23 January 2023
Digital health

European doctors publish proposed amendments to European Health Data Space

European doctors have published proposed amendments to the European Health Data Space, which are based on our position adopted in October.
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European doctors have published proposed amendments to the European Health Data Space, which are based on our position adopted in October.

CPME highlights the following in relation to health issues:

  • Recitals 2 and 7 – quality and prevention need to be mentioned under the primary use regime, as well as recognised the impact on medical practice (implementation costs, capacity building, human resources) where precise direct support from Member States is needed.

  • Recital 64 (new) – Member States should consider criminalising unauthorised re-identification and disclosure of de-identified personal data to serve as a deterrent measure.

  • Article 3(6) and 7 of the EHDS – clarifies that as the EHR is a clinical tool, new data inserted or rectified must be validated by an identified, registered health professional with the relevant competence, and that this process needs to be secure. In addition, only certified applications should be linked to the EHR with the agreement of the treating physician and the apps may not access (or retrieve) data from the EHR (Annex II, point 1.4).

  • Articles 3(9) and 4(4) of the EHDS – In case of restrictions introduced by patients in the EHR, Member States need to be able to determine the consequences for medical liability and health data research and quality development; and the existence of a restriction made by a natural person must be clearly indicated in the EHR.

  • Article 3(10) of the EHDS – the right to know if health professionals accessed the EHR of a patient cannot be made in detriment of the protection and safety of healthcare professionals. Doctors have been assaulted or even killed by their patients due to medical orders of psychiatric supervision. Exceptions must be allowed to protect the integrity of health professionals.

  • Article 4(3) of the EHDS – health professionals should be able to easily select relevant information in the EHR.

  • Articles 7, 33 (2) and recital 40 of the EHDS – the once only principle should apply, where healthcare professionals only register data in the electronic health record (EHR) – for primary use only – to respect medical confidentiality and professional secrecy; extend the exemption to small enterprises in relation to the obligation to make data available for secondary use. 

  • Article 15(1) of the EHDS – third-party conformity assessment procedure for EHR systems and products claiming interoperability should be introduced.

  • Article 33(5) of the EHDS - the requirements for access to electronic health data, such as the consent of natural persons, a right to object to the disclosure of their health data or the involvement of ethics committees, must be met before providing access to electronic health data.

  • Article 34(1)(e) of the EHDS– narrows down the concept of scientific research.

  • Article 35(e) of the EHDS – adds as an additional prohibited purpose the use of health data to develop products with nicotine, weaponries or that incite addition, including digital addiction.

  • Article 49 and recital 53 – delete the reference to single data holder to ensure data permits coherence and a secure processing environment.

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