Europe: Health Technology Assessment (centralized HTA) and the electronic health record
Today, Monday, November 28th, Member State Coordination Group on Health Technology Assessment (HTACG) is going to celebrate a new meeting, aligned with European strategy set up by Regulation (EU) 2021/2282. This new European regulation is going to be applied during these next three years (2022–2025) with the aim of being 100% implemented in January 2025.
European Union wants to introduce a fixed common framework with the idea of creating unique procedures, joint work and centralized clinical evaluations, promote unified scientific consultations, improve the identification of emerging health technologies, and implement voluntary cooperation mechanisms.
A key aspect for the implementation of this strategy is the existence of a European digital medical record. The only way to handle clinical data transnationally, to be able to measure, advance data privacy policies, large-scale analysis, decision-making, etc.
The electronic health record (EHR) is a system that collects, deals with and stores patients’ data in a digital format. If this information is to be used to improve clinical care and epidemiological surveillance, these data must be interoperable between different government bodies and countries. A new report by the European Commission, led by the renowned UOC spin-off company Open Evidence, has examined the implementation of the electronic health record in the European Union countries, Norway and the United Kingdom, and the current degree of interoperability.
The results of the report present a mixed picture of the development of this basic technological system for digital health. “While most countries have established digital health record systems, an interoperable EHR is not in force in most of the systems studied, and many patients cannot easily access and use their data, or transfer them between healthcare providers,” said Francisco Lupiáñez Villanueva, a member of the Faculty of Information and Communication Sciences of the UOC and the managing partner of Open Evidence.
This variety is applied both between countries and between regions within the same country. “Europe’s healthcare systems are organized in many varied ways: They are centralized, decentralized, dependent on public insurers, private, etc. This variety means that it is difficult to create a definitive profile, as there are interoperable systems between some regions and even between entire countries, as is the case with Estonia and Finland, but they are not the majority, which is a barrier to interoperability at the European level,” explained Francisco Lupiáñez.
Spain: limited interoperability between autonomous communities
In the case of Spain, the researcher pointed out that the country has a level of digitization which is “very high, at the level of the most advanced countries in Europe, such as Estonia, Denmark, Finland and Sweden,” but he qualified his assessment: “the autonomous communities are leaders in Europe, but not the central government. Because we have a highly decentralized healthcare system, the interoperability of data between the autonomous communities is very limited, and this affects the mobility of data, and therefore the quality of health services for citizens, who may have difficulties with their data being accessible in other autonomous communities.”
Apart from that reality, The General Secretary in Digital Health is making great progress, we will share in our last post in this 2022.
A tool to address shared challenges
The barriers to exchange health data and information in Europe have become apparent with the COVID-19 pandemic. “On a day-to-day basis, the problems for citizens caused by the lack of interoperability at the European level are not particularly obvious, but the need for interoperability emerges whenever there is a challenge that goes beyond a specific country or region, such as the coronavirus.”
This challenge also goes beyond the sphere of public health and affects the common European market. “If a supplier from one country wants to enter the market of another EU country, it has to adapt its product to different systems, which means it is not a uniform market,” explained the faculty member.
Progress in the legal framework
Despite these limitations, the report also shows that some progress has been made in legal frameworks and institutional environments in most of the countries studied. “Eighty per cent have now passed national EHR legislation, 26 countries now by law give their citizens access to EHR data, and 20 have included mandatory public access in their legislation regardless of the availability of technology,” according to the report.
In fact, 18 countries now have a law that allows EHR data to be shared across national borders, but only the Czech Republic, Lithuania, Latvia, Poland and Slovakia can send or receive summaries of patients’ records to other countries.
Denmark, Estonia and Finland lead the way in the use of EHR
En cuanto al uso de la historia clínica electrónica, los países que tienen los niveles más altos son Dinamarca, Estonia y Finlandia, mientras que el servicio más común es la visualización de los resultados de las pruebas, seguido de los servicios de receta en línea y cita previa. Algunas regiones en España están ya a este nivel.
The countries with the highest levels of use of electronic health records are Denmark, Estonia and Finland, while the most widely used service is viewing test results, followed by online prescriptions and making appointments. Some regions in Spain are now at this level.
Lupiáñez mentions specially that “the problem to implement HER systems and its operability is not only technological, but also political”, and adds that “it´s necessary to see HER and digital health like an opportunity not only for healthcare systems. It´s an intensive sector about R+D which can generate employment, putting Europe in a relevant role in front of US and China”, he concludes.
As for the accessibility of clinical information, most countries have conditions in place for altering and archiving electronic health data, but only about a third allow citizens to correct the data that have been entered in their EHR.
Thiel, R., Lupiáñez-Villanueva, F., Deimel, L.; Gunderson, L.; Sokolyanskaya, A. (2021). eHealth, Interoperability of Health Data and Artificial Intelligence for Health and Care in the EU. SMART 2019/0056. European Commission.
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance).
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