May 2021 – Telemedicine has been one of the fastest growing areas within the healthcare sector during the current coronavirus pandemic. But even in 2018, well before the COVID-19 outbreak, the European Commission predicted in its Market study on telemedicine that by 2021 the global telemedicine market would be worth around EUR 37 billion, with an annual growth rate of 14 percent. It is now evident that the pandemic has led to a massive growth of this market.
The term “telemedicine” or “telehealth” is used in numerous ways. For the purposes of this newsletter, we use the following definition: telemedicine includes healthcare services that are provided remotely, and where healthcare professionals communicate, diagnose and treat patients through advanced technology that can be operated at a distance.
The main aim of telemedicine is to (i) provide clinical support; (ii) overcome geographical barriers by connecting users who are not in the same physical location; and (iii) improve patient health by incorporating various types of information and communication technologies.
In this newsletter we will examine the measures taken by individual countries in the region to respond to increased demand for telemedicine and to facilitate further growth of this industry.
In Bulgaria, despite the current COVID-19 pandemic, no explicit regulation or regulatory regime is in place for telemedicine services. The provision of healthcare services remotely via telecommunication means is not prohibited or restricted, but it must be provided in compliance with the regulations and standards generally applicable to the medical profession and its services. In this respect, the existing reimbursement regime has also not been adapted to specifically accommodate and facilitate medical assistance via telemedicine.
In practice, the telemedicine sector in Bulgaria is not highly developed. However, it has improved over the last year as a result of the crisis-related pandemic response. Much of the efforts, however, came from the private sector, since public officials have shown resistance to offers of outside assistance. Such a private effort came from various newly created mobile apps and platforms, such as Haalee, Consento, Synevo HomeDoc and EasyDoc, that allow practitioners to offer consultations to their patients remotely. This private practice filled a pandemic-related gap between demand and supply for technological advancement in the healthcare sector.
Bulgaria has not yet moved into the realm of paperless healthcare. The current pandemic has only exemplified the challenges associated with such a shift. Presently, the Ministry of Health maintains a National Health Information System, which provides centralized management and storage of information on electronic referrals and electronic prescriptions. A separate medical assessment processing system is used by various Bulgarian public authorities. The purpose of the system is to maintain electronic profiles and health records for all persons undergoing, or who have undergone, a medical examination. The system is available to doctors, the social security authorities, medical commissions and other local medical bodies that can all add and locate information concerning the past healthcare status of the respective person. However, the system is still in process of implementation and development.
In 2020, the greatest telemedicine-related advance in Bulgaria was the introduction of e-prescription. Medical professionals can now prescribe medication electronically; records can then be accessed by pharmacists through an electronic system. The aim is for this process to become completely paperless – but no official timeframe has yet been unveiled.
Simultaneously, several hospitals with COVID-19 departments have established a web-based telemedicine model, which transcribes several patient health indicators such as temperature and heart rate, and presents this in real time via an app that all caregivers can access remotely. The aim is to increase doctor safety, spending less in-person time with patients, while at the same time doing their jobs as efficiently as possible.
So far, the Bulgarian approach has been to store and forward patient health status information. Regulation of other activities, such as remote diagnoses, setting up therapy programmes, offering consultations, medical care, therapy and rehabilitation – all without the physical presence of medical professionals – has not yet been implemented by the government.
The outbreak of the COVID-19 pandemic placed an unexpected burden on physicians and patients and significantly accelerated the development of telemedicine in the Czech Republic. Until March 2020, Czech health insurance companies did not reimburse telemedicine services via health insurance – thus, physicians provided remote consultations for free. Currently, about ten procedures which are reimbursed from public health insurance may be performed remotely. These include procedures performed by general practitioners and certain specialists, e.g. clinical psychologists and psychiatrists.
Telemedicine services are primarily intended for the established patients of a given doctor. Accordingly, the patient is already registered with their physician, ongoing treatment has been taking place, and the physician provides a consultation during regular office hours. However, in recent months an increase has taken place in the number of telemedicine consultations where physicians are available on an out-of-hours basis and remotely examine non-regular patients. Such consultations are not covered by public health insurance and are covered directly by patients.
Explicit legal regulation of the telemedicine industry is still absent. The Ministry of Health has presented an Electronic Healthcare Bill which is currently being discussed by the Czech parliament. In September 2020, the Society of General Practice (Společnost všeobecného lékařství) presented a document titled Recommended Diagnostic and Therapeutic Procedures for General Practitioners in the Field of Telemedicine, to be used as interim guidance.
The Electronic Healthcare Bill introduces rules for the secure sharing of information. It provides for the creation of three registers: a register of healthcare providers, healthcare professionals and patients. The registers will be connected via a non-public system, which will be accessible only to authorized persons. Patients will have access to their health records through the eHealth Portal.
The first wave of the COVID-19 pandemic cast a new light on the importance of telemedicine in Hungary. A telemedicine regulatory regime was first introduced in April 2020 on a trial basis. As a result of the positive experiences gained during this initial phase, the Hungarian government extended the trial and subsequently enacted a permanent telemedicine regulatory regime applicable irrespective of the current COVID-19 pandemic.
Under this telemedicine regulatory regime, applicable from September 2020, healthcare services may be provided by healthcare professionals via IT infrastructure from a remote location, provided that the nature of the treatment and healthcare considerations permit the use of such telemedicine services.
Within telemedicine services, healthcare professionals may – among others – establish diagnosis and set up therapy programmes, offer patient consultancy services, provide medical care, carry out therapy and rehabilitation activities, and prescribe pharmaceutical products and medical devices.
Healthcare providers must provide the appropriate IT devices and medical devices necessary for carrying out telemedicine services in compliance with data protection rules governing health-related data. In addition, healthcare providers must provide patients with a policy and patient information guide related to the specific telemedicine services offered by the given healthcare provider. Healthcare providers must also guarantee appropriate internet connections, data transmission, data security and cyber security. A separate regulatory regime has been enacted under which telemedicine services may be reimbursed.
The above rules serve as a general framework for the Hungarian telemedicine regulatory regime. We anticipate that detailed rules will be introduced gradually. The most recent government decree enacted in the area of telemedicine was published in February 2021 regarding facial recognition video technology for the period of the state of emergency in connection with COVID-19, which also suggests that telemedicine is a developing field in Hungary.
In Romania, the first telemedicine legislation was adopted in 2018. The creation of a legal framework for telemedicine was subsequently accelerated by the COVID-19 pandemic. In March 2020, the Romanian government adopted temporary rules on remote consultations, valid during the existing state of emergency. The temporary legislative framework on telemedicine was kept in force by a Romanian Government Emergency Ordinance until the end of September 2020.
As of November 2020, a permanent telemedicine regulatory regime was introduced via Government Emergency Ordinance no. 196/2020. This enactment introduces only a few general rules on telemedicine, defining the concept as being all remotely provided medical services, without the physical presence of medical personnel and of the patient. This was undertaken for the purpose of (a) establishing a diagnosis, (b) determining treatment, (c) monitoring diseases, or (d) providing remedies for preventing diseases, via IT infrastructure.
The norms for implementing the general rules outlined above have not yet been adopted. A draft enactment providing such implementation rules was published on the official website of Ministry of Health in February 2021. Aside from rules on the general conditions for granting medical assistance via telemedicine, the draft enactment provides a list of medical services that may be provided remotely (e.g., teleconsultations, telepathology, teleradiology) and the areas of practice falling under the umbrella of telemedicine (e.g., endocrinology, cardiology, gastroenterology).
According to this draft enactment, telemedicine services may be provided: (a) via a real-time remote consultation between the healthcare professional and the patient, or (b) by exchanging recorded medical information, with the simultaneous presence of healthcare professionals and of the patient not required.
It remains to be seen if this draft is approved in its current form or if it will be subject to further amendments. We also anticipate that additional detailed rules will be gradually introduced.
The application of telemedicine and other remote healthcare services in Serbia has been on the rise for several years, particularly with respect to private healthcare providers. A number of applications and websites offering telemedicine services are available to patients, such as the DokTok application and LekarInfo website – both enabling the scheduling of video calls and consultations with medical professionals at short notice.
Despite this, the Healthcare Protection Act adopted in 2019 failed to introduce even basic high-level rules in this respect. The provision of telemedicine services is not in any way separated from rules on regular patient examinations – i.e. it falls under the same scope of general rules on medical examinations and relations between patients and medical professionals as provided by the Healthcare Act and Patient Rights Act of 2013, as amended in 2019.
However, it should be noted that the Serbian state does not prohibit or impair the development of the local telemedicine sector in any way. Indeed, it appears that, in fact, the state is facilitating the development of telemedicine by introducing its own solutions that enable online communication between patients and medical professionals. The most notable example of such practices is the government website eZdravlje, which is envisaged as a platform through which a patient will be able to “…connect with a doctor, counsellor, trainer, friend, insurance company, exchange directly information about habits, physical activities, certain laboratory parameters, radiological recordings and therapies”. Although this website is still under development, it has already found use during the COVID-19 pandemic by providing valuable information and enabling medical consultations for potentially infected patients, or those subject to quarantine orders.
In our view, the future outlook for telemedicine in Serbia is strong, and it is only a matter of time before a more comprehensive regulatory environment is established.
No specific legislation regulates telemedicine in Slovakia. Act No. 153/2013 Coll., on a National Health Care Information System created a legislative framework for the introduction of e-health services. The law created several administrative registries, including for healthcare professionals, providers, and also disease registries. Electronic health records of outpatient care providers are mandatory and allow information to be shared among providers. The majority of patients now take advantage of e-prescriptions. Using electronic national ID cards, any patient can access their electronic medical records. The secondary usage of data collected by the National Health Care Information System for research and public health is presently restricted.
Emergency rescue service providers have been using STEMI and STROKE Android-based mobile applications since 2017. The Emergency Services Operations Centre procures licenses centrally; usage is based on expert guidance issued and regularly amended by the Ministry of Health. STEMI facilitates ECG scanning and communication with the nearest cardiological centre to shorten ischaemic times where the patient is suspected to have myocardial infarction. STROKE has a similar usage for suspected strokes.
The present government programme includes references to telemedicine and new technologies. The government has committed itself to support the introduction of innovative modern technologies through payment mechanisms. In 2020, the Ministry of Health created a specialised work group on telemedicine and new technologies with the participation of external experts.
The COVID-19 pandemic has significantly reduced the number of patients visiting general practitioners and specialists. The Ministry of Health has issued various guidelines allowing consultations by email, web applications or via voice and video calls. Such consultations are reimbursed from public health insurance by all insurers and serve as a form of triage to assess patient problems leading to further referrals.
Official discussions for establishing a telemedicine system began in Turkey via an e-health conference in 2008. After this conference, an E-Health Working Group was established under the coordination of the Ministry of Health. This working group then prepared an action plan within the scope of a broader Turkey e-Transformation Program.
As a result of these efforts, in 2015, the Ministry of Health introduced, on the basis of Article 3 of the Fundamental Law on Health Services (Law No. 3359), an E-Pulse System, which currently provides the widest range of online health services. The E-Pulse System essentially provides a single platform where patients may access their personal health data at any time and schedule appointments with physicians at public health institutions. Since 2018, the E-Pulse System has also integrated a “teleradiology and telemedicine system” service allowing the patients and physicians to access images of radiological examinations and enabling teleconsultations between radiologists for the purposes of consolations.
Beyond the functions outlined above, the E-Pulse System did not enable patients to obtain online medical advice prior to the current COVID-19 pandemic.
In October 2020, the Ministry of Health issued a Tele-Health Integration Guide and introduced a Visual Examination Appointment service enabling patients in contact or diagnosed with COVID-19 (within a so-called “Risk Group”) to be examined via a Central Physician Appointment System (MHRS) without the need to visit the relevant public health institution. Through this service, Risk Group citizens are able to make an appointment with public health institutions that have the infrastructure to perform video examinations by physicians. Accordingly, patients can be examined, diagnosed and issued e-prescriptions for treatment. Although this system only covers public hospitals, most private hospitals and clinics have also modified their own e-appointment systems to enable patients to consult physicians via video calls – irrespective of whether or not they are in the Risk Group.
Despite these developments, there is still no precise legal instrument in place that encompasses telemedicine practices in Turkey. In addition, certain healthcare regulations maintain that, in principle, physicians must examine patients physically before prescribing any treatment. We anticipate that the Turkish government will take further steps to regulate telemedicine services and to resolve the current conflict between healthcare institution practices and the associated legal framework.
Certain demographic and geographic factors, such as considerable distance between cities and rural areas, a significant rural population and poorly developed infrastructure, spurred the development of telemedicine in Ukraine even before the relevant legislation was adopted. Initial debates on the introduction of a telemedicine regulatory environment began at a national level in 1994.
In 2007, the Ministry of Health established the State Telemedicine Clinical Research Center to coordinate the establishment of telemedicine systems throughout the country. Furthermore, industry-specific regulation was also introduced, establishing a legal framework for the functioning of telemedicine. In some regions of Ukraine, pilot telemedicine projects have taken place. Additionally, private clinics have used telemedical consultations to facilitate doctor-patient consultations. Since 2016, a number of digital health platforms and apps, such as Doctor Online, Medikit, and Medinet, have been developed and launched by the private sector. Some have provided free-of-charge access to certain services during the COVID-19 pandemic.
The adoption of the Increased Availability and Quality of Medical Services in Rural Areas Act in 2017, introducing a nationwide telemedicine system, meant that this field became a priority area for the Ukrainian government. In February 2018, the Ministry of Regional Development, Construction and HCS, the Ministry of Health, the World Bank and the Canadian Ministry of Foreign Affairs signed a joint Memorandum on the Introduction of Telemedicine Services. Furthermore, the Ministry of Health developed a roadmap on the introduction of a nationwide telemedicine system, and, in 2019, also approved a document titled Methodological Recommendations for the Diagnosis and Treatment of Certain Diseases using Telemedicine. That same year, the Ministry of Health, together with international partners, launched a pilot project introducing a telemedicine system across several regions of Ukraine. The pilot program was the first step aimed at the development of a nationwide system. Crucially, in Ukraine, telemedicine may be applied at all levels of medical care and is not subject to additional licensing requirements.
In response to the current COVID-19 pandemic, the Ministry of Health has approved the use of telemedicine in the course of treatments.
Given the growing trend of digitalization, including in the healthcare sector, as well as specific demographical and geographical factors, we anticipate a further expansion of the use of telemedicine throughout the country in the coming years.
For more information please contact Tomáš Čihula, Partner, Head of Life Sciences & Healthcare, at .
Bulgaria: Svilen Issaev, Donika Stavreva
Czech Republic: Tomáš Čihula, Sabina Skoumalová
Hungary: Eszter Takácsi-Nagy, Flóra Szalai
Romania: Iustinian Captariu, Maria Madalina Anghenie
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