The European Commission has just presented an ambitious project for a European health data area. There seems to be governance, quality and data interoperability, as well as level infrastructure.
The European Union is taking a huge step towards the digitization of healthcare. “The European Commission is launching the European Health Data Space (EHDS) today, the foundation for building a strong European Health Union.” This is how the European organization presented its project. He said that “the EHDS will enable the Union to change the way it provides healthcare to its citizens across Europe. It will enable citizens to control and use their health data both in their country of origin and in other member states.” Will be a ‘new start’ for digital health policy, which will make health data work for people. For citizens and science. ”The Kovid-19 epidemic has shown some weaknesses in the current system and the need to quickly renew itself with safe solutions.
This space should be federated as a single market for digital health products and services and provide a coherent, reliable and efficient framework for research, innovation, policy-making and regulatory use of health data while respecting GDPR. Stella Kiriakaids, Commissioner for Health and Food Safety, continues: “European health data space is a fundamental game-changer in the digital transformation of healthcare in the European Union. This data, which will be accessible under strong security and privacy protections, will also be a gold mine for scientists, researchers, inventors and policy makers working on life-saving treatments. “
Citizens, master their health information
Thanks to EHDS, citizens will have instant, free and simplified access to their health data in electronic form. Specifically, they will be able to share this data with member states and other health professionals in order to improve the delivery of healthcare. They will be able to exercise complete control over their data, and will be able to add information, correct inaccurate information, and even restrict access to their data for other people and get information about how their data is used. And for what purpose.
In this sense, member states must ensure that all documents are issued and adopted in a common European format. These include patient records, electronic prescriptions, medical imaging images and reports, lab results and hospital discharge letters. The Commission seeks to keep integrity and security at the center of this transformation. In fact, manufacturers of electronic medical record systems need to certify compliance with these standards. In addition, all member states must nominate digital health authorities to participate in a cross-border digital infrastructure (MyHealth @ EU) Which will help patients share their data across borders.
Sharing health information for research purposes
EHDS builds a strong legal framework for research, innovation, public health, policy-making and use of health data for regulatory purposes. Under strict conditions, researchers, inventors, public institutions or companies will have access to huge amounts of high-quality health data. The purpose is, thanks to this sharing, to create life-saving treatments, vaccines or medical devices, and to guarantee better access to healthcare and more resilient health care systems. To access this data, researchers, companies or institutions need to request approval from the organization responsible for accessing health data established in each member state.
Access will only be granted if the requested data is used for a specific purpose, in a closed and secure environment and without disclosing the identity of the person. It specified that it was “strictly forbidden for citizens to use data to make harmful decisions, such as designing harmful products or services or increasing the amount of insurance premiums”. The organizations responsible for accessing health data will be linked to the newly created EU decentralized infrastructure for access to secondary data called HealthData @ EU and will support cross-border projects.
A legal point
EHDS is an extension of the General Data Protection Regulation (GDPR), the proposed Data Governance Act, the proposed Data Regulation and the NIS guidelines. It complements these initiatives and provides more appropriate rules for the health sector EHDS will use ongoing and future deployments of public digital products in the EU, such as artificial intelligence, high-performance computing, cloud and intelligent middleware. In addition, the framework for AI, electronic identity, and cyber security will support this space. The proposals presented by the European Commission must now be examined by the Council and the European Parliament.