The regulation of telemedicine: a Latvian–EU perspective

Telemedicine started to develop rapidly with the advent of information technology in society – with the development of means of remote communication, such as telephone and fax. Nowadays, telemedicine includes innovative information technology tools that provide patients with a more accessible, lower-cost healthcare service.

The essence of telemedicine is evolution, innovation, continuity and change in telemedicine. The author calls attention to the broader nature of telemedicine development, which also explains the stages, progress, stagnation and moments of regression in the long history of telemedicine. Indeed, the history of telemedicine would not be complete or fully appreciated without a sound understanding of the nature of healthcare in its development and persistence over many decades. Similar to other major innovations in medicine and medical technology, telemedicine did not evolve without certain stages of development, identification of needs, design, implementation and refinement. The development of telemedicine reduces the need for acute, emergency medical care (Latvia's health care master plan, 2016).

The fastest development of telemedicine took place concomitant with the introduction of the telephone into people's daily lives. It is important to note that there is no one single “inventor of the telephone”. The invention of the telephone is attributed to several people from several countries – the United States, England and Scotland. Alexander Graham Bell (1847–1922) is often credited as the inventor. However, the modern telephone is the result of the efforts of many people. In Germany it was Philipp Reuss (1834–1874) who is considered the legitimate inventor, because in 1863 he developed an apparatus for transmitting and receiving a sound signal, which he called the “telephone” (Bargellini, 2006). In France, Charles Bursl (1829–1907) is considered to be Bell's predecessor. In 1854, he put forward the idea of using a diaphragm during transmission, whose vibrations were able to change the current acting on the diaphragm at the receiving end. It is thus accepted that Bell was only the first to receive a patent “for some new and useful inventions in telegraphy” (Rashid and Gary, 2009).

To quote an aphorism from the Hippocratic Writings (Gaile and Hoff van, 2003): “Life is short, but the art of the craft takes time. The right moment is fast fading, experience is changeable and judgement is hard to make. The doctor must not only perform his own duties, but must also ensure that both the patient and the people around him perform their duties and that the external conditions are favourable.” In ancient Greece, Hippocrates, who is considered to be the developer of medicine, already identified the need for the development of medicine to keep pace with the times, with developments and with technological progress. The development of medicine must necessarily be the outcome of spending the required amount of time analysing, proving and putting into practice evidence-based theories; similarly, any development of a platform for the provision of medical care must ideally have originated via rational development processes organised with the best interests of the patient in mind, should not involve denying the patient's self-determination and should enable achievement of the goal of healing; and these are aphorisms applying equally well to the development and practise of telemedicine.

The impetus for telemedicine was the same in the 1970s as it is now. It was essentially seen as a technologically based solution to the problems of limited access to healthcare for certain patient groups, uneven geographical access to healthcare and the ever increasing cost of infrastructure.

Healthcare scientists have advocated various solutions to one or more of these problems, but none has so far been a complete and lasting success. Thus, the promise of a possible telemedicine solution to some or all of these problems remains too tempting to ignore. Telemedicine needs to be explored systematically through evidence-based research.

Most of the information from this experience on the beginnings of telemedicine has been conveyed in the form of interesting stories that reflected the novelty of this modality of care and some of the initial awkwardness of adapting to the new developments in telemedicine. For example, Kenneth Baird reported the frustration of patients, physicians and nurse clinicians when a third party seemed to take a back seat and get in the frame (Ostrom, 1973). Erving Bush observed that patients were uncharacteristically uninhibited in describing sexual behaviour using a photophone in the urology department of an online Cook County hospital. It was as if being online guaranteed them privacy. Charlotte Sanborn described how a patient objected to having another doctor in the examination room during a gynaecological examination, but the same patient consented to the “other doctor” observing the gynaecological examination on television in an adjacent room (Park, 1974). The immediacy provided them with a sense of privacy. Thomas Dwyer reported that for mental patients, “interactive television was more comfortable for the patient than ordinary face-to-face communication”, as if face-to-face communication reduced the emotional sensation of revealing personal information (Dwyer, 1973).

Curiously, there were instances of care where online monitors were placed at different heights for doctors and nurses. This happened in the Mount Sinai–Wagner Clinic telemedicine programme in New York, through which the clinic nurses usually communicated with the hospital doctor. The online monitor in the clinic, the room where the nurses were located, was placed high on the wall, while in the hospital the online monitor was placed at eye level with the doctors. The nurses therefore had to raise their eyes when talking to the remote doctors. Nurses commented that the image of the “face of God” was invoked when looking at an authoritative doctor providing knowledge from above (Wallerstein et al., 1973). This only compounded the problem that when images of the doctor and nurse were shown on the same screen, the image of the nurse was significantly smaller. However, the asynchronous relationship was soon resolved following professional interaction between nurses and doctors. In describing each of the telemedicine programmes established in the 1970s, most of which started with high expectations, great care was exercised to take a more global view in order to identify some of the key trends that characterised telemedicine activity in that era. Some of the factual information on telemedicine activity in the 1970s does not meet the requirements of the time; telemedicine evolved in later decades into a form germane to the context and nature of telemedicine characterising that era. Today's growth in telemedicine occurred right at the time of the pandemic. Modern telemedicine is an innovation in the healthcare system, and has a great potential to improve access, coordination, quality and cost of healthcare. Telemedicine is not a single technology or a single set of related technologies, but rather a large and non-normative set of clinical practices, technologies and organisational arrangements. Moreover, the widespread adoption of effective telemedicine applications depends on the information technology infrastructure and the practical skills of its users in using these infrastructures. Telemedicine is only partially established and is significantly affected by the rapid changes in healthcare, information technology and communication systems (Institute of Medicine, 1996).

Article 1(29) of the Law on Medical Treatment also provides a definition of telemedicine. This definition describes telemedicine as the provision of a remote healthcare service using information and communication technologies. At the same time, it was defined that telemedicine includes, inter alia, the secure transmission of medical data and information in text, sound, image or other formats necessary for medical treatment (Law on Medical Treatment, 1997). In view of the above, it follows that telemedicine is defined as a remote healthcare service, where the word “remote” is understood to mean that a service or a certain activity is provided from a distance, that is to say the provider of the medical service and the patient are not in physical contact. In principle, the healthcare providers and the patient meet in a virtual environment, online or offline. This is of course a challenge for both the healthcare provider and the patient, as certain skills and competences are needed to provide such a service.

Regardless of the manner in which a health care service is provided, it is constitutionally important to ensure that the service is provided in accordance with the requirements set out in the Satversme of the Republic of Latvia and other normative acts. Telemedicine must be provided in accordance with fundamental rights – in accordance with Article 111 of the Constitution of the Republic of Latvia. The Constitution obliges the State to protect human health; and the State must guarantee a certain minimum of medical assistance to everyone. Since telemedicine is also tasked with protecting human health, despite the fact that various data transmission devices are used in the provision of the service, the patient must still be provided with the relevant service in accordance with, among other things, the Law on Patients' Rights. During remote consultations, as during face-to-face consultations, it is necessary to ensure, for example, that entries are made in the medical records. Telemedicine consultations are subject to essentially all the same requirements as face-to-face consultations, including in terms of data protection, communication, etc.

In addition, telemedicine has terms that are relevant to connectivity, for instance telemonitoring, which at the same time opens up the possibility of remotely monitoring the health statuses of patients (Paré et al., 2007) by acquiring data synchronously or asynchronously through some devices, such as automatic electronic arterial pressure measurements, which, in connectivity with Internet data overlay transmission, are able to record measurements and store them, allowing clinicians to analyse these data to determine better treatments. Telemedicine is changing healthcare; telemedicine is the use of telecommunications and computer technology to transfer medical images and other medical data between doctors and patients. Telemedicine has become an increasingly important way to improve healthcare while reducing costs. The development of telemedicine is partly linked to technological advances. With the latest generation of technological devices in hospitals and the digital skills developed by medical practitioners, faster treatment is possible, as well as less time to receive a service, ensuring that appropriate services are available. In addition, online tools allow clinicians to review images and other medical data directly from a computer or smartphone. This also increases the efficiency of patient care by making it easier for patients to obtain the information they need about their health.

Overall, the development of telemedicine is changing healthcare in different ways – for the better, for example in terms of accessibility and cost of resources, and for the worse, that is to say in the context of challenges to the protection of medical data. However, with careful planning and implementation, it could soon become an even more important part of our national healthcare infrastructure.

For the implementation of telemedicine, a telemedicine action plan should be developed in the country, which Latvia has developed based on the experience and practice of other countries (European Commission, Directorate General for Structural Reform Support, 2022). This action plan covers a range of tasks and functions to be developed for all parties involved in the process, such as the Health Inspectorate, State Agency for Medicinal Products, Centre for Disease Prevention and Control, State Agency for Medicinal Products and National Health Service. The Action Plan defines the scope and implementation of telemedicine. It has to be agreed that the essence of telemedicine in modern medical service delivery is interacting with the parallel definitions of telehealth, digital health and e-health, which provide a view of the whole of the medical treatment process.

The relevance of telemedicine started to provide patients with access to healthcare services, including specialists, in a place convenient for the patient; the greatest relevance started with the COVID-19 pandemic, when access to hospital healthcare was limited; the situation stimulated the development of telemedicine, and gaps in service provision were identified.

Telemedicine has a wide range of possibilities, and can also be used in rehabilitation, with telerehabilitation services also available in Latvia. Telerehabilitation services can provide multiple services to patients, allowing for a tailor-made rehabilitation programme, reaching patients in remote regions as well as providing telerehabilitation services at a time and place convenient for the patient. A number of telerehabilitation programmes have already been developed:

Muscle strength and balance

Patients have used the telemedicine programme for hand exercises, the telemedicine programme for fine motor exercises, audio speech therapy exercises and cognitive games and exercises. All services were provided on a digital platform. What is noteworthy is the wide range of telemedicine, which allows us to infer the timeliness and relevance of the development of telemedicine in Latvia alongside face-to-face treatment. This trend points to an urgent need to regulate telemedicine, highlighting the need for a clarification of the actual extent up to which telemedicine's potential in serving as a substitute for face-to-face treatment can be realised. According to Article 1 of the Law on Medical Treatment, medical treatment is both prevention and rehabilitation. What can already be deduced is that treatment or its methods are realised through telemedicine in parallel with face-to-face treatment, creating both a multidisciplinary team approach and a multimodal information technological approach, thus achieving a wide comprehensive treatment service, contributing to a patient-centred health service.

Although telemedicine is able to provide a service anywhere, providers faced problems with payment for this service. Patients have limited possibilities to afford this service due to the cost of the service, and the Latvian State has not included this service in the range of State-funded services. Healthcare professionals are willing to include telemedicine in rehabilitation but are unable to do so due to lack of funding. It should be appreciated that patients lack information technology skills, but this lack of digital skills has already been anticipated by service providers, who have accordingly developed dedicated patient education tools and use these to educate patients at the beginning of the service as to what is involved in receiving the telemedicine treatment, and have additionally made the tools of the telemedicine digital platforms as comprehensible and easy to use as possible. It can be concluded that providers are willing to provide increasingly innovative services, but that the current legal framework is inadequate and incomplete, which also stagnates innovation in the telemedicine healthcare services market. This also implies challenges related to the financing of telemedicine from the State budget, based, among other things, on methodological costing of services and professional ethical issues.

The service uses secure cloud databases to store patient medical records, following the common secure fast healthcare interoperability resources (FHIR) standard (Braunstein, 2018). Telemedicine providers, in their submissions, already point to the need for regulation of telemedicine. The author notes that the absence of regulation on the one hand complicates the relationship that develops between the provider and the patient; and on the other hand opens the opportunity, given that the range of existing telemedicine is known, to start work on the development of a new, modern regulation, including using the experience of existing EU countries.

Evaluating the professional experience of the online clinical Medon, it can be concluded that during the 2 years of its existence, 659 patients have been registered and 379 telemedicine remote consultations have taken place. Telemedicine is the primary service provided by the clinic and the highest demand has been for consultations with dermatologists, gynaecologists, obstetricians, cardiologists and general practitioners. In setting up the online clinic, the provider admits that initially it was difficult to attract specialists to the clinic because they had to be convinced of the services offered by the clinic. It should be noted that the clinic started its work during the COVID-19 pandemic, when doctors had a very heavy workload, and it was also a breakthrough for telemedicine in health services, with the specialists now confident that they can provide high-quality and patient-safe telemedicine.

The provider cites public awareness of the service as a challenge, as patients are sceptical about telemedicine. The absence of a legal framework for Medon online clinical view has negative consequences and prevents the development and improvement of the service, as well as serves as a reason for patients' concerns about the service. The clinic points out that the development of a legal framework would allow for a faster and more successful introduction of telemedicine to the Latvian population.

Telemedicine is a tool that makes healthcare more accessible, more cost-effective and more efficient, and increases patient engagement in the treatment process. Since the beginning of technological development around the late 1950s, telemedicine advances have helped healthcare. Patients living in remote regions who previously faced difficulty in making physical visits to their doctors can now be reached virtually through technological means. Doctors and patients can share information in real time, for example from one computer screen to another. Further, they can even see and take readings of medical devices in another location; for example, patients with implanted pacemakers can transmit pacemaker device measurements to their cardiologist using the recommended software.

Using telemedicine software, patients can contact doctors for diagnosis and treatment without waiting for an appointment at an outpatient clinic. Patients can consult medical practitioners from the comfort of their home without having to go to an outpatient facility.

In Latvia, a rapid introduction of telemedicine into the healthcare service offer took place concomitant with the COVID-19 pandemic. At a time when the epidemiological situation posed risks to public health, in order to reduce the spread of COVID-19 infection and based on the Cabinet of Ministers Order No. 103 of 12 March 2020 “On Declaring an Emergency Situation”, several measures were brought into force that had the effect of, inter alia, curtailing non-essential health services; specifically, this Order provided certain rights to the Minister of Health of the Republic of Latvia, such as sub-clause 2.1, which provided for the right of the Minister of Health, after assessing the epidemiological risks and in agreement with the representatives of the medical sector, to restrict the provision of healthcare services (preserving those healthcare services that are life-saving and require continuity of treatment), including restricting the right of a medical practitioner to provide healthcare services in several medical establishments. Accordingly, on 25 March 2020, the Minister of Health issued Order No. 59 “On restricting the provision of healthcare services during an emergency” (Cabinet Order No. 103, 2020), which stipulated that patients with chronic diseases should be provided healthcare services remotely or through telemedicine as far as possible. Accordingly, the National Health Service prepared a contract for the provision and payment of secondary outpatient healthcare services. In clause 1.1, the contract stipulated for the provision of the services specified in the Ministry of Health Order No. 59 of 25.03.2020 “On limiting the provision of health care services during an emergency” in accordance with the procedure set out in clauses 1.2.4.1 and 1.2.4.2 of this document. The doctor is entitled to decide whether the consultation is to be provided face-to-face or remotely. Also stipulated as part of the same order were the provision and payment arrangements for secondary outpatient healthcare services in the event of a subsequent wave of the COVID-19 pandemic occurring in 2022.

In order to assess the use of telemedicine paid for by the National Health Service, the National Health Service was asked to provide data on the services provided, as well as on how many medical institutions the National Health Service concluded such agreements with, how many remote consultations were provided under this agreement and how this contributed to the development of remote consultations or the introduction of telemedicine (according to the transcript of the communication on the arrangements for the provision and payment of secondary outpatient health care services during the COVID-19 pandemic).

When the data for 2020, 2021 and 8 months of 2022 are considered and analysed, it can be concluded that the relevance of and demand for telemedicine are well substantiated, given the background of the limited availability of health care service under the conditions of the COVID-19 pandemic; telemedicine promotes access to health service in rural areas where high profile specialists, such as clinical university specialists, can also provide remote consultations, and such ready access to specialised health care provided by an integrated telemedicine system will be a major contributing factor in realising universalised health care for everyone.

In Latvia, a large telemedicine provider that provides remote telephone consultations is a subordinate unit of the State Emergency Medical Service of Latvia; in accordance with the Cabinet of Ministers' meeting minutes of 8 September 2017, Minutes No. 44, § 1, item 27, the State Emergency Medical Service of Latvia was instructed to take over the function of this service from Health Centre 4 as of 1 January 2018. This telemedicine is free of charge for the caller, but it is paid for from the State budget funds, according to the Health Financing Law (Cabinet of Ministers Regulation No. 555, 2018); on a daily basis, health care workers provide the caller with advice on how to deal with various illnesses, such as high arterial pressure, psycho-emotional distress, minor injuries and high temperature; they also provide advice on elementary medical tactics, including the prescription and use of medications, together with necessary dosages and correct times of administration. The opening hours of the GP Advice Line are weekdays from 17:00 and weekends and public holidays 24 h a day, with the aim that patients have access to advice on health issues outside GP working hours. During the COVID-19 pandemic, when the whole healthcare system was overwhelmed by the huge number of patients, the GP Advice Line worked 24 h a day on weekdays also, a particularly important motive being the preservation the functionality structure of the State Emergency Medical Service of Latvia. Today, four consultants provide telemedicine consultations on a daily basis. This service is also used by Latvian residents when they are outside Latvia, often the Latvian diaspora from England and Ireland, who consult on the use of medicines or on which tests to perform to diagnose a disease.

Considering the general number of telephone consultations provided during the COVID-19 pandemics period, it can be concluded that the demand for these consultations is high and it is a convenient service for patients as there is no need to go to an outpatient medical facility, which would be time-consuming, and there is no transport cost and no co-payment by the patients while visiting the doctor; thus, due to various socio-economic upheavals and geographical infrastructure, patients find this service more convenient; hence, the demand for this service is increasing. Patients are advised by their general practitioners to seek help in case of need.

The State Emergency Medical Service of Latvia keeps a record of the conditions for which consultations are most frequently sought; at the time of the highest prevalence of COVID-19 in 2021, the highest number of telephone consultations for this condition were also provided. The author concludes that if an urgent case is identified during the consultation, where the patient requires immediate investigation, the patient is immediately connected to The State Emergency Medical Service of Latvia call-taker and the emergency medical team is dispatched to the patient for clarification of the diagnosis and treatment.

Looking at the statistics available for the 11 months of 2022, it can be concluded that there is a demand for telemedicine; given the current situation in the health system, there are seasonal illnesses and the number of consultations is increasing accordingly (Public Review of the Emergency Medical Assistance Service, 2022).

The State Emergency Medical Service of Latvia 2022 Development Plan foresees an increase in the proportion of telephone call-outs, an increase in the volume and capacity of the advisory service, and an increase in the proportion of telephone call-outs in the call structure. Accordingly, there is a need to ensure capacity building of the staff capacity of the GP Advice Line by improving the functionality in place to handle calls for people with disabilities. The development of the concept for the development of the GP Helpline through the introduction of basic telemedicine functionalities is also planned. Teletriage in emergency medicine in the pre-hospital phase is aimed at prioritising patients by identifying potential secondary call-outs at times when there is a limited resource of help providers. Tele-resuscitation considers system structure, safety and efficiency. The demand for emergency medical services has increased in many countries (Wellington Free Ambulance, 2012). Demand is also projected to continue to increase, mainly driven by increasing patient survival or the number of chronically ill people. Particularly among the elderly, demand for emergency care will increase disproportionately (Marks et al., 2022). These patients are triaged during telephone triage and are classified as low priority, with no or minimal life-threatening impairments, and can wait up to 4 h for help. The provision of assistance on secondary calls may create the risk that the use of emergency medical resources for low priority cases may potentially inhibit the rapid response to high priority life-threatening calls requiring more urgent medical attention (Audit Commission for Local Authorities and the National Health Service in England and Wales, 1998). An important way of addressing this could be the use of strategic measures such as telephone triage to divert ambulance calls to patients classified as low priority to alternative options for help. The State Emergency Medical Service of Latvia uses a computerised priority dispatching system “EMY” to perform primary triage and assign a priority level on receipt of a call, in the State Emergency Medical Service of Latvia call centre. Based on the computerised prioritisation and categorisation, the State Emergency Medical Service of Latvia medics with different skill levels are dispatched to provide assistance and treatment as needed, after which the patient is taken to the emergency department of an appropriate hospital. Telephonic triage is provided by the attending physicians who, together with the information technology solution, determine the priority.