The aim of this Regulation |
The COVID-19 pandemic highlighted the imperative of having timely access to quality electronic health data ... |
The COVID-19 crisis strongly cemented the work of the eHealth Network, a voluntary network of authorities responsible for digital health, ... |
Given the sensitivity of personal electronic health data, this Regulation seeks to provide sufficient safeguards ... |
The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 ... |
More and more individuals living in the Union cross national borders to work, study, visit relatives, or for other reasons. ... |
In health systems, personal electronic health data are usually gathered in electronic health records, which typically contain a natural person's medical history, ... |
Regulation (EU) 2016/679 sets out specific provisions concerning the rights of natural persons in relation to the processing of their personal data. ... |
While the rights conferred by Regulation (EU) 2016/679 should continue to apply, the right of access to data by a natural person, established in Regulation (EU) 2016/679, should be further complemented in the healthcare sector. ... |
It should be considered that immediate access of natural persons to certain categories of their personal electronic health data could be harmful for the safety of those natural persons or unethical. ... |
This Regulation does not affect Member States' competences concerning the initial registration of personal electronic health data, such as making the registration of genetic data subject to ... |
In order to complement the information available to them, natural persons should be able to add electronic health data to their EHRs or to store ... |
Enabling natural persons to more easily and quickly access their personal electronic health data will enable them to notice possible errors such as incorrect information ... |
Under Regulation (EU) 2016/679, the right to data portability is limited to data processed based on consent or contract and provided by the data subject to a controller. ... |
The framework laid down by this Regulation should build on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their personal electronic health data, ... |
Access to electronic health records by healthcare providers or other individuals should be transparent to the natural persons concerned. ... |
Natural persons might not want to allow access to some parts of their personal electronic health data while enabling access to other parts. ... |
In addition, due to the different sensitivities in the Member States on the degree of patients' control over their health data, Member States should be able to provide for an absolute right to opt out ... |
Timely and full access by health professionals to the medical records of patients is fundamental for ensuring continuity of care, avoiding duplications and errors, and reducing costs. ... |
In order to facilitate the exercise of the complementary access and portability rights established under this Regulation, Member States should establish one or more electronic health data access services. ... |
Natural persons should be able to provide an authorisation to other natural persons of their choice, such as their relatives or other close natural persons, ... |
In some Member States, healthcare is provided by primary care management teams, which are groups of health professionals focused on primary care, such as general practitioners, ... |
The supervisory authorities established pursuant to Regulation (EU) 2016/679 are competent for monitoring and enforcing the application of that Regulation, in particular for the monitoring of the processing of personal electronic health data ... |
Member States ought to strive to adhere to ethical principles, such as the European ethical principles for digital health adopted by the eHealth Network on 26 January 2022 and the principle of health professional-patient confidentiality ... |
The relevance of different categories of electronic health data for different healthcare scenarios varies. ... |