3 May of 2022 the European Commission has presented a draft regulation aimed at establishing a European Health Data Space. The proposers justify the project by the need to realise the potential that lies in the vast wealth of health data collected by healthcare providers across the EEA. The aim is to establish a detailed framework for the exchange of health data, clear rules and common standards and infrastructure for the use of electronic health data by patients. Health data is also intended to be used for scientific, statistical, innovation, policy-making and patient safety purposes. The creation of this new space will empower individuals to access their health data digitally through a mobile application. The app will also enable the introduction of uniform health records across the European Union.
The creation of a common framework for the exchange of health data will also improve the efficiency and effectiveness of healthcare services. Medical staff will gain access to patient records, including those created abroad. Thanks to such solutions, it will be possible to bypass the entire process of diagnosis or duplication of tests, which will speed up the process of making key decisions and reduce healthcare costs.
Ensuring appropriate guarantees in the process of data sharing, e.g., anonymisation, will allow the data to be used for scientific purposes or to obtain high quality information which will allow to create the policy of health care system functioning. The data will be accessible from the competent data access authority, which will guarantee an appropriate level of confidentiality and privacy for patients, while ensuring data quality without excessive costs.
It is also envisaged that a European Health Data Board will be established to ensure that the provisions of the proposal are applied consistently across the EU and to cooperate with other actors in this area.