Healthy Data, an online citizen consultation about health data reuse – intermediate report

Introduction The present report is an overview of participants’ opinions gathered through a pilot public econsultation conducted between December 2021 and May 2022, primarily in France, Belgium and the UK, in order to develop citizen inspired recommendations regarding the reuse of their data and their role in this governance. The Healthy Data online consultation platform aimed to inform citizens about health data reuse, deliberate together with citizens about an ethical, legal and societal framework and produce recommendations for the development of the European Health Data Space. Methods To reach a broad audience, a largescale communication campaign was launched, including many partnering organisations who leveraged their networks to bring attention to the initiative. A large body of content was created in different formats, such as text, videos, visuals, an interactive quiz and cases. The content was updated regularly to attract different publics. Every piece of content provided neutral information and was centred around key questions about health data reuse. Results: 4.244 citizens completed the interactive quiz and 5.932 ideas about health data reuse were shared on the platform. These contributions were thematically analysed to identify the overall narrative and the key values and principles that need to be respected when establishing the European Health Data Space. Considerations about data and data reuse: The contributors considered data to be powerful: It is going to exist somewhere with the perpetual potential to be used to do something which impacts the person behind the data. This power can be harnessed for good, but also cause harm, so it is important to be conscious of this power and to respect the rights of the people behind the data. The citizens identified fundamental individual and social aspects in health data. On the one hand, citizens wrote about ‘my data’, ‘I own my data’, ‘I should be in control’. On the other hand, they would talk about reuse systems, platforms, scientific research, databases, commercial use, … which can all be defined as fundamentally social in the sense that it is intrinsic to these practices that health data of many individuals is combined. Finding a balance between benefits and risks of health data reuse: The purpose behind reuse was a key question for participants. They generally supported health data reuse to support the common good (they mention: improve public health, healthcare, research and policy). Conversely, many contributors were against reuse for commercial purposes. Commercial aspects of health data reuse are often referred to within contributions. If some participants argued that involved private actors can be beneficial in multiple ways, a strong majority shares their concerns regarding their involvement within health data reuse. Participants referred to the need to protect their privacy and to acknowledge the technological limits of data security. In this regard, anonymization was the most mentioned concept within the consultation, but it divided participants on whether data should be anonymized or not. Overall, citizens also believed that the chosen safeguards should depend on the level data has been anonymised. Finally, some participants believed a certain form of citizens’ control was legitimate and should be allowed to minimize risks from health data reuse. Healthy Data, an online citizen consultation about health data reuse – intermediate report 4 Information, Communication and Engagement: Citizens expressed a broad range of preferences regarding the information they wish to receive, the methods used to communicate with them and the opportunities that are provided with for engagement. Views range from a preference for none of the above either because of an objection towards the reuse of data or their perceived ability to participate in decision making, through to complex processes that would allow for citizens to know in real time what data is being used, who it is being used by, how they are using it and what their intentions are. At this higher level of complexity and involvement, they would also have an ability to make decisions about each and every potential of reuse of data. In reality though, results suggest that citizens views sit somewhere between these two extremes and allow for citizens to receive information and communication that is personalised to them, and engagement mechanisms that give a place to individual citizens, their representatives, and professionals in such a way so as to allow reuse that supports the public interest, promotes the safe and ethical reuse of data, and is conducted in a transparent and inherently trust building manner. Framework: A solid framework for health data reuse could be an overarching safeguard against reuse-associated risks, yet only if citizens trusted the authorities behind it. In case of a lack of trust, however, citizens usually did not trust health data reuse, nor its regulatory framework. A framework should also create transparency and allow for citizen involvement in the governance of health data reuse, if desired. Trusting the authorities behind the framework could decrease the wish to be involved yet being informed about reuse usually remained a necessary condition for public trust. Conversely, a certain distrust regarding the current framework could instigate the wish for a more active involvement of different stakeholders, including citizens. Participants also expressed specific ideas about the legal, ethical and societal dimensions of a suitable framework. A binding legislation for health data reuse, possibly starting from existing regulations such as the GDPR, should delineate authorised data users and reuse purposes. It should also clarify accountability claims and foresee in preventive and sanctioning measures regarding data abuse. Besides, ethical standards should define an overarching code of conduct. Confidentiality, equality, and individual freedom were mentioned as values of utmost importance. Finally, the framework should respect societal values that acknowledge the collective nature of health data reuse. Solidarity and avoiding discrimination were central concerns within the societal dimension of health data reuse. Discussion: Citizens’ attitudes towards health data reuse can be described as conditional beneficence, as they perceive it as beneficial at a societal level but also as potentially dangerous. Several aspects seem to have a major impact on their preferences. First, commercial aspects have a major impact on citizens’ perceptions of health data reuse and the framework that should be put in place. Then, whether data is anonymized or not seems to have a fundamental influence over citizen support for a general framework or other safeguards. As a basic rule, health data should be reused for goals that are in line with citizens’ values. The overall framework for health data reuse should pursue the common good and include solidarity-based values, while implementing appropriate safeguards. Healthy Data, an online citizen consultation about health data reuse – intermediate report 5 This conditional beneficence is based on both trust and the fear that health data might be reused against citizens, since complete control is not possible. Trust is of utmost importance and should be earned and fostered by respecting citizens’ values. One of these central values is co-creation, in which citizens need to be treated as partners and the framework for health data reuse needs to be co-constructed by them and other stakeholders. Conclusion: It is up to stakeholders to develop a framework based on this conditional beneficence, ideally in an open dialogue with citizens. This report serves as a starting point for discussions to translate citizens’ contributions about what the EHDS should look like.