09 November 2022
Digital Health

The European Health Data Space must respect medical ethics and national competence

European doctors have today published a position on the European Commission’s proposal for the European Health Data Space (EHDS), raising concerns about medical ethics, the burden on doctors and the national competence of Member States.
Download position

CPME believes that the EHDS can help improve the quality of healthcare to patients and stimulate the availability of health data for scientific research. At the same time, the proposal will touch upon the very core of the patient-doctor relationship, defining the framework for patient-doctor confidentiality, patient privacy and patient-doctor trust.

In order to respect existing structures in Member States, European doctors urge that there should be national discretion with regard to the implementation of ethical safeguards. This includes ethical requirements in relation to the secondary use of health data, such as the duty to obtain patients’ consent or to involve ethics committees.

“The design and technical implementation of the EHDS must comply with the principles of medical ethics and cannot pose any risks to medical confidentiality. Otherwise, patients may become reluctant to provide information or even consult with their doctor if they fear that their health data will not remain secret.”

CPME is also concerned about the implementation costs of the proposal, and whether the EHDS can maintain a high level of protection of fundamental rights, including personal data, with sound procedures that respect human dignity, autonomy, and privacy of individuals. Strong obligations for software manufacturers for interoperability and usability must be made mandatory. A better assessment of the legal, social, technical, and financial consequences for doctors, other healthcare professionals, patients and the provision of healthcare is needed.

Importantly, legal accountability on the EHDS must not go beyond the doctors’ competency or responsibility.  

“The EHDS should not impede doctors’ ability to provide timely quality healthcare. Issues of liability and accountability have not been sufficiently clarified. Doctors can only be responsible for the data they have inserted in the electronic health record.”

 

The full Position on the European Health Data Space is available here.

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