Stakeholders express their positions on the European Health Data Space

These positions are published in a very timely manner considering the ongoing legislative process of the EHDS Commission proposal, and especially the upcoming opportunity for MEPs to put forward amendments during which input from key opinion leaders is welcomed on many occasions.

The Standing Committee of European Doctors (CPME).

In its position, CPME highlights the following considerations:

• National discretion when it comes to the implementation of ethical safeguards should be ensured. 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.
• Strong obligations for software manufacturers for interoperability and usability shouldbe 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.
• Legal accountability on the EHDS should not go beyond the doctors’ competency or responsibility.

Moreover, concerns are raised about the implementation costs of the initiative and whether a high level of protection of fundamental rights can be maintained, including personal data, with sound procedures that respect human dignity, autonomy, and privacy of individuals.

The Pharmaceutical Group of the European Union (PGEU).

Within its position paper, the PGEU highlights among others the following priorities:

• The EHDS should not place excessive burden on healthcare professionals with time-consuming obligations that can potentially compromise the provision of care.
• Legal certainty should be increased by clarifying the uses of health data, further developing strong anonymization standards for secondary uses, and considering ethical duties of healthcare professionals set out in national regulations.
• The provisions on the re-use of data should be amended to guarantee a higher protection of fundamental rights and effective control mechanisms for citizens.

The European Federation of Pharmaceutical Industries and Associations (EFPIA).

Although overall high support for the file was expressed by EFPIA, together with 29 other stakeholders the Federation put forward some recommendations related to developing the more specific implementation plans across Member States. The recommendations include, but are not limited to:

• A broad range of stakeholders should be strongly involved from the outset of the process to guarantee the success of the EHDS.
• There must be harmonised interpretation and implementation of the Regulation across the EU.
• Approvals for the secondary use of health data must be consistent and harmonised across Europe.
• The scope of EHR systems must be defined clearly within the Regulation.
• The successful implementation of the EHDS must be adequately resourced.
• Existing health data infrastructures must be leveraged to allow continuity and build on existing expertise.

Background

• The CPME is the European association representing national medical associations across Europe and is devoted to representing the medical profession’s point of view within EU policy-making.
• The PGEU represents the Community Pharmacy perspective in Brussels and was established to advance the contribution of Community Pharmacists to European health systems, society, individual patients and corresponding policy.
• EFPIA represents the pharmaceutical industry operating in Europe.