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By Filip Karan, Policy Assistant, EPHA 

On May 3rd, 2021, the European Commission published a public consultation on the European Health Data Space (EHDS) which will remain open until July 26. As a policy initiative, the EHDS aims to provide a common framework across EU Member States for the sharing and exchange of quality health data such as electronic health records, patient registries, and genomic data, in order to support healthcare delivery, but also to facilitate health research, policymaking, and legislation.

Split into three sections: access and use of personal health data, digital health services and products, and Artificial Intelligence in healthcare, the consultation aims to gauge which policy options are preferred for the implementation 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 patient health records containing information such as patients’ allergies, current medication, and previous illnesses. However, most EU countries do not make these records freely accessible to patients yet. The platform for cross-border exchange of patient data under the EHDS is planned to be operational in only 15 Member States by the end of 2021. By 2023, however, 24 EU countries (aside from Bulgaria, Austria, and Denmark) should be equipped for cross-border patient data sharing.

The second section of the questionnaire seeks to collect input on the development and use of digital health services and products within the EU. These services and products include remote care delivery, monitoring, diagnosis, and therapeutic services, but also the management of patient health data. If these services were to be offered without barriers across the EU, citizens could reap great benefits from them, however, it is crucial that data privacy and liability are ensured. Hence, the second set of questions aims to collect feedback on policy preferences for minimum quality standards for example through certification and labeling, for interoperability of these services, and for reimbursement of healthcare costs.

Furthermore, the goal of the last part of the survey is to draw appropriate rules regarding the use of Artificial Intelligence (AI) in healthcare and to identify potential ethical concerns that the use of AI in daily clinical practice might have. When managed successfully, AI can improve diagnosis, prognosis, treatment, and management of patients. Yet, AI is prone to bias and can have negative consequences on the wellbeing of patients. For example, a study published in Science found that an algorithm commonly used in American hospitals to allocate health care to patients systematically prioritized white people over black people who were equally sick. Thus, ethical concerns must be considered when designing and implementing AI in healthcare to prevent discrimination from arising.

This public consultation offers a great opportunity for the public health community to make their voices heard in light of increased complexities posed by digitalization, and to ensure that EHDS, as intended, further advances patients’ rights and positively impacts the accessibility and quality of medical care they receive. 

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