy Data consultation. Once again, we would like to express our gratitude to all the partners who helped us disseminate the platform, and to the citizens who participated in the consultation. It is now time to move on to the next steps of our project in order to translate citizens' preferences into concrete policy recommendations for the European Commission! Although the consultation is now closed for participation, the Healthy Data project will have a busy agenda this autumn. In September, each participating country of the project -namely Belgium, France and the UK- will organize an online national workshop with stakeholders of their respective health data ecosystem in order to gather their perspectives on the results of the consultation in light of their national contexts, to build a starting point for our policy recommendations. In October, we will receive European and national stakeholders in Brussels, at the Hungarian Permanent Representation, for a hybrid European workshop, where we will also present our results, as well as our findings from the national workshops, to further build our recommendations in a European context and in light of the European Health Data Space proposal. We will then have several weeks to consolidate our preliminary work, citizens' contributions and stakeholders' perspectives to build these recommendations to publish them in February 2023. Are you interested to know more about the workshops? Are you a stakeholder willing to participate? You can find the contact person below: Belgian and European workshops: Louise Mathieu (firstname.lastname@example.org) Workshop in France: Elisa Regnier (email@example.com) Workshop in the UK: James Maddocks (firstname.lastname@example.org)
Our report is out!
Participation to our consultation has ended. Between December 2021 and May 2022, our platform received more than 24,500 visits and we collected almost 6,000 contributions. We warmly thank all the citizens who participated in this debate, as well as all the partners who supported us during this process. Since then, we have analysed your ideas and published our interim report on the citizens' contributions. The report in a nutshell Most participants recognised the societal benefits of sharing health data, such as improving public health, but remained concerned about the potential risks associated with its use, particularly regarding breaches of their privacy. A key requirement for citizens is therefore to achieve a balance between the benefits and risks of re-using health data. Amongst other things, the purpose of reuse seems to have a major impact on citizens' preferences, notably through the guarantee that their data is used in the public interest, whether through research or the implementation of public policies. Nevertheless, some aspects clearly divide citizens. Indeed, their opinions differ as to the possibility of pursuing a commercial purpose or allowing access to data to commercial actors, and also as to the need to anonymise data or not. Finally, the need for information and transparency is a recurrent statement in your ideas. This, together with the need to have a solid general framework in place, would help to build confidence among participants in the re-use of health data. What is the place of citizens in this framework? Many of you have commented on this question, with extremely diverse answers. What remains certain is that public trust depends on respect for the values promoted by citizens in the framework put in place. Beyond a concrete choice of commitment by citizens, they wish to be perceived as real actors and partners in the re-use of their health data, whether through policy decision-making processes or the governance of their data. And now what? The aim of the Healthy Data project is to provide guidance on how to engage citizens in the future European Health Data Space, the first proposal of which was published in early May. In order to transform the contributions we have collected into concrete recommendations, we want to get feedback from stakeholders in the health data ecosystem through a series of workshops: Three national online workshops conducted in the three partnering countries of this pilot project, i.e. in Belgium, France and in the UK One European hybrid workshop hold in Brussels Thanks to the perspectives of these actors, and based on our preliminary work and the contributions of citizens, we will be able to formulate these recommendations in the course of the end of the year, in order to be able to present them to the European Commission in February, in 2023. Discover our report!
Citizen participation at the heart of the Healthy Data debate!
Following their partnership on health data and their commitment to improve the participation of civil society, the Health Data Hub and France Assos Santé wanted to involve citizens in their reflections. On the occasion of the e-consultation, they put this into practice by bringing together a small focus group, looking at how they perceived the consultation and its presentation. One of the objectives was to be able to start an open reflective process and to understand what keys they might be missing in reading the debate but also in the way it was addressed to them. This debate on health data allows citizens to have their say. The latter were also involved in the very construction of this online consultation project. In particular, there was a group of several citizens who were mobilised to deepen the educational content around health data. Led by France Assos Santé and the Health Data Hub, these volunteers were able to discuss ways of producing clear, accessible and entertaining information for all citizens. Different types of recommendations were formulated. First of all, for the group, the important thing was to raise general awareness on the subject of data. To do this, the important thing is not to display a whole range of information at once, but to show the essential. To do this, and drawing inspiration from the Facile A Lire et A Comprendre methods, the group insisted on the importance of producing and disseminating content that is not too dense, and of placing much more emphasis on visuals. And to allow citizens, once interested, to easily find more dense and complete information. Also, both necessary to understand the theme of this e-consultation on the second life of health data but also to hook the readers, according to the group, the primary entry point into the issue of health data is the difference between primary and secondary use of health data. Based on various discussions, the group proposed to co-construct a visual or infographic to illustrate this difference. This involved illustrating the sources of health data (hospitalization, outpatient medicine, connected objects, etc.), the ways in which the data is processed, and the benefits of using these data. It also made it possible to emphasise a few key concepts that were valuable to the group, including anonymisation, pseudonymisation and aggregation. The Health Data Hub and France Assos Santé would like to thank the citizens who participated in this working group: Maëlys Jégu, Rosine Le Bail, Serge Lafargue, Jean Arnaud Elissalde.
Healthy Data - Discussion Evening in Ghent (BE)
On Wednesday 25 May 2022, we organize a Healthy Data discussion evening in Ghent (Belgium)!This will give you the opportunity to discuss your ideas live and to learn from other citizens’ opinions. The evening will take place in a casual atmosphere and your ideas and concerns will be at the centre of the evening.To give you a clear idea of how health data reuse actually works in practice, what its consequences might be and which possibilities it might hold for the future, three experts in health data reuse will briefly present a case. They will talk about cancer care and research, the reuse of COVID-19 numbers and the idea of a personal health data pod making you the manager of your own data.Next it’s up to you!In small discussion groups, we invite you to share your ideas on these cases and to talk about valuable purposes for health data reuse, conditions and safeguards that should be in place and the way you want to be involved in processes of health data reuse. We are there to facilitate the discussion and the experts will remain on hand should you have any questions. We provide interactive discussion techniques to support you and further elaborate your ideas and we make sure everyone’s voice will be heard.To wrap up the discussion evening, every group briefly presents its ideas to the others. Together we will formulate conclusions that will be shared with the European Commission to guide future policy decisions on national and international health data reuse.Afterwards, you’re kindly invited to have a drink with us!More information and registration: https://www.demaakbaremens.org/agenda/gezondheidsdata/ Practical: - The discussion will be in Dutch, yet the evening is open to everyone- You don’t need any prior knowledgeWe’re looking forward to welcoming you!
Patients and health data: uses and perspectives - French Federation of Diabetics
The collection of health data (blood glucose levels and treatments), initially an analog (manual?) process which was later digitised, has always played an important role in the daily life of people with diabetes. For a long time now, diabetics have used the recordings of their biological data (collected by glucose meters) to measure their daily, or even multi-daily, blood glucose levels, in order to monitor their glycemic balance, or to adapt their treatment and in particular their insulin doses. A certain number of "capillary" glucose meters have already become "connected" when coupled with digital applications that faciliate monitoring and personalised treatment. This practice has evolved with the arrival of continuous, digital and connected glucose sensors, which allow data to be collected and transmitted to servers via mobile applications, or even transmitted directly to medical devices (pumps) that administer insulin semi-automatically (conventional pumps or so-called hybrid closed-loop pumps) While this data represents a value source for the evaluation of medical technologies or research, it is also of immense individual interest to personalise the treatment of all diabetics. The advent of telemedicine allows us to enrich this use in other ways. As a result, digital health care is a major topic of reflection for the French Federation of Diabetics. One of their core missions is to contribute to the improvement of care and support for patients. This desire led the president Gérard Raymond at the time to create the "Diabetes-LAB". It is a study and research structure whose mission is to design and carry out studies on the daily life of people with diabetes and their experience as patients. For more than six years, Diabetes-LAB has been conducting numerous studies at a rate of about fifteen per year: either qualitative in the form of individual interviews or focus groups or quantitative through online questionnaires from a database of more than 40,000 email addresses including nearly 6,000 diabetes-actors (people who volunteer to participate regularly in these studies) these studies have even been extended to the National Health Data System with the methodological support of the Health Date Hub (HDH) and the clinical research company Sanoia, which provides an exhaustive view of practices based on the medico-administrative databases of the Health Insurance and Hospitalization (PMSI). The analysis of all these data, which may be medical, behavioral, social, or even economic (consumption of care), makes it possible to assess the use made by diabetics of different drug or non-drug therapies, medical devices and care pathways. Schematically, the use of digital health data can be classified into five objectives: SELF-EMPLOYMENT - This is first of all the use by the patient and for himself. The tools allow the patient to manage his or her disease on a daily basis in a much more optimal and autonomous way than in the past. COORDINATION, FOLLOW-UP BY THE CARE TEAM - The transmission of this data allows communication with the doctor or his team thanks to a large amount of information collected and sent by these digital tools via the various applications or hosts. ACCESS TO CARE - New technologies allow patients to be monitored remotely, for example, through remote monitoring programs or to have recourse to expertise that is not available locally through remote monitoring or tele-expertise. EVALUATION OF TREATMENTS, PATHWAYS AND HEALTH POLICIES - Digital technology can enable patients to participate, with the help of structures, in the evaluation of treatments or care methods in real life, via the transmission and collection of their data. This evaluation of both technologies (devices or drugs) and health policies (pathways - recommendations, etc.) is an essential aid in choosing the best strategies in terms of quality, safety and efficiency. This is also the purpose of Article 51-type experiments. RESEARCH - The mass of data generated by patients can feed gigantic real-life databases that will enrich research. It is therefore necessary to contribute to this collection in order to ensure our digital sovereignty in health, by enriching, for example, the catalog of HDH data warehouses. But these exciting prospects come up against two major obstacles: First, the absolute necessity of establishing a consensus or a semantic interoperability repository. These data must not only be structured to be intelligible, but also compatible with each other in order to be used, collected and adapted to monitoring tools. The examples of remote monitoring and insulin pumps highlighted in the Diabetes-LAB studies highlight this difficulty. Secondly, this evolution comes up against a digital divide that is not always linked to age. While it is true that in general it is the younger patients who are the most comfortable with digital health care, things have changed in recent years. Today, patients over 60 have little or no problem using the digital tools they have learned to use during their professional lives and is it mainly patients over the age of 80 who struggle with new digital care solutions. Age-related considerations remain, however the real divide is at the social level. All the studies show that the most socially disadvantaged people are also those who are the furthest from healthcare and digital health. This is a real challenge for the future. It is the challenge of learning e-literacy in health: a social problem of health promotion that must be addressed from a very young age. To better understand this reality, the Federation has undertaken a national study to determine the profile of diabetics who, in 2021, have used telemedicine and teleconsultation, and thus to identify those who have not. This will allow the design of training programs for professionals and patients adapted to the needs of this population. The collection of patient data, which belongs to the patients first, is a real collective asset, provided that patients have access to these data and that associations can be real stakeholders in these studies. Beyond the real-life evaluation of health technologies, this will make it possible to go further and participate in the evaluation not only of treatment paths, or even of funding, but above all of our country's health policies. When all this is in place, we will have taken another step towards democracy in health care. JEAN-FRANÇOIS THEBAUT, NICOLAS NADITCH, MANON SOGGIU Fédération Française des Diabétiques How would you like to be involved in health data reuse? Have your say here!
Find here the position paper co-signed by our experts
The Healthy Data team is supported and accompanied by specialists through an advisory group selected on the basis of an open call. Indeed, the project requires extensive specialist expertise and a variety of different partners and stakeholders across Europe are involved in this project. European organizations covering academia, business, public sector and NGOs participate in the Advisory Group to share their expertise. We're proud to share with you today the position paper co-signed by our experts. Find here our entire group of experts. How would you like to be involved in health data reuse? Have your say here!
Act on Rare Disease Day 2022!
The 28th of February marks the 14th edition of the international awareness campaign for rare diseases. It is estimated that 300 million people worldwide are currently living with one of the 6000 rare diseases that have been identified. Reusing health data offers opportunities to advance scientific research and improve health outcomes. This potential can only be fully realised through combining and sharing biomedical data. This is particularly true in the case of research on diverse and rare diseases. Patients suffering from them are geographically dispersed and in low numbers. Sharing data and combining health records could create knowledge and avoid duplicated studies, benefitting patients care. Did you know that… as the prevalence of a rare disease in a population is quite low, developing treatments is an ongoing challenge. Our understanding of how diseases develop and evolve is usually incomplete, and recruiting patients to participate in research can be difficult. European regulations around rare diseases and digital health can be an opportunity to ensure access to safer and better health data to improve patient care. Discover more by listening to this podcast Rare diseases represent a paradoxical example of the opportunities and challenges of reusing health data. On the one hand rare disease research has a greater need to harness the potential of data reuse, but on the other hand the protection of patients' interests can be more complicated to ensure. Patients can be concerned about questions of data security and misuse, and fear that data sharing could lead to discrimination. This is why we need to understand patient needs to ensure their participation and engagement in research. Engaging patients living with a rare disease can also help to improve safeguards, reduce risks and increase the benefits resulting from the reuse of their health data. Did you know that… The European LeukoTreat project aims to compiling a European wide database about leukodystrophies, a form of rare disease. The research team surveyed patients and their families to gather their views on the sharing of their health data. This process allowed them to imagine an ethical framework for the use of this database, where patients could be asked to provide a broad consent* followed by ongoing information, with an independent ethics steering committee in place. The article presenting this study is available here. *Broad consent: consenting to the development of research in a pre-defined and broad field without the necessity to re-consent How would you like to be involved in health data reuse? Have your say here!
Act on World Cancer Day 2022!
Whenever we go to a doctor or a hospital, they collect data about us, our health and our lifestyle. This is recorded and stored in our patient record. It may include our height and weight, whether we smoke, how much we drink, details of any allergies, what aches, pains or infections we’ve got, and what medications we are taking. National health systems use this information to help provide the best clinical care for us. But health data can also be reused for purposes beyond direct care including to improve health, care and services through research and planning. Therefore, your data can help you directly, as an individual, to provide you with care, but it can also help other people’s lives by benefiting everyone else. Data from previous cancer patients can help current patients' treatments, while their own data will help refine treatments for future ones. Sharing patient data is therefore an opportunity to fight cancer. Inaugurated in 2000, World Cancer Day is an opportunity to raise awareness and remind people that we all have a role to play in reducing the global impact of cancer. Without significant action, the World Health Organisation estimates that the European region could reach an incidence of 5.4 million cases of cancer, and nearly 2.5 million deaths per year by 2030. To mark this occasion, the Healthy Data team has developed an interactive comic book, where users can follow the story of Robert, 50, who has been diagnosed with and treated for colorectal cancer, and suffers from Lynch syndrome, an inherited genetic mutation. Discover Robert's story and how his data can be reused, under what conditions and most importantly how he can get involved in the governance of his health data. Discover Robert's story!
In the age of digital communication, more and more data is being collected. This technological opportunity can bring considerable benefits, also in the health sector. Healthcare professionals can share information about a patient more easily, which facilitates and improves the medical care received. During all our interactions with the health system and the individual care we receive, we leave behind data that can have a "second life". This secondary use is regulated and the security of our health data is ensured. Health data can be reused in many ways, such as through research to improve the quality of treatment and care received in cancer management, as shown in our second video below. For what purposes should health data be reused, under what conditions, and what role do you as a citizen want to play in this? Have your say here!