The European health data space: an opportunity for the public health community


By Filip Karan, Policy Assistant, EPHA

On May 3, 2021, the European Commission published a public consultation on the European Health Data Area (EHDS) which will remain open until July 26. As a policy initiative, the EHDS aims to provide a common framework for all EU Member States for the sharing and exchange of quality health data such as electronic health records, registers and data. genomics, to support the delivery of health care, but also to facilitate health research, policy development and legislation.

Divided into three sections: access and use of personal health data, digital health products and services and artificial intelligence in health care, the consultation aims to assess the policy options to be favored for the implementation. work of the EHDS. The legislative proposal resulting from this consultation is expected to be adopted in the fourth quarter of 2021.

Currently, most EU member states have adopted electronic health records containing information such as patient allergies, current medications and past illnesses. However, most EU countries do not yet make these records freely accessible to patients. The EHDS cross-border patient data exchange platform is only expected to be operational in 15 Member States by the end of 2021. By 2023, however, 24 EU countries (except Bulgaria, Austria and Denmark) should be equipped for cross-border sharing of patient data.

The second section of the questionnaire aims to collect information on the development and use of digital health services and products in the EU. These services and products include the provision of remote care, monitoring, diagnosis and therapeutic services, as well as the management of patient health data. If these services were to be offered barrier-free across the EU, citizens could reap great benefits, however, it is crucial that data privacy and accountability are guaranteed. Therefore, the second set of questions aims to collect feedback on policy preferences for minimum quality standards, for example through certification and labeling, for the interoperability of these services and for reimbursement of health costs. .

In addition, the aim of the last part of the survey is to establish appropriate rules regarding the use of artificial intelligence (AI) in healthcare and to identify potential ethical issues that the use AI in everyday clinical practice might have. When managed successfully, AI can improve the diagnosis, prognosis, treatment, and management of patients. Yet AI is prone to bias and can negatively impact patient well-being. For example, a study published in Science found that an algorithm commonly used in US hospitals to allocate health care to patients consistently prioritized whites over blacks who were also sick. Thus, ethical concerns should be taken into account when designing and implementing AI in healthcare to avoid discrimination.

This public consultation provides an excellent opportunity for the public health community to make its voice heard in light of the increased complexities posed by digitization, and to ensure that EHDS, as intended, further advances patients’ rights. and has a positive impact on the accessibility and quality of medical care. they receive.


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