The development of information technology (IT) has made it possible to significantly optimise processes in various areas of life. Telemedicine technologies are one of the most innovative manifestations in the field of IT healthcare. We believe that the successful development and implementation of telemedicine technologies can play a significant role in the social and economic development of the state and society, by improving the quality and accessibility of individual medical care, as well as creating additional opportunities for private healthcare organisations. Our team has prepared an overview of the use of these technologies in the Baltics and Belarus, as well as of the regulatory requirements in each country.
- Legal aspects of telemedicine in Estonia
- Legal aspects of telemedicine in Latvia
- Legal aspects of telemedicine in Lithuania
- Legal aspects of telemedicine in Belarus
Pursuant to the EU Commission’s communication, telemedicine is the provision of healthcare services, through the use of ICT, in situations where the health professional and the patient (or two health professionals) are not in the same location. It involves secure transmission of medical data and information, through text, sound, images or other forms needed for the prevention, diagnosis, treatment and follow-up of patients. Although in the aforementioned communication from 2008 the EU Commission had already found telemedicine to have huge potential in improving patient care and healthcare systems in general, telemedicine has started to boom only recently. Nonetheless, regulatory requirements differ from country to country which means that every healthcare provider using telemedicine solutions must be acquainted with the relevant countries’ requirements.
The provision of telemedicine services is allowed under Estonian law, and it is used on a regular basis. Telemedicine is to a large extent unregulated, and thus the rules and requirements applicable to regular healthcare services apply also to telemedicine services. For example, the law does not prescribe what kind of means can or should be used in case healthcare services are provided as telemedicine services. The only exception is when services are reimbursed by the Estonian Health Insurance Fund (EHIF).
Namely, remote appointments to specialised HCPs are covered by the EHIF only if certain conditions are met. The quality of the appointment must be at least equal to the quality of a physical appointment, the remote appointment must be suitable for the treatment of the specific health condition, the patient must have given documented consent to the remote appointment, the patient must be identified by the HCP, the appointment must have taken place by way of synchronised communication, and the technical means used for the remote appointment must ensure the protection of personal data.
Separate fields of telemedicine are e-prescriptions and e-pharmacies. In relation to these, Estonian law stipulates quite distinct rules:
Estonian HCPs must as a rule only issue electronic prescriptions within the Estonian National Health Information System. Until recently, such e-prescriptions could only be used on the territory of Estonia, but thanks to the European Union’s eHealth initiative, it is now possible for Estonian citizens to purchase their medicines on the basis of e-prescriptions in Finland and Croatia as well. Under the eHealth programme, the next step will be the creation of a cross-border system for exchanging patients’ data. This should be enabled in the near future, but initially it will be possible only with the Czech Republic, Malta, Croatia and Luxembourg.
E-pharmacies are getting more popular in Estonia even though the law regarding them is still somewhat clumsy and over-restrictive. Pharmacies which would like to apply for an e-pharmacy licence must first have the usual pharmacy licence (i.e. meet all room requirements) and an e-pharmacy licence can be applied for in addition to this. At the moment, according to information published by the Estonian State Agency of Medicines, there are five e-pharmacies in Estonia. It is possible to purchase both over-the-counter medicines and prescription drugs.
In Latvia, there are no detailed regulations or requirements for telemedicine. Thus, the general requirements for healthcare services apply, in particular the Medical Treatment Law (MTL), which regulates qualified prophylaxis, diagnosis, and the medical treatment and rehabilitation of patients, and determines special provisions for the economic activity of medical treatment institutions.
Telemedicine is a part of healthcare: the range of measures implemented by healthcare service providers. The MTL defines telemedicine as “provision of remote healthcare service, by using information and communication technologies. It includes secure resending of medical data and information necessary for medical treatment in the form of text, sound, pictures or other.”
The definition of telemedicine was included in the MTL in 2014 as part of the implementation of EU directive 2011/24/EU on the application of patients’ rights in cross-border healthcare. However, healthcare practitioners have only recently started to incorporate remote healthcare elements in practice, mainly due to the restrictions resulting from the Covid-19 pandemic.
In addition, there are several telemedicine service providers which provide intermediary services – online platforms which healthcare practitioners can use for consultations with patients. The first platform of this kind in Latvia was launched in 2020.
Necessary preconditions for telemedicine usage
Latvian law does not provide for specific regulations on telemedicine; thus, the general requirements for healthcare institutions and healthcare practitioners apply.
Healthcare institutions and healthcare practitioners
If a healthcare institution or a healthcare practitioner wishes to provide healthcare services remotely (via video calls, etc), it must comply with the general requirements of Latvian law.
Healthcare institutions must be registered in:
- the Commercial Register as a merchant or with the State Revenue Services as a performer of economic activity;
- the Register of Medical Treatment Institutions of Latvia.
Healthcare institutions must comply among others with the requirements set by the Cabinet Regulations No. 60 of 20 January 2009 “Regulations Regarding Mandatory Requirements for Medical Treatment Institutions and their Structural Units”, including requirements for their premises.
Healthcare practitioners are permitted to engage in medical treatment in the relevant profession in conformity with the competence if they have been registered in the Register of Medical Practitioners of the Republic of Latvia (and thus have acquired the necessary education and obtained a certificate). Under Latvian law, healthcare practitioners can provide healthcare services via medical treatment institutions only. Nevertheless, under the MTL, individually practicing doctors also fall under the definition of medical treatment institution. Namely, according to the law, the possible kinds of medical treatment institutions are doctors’ practices, state and local government institutions, performers of economic activity and commercial companies. Individually practicing healthcare practitioners are free to choose the legal form of establishment.
The law does not include a list of healthcare services that cannot be provided remotely. The healthcare practitioners themselves must assess whether this is possible.
Intermediary service providers – online platforms
Other type of services regarding telemedicine includes companies which are not healthcare institutions or practitioners and do not offer healthcare services themselves, but provide intermediary services for healthcare service providers. These are online platforms that ensure easy arrangement of appointments, secure communication and exchange of data, and invoicing. These companies do not have to comply with the requirements for healthcare institutions or practitioners. For example, in Latvia there are such online platforms as DoctorOnline and telemedicīna.lv.
What information is provided to the patient when providing medical care using telemedicine technologies?
The law does not specify that there must be differences between the information provided to the patient during remote medical care remotely and in face-to-face consultations with a patient. Thus, in a remote consultation the doctor should provide the same information as in a traditional consultation, including information about diagnoses, recommendations for treatment, prescriptions, etc.
What does the patient receive after the consultation?
Patients should receive an invoice approving payment for a healthcare service via e-mail or other means of communication. Just like the receipts from healthcare institutions’ cash registers, these issued invoices may be submitted to the health insurer for compensation or to the State Revenue Services in order to reduce personal income tax.
More detailed aspects of health care service invoicing are regulated by the Cabinet of Ministers Regulations No. 555 of 28 August 2018 “Procedures for the Organisation of and Payment for Healthcare Services”.
In Latvia it is possible to issue an e-prescription via the state’s maintained system e-Veselība. Healthcare practitioners can easily prescribe medicines both in traditional and remote consultations, provided that general requirements for prescription of medicinal products are met.
Pursuant to European Union (EU) regulations, the EU is now implementing ePrescriptions1, which should allow the exchange of patient data and cross-border digital prescriptions. However, at the moment, recognition of cross-border prescriptions is still in the development phase in Latvia.
3. Medical examination referral
From 1 January 2019, it is possible in Latvia to make an e-referrals on e-Veselība. Thus, doctors providing remote healthcare services can easily issue referrals. E-referrals can be used for consultations with specialist doctors, diagnostic tests and other services. Exceptions are laboratory tests and referrals for home healthcare.
4. Sick leave certificate
If necessary, the healthcare practitioner may issue a sick leave certificate electronically via e-Veselība after a remote consultation.
1) Available here.
While remote healthcare services are allowed, there are no detailed regulations regarding this. The general requirements for healthcare provision and quality apply.
Every healthcare practitioner who has the right to practice can provide the relevant healthcare services remotely. A healthcare practitioner must decide whether it is possible from a professional perspective to provide a specific healthcare service without physical examination of the patient.
Other type of services related to telemedicine include companies which are not healthcare institutions or practitioners and do not offer healthcare services themselves, but provide intermediary services for healthcare service providers, like online platforms.
While providing healthcare services remotely, healthcare practitioners may issue, with a few exceptions, the same documents as during a face-to-face consultation, including invoice, prescriptions, medical examination referrals and sick leave certificates. In most cases they can provide the same information as in a face-to-face consultation, as far as remote examination of the patient is possible.
In Lithuania, the Rules on Distance Consultations of the Minister of Health of the Republic of Lithuania, which provide detailed regulation of distant medicine services, were adopted on 10 November 2020 (hereinafter “the Rules”) and entered into force on 1 January 2021.
Under the Rules, distance consultations may be provided:
- to patients by a doctor (a family doctor or specialist doctor) or family doctor team member (general practice nurse, advanced practice nurse, community nurse, midwife, lifestyle specialist, physiotherapist or social worker);
- to doctors (family doctors or doctors providing primary outpatient mental healthcare) by other doctors (specialist doctors, family doctors or doctors providing primary outpatient mental healthcare).
Healthcare institutions are allowed to choose whether to provide distance or contact consultations based on the specific needs of particular patients; however, it is prohibited to only provide distance consultations.
The Rules put forward general requirements for both healthcare institutions and doctors/ family doctor team members with regard to providing distance consultations.
It is important to note that the Rules explicitly shall not apply to telemedicine services, which under Lithuanian laws are understood as:
- the digital transmission of data from a medical examination conducted at one healthcare institution (via the internet or on digital media) to another healthcare institution, the evaluation and description of the data from these examinations and the transmission of the results (data description and conclusions) to the healthcare institution that conducted these studies;
- emergency counselling via specialised audiovisual information services and electronic communications provided by a doctor working at or advising a type C emergency department providing multidisciplinary tertiary inpatient personal healthcare services to a doctor and/or patient from another healthcare institution emergency department.
In addition to this, distance consultations by doctors providing primary outpatient mental health care are generally regulated by the Rules on Provision of Primary Outpatient Mental Health Care, and therefore, the provisions of the Rules are applicable to a lesser extent in this field.
Since the scope of telemedicine services in Lithuania is very specialised and consequently narrow, general requirements and outcomes regarding distance consultations to patients, including several specific points regarding primary outpatient mental health care, are discussed below.
First of all, healthcare institutions and doctors/ family doctor team members providing distance consultations, including primary outpatient mental healthcare, are required to comply with the general licensing requirements which also apply to contact healthcare services.
Secondly, distance consultations, including primary outpatient mental healthcare, may be provided by the means chosen by healthcare institutions (e.g. phone, communication platforms, etc.); however, healthcare institutions are required to choose safe and secure means. Moreover, it is prohibited for doctors/ family doctor team members to use personal devices or personal accounts while providing consultations of this kind. In addition to this, all patient data and medical records related to distance consultations, must be processed in national Electronic Health Services and Collaboration Infrastructure Information System (ESPBI IS) and Pre-registration of Patients Information System (IPR IS). Nevertheless, it is explicitly prohibited to make video and/or audio recording during distance consultations.
Finally, healthcare institutions providing distance consultations are required to adopt and publicly announce a document or documents, that stipulate:
- identification procedure for the patient to whom distance consultation shall be provided;
- procedure to obtain the patient’s consent to receive such a distance consultation;
- detailed information regarding how a patient or doctor applies for a distance consultation procedure;
- procedure for providing distance consultations.
In case of primary outpatient mental healthcare distance services, healthcare institutions are also required to adopt documentation regarding the identification of a patient, the procedure for obtaining his/her consent, the procedure of applying for and obtaining distance services; however, the scope and level of detail that such a document should have is not specified.
What information is provided during the distance consultation and what does the patient receive after it?
When a particular distance consultation is provided, with the exception of primary outpatient mental healthcare, the patient receives:
- an assessment of the patient’s health condition;
- consultation, conclusions and recommendations from the doctor;
- medical records provided to ESPBI IS;
- appointment of diagnostic and/or medical services, tests and procedures;
- evaluation and discussion of the results of performed diagnostic and/or medical services, tests and procedures;
- prescription and/or renewal of prescriptions for medicinal products and/or medical aids and medical devices via ESPBI IS;
- electronic sick leave and maternity leave certificate, when the issuance or renewal of them by electronic means is allowed by specific legislation;
- appointment for contact consultation when this is necessary.
If the consultation of the patient is provided by a family doctor team member due to specifics of the question, the patient may not obtain electronic sick leave and maternity leave certificates.
In case of primary outpatient mental healthcare distance services, the purpose of these services is to prescribe re-examinations to the patient, to continue prescribing medicinal products or to provide psychological counselling services. As a result, when primary outpatient mental healthcare distance service is provided, the patient receives only:
- renewal of prescriptions for medicinal products that have been prescribed before (for children – for no longer than a month);
- appointment for repeated examinations, explanation of the results of the examinations performed, and adjustment of treatment and medication accordingly;
- psychological counselling.
The development of information technology (IT) has made it possible to significantly optimise processes in various areas of life. Thus, in the field of healthcare, IT contributes to the implementation of the main tasks in this sphere: improving the quality of medical care and ensuring its accessibility.
Telemedicine technologies are one of the most innovative manifestations of IT in healthcare. This term got its legal definition after the new version of the Act “On Healthcare”2 (hereinafter “the Act”) came into force.
Article 37-7 of the Act refers to telemedicine technologies as information technologies that provide for remote interaction of medical workers with each other and with patients for the purposes of:
- conducting medical consultations;
- providing an additional medical opinion on the assessment of the patient’s health status, clarifying the diagnosis, determining the prognosis and methods of medical care;
- physicians remotely carrying out medical monitoring of the patient’s health after an in-person appointment (examination, consultation);
- conducting medical examinations.
Thus, taking into account the purposes of using telemedicine technologies, two main types of use of such technologies can be distinguished in Belarus: telemedicine counselling and medical care with the use of telemedicine technologies.
Telemedicine Counselling (TMC) is the earliest example of the introduction of IT in healthcare. The need to develop the TMC system was first identified in the subprogram “E-health” of the National Program for Accelerated Development of Services in the field of information and Communication Technologies for 2011-2015 3. This type of counselling does not provide for direct involvement of the patient – it is instead a tool for:
- elimination of the negative consequences of staffing issues (when a healthcare organisation does not have the necessary kind of specialised physician);
- interactions between doctors of the same profile who have different skill levels, making it possible to make better decisions regarding the diagnosis and treatment of patients (a kind of “online consultation”).
The provision of medical care using telemedicine technologies is an innovation in the healthcare system of Belarus – on 23 July 2021, simultaneously with the new version of the Act, the Decree of the Ministry of Healthcare of the Republic of Belarus No. 65 dated 28 May 2021 “On approval of the Regulation on the Specifics of Providing Medical Care Using Telemedicine Technologies” came into force. This type of medical care involves interaction between a doctor and a patient and, in fact, can replace a regular face-to-face visit to a healthcare organisation.
Both for TMC and for the provision of medical care using telemedicine technologies, certain features are established in terms of procedures and their significance for patients. An expert overview of the major features is below.
2) Act of the Republic of Belarus of 18 June 1993 No. 2435-XII (as of 11 December 2020) “On Healthcare”.
3) Approved by the Decree of the Council of Ministers of the Republic of Belarus dated 28 March 2011 No. 384 (as of 12 June 2015) “On Approval of the National Program for Accelerated Development of Services in the Field of Information and Communication Technologies for 2011-2015”.
Necessary preconditions for telemedicine usage
Legal regulation of TMC is established in the Regulations on Telemedicine Counselling in the Republic of Belarus4.
The main subjects of TMC are the subscriber and the consultant. The subscriber is a doctor or a healthcare organisation that is a recipient of TMC services. The consultant is defined as a physician or a group of physicians providing TMC services.
There are two main types of TMC: online (conducted using video conferencing) and offline (the consultant prepares an opinion based on the results of an analysis of documents provided by the subscriber, without direct interaction with the latter).
Key preconditions for carrying out TMC are the patient’s consent and the presence of indications for TMC.
If both preconditions are met, a request for TMС is submitted (for online consultations) or the patient’s data is uploaded to the Republican Telemedicine server (for offline consultations).
At the consulting organisation, requests for online and offline consultations are examined by the coordinator on duty, who will further engage relevant specialists for the implementation of TMC.
Based on the results of the analysis of the submitted documents, the consultant issues an advisory opinion and recommendations, which are sent to the subscriber and are binding for them.
Unlike TMC, the provision of medical care using telemedicine technologies involves a direct dialogue between a physician and a patient.
The main precondition for the provision of medical care using telemedicine technologies to correct previously prescribed treatment is that a diagnosis was conducted and initial treatment was prescribed at a face-to-face appointment.
4) Approved by the Order of the Ministry of Healthcare of the Republic of Belarus dated 31 October 2017 No. 1250 “On Certain Issues of Telemedicine Consulting in the Republic of Belarus”.
What information is provided to the patient when providing medical care using telemedicine technologies?
Before performing TMC, the attending physician should give the patient or their legal representatives explanations regarding the necessity or desirability of TMC, as well as the possibilities and limitations of TMC. Likewise, it is mandatory to obtain the patient’s written consent to carry out TMC and to send information about their health status via telecommunication channels.
Before carrying out medical care using telemedicine technologies, the healthcare organisation is obliged to provide the patient with a wide range of information in an accessible form, including the scope of medical and diagnostic capabilities (for non-governmental healthcare organisations, the scope of the licensed work and services), about the consulting physician, about the forms and procedure for giving and withdrawing consent to processing of the personal data of the patient, about the remuneration of services, etc.
What does the patient receive after the consultation?
TMC is, in essence, a means of interaction between physicians and does not directly involve patients. Thus, for the latter, the main result of TMC is higher-quality medical care. The legislation also stipulates the right of patients to review the results of the TMC conducted and the decisions taken based on the results of its implementation.
Unlike TMC, the main goal of using telemedicine technologies is increasing the availability of healthcare. Thus, a patient who has received an initial diagnosis during a face-to-face visit can later seek advice and correction of their treatment, as well as receiving electronic prescriptions, certificates of health status, and extracts from medical documents without the need to visit a healthcare organisation.
The successful development and implementation of telemedicine technologies can play a significant role in the social and economic development of the state and society by improving the quality and accessibility of medical care for individuals, as well as creating additional opportunities for private healthcare organisations.