Main trends in development and law regulation of electronic health in the European Union

Sergey M. Grishin, Stanislav V. Odintsov. Main trends in development and law regulation of electronic health in the European Union. Cardiometry; Special issue No. 25; December 2022; p. 25-30; DOI: 10.18137/cardiometry.2022.25.2530; Available from:

In recent decades, the countries of the European Union have shown a vivid example of a post-industrial transition to an information society and a knowledge society. The EU policy standards used as a basis for most of the national digital infrastructures in the healthcare sector are aimed at creating an ecosystem of digital (electronic) healthcare (eHealth/digital healthcare), which provides a wide range of data, information and infrastructure services to enable information and communication (network)) security, confidentiality and safety.

The digitalization of healthcare has been dynamically gaining momentum over the past decade, driven by the emergence and adoption of mutually complementing innovations such as the Internet of Medical Things (IoMT), telemedicine (telehealth/telemedi-cine), and artificial intelligence (AI) based medical algorithms and resources. All this not only indicates positive progress in this area, but also suggests the formation of a new paradigm for improving the public healthcare system, including an emphasis on health care personalization.

Digital medicine resources can fundamentally deliver the up-to-date information and tools to healthcare, pharmaceutical, insurance, and state/municipal entities and institutions they need to manage their healthcare systems. Digital health technologies enable medical clinics to apply advanced technologies in the field of telemedicine, covering remote patient diagnostics. The indisputable advantages are the timeliness factors and an increase in the accuracy of diagnostics, diagnosing the state of health using virtual reality, artificial intelligence or big data.

The main trends in the field of digital health

The World Health Organization has defined the concept of digital health as follows: the use of information and communication technologies (ICT) while “it

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refers to forms of prevention and education, diagnostics, therapy and care delivered through digital technology, independently of time and place” [14].

The digitalization of healthcare has gained momentum over the past two decades, especially with the appearance of innovations such as the Internet of Medical Things, telemedicine, and AI-based medical tools.

The role of digital technologies is defined as a means of promoting and consolidating the public interests of affordability, cost effectiveness and equity in health care systems [4].

The eHealth, among other things, includes the following innovative areas:

• •    Internet of medical things (IoMT);

• •    electronic prescription systems and electronic record management as tools for making clinical decisions to provide medical care servicing;

• •    artificial intelligence (AI) and machine learning (ML);

• •    nanotechnologies and medical robotics;

• •    mobile health applications (mHealth apps) used for the purposes of monitoring and prevention;

• •    services providing integration and interoperability of medical information systems (fast healthcare interoperability resource/FHIR);

• •    telemedicine (telehealth/telemedicine) and remote monitoring of patient health parameters;

• •    cloud data technologies (data computing and storage);

• •    electronic prescription systems, other medical documentation.

Let us take a closer look at some of these areas.

Internet of medical things (IoMT)

The IoT systems generate a constant stream of data that uses continuous monitoring for medical care in diagnosing diseases, notifying directly responsible caregivers or doctors through a remote timely alert system, providing medical assistance in decision making with automated decision support systems (DSS), i.e. certain diseases can be detected and treated before they progress.

Artificial Intelligence (AI) in healthcare

While evidence of the potential benefits of AI applications in healthcare is growing, a number of challenges remain on the agenda, connected with the widespread adoption of AI tools and resources. First, the current level of digitalization of healthcare remains poor. Secondly, there are certain problems with financing. Thirdly, there are currently some problems related to the quality of the AI medical services. Obtaining clinical evidence of quality and effectiveness is a challenge that AI faces in healthcare nowadays.

Telehealth and telemedicine

The terms “telehealth” and “telemedicine” refer to the remote provision of medical services. “The greatest relevance and demand for the remote method of providing medical services via the capabilities of telemedicine technologies are for those patients who may experience difficulty in accessing stationary institutions (hospitals and clinics)” [8] , for example, persons on sea/ocean vessels, individuals residing on isolated islands / archipelagos and in some other hard-to-reach areas. As telehealth and the technologies that support it have become increasingly popular in recent years, the Member States in the WHO European Region are testing various methods to find the best ways to expand and improve health services, as well as increase the efficiency and quality and reduce the cost of medical care [9].

Mobile Health

The term “mHealth” refers to the use of mobile technologies to support the transfer of health information and the implementation of medical practice [9].

Mobile health is a component of eHealth [13]. To date, mHealth does not have a well-established, standardized definition. For the study purposes, Mobile Health, or mHealth, was defined by the Global Observatory for eHealth as medical and public health practices supported by mobile communication devices such as mobile phones, patient health monitors, personal digital assistants (PDAs) and other wireless devices.

Mobile health includes the use and capitalization of the core mobile phone tools of voice and short message service (SMS), as well as more sophisticated features and applications, including the General Packet Radio Service (GPRS) of the 3rd and 4th mobile communication system generations (the 3G and 4G systems), global navigation satellite system (GPS) and Bluetooth technology. Mobile healthcare offers a number of advantages over traditional methods of rendering medical and preventive services, since it provides a convenient and, most importantly, a real-time access to information and services using portable mobile devices.

Electronic health records

Electronic health records (EHRs) support healthcare decision making, promote efficient delivery of healthcare, and provide quality and safety. “In Russian national practice, in accordance with Federal Law No. 242 “Amendments to Separate Legislative Acts of the Russian Federation on the Application of Information Technologies in the Area of Health Care” related to Federal Law No. 323 “The Fundamentals of Protecting the Health of Citizens in the Russian Federation” dated November 21, 2011, EHR is an important component of eHealth, which is integrated and referred to the Unified State Health Information System (USHIS), taking into account the fact that all the information contained in the EHR is also contained in the common system, which serves for them as a kind of digital platform.” [8]

The use of the DLT technology, including blockchain, allows for high standards of privacy and cybersecurity, with an advantage of almost unlimited scalability. A machine learning (ML) system looks at available data and compares them to expected results, quickly alerting clinicians to any potential health risks.

It is worth noting that telemedicine, which has been developing for about two decades, has been reasonably given a serious impetus under the stressful conditions of the COVID-19 lockdown restrictions. The application of new digital technologies has provided new opportunities in the field of monitoring, diagnostics and treatment, and it has also triggered many start-ups.

• 1)    The National Diabetes Registry was first established in 2000 in Croatia. The registry, called CroDi-ab, is a web-based system for collecting information about patients with diabetes that allows healthcare professionals to focus on their individual needs and select the best treatment options.

• 2)    In Slovakia, their new technology allows reducing the average time spent by a radiation oncologist in planning patient radiotherapy at least by thirty percent [9].

• 3)    Many people with chronic diseases find it important to get support by other people who face the same problems that is of great significance. Recognizing this fact, the Elsa Science app has been developed in Sweden to connect patients who want to share their

experiences, get informed about their condition and take an active part in their care [9].

Technologically advanced countries are improving and approving digital-related regulations and standards as a matter of priority.

Recognizing the important role in rendering digital medicine services in terms of access to medical records of patients, regulation at the legislative level of maintaining a medical record in electronic form is important, too. The experts note “the achievements of the practice of using electronic health records in Denmark, which allows medical organizations within the country to access patient documents from many devices within the network” [11].

Denmark is implementing one of the greatest digital health strategies in Europe, with the government investing through the country’s technology investment fund in creating a World-Class Digital Service (WCDS) platform to access aggregated data on Danish citizens. Sharing IT infrastructure with other government services, such as citizen identification systems, can speed up the process of developing a common platform that motivates patients to switch to digital services: in Estonia, an electronic health record is a part of a common health information exchange platform in the country [10].

In many respects, it is just the state that becomes a pioneer of innovations in the healthcare system. For example, “the initiator of the introduction of electronic health records for patients is the Ministry of Health of the Netherlands” [12].

European model of regulation of digitalization in medicine

Already at the very beginning of the 1990s, most of the European university health care providers created their own medical databases, and the next significant task of harmonization was an attempt to combine them.

The European legislative acts on digital health stem from the 1999 initiative of the European Commission “eEurope: Information Society for All” [5]. The initial document submitted by the European Commission has identified three main objectives: to transfer all subjects of law into the digital age and provide them with an online access; to introduce in Europe a digital culture based on an entrepreneurial spirit, favorable for financing and the development of new ideas; make sure that the entire process is aimed at social integra- tion, gaining consumer confidence and strengthening social cohesion. These interrelated programs have made it possible to analyze the collected health data. That is followed by new opportunities in health data management, which allows developing new medical services, new organizational and business models.

“The regulation of digital health in the EU can be divided into standards in the field of information services, the transfer of personal data and the provision of medical services” [6].

Let us especially note the Directive 2000/31/EC of the European Parliament and the Council of the European Union of June 8, 2000 “On certain legal aspects of information services in the internal market, in particular, on electronic commerce” [2].

The rules and regulations applicable to medical services are given in the relevant Directive [1]. It is also important to note that the patients in the EU Member States are not discriminated against on the basis of nationality.

On the territory of the EU states, three types of patient data storage models are relevant, distinguished by the method of centralization, which are as given below: the centralized model, the decentralized model and the patient-oriented model [8].

This was followed in 2012 by the adoption of the European health policy “Health 2020”, which was approved by the WHO Regional Committee for Europe in 2012 and which was aimed to analyze the reasons that could in any way slow down the development of eHealth.

On 14 September 2020, health ministers and public healthcare leaders from the 53 Member States of the WHO European Region, in Copenhagen, Denmark, approved a new five-year vision, the European Program of Work (EPW) 2020–2025 - United Action for Better Health in Europe [3] , which identified the ways to improve by WHO/Europe and their Member States health care in Europe. Within the framework of the EPW, the European Member States are adhering to their three main priorities: guaranteeing the right to universal access to quality healthcare without fear of financial hardship; protection from healthcare emergencies; creating healthy communities where public health actions and related government policies provide a better life in a welfare economy.

The latest pandemic has forced to solve this sort of problems very rapidly. Thus, the WHO Regional Office for Europe has identified four flagship initiatives 28 | Cardiometry | Issue 25. December 2022

that complement the EPW, which defines the healthcare priorities for the next five years, among which of importance is expanding digital health capabilities: the Empowerment Through Digital Health initiative, in the context of the research topic [7].

As a part of the Empowerment Through Digital Health initiative, the following steps are to be taken:

• -    to analyze the use, gaps and effectiveness of digital healthcare solutions employed in response to the COVID-19 crisis;

• -    to complete the European Roadmap for the Digitalization of Health Systems as a blueprint for designing digital architectures for health and social care; as a basis for targeting and measuring digital health investments and reforms; and as a catalyst for funding, research and engagement with digital health partners;

• -    to develop a European Health Data Management System based on the European Charter for Health Data Management, which states a set of the European values, principles and methods for accessing, managing, guiding and using health data to ensure the effectiveness of healthcare systems and public healthcare actions. This will enhance the existing efforts to protect data rights and individual privacy and provide a description of the elements and processes that make up good data management as an integral part of well-functioning national health information systems. This framework will support the use of quality health data for decision making at all levels of the healthcare system, strengthen public health forecasting and actions, and facilitate the reuse of health data for research and development of new clinical interventions;

• -    to support countries in using digital technologies to improve interactions between individuals and health service entities; improve the functioning of the healthcare system; and strengthen key public healthcare functions, including disease surveillance, early warning and risk assessment.

This flagship initiative complements and operationalizes the draft WHO Global Digital Health Strategy by filling gaps in the Region’s overarching digital framework that are holding back the rapid deployment of innovative digital solutions emerging across countries.

Analysis of healthcare digitalization problems in the EU states

In addition to achievements, there are also some challenges in the European digital health infrastruc- ture found in politics, in compliance with regulatory requirements, in cybersecurity and exclusive rights to medical (personal) data, in the interoperability of national digital health platforms across Europe, in the principles of health information (data) circulation, in digital therapy, in European electronic health records, as well as in the perception of digital health by the EU public healthcare concerned parties.

In this connection, we should note the main trends as given below:

• a)    An active digital health policy is required at this stage, as even the most recent European initiatives often rely on obsolete regulatory practices.

• b)    Transition to automated, possibly tokenized matching. Most of the regulatory requirements in healthcare originated when obsolete procedures were computerized. New approaches are required, focusing on digital tools to achieve full automation with inherent interoperability. A future automated compliance could be tokenized to implement decentralized management based on so-called smart contracts.

• c)    Focusing on data security. Cybersecurity threats to medical data and digital health infrastructure are exacerbated with the rise of the Internet of Medical Things (IoMT) and support by some government actors due to the implied privacy of medical (personal) data. In addition, the burden on existing networks causes new digital features to depend on older communication networks, making new features useless or costly.

• d)    Simple and smart electronic health records are not accepted throughout Europe. Some EU countries have switched to electronic health records, while other states still support predominantly conventional hardcopy-based systems. Therefore, the full coverage is not available and is expected to be generated in the coming years. National systems have limited compatibility, so there is no interoperability available. Telemedicine and clinic interactions suffer as patients move within the EU, and a fully open, secure access is being expected throughout Europe.

• e)    Virtual medical recording as medical documentation management. Intelligent clinical support systems currently belong to the previous generations, where their role is limited to the referents, and it is expected that they will be transformed to full-fledged assistants to doctors. Virtual nurse assistants are also expected. AI and machine learning are supposed to become a standard feature of such tools.

Conclusions

To date, digital health in the EU is an area with an increased activity, undertaken both by public authorities and national healthcare entities and social protection organizations, local health care providers, representatives of start-ups, medical and nursing personnel, allied healthcare staff, as well as managerial and engineering IT staff, data experts and analysts.

The Covid-19 pandemic has certainly given an additional impetus to the development of the market for remote medical services, and especially telemedicine.

The European digital health infrastructure, along with its achievements, is also experiencing some difficulties, among which obsolete regulatory requirements in healthcare can be found. New approaches are required to focus on digital tools in order to provide its full automation with inherent interoperability.