THE ADOPTION OF COMMON STANDARDS BETWEEN MEMBER COUNTRIES ENABLES THEM TO EXPLOIT THE FULL POTENTIAL OF THE SECURE EXCHANGE AND USE OF HEALTH DATA AND ALLOWS FOR IMPROVED TREATMENT, MEDICAL CARE AND SCIENTIFIC RESEARCH.
The EU promotes the adoption of innovative and technologically advanced solutions that foster the digital transformation process of European health and care systems in order to improve disease management and accelerate scientific research.
The European Parliament and the European Council have reached an initial agreement on a new law that aims to make it easier for European citizens to access their health data at EU level and to allow it to be made available in an anonymous and restricted form to researchers, public institutions, professionals and industries. This is a leap forward towards the European HealthData Space, i.e. a secure and efficient environment for the exchange of health data promoted by the European Commission and aimed at improving prevention, treatment and scientific research.
An initial contribution towards the implementation of the EHDS is MyHealth@EU, an ongoing European initiative, already adopted by 11 Member States, which envisages the use of a common standard for electronic prescriptions and patient summaries aimed at improving the cross-border care and assistance provided to European citizens and the sharing of health data.
Thanks to this infrastructure, a citizen of a Member State can obtain medicines in other European countries, and information on his or her medical history and current condition can be shared with healthcare facilities and professionals in the EU.
Alongside MyHealth@EU, in 2022 the European Commission launched the pilot project HealthData@EU involving 17 partners, including international and European organisations, licensing bodies and health data access authorities, aimed at building solutions for secondary use.
The aim is to implement a scalable network infrastructure at European level to connect the various platforms and exploit the great potential of collected data to accelerate scientific and pharmaceutical research, monitor the spread of diseases at EU level, deal with health emergencies such as pandemics in a coordinated manner, assess global health and develop health policies.
The HealthData@EU project, in fact, includes the development of guidelines for data quality and security and the transfer of data between the different Member States.
International standards for interoperability and security such as HL7 FHIR therefore become fundamental requirements for the EHDS and companies dealing with electronic health record systems will have to certify their compliance.
FHIR®, Fast Healthcare Interoperability Resources, is one of the most widely used interoperability standards for the exchange of healthcare data between different information systems.
The FHIR® protocol, developed by the non-profit organisation HL7, (Standards Developing Organisations accredited by the American National Standards Institute), uses web technologies for data exchange that make it much more efficient than previous versions of interoperability standards in use.
FHIR®, thanks to its Restful API approach and the use of data formats such as JSON, XML, HTTP or RDF, enables the seamless, fast and secure querying and transmission of a large amount of data between different healthcare systems and applications (platforms, apps, mobile or wearable devices).
It is based on a modular structure, the information is organised into ‘Resources’, healthcare-specific concepts such as ‘Patient’, ‘Condition’ (patient’s medical condition), ‘Medication’, ‘DiagnosticReport’ (diagnostic test results), ‘Care Plan’ etc., and can be adapted to specific situations. This makes this standard particularly versatile and easy to implement, and the possibility for developers to work with data from different sources and formats means that its adoption is becoming increasingly widespread.
The EMA, the European Medicines Agency, itself uses a common EU standard based on FHIR® to support the ePI (Electronic Product Information) project, aimed at digitising and standardising information on medicines for human use and sharing it between networks.
This protocol is also used by the National Telemedicine Platform (PNT), to facilitate interoperability between telemedicine systems throughout the territory, and the Electronic Health Record (Fascicolo Sanitario Elettronico– FSE), to enable the efficient and secure exchange of data between healthcare facilities and health professionals.
The adoption of the FHIR® protocol is a significant step towards the implementation of the European Health Data Space (EHDS) and the realisation of an advanced and interoperable digital health infrastructure at European level. Its flexibility, efficiency and security make it a fundamental standard for health data interchange, for both primary and secondary uses. With its continuous development and updating by HL7, FHIR® is confirmed as an essential resource for companies and institutions engaged in the digital transformation of the healthcare sector, helping to improve disease management, accelerate scientific research and ensure better healthcare for all European citizens.
