Executive Summary The secondary use and sharing of health data can be beneficial for public health and improve healthcare in multiple ways. However, many challenges of different nature arise when health data is being processed. The role of citizens in the processing of health data seems to be increasingly acknowledged at the European political level. Nonetheless, the only form of citizen’s involvement that seems to exist in the legislation is the pre-requirement for consent. This exploratory literature review aims at deepening our knowledge on citizens’ perceptions of and involvement with the secondary use of health data in Europe. It will help us identifying the key insights which have to be considered in our two next deliverables: a citizen e-consultation, and recommendations to encourage the involvement of citizens in the future European Health Data Space, which will be delivered to the EU Commission. This executive summary highlights the key conclusions that we drew from this literature review.
Ethical considerations regarding health data secondary use and sharing
The first identified debate among our selection of articles relates to the different definitions of the concept of data ownership. Some authors do contest its applicability in the context on health data, and the myth that it provides absolute control to the owner. Several authors defend other approaches, such as a state claim to data ownership or to access to data, a collective data ownership, resulting from the multi-stage and collaborative process that creates the value of data, or such as the fact that the relationship between individuals and their health data would not be based on property but on the fact that data relates to them and that their use can affect their wellbeing. The concept of ownership is usually linked to the protection of individual rights regarding the secondary of health data, such as the respect for autonomy and the protection of privacy of the individuals. Some authors highlight that privacy should not be presumed as an absolute right. They raise the need to evaluate the ratio between risks and benefits of a particular research. The extent to which those risks can affect us is more debated, as is the question of how to determine societal benefits. Authors suggest several criteria to evaluate the public interest of a project, including the public nature of the projected benefit, the principle of distributive justice, how benefits are shared, the need for transparency, and the extent of citizens’ involvement in the secondary use of health data. Moreover, while the respect of those rights seems to be translated in practice by asking the explicit and informed consent of the individual, authors often refer to it as one of the main challenges in the context of health data secondary use. Problematic aspects of this system reportedly include its lack of adaptability to technological aspects, the impossibility to anticipate all future reuses, or the impossibility to systematically come back to the person. However, not requiring consent explicitly can have, according to these authors, a negative impact on public’s trust, which is according to many sources the cornerstone of secondary use and sharing of health data.
Citizens’ role and involvement
Our review highlights the relative novelty of perceiving the citizen-patient as a key actor of the governance of health data secondary use and sharing. His role in the ecosystem is also debated within the academic community: while there is a consensus on the need for greater transparency and education with regards to health data, it is not the case for more active forms of involvement. There is for instance no clear consensus on which kind of consent system should be implemented to authorize the secondary use and sharing of health data. Five main types of such systems have been identified and promoted in the literature covered by this review: the opt-out system – in which health data are presumed reusable for certain purposes unless the citizen explicitly oppose to it; the traditional systematic informed consent system, which can translate in dynamic consent systems – enabling citizens to dynamically consent or oppose to the use of their related health data on a dedicated website or application; the broad consent system – where citizens indicate at the data collection point whether they agree with the use of their related health data in the future according to certain rules or principles; the tiered consent system – defining different levels of access depending on several variables, such as the objective of the project or the nature of the user; and the metaconsent system – which enables citizens to choose which type of consent system he or she would like to use. Beyond consent, other forms of citizen’s involvement mechanisms are also subject to debate within the academic community. Sources covered in this review promoted different models, including the involvement of citizens in the decision-making processes related to the governance of health data, or their participation in research projects. These models varied depending on the degree of involvement and power that citizens had on the decisions and actions taken. With regards to their involvement in the governance of health data, the presented and promoted models went from the use of public consultations and surveys to inform decisionmaking processes at the political level, through the allowance of a seat in governance bodies or access committees of databases, to the creation of data cooperatives, in which citizens are at the centre of the decision-making process. As for their involvement in research projects the different forms identified by the literature covered contributory, co-construction and citizeninitiated models. It remains to be seen which methods of citizens’ involvement would be the most suitable for the future European Health Data Space. This question needs to be asked for two types of health data secondary use and sharing systems: one the one hand, systems based on data altruism, defined defined by the Data Governance Act (Article 2, paragraph 10) as data voluntarily shared by data subjects/holders including individuals or companies for general interest purposes and addressed in TEHDAS by the WP8.2; on the other hand, systems based on the reuse of health data collected by the public and private sectors.
State of citizens’ perceptions towards health data secondary use and sharing
Finally, with regards to citizens' perceptions of the secondary use of health data and their governance, the literature review highlighted that they are mainly influenced by 4 factors, namely:
- the nature and objectives pursued by actors being granted access to health data
- the type of governance that regulates access to health data
- the measures taken to ensure the confidentiality and security of the data
- and the level of knowledge that citizens have of the topic.
According to the results of the surveys and consultations covered in this review, this knowledge is particularly low and would reportedly impede on the establishment of trust between citizens and the other stakeholders of the health data ecosystem. However, when questioned on the topic citizens express a need for greater transparency and education on health data. Another insight gained from this review is that citizens are relatively little asked to express their preferences regarding their potential involvement in the governance of health data secondary use and sharing. Moreover, health data are perceived differently by citizens compared to other types of personal data, and they express a greater need for protection and control for the former. However, this reportedly does not have a negative impact on citizens' willingness to share. Finally, some sources of the literature also highlighted that citizens do not seem to be opposed to the cross-border sharing of their data and would even in favour of it, as long as it remains within the borders of the European Union.
Download 895.77 KB