The European Health Data Area Raises Medical Ethics Issues –

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

On Wednesday (9 November), the Standing Committee of European Doctors (CPME), which represents national medical associations across Europe, published a position on the European Commission’s proposal for the European Health Data Area (EHDS). ), underlining 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 at the fore. The proposal aims to overcome the limitations of the use of digital health data in the EU, due to differences in standards between Member States, and interoperability.

Although the CPME has recognized the merits of a health data space, such as improving the quality of health care for patients and increasing the availability of health data for scientific research, concerns have been raised about the medical relationship. patient.

In its position paper on Wednesday, the CPME described trust and recognition by patients and healthcare professionals as “milestone of a successful EHDS“.

The design and technical implementation of the EHDS must respect the principles of medical ethics and cannot present any risk to medical confidentiality.CPME President Christiaan Keijzer said after the position was published.

The risk is thatpatients become reluctant to provide information or even consult their doctor if they fear that the confidentiality of their health data is not being respected“, Underlined Mr. Keijzer.

The CPME therefore called for compliance with the existing structures in the Member States, leaving national room for maneuver as regards the implementation of ethical safeguards, such as the requirements for the secondary use of health data, the obligation to obtain the consent of patients. or to use ethics committees, for example.

Personal data protection

The importance of maintaining a high level of protection of fundamental rights, including for personal data, was underlined, “with solid procedures that respect the human dignity, autonomy and privacy of people“, Indicates the document.

Commenting on the Commission’s proposal, an EU official said that to ensure the utmost care of personal health data, “a kind of GDPR + systemwill be implemented, with reference to the EU legislation on data privacy.

In this new system,if citizens have consented to the use of this data and have declared that they want to be able to control the processing of their data, they will not have to provide specific consent“.

Most of the health data will be anonymous or will use pseudonyms andvery strict guaranteeswill be set up so that other parts can only view patient data, not access it.

The CPME has called for stringent obligations for software manufacturers regarding interoperability and ease of use. The Committee also calls for a better assessment of the legal, social, technical and financial consequences for doctors, other health professionals, patients and the provision of health care.

EHDS should not hinder doctors’ ability to provide timely and quality healthcareCPME Vice President Ray Walley said, stressing that the issues of accountability and accountability are not explicit enough in the proposal.

Doctors will only be responsible for the data they have entered into the electronic medical recordsaid Mr. Walley.

The CPME also fears that the costs of implementing the proposal will worsen the already strained economic situation of health systems.

In the hands of the Parliament and the Council

The health data space is one of the essential elements for the solidity of the European Health Union. The EHDS should allow citizens 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 coherent, reliable and efficient framework for using health data for research, innovation, policy making and regulation, while ensuring full compliance with strict data protection rules.

The health data space is the first sectoral legislation that should build on the horizontal legislation on data governance and the Data Act, a recently presented European legislation on data sharing.

The Commission’s proposal on the EHDS is currently under consideration 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 allocate this space exclusively to the (FREE) Civil Liberties Committee.

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

An investment destined to pay off

The EHDS budget amounts to € 800 million and comes from various EU funding programs, such as EU4Health, Digital Europe and Horizon Europe. Additional funds may also come from the resilience and resilience mechanism.

However, the EHDS system is expected to provide significant savings. For example, EU countries spend € 1.4 billion annually on medical images, 10% of which is unnecessary.

When the same standards and specifications are available in all Member States, it will be possible to create a European market for electronic health records.

So far, digital health service providers have faced obstacles, limited interoperability and additional costs to access Member State markets.

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