February 2022 – As previously reported, eHealth (including telemedicine) has been one of the fastest growing areas within the healthcare sector over the last two years. Governments as well as healthcare sector operators across Central and Eastern Europe and Turkey continue to implement new solutions with a view to improving the provision of healthcare services and to enhance the digitalization of healthcare systems.
Private healthcare providers and the various newly created eHealth providers and start-ups are crucial in pushing development in this highly dynamic area. Innovative solutions include online consultations and health examinations, the possibility of remote patient health data monitoring as well as electronic drug prescriptions. Most of the aforementioned countries are also improving their overall digital healthcare infrastructures, seeking to make the provision of healthcare services more efficient and also more secure.
Since our May 2021 report, several countries in the region have introduced improvements in the area of eHealth: New legislation creating a general legal framework for electronic healthcare has been adopted in the Czech Republic. The Serbian government has been preparing a plan to implement digitalization into its healthcare system. And the Turkish Ministry of Health has published new draft legislation to regulate a remote healthcare information systems framework.
Below we present updated country overviews of current eHealth trends across Central Europe and Turkey. The update also includes a country overview from the healthcare specialists at Kinstellar’s new Croatia office.
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 two years as a result of the pandemic response. Much of the efforts, however, have come from the private sector, as public officials have shown resistance to offers of outside assistance. Such private efforts came via a number of newly created mobile apps and platforms, such as Haalee, Consento, Synevo HomeDoc and EasyDoc, that allow practitioners to offer remote consultations to patients. This private practice filled a pandemic-induced gap between demand and supply for technological advancement in the healthcare sector.
Bulgaria has not yet moved into the realm of paperless and contactless healthcare. Indeed, the ongoing Covid-19 pandemic has only exemplified the challenges associated with such a shift. Presently, the Ministry of Health maintains a National Health Information System (NHIS), 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 NHIS is to maintain electronic profiles and health records for all persons undergoing, or who have undergone, a medical examination. The NHIS is available to doctors, the social security authorities, medical commissions and other local medical bodies, who can all add and locate information concerning the past healthcare status of the respective patient. However, the system is still in the process of implementation and development.
So far, the greatest government-backed telemedicine-related advance in Bulgaria has been the introduction of e-prescriptions in 2020. Medical professionals can now prescribe medicinal products electronically; records can then be accessed by pharmacists through an electronic system. Another improvement is the introduction of e-referrals for medical diagnostic tests (for example PCR tests), which has become widely used by general practitioners. The aim is for this process to become completely paperless – but no official timeframe for this has yet been unveiled.
Simultaneously, several hospitals with Covid-19 departments have established web-based telemedicine models, which transcribe a select number of patient health indicators, such as temperature and heart rate, and present this in real time via an app which all caregivers can access remotely. The aim is to increase doctor safety, reducing in-person time with patients, while at the same time increasing overall efficiency.
In 2021, the Ministry of Health introduced a procedure for financial aid to state-owned and municipal medical institutions with a proposed budget of nearly BGN 129 million. The aim of the project is to move past the pandemic and strengthen the overall healthcare system. Medical institutions were able to apply and obtain state aid based on set criteria and methodologies, including the implementation and development of telemedicine.
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.
In Croatia, the legal framework for telemedicine is prescribed via the Healthcare Act and Ordinance on the conditions, organisation, and manner of performing telemedicine. Under this regime, healthcare professionals can provide remote healthcare services by using communication technologies and, more precisely, provide remote patient monitoring, consultancy healthcare services, preventive measures, diagnostic and therapeutic procedures, and so forth. The law differentiates telemedicine from so-called mobile healthcare (in Croatian: mZdravstvo), which includes using mobile technologies for the collection of medical and public health data.
Telemedicine services are intended to be provided equally at the primary, secondary and tertiary levels of healthcare by both public and private healthcare organisations. A majority of these are within the fields of cardiology, neurology, radiology, and neurosurgery, are predominantly in the private sector, and cover healthcare professional-to-healthcare professional relations. A few exceptions are found where telemedicine has been applied for patient communications and patient treatment. Various pilot projects have been implemented in Croatia. So, far, the app “Staying Alive” app is widely viewed as producing the best results, particularly during the tourist season. The app was developed in collaboration with the French AEDMAP foundation and can recognize the current location of users and display the nearest AVD (automatic external defibrillator) devices. It also contains a guide on how to perform the resuscitation procedure and locates the nearest properly trained volunteer to carry out a resuscitation. Meanwhile, mZdravstvo services are widely available and offered through an e-citizen platform introduced by the Croatian Government in 2014. All personal medical data, prescriptions, referrals, past and future scheduled visits to primary healthcare physicians, medical results, applied therapy and so on are available online by simply entering one’s ID credentials. Medical data is at the same time available to healthcare professionals and organisations through an internal system called Healthnet, leading to an almost paperless system. One Healthnet feature, namely the so-called A5 prescription, particularly proved its usefulness during the Covid-19 pandemic (which placed a huge burden on specialized physicians). Using A5 prescriptions means no need for direct appointments with medical specialists, with primary healthcare doctors able to seek a specialist opinion through the Healthnet system.
Asides from the above-described developments, as well as the ability to schedule online vaccination appointments and PCR tests, the ongoing Covid-19 pandemic has had no significant impact on the practical implementation of telemedicine services in Croatia. One of the few projects successfully launched by the Croatian Government during the pandemic is known as “Digital Assistant – Andrija”, an artificial intelligence-based platform that is available through the WhatsApp messaging app. The platform helps users to assess the severity of Covid-19 symptoms. The existing Croatian legal framework also offers more room for the future development of telemedicine services – which has clearly not yet been fully realised.
Telemedicine is recognized in the Ministry of Health’s Strategic plan for 2020-2022 as an important factor in ensuring more accessible health care, especially for those Croatians who live on the county’s many islands, or in rural areas, areas of special state care, and for healthcare organisations lacking professional staff. The same efforts will likely continue in the ensuing years, with the development of telemedicine services following the general direction of the digitalization of Croatian public services.
Since our previous report, significant developments have occurred in eHealth-related legislation in the Czech Republic. Crucially, the Act on Electronic Healthcare entered into force on 1 January 2022 (with certain of its provisions subsequently entering into force between February 2022 and January 2024). The Act on Electronic Healthcare serves as a general legal framework for all healthcare services provided by electronic means. It introduces the basic infrastructure of different subjects in the electronic healthcare system and stipulates their rights and obligations, as well as the rights and obligations of patients connected through eHealth services. The law sets uniform standards for the provision of electronic healthcare in the Czech Republic.
The Act on Electronic Healthcare further establishes a new public administration information system called a Data Integration Interface, administered by the Ministry of Health, and operated by the Institute of Health Information and Statistics of the Czech Republic. The Data Integration Interface will contain registers of healthcare providers, healthcare professionals and patients and services linked to these registers. The Data Integration Interface is scheduled to become operational on 1 January 2023.
In terms of the current status of eHealth services, Czech health insurance companies presently reimburse certain telemedicine services. Reimbursed remote medical procedures include those performed by general practitioners and clinical psychologists and psychiatrists. This reimbursement of remote treatment through public health insurance is expected to broaden in scope in the course of 2022. Some pilot projects are already running in fields such as cardiology, diabetology and gastroenterology. Based on the formal evaluations of these projects, health insurance companies are expected to determine whether to extend the scope of reimbursement for eHealth services provided in other areas.
Telemedicine services are primarily intended for established patient-doctor relationships. Accordingly, the given patient is already registered with their physician, ongoing treatment is taking place, and the physician provides consultations during regular office hours. Other telemedicine services may require a patient to record certain parameters, such as blood pressure, at home and to upload the results through a secure interface. These are then accessed and assessed by the respective physician.
In order to help doctors to better adapt to new telemedicine trends, the Society of General Practice (Společnost všeobecného lékařství) has published a document titled Recommended Diagnostic and Therapeutic Procedures for General Practitioners in the Field of Telemedicine, offering interim guidance on telemedicine practices.
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 pandemic.
Under this regime, healthcare services may be provided by healthcare professionals via IT infrastructures from a remote location, provided that the nature of the treatment and healthcare considerations permit their use.
As part of telemedicine services, healthcare professionals may – among others – establish diagnoses 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 cybersecurity. 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 first telemedicine-related legislation in Romania 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 the 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 will be 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 formally prohibit or hinder the development of the local telemedicine sector. Indeed, the state is in fact facilitating the development of telemedicine by introducing solutions that enable online communication between patients and medical professionals. The most notable example is the government website eZdravlje, 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, providing valuable information and enabling medical consultations for potentially infected patients, or those subject to quarantine orders.
Moreover, in the course of a public debate over the Draft Program of Digitalization in the Healthcare System of the Republic of Serbia for the Period Between 2022 and 2026, which took place in November 2021, AmCham Serbia proposed, and the Serbian Ministry of Health accepted, the preparation of a plan for the implementation of telemedicine into the Serbian healthcare system by June 2022. Serbia is evidently well on its way towards establishing a regulatory eHealth framework, thus remedying the omissions of the current Healthcare Protection Act in this regard.
In 2019, the Slovak government adopted a Digital Transformation Strategy 2030 to serve as a policy document defining specific priorities in the context of the digital transformation of the economy and society. The document also addresses the transformation of the healthcare sector with regard to emerging digital technologies.
No specific laws currently regulate eHealth in Slovakia. However, Act No. 153/2013 Coll., on a National Health Care Information System, did create a legal framework for the introduction of eHealth 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 government’s current policy programme includes references to telemedicine and new technologies. Moreover, the government has committed itself to support the introduction of innovative modern technologies through current payment mechanisms. In 2020, the Ministry of Health created a specialised working group on telemedicine and new technologies with the participation of a number of leading 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 call technologies. Such consultations are reimbursed from public health insurance by all insurers and serve as a form of triage to assess patient medical needs leading to further referrals. In 2021, the reimbursement of email, video messaging and e-prescriptions tripled year-on-year.
In addition, Act No. 358/2021 Coll., on a National Institute for Value and Technology in Health Care, was adopted in September 2021. The Act creates a legal framework for health technology assessments. The Institute was established on 1 January 2022 and its activities are expected to drive the introduction of new telemedicine technologies.
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 in the country. The E-Pulse System offers a single platform where patients may access personal health data at any time and also schedule appointments with physicians at public health institutions. Since 2018, the E-Pulse System has also offered an integrated “teleradiology and telemedicine system” service allowing patients and physicians to access radiological examination imagery and enabling teleconsultations between radiologists for the purposes of consultations.
Prior to the current Covid-19 pandemic, beyond the functions outlined above, the E-Pulse System did not enable patients to obtain online medical advice. 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 those public health institutions that have the infrastructure to perform video examinations by physicians. Accordingly, patients can be examined, diagnosed and issued with the respective e-prescriptions. 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 with physicians via video calls – irrespective of whether or not they are in the Risk Group.
Despite these developments, other existing healthcare regulations still maintain the principle that physicians must physically examine patients before prescribing any treatment. In order to resolve this discrepancy between post-Covid-19 healthcare practices and the applicable regulatory framework, as well as in response to an increasing need to expressly regulate telemedicine practices, in February 2022 the Ministry of Health published the Regulation on the Provision of Remote Healthcare Services (the “Regulation”).
The Regulation envisages the establishment of a framework for remote healthcare information systems to be developed by the Ministry of Health, or by developers approved by the ministry, enabling written, audio or visual communication between the patients and healthcare professionals. Such remote healthcare information systems will be registered with the Ministry of Health and any healthcare institutions seeking to provide remote healthcare services will be required to obtain a permit from the ministry and to use a remote healthcare information system that has been registered with the ministry. Healthcare institutions providing remote healthcare services will have to obtain a permit within six months of the publication of the Regulation. In the event a given healthcare institution provides remote healthcare services without an operation permit, the Regulation authorises the respective local governorship to immediately terminate its operations.
The Regulation stipulates that only certain healthcare services can be provided remotely by healthcare institutions, chiefly including examination and consultation (to the extent it can be provided remotely under the specific circumstances), the evaluation of clinical parameters (such as blood sugar or blood pressure), certain services relating to interventional and surgical operations (within a scope to be determined by the Ministry of Health), the issuance of e-prescriptions and the tracking of health data through wearable technologies. If any healthcare institution provides remote services other than those listed in the Regulation, the healthcare institution will first be issued with a warning and instructed to remedy the non-compliance within a one-month grace period. In the event of repeated failures to comply with the Regulation, the relevant healthcare institution may face the termination of the relevant service and the withdrawal of its operation permit along with a ban on applying for a new permit for a period of one year.
The Ministry of Health’s enactment of the Regulation reflects a clear recognition of the necessity of regulating telemedicine services. The Regulation not only introduces a centralized information systems framework and a requirement to obtain an operation permit for healthcare institutions seeking to provide remote services, but also clarifies which healthcare services can be provided remotely. As such, the Regulation delineates the scope of telemedicine services that are essentially exempt from the legally enshrined principle that physicians must examine patients physically before prescribing any treatment.
Certain demographic and geographic factors, such as a considerable distance between cities and rural areas, a significant rural population and a poorly developed infrastructure, spurred the development of telemedicine in Ukraine even before the relevant legislation was adopted. Indeed, the 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 matter now became a priority 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. The Ministry of Health then 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. Crucially, in Ukraine, telemedicine may be applied at all levels of medical care and is not subject to additional licensing requirements. Telemedicine has been included in the Healthcare Guarantee Programme. Hence, applicable services will be reimbursed by the National Health Service of Ukraine. This factor is contributing to a wider use of telemedicine for primary health care.
As of January 2022, telemedicine networks have only been created at a regional level. Thus, the possibility of telemedicine consultation is limited to healthcare facility specialists connected to the respective telemedicine network within a certain region. A nationwide telemedicine system is yet to be established. To make this possible regulation will need to be introduced and the IT infrastructure within healthcare facilities will have to be improved significantly. 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.