Ensure a safe digital transformation of healthcare

The EU, and all public and private stakeholders across Europe, must respect ethical principles of medical confidentiality and professional secrecy of health data. 

EU health data exchange frameworks, including IT infrastructures, must be trustworthy and robust, otherwise patients may become reluctant to provide information or even to consult with their doctor with confidence if they fear that their data will not remain secret.  

We need to optimise functionality of digital health tools as doctors’ time should be spent on patient care and should not be diverted by excessive administration. The digital health transformation cannot advance without doctors being fully supported with resources for digitisation and tools for digital literacy.  

CPME welcomes that both the Council and the European Parliament have recognised the core principles of the “patient-doctor” relationship in the European Health Data Space Regulation. We can only gain the trust of direct users, patients and healthcare professionals alike, if we observe (and apply) the ethical principles that guide professional conduct and ensure the respect for private life.

Patients need to feel that the information shared with the doctor remains secret and that only when there is a higher value to protect, which enters in direct conflict with the information covered by professional secrecy, the doctor, complying with the national procedures to waive medical confidentiality, can disclose the relevant personal health information. These principles also serve the society at large, pursuing an objective of general interest of free access to healthcare.

However, as the Regulation introduces the obligation for “health data holders” to make health data available for secondary use purposes, where any natural or legal person, public authority, agency or other body in the healthcare or care sectors will have to provide data when requested by the competent authority for research, innovation and policy-making purposes, it remains to be seen how the personal health information will be effectively pseudonymised and anonymised in a way that the process remains ethically sound, and by whom.

From the European doctors’ point of view, sharing personal health data as a result of a legal obligation, should be easy and straightforward - with a click of a button. Only this way we can avoid aggravating administrative burnout and ensure that the time allocated to patients is not diminished.

In addition, doctors need to have an active role in the development, implementation and governance system of the electronic health records (EHR), and local teams require continuous systemic support. Organisational capacity needs to be built at national level from the healthcare providers’ side and across medical specialties. A profile of doctors with IT academic competence per medical specialty which can be part of a formal network that can be consulted when developing and implementing the EHR is needed.

Finally, the EHR should not be an open door for mistrust and litigation with healthcare professionals.