Doctors concerned about medical ethics in the European health data area

Doctors concerned about medical ethics in the European health data area

European doctors have raised concerns about medical ethics, the burden on doctors and the national competence of Member States in the European Commission’s proposal for the European Health Data Area (EHDS), currently underway for discussion in the European Council and Parliament.

On Wednesday 9 November, the Standing Committee of European Doctors (CPME), representing national medical associations across Europe, published a position on the European Commission’s proposal for the European Health Data Area (EHDS), emphasizing the importance of respect for medical ethics and national competence.

The Commission’s proposal for the EHDS was presented in May, with data protection, citizens’ rights and digitization in the foreground. The proposal aims to address the limited use of digital health data in the EU due to differences in standards between Member States and limited interoperability.

While CPME agreed on the benefits of the health data space, such as improving the quality of healthcare for patients and boosting the availability of health data for scientific research, concerns were expressed in the patient-physician relationship.

In Wednesday’s position paper, the CPME called the trust and acceptance of patients and healthcare professionals “cornerstone of a successful EHDS”.

“The design and technical implementation of the EHDS must respect the principles of medical ethics and cannot pose any risk to medical confidentiality,” said CPME President Christiaan Keijzer in a statement issued after the publication of the position.

If this is not respected, “patients may become reluctant to provide information or even to consult their doctor if they fear that their health data will not remain secret,” Keijzer pointed out.

Therefore, CPME called for the respect of existing structures in Member States by having national discretionary power with regard to the implementation of ethical safeguards, such as ethical requirements for the secondary use of data from health, for example, the obligation to obtain patient consent or involve ethics committees.

Protection of personal data

The importance of maintaining a a high level of protection of fundamental rights was underlined, including for personal data, “with robust procedures that respect human dignity, autonomy and the privacy of individuals”, indicates the newspaper.

Commenting on the Commission’s proposal, an EU official said that to ensure the utmost care for personal health data, “a sort of GDPR+ system” will be built, referring to EU legislation on the data confidentiality.

In this new system, “if citizens have agreed to use this data and have stated that they wish to be able to control the processing of their data, they would not need to give specific consent”.

Most health data will be anonymized or pseudonymized and there will be “very strict safeguards” that other parties can only view but not access patient data.

CPME called for strong obligations on software manufacturers regarding mandatory interoperability and usability. Another plea is to better assess the legal, social, technical and financial consequences for doctors, other healthcare professionals, patients and the supply of care.

“The EHDS should not hamper doctors’ ability to deliver quality healthcare in a timely manner,” said CPME Vice President Ray Walley, stressing that liability and liability issues have not been sufficiently clarified in the proposal.

“Physicians can only be responsible for the data they put into the electronic health record,” Walley said.

CPME is also concerned that the costs of implementing the proposal will aggravate already strained health systems.

In the hands of Parliament and the Council

The health data space is one of the core elements of a strong European Health Union. The EHDS aims to empower people to control and use their health data in their home country or in other Member States by promoting a single market for digital health services and products.

It should also provide a consistent, reliable and efficient framework for the use of health data for research, innovation, policy-making and regulatory activities, while ensuring full compliance with high data protection standards. of the EU.

The Health Data Space is the first sector-specific legislation intended to build on the Data Governance Act and Data Act, Horizontal Data Governance Legislation and a recently presented European Data Sharing Act. data.

The Commission’s proposal on EHDS is currently being examined by the Council and the European Parliament.

In mid-September, it was announced that Parliament’s Health Committee (ENVI) would co-lead the health data space dossier despite the initial decision to assign the health data space exclusively to the committee. civil liberties (LIBE).

One of the main competences of the LIBE Committee concerns the areas of transparency and the protection of individuals with regard to the processing of personal data, while ENVI is the main point of reference in the European Parliament for all this relating to public health.

An investment meant to pay off

The EHDS is endowed with a budget of 800 million euros from different EU funding programs such as EU4Health, Digital Europe and Horizon Europe. Additional funds can also come from the Recovery and Resilience Facility.

However, the EHDS should generate significant savings because, for example, EU countries spend €1.4 billion on medical images every year, of which 10% is unnecessary.

Once the same standards and specifications are available in all Member States, the creation of a European market for electronic health records could be possible.

So far, digital health service providers have faced barriers, limited interoperability and additional costs when entering Member State markets.

[Edited by Zoran Radosavljevic]

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