What is EHRxF?
What is EHRxF?
EHRxF in a nutshell
The European Electronic Health Record Exchange Format (European EHRxF in short), introduced by the European Commission in 2019, aims to ensure secure, interoperable, cross-border access to electronic health data across the EU. It establishes guidelines for cross-border data access and exchange, sets common technical standards, and supports ongoing development of a standardised format improving care quality for EU citizens.
The EHRxF is crucial for transforming digital health and care in the European Union (EU). This transformation is based on three main goals outlined by the European Commission:
- Secure data access and sharing.
- Connecting and sharing health data for research, quicker diagnoses, and improved healthcare.
- Empowering citizens and improving individual care through digital services.
Focus on six categories of data
The format currently focuses on six different priority categories of personal electronic health data for primary use as defined in the EHDS Regulation provisionally approved as of April 24th, 2024:
- Patient summaries;
- Electronic prescriptions;
- Electronic dispensations;
- Medical imaging studies and related imaging reports;
- Medical test results, including laboratory and other diagnostic results and related reports;
- Discharge reports.
Scenarios
In order to make the concept of the European EHRxF more relatable to real life situations, a number of scenarios have been drafted that showcase the use of the European EHRxF in various settings. You’ll find them under Using EHRxF.
European Health Data Space and EHRxF
The objective of the European Health Data Space (EHDS) Regulation is to provide a legal basis for the secure exchange of personal electronic health data for care provision and access to health data for secondary use in research. It aims to support the rights of natural persons, as specified in the General Data Protection Regulation19 (GDPR) in relation to access to and portability of personal electronic health data processed as part of the provision of healthcare services.
The EHRxF helps make health data accessible for research, policy development, and other uses by improving data quality, transfer, and harmonization by ensuring:
- Authorized access to patient data for better diagnosis and care continuity.
- Access to anonymized data for research and policymaking.
- Patients’ access to their health data, with the ability to update it, helping them take an active role in managing their health.
Interoperability
The health system and the relevant organisations are responsible for adopting Electronic Health Record (EHR) systems to support the provision of healthcare. These EHR systems allow healthcare professionals (or workforce) and patients (or citizens) to view the relevant portions of the electronic health record. This is where the trusted data needs to flow, both from the EHR systems that hold portions of a patient’s health record, and to the EHR system that is being used at the point of care. That is what is meant by “interoperability”. The graphic below illustrates the diverse perspectives on the sharing of personal health data.
One of the key objectives of the European Health Data Space (EHDS) regulation is “to improve access to and control by natural persons over their personal electronic health data in the context of healthcare”. Citizens, and their circle of informal care givers, play an increasingly important role in the maintenance of their own health. They want to meet with a professional team that is well informed and up-to-date about their particular medical situation and any relevant history they bring. This is where the EHR exchange format comes in: it enables the citizen to share their data with the team of their choice. Having access to this information and being able to share it with others empowers patients to take control. Such empowerment in turn can be used by citizens to navigate the health system for prevention, care, and wellness; and can also support citizens in active involvement in health maintenance and care decisions.
Healthcare professionals’ practice has changed profoundly over the years, due to sub-specialisation, rapid pace of innovation, availability of immense amounts of information, relevant or not, and the changing practice of (medical) care in relation to other professionals and patients. More often than not, these healthcare professionals are supported by a diverse group of other workers with a variety of complementing expertise (e.g. social care or experts by experience). The objectives and motives of this workforce is often quite different from what provider organisations and healthcare system administrators expect. Their main driver is to provide safe and high-quality healthcare services, i.e. to do their job well and to do good to their clients, patients, and customers (i.e. the citizens), and facilitate coordination and continuity of care for the patient across care settings and provider organisations. When the continuity of care is at stake, for instance when a patient is referred to another professional in a different organisation, effective sharing and use of the information needed in different systems depends on a common EHR exchange format.
The health system perspective relates to governments and regulators that have responsibility for the operation of health services in a specific jurisdiction, as well as the healthcare provider organisations that deliver healthcare within that jurisdiction. Health outcomes of the population covered reflect the quality of the health system. In that sense, the health system is the provider of services, while the health workforce and citizens are the co-producers of health and the customers or beneficiaries, respectively. Policy makers need to make sure the system is sustainable, and both the workforce and the citizens are satisfied with the health services delivered. Within the health system, depending on its particular organisation, healthcare provider organisations are the ones that buy, implement, and operate the EHR systems that the workforce in their organisation uses on a day-to-day basis. The health system is also responsible for providing the citizens with access to their personal electronic health data, as well as to share their information using the EHR exchange format.
The variety of health services needed in a well-functioning health system makes it hard to agree on a single IT solution or a single IT vendor that serves multiple provider organisations. Therefore, a large variety of Health IT solutions are offered on the market by different vendors, ranging from local small and medium enterprises to large global players. They can offer highly integrated hospital management systems that include the full electronic health record, or just a simple app that supports a patient to better manage their health condition. All handle personal electronic health data. The European Health Data Space (EHDS) regulation aims “to improve the functioning of the internal market […] for the development, marketing and use of electronic health record systems (‘EHR systems’)’. The EHR exchange format is one of the requirements that will help regulate this important market and improve interoperability between the solutions offered on the market.
Looking Forward
The European EHRxF is transforming healthcare in the EU by making it easier to share and protect citizen’s health data. New features like the xShare Yellow Button will empower patients to control and securely share their health data with trusted third parties, improving collaboration and continuity of care. Automating the process of finding clinical trials supported by the EHRxF will also help patients get involved faster. Telemedicine, supported by EHRxF, will improve access to healthcare, especially for people in remote areas. The EHRxF will also support public health by using anonymous data to study health trends and enhance pandemic preparedness. Start-ups and health tech companies will use EHRxF to create new tools for better care, like apps for managing medications and AI diagnostics. Overall, the EU’s push for a unified health data system will lead to more connected, efficient, and inclusive healthcare.