DataCom · A new EU Framework for an Ethical Re-use of Health Data

A new EU Framework for an Ethical Re-use of Health Data

In recent years, health data sets have turned into an economic asset, directly or indirectly monetized by companies and institutions, to such an extent that a health marketplace has been created. They are also being employed in the public sector for a large number of applications: disease control and fighting; pandemic-related decision making; public health expenses estimation; machine learning training, etc. The European Commission set out the intention of taking action on citizens' secure access to and sharing of health data across borders and on better data to advance research, disease prevention and personalised health and care . However, without appropriate safeguards, citizens’ data are subject to the risks of data accumulation and exploitation and data subjects might lose control over such sensitive information. Public entities (e.g., hospitals) hold a huge amount of health data; however, the legal framework regarding the possibility of re-using and exploiting such data is still unclear and fractionated among Member States (MS), and needs to confront with the relevant data protection laws and regulations (GDPR, Regulation EU2018/1725, Convention 108+). Health data is, thus, pseudonymized, de-identified, or anonymized using different techniques. Because anonymized data sets are not considered personal data anymore, they are left without legal protection. They are often commercially exploited and re-used without assessing the risks and expectations of data subjects, sometimes without informing them, even for detrimental purposes. Existing scholarly opinions have focused either on considering personal data as untradeable or on allowing its full exploitation with the consent of the data subject. OVERALL OBJECTIVE: DataCom aims at building a new framework to facilitate an ethical secondary use of health data held by public bodies, with the aim of improving accountability and enhancing responsible re-use, bridging gaps in scholarly efforts but also providing policy suggestions to EU institutions, facilitating decision making, and ensuring that health data in the EU does not become a mere exploitable commodity.To build this new framework, DataCom will develop and test in intersectoral practical environments the innovative concept of “Ethical Commodification”: the possibility of exploiting personal data in an ethical way for the public good, in accordance with data subject’s expectations and needs and taking into account the risks associated with the exploitation of anonymized data sets, focusing on 3 MS, Italy, Spain, and the Netherlands. In order to reach this objective, DataCom has a strong interdisciplinary and intersectoral approach, bridging law, ethics, and computer science, taking into consideration the needs of the public sector and those of citizens. In order to reach this urgency DataCom focuses on the following specific objectives: SO1) developing a “New EU Framework of Ethical Commodification”, by examining the existing theoretical frameworks of re-use of health data based on desk research; SO2) mapping the actors involved in health data re-use (i.e. health care public servants, researchers, professional/patients associations of 3 selected MS), to assess their needs and knowledge about the consequences of health data handling and re-use on citizens (surveys, interviews and focus groups); SO3) promoting awareness strategies among public servants in the 3 selected MS, drafting the manual “Guidelines for public bodies to responsibly re-use citizen’s health data” in order to provide them with the appropriate means to exploit data in a privacy-preserving and ethical way. To answer DataCom’s research question, an interdisciplinary approach combining insights from computer science (anonymization, security), law (privacy), and ethics (data ethics, human rights) is highly advantageous. AI, Ethics, and Law are essential to the study of health data re-use and the development of the “New EU Framework of Ethical Commodification”. DataCom will build upon legal and ethical scholarship on data re-use, and study data science techniques through the lenses of applied ethics on the topic, which allows the project to move beyond an exclusive focus on either law or ethics. Methodologically, DataCom will combine Law and Sociology: the use of process tracing and the combination of document analysis, interviews, and focus groups is in line with the social science methodology, while legal sources will be mapped and analysed on the basis of legal scholarship. DataCom has also a strong intersectoral dimension, as it will be hosted both by universities and public institutions.

Текст от CORDIS, на английски · Данни: CORDIS, © Европейски съюз