Telehealth Regulation

There are currently no laws or regulations specifically relating to telehealth in Australia.  Existing laws and regulations relating to the provision healthcare apply to telehealth.  However, various regulatory and industry bodies across the healthcare profession have released guidance notes on delivering services via telehealth.

For example, the Australian Health Practitioner Regulation Agency ("AHPRA"), the federal body responsible for regulation of all recognised health professionals in Australia (including medical doctors, dentists, nurses, optometrists, psychologists and numerous others) has published on its website a telehealth guidance for health practitioners ("AHPRA Guidance").  The AHPRA Guidance states that all registered health practitioners can use telehealth as long as it is safe and clinically appropriate for the health service being provided and suitable for the patient.

The AHPRA Guidance also observes that no specific equipment is required to provide telehealth services and that services can be provided through telephone and widely available video calling apps and software. However, the AHPRA Guidance continues to note that free versions of applications (i.e. non-commercial versions) may not meet applicable laws for security and privacy and practitioners must ensure that their chosen telecommunications solution meets their clinical requirements, their patient’s or client’s needs and satisfies privacy laws.

The Medical Board of Australia ("MBA"), being the regulator of the medical profession has recently published an advance copy of telehealth guidelines for medical doctors entitled “Guidelines: Telehealth consultations with patients”, which complement the existing code of conduct for medical doctors, entitled “Good Medical Practice: A Code of Conduct for Doctors in Australia”.  These new guidelines will take effect from 1 September 2023 and are discussed in the “Anticipated Reforms” section of this guide. The MBA’s current guidelines, “Guidelines for technology-based patient consultations”, will continue to operate until 31 August 2023.

No explicit regulations relating to telehealth are in place. Relevant provisions from which to source some guidance can be found inter alia in the Federal Doctors Act (ÄrzteG), Federal Dentist Act (ZahnärzteG), Federal Health Telematics Act (Gesundheitstelematikgesetz) and the Health Telematics regulation (Gesundheitstelematikverordnung). The latter specifically deals with the processing of personal electronic health data and genetic data by healthcare providers (see Privacy and data protection).

In 2013, the Minister of Health established a TeleHealth Commission (Telegesundheitsdienste-Kommission) which continues to work on improving the scope of telehealth. The Commission also adopts resolutions and provides reports to the competent Ministry of Health.

The relevant authorities in Bahrain have issued decisions, procedures and guidelines to regulate the use of telehealth in Bahrain. This includes but is not limited to the following:

• The Supreme Council of Health’s Decision No. 2 of 2019 relating to the Technical and Engineering Requirements of Health Care Facilities;
• The National Health Regulatory Authority’s (NHRA) Guideline on the Health Requirements, Technical Standards and Safety Requirements to be available in the premises and fittings of Healthcare Facilities (2019); and
• The NHRA Telemedicine Dispensing Procedure (2020).

Please note that the provision of medical consultation by a licensed physician through means of communication such as telephone, video conferences or any other electronic means is forbidden except after obtaining a license from the NHRA in Bahrain. All medical professionals are therefore subject to the technical standards and procedures set out by the NHRA.

Following the COVID-19 pandemic, there have been some recent developments with regard to teleconsultations.

Firstly, the NCOP has issued a new guidance regarding teleconsultations on 18 June 2022, which can be consulted here. From now on, teleconsultations are explicitly recognized and allowed by the NCOP on a permanent basis. However, this guidance contains several conditions (f.ex.: the doctor’s ability to control the patient’s identity, the patient’s free will, …) that have to be met in order to proceed with the teleconsultation. Additionally, a therapeutic or care relationship must exist between the person in need of care and the doctor before the teleconsultation. This will have to be proven in accordance with the regulations on electronic evidence of a therapeutic care relationship.

Secondly, on 1 August 2022, a new framework for the reimbursement of teleconsultations has entered into force. Telephone and video consultations will be unlimitedly reimbursed, if they occur (i) with healthcare professionals with whom the patient already has a treatment relationship, (ii) with a specialist on referral from a general practician, or (iii) within medical guard service.

The COVID-19 pandemic brought acceleration to the process of implementing digital routines in healthcare.

The fact is that significant steps have been taken in the last few months to define clearer criteria for the still early-stage idea of Digital Health in the country – and most of those are already strongly accepted by most of the market players. All of them have the primary objective of facilitating the continuity and development of the entire supply chain of products and services associated with digital therapeutics, as well as the ability to enter and expand upon the domestic market. This growth inevitably drives healthcare consumerism, so the pursuit of disruptive and revenue-generating opportunities should be – and, for some, has already been – a point of great attention.

The Federal Law n. 14,510/2022 came into force in December 2022, incorporating telehealth into the Brazilian healthcare system. It now authorizes and regulates the practice of telehealth throughout the domestic market, both in the public and private health systems, covering the provision of services related to all regulated health professions in the country. It also encompasses offsite care in nursing, physiotherapy and psychology. It also authorizes and describes the practice of telehealth, defined as the modality of providing health services remotely through the use of technology in its lato sensu.

The modality is now also supported, from an ethical perspective, by regulations from many of the respective Professional Boards, such as the Medicine, the Pharmacy, the Dentistry, and the Nursing ones. For example, The Brazilian Federal Council of Medicine (in Portuguese, “Conselho Federal de Medicina” or “CFM”), through its Resolution n. 2,134/2022, which is into force since last May, regulates the practice of telemedicine and, in general, disciplines and safeguards (i) the confidentiality, privacy and protection of the data and image of patients appearing on physical or electronic medical record (i.e., which shall meet all the representation, terminology and interoperability standards); (ii) the professional’s autonomy regarding the decision to use the telemedicine, as well as on when using it (i.e., including the first consultation, the medical assistance or the respective procedure), except concerning the medical treatment for chronic diseases and/or diseases which require a long-term monitoring, related to which the personal presence is required; (iii) the patient’s and/or legal representative’s informed consent; (iv) the possibility of telehealth’s exercising in the modalities of teleconsultation, teleinterconsultation, telediagnosis, telesurgery, telemonitoring or telesurveillance, teletriage and teleconsultancy; (v) the patient’s and doctor’s full right to discontinue the telemedicine consultation/treatment and/or opt for the face-to-face modality; and (vi) the several mandatory information to be included in the medical reports, certificates and/or electronic medical prescriptions. When it comes to telepharmacy, the Federal Council of Pharmacy (in Portuguese, “Conselho Federal de Farmácia” or simply “CFF”) approved a resolution allowing pharmacists to use technology to deliver services to their patients, covering the provision of offsite pharmaceutical care and other healthcare services through video calls, telephone or chat, so that patients can get answers to their questions about pharmacotherapy and adverse drug reactions easily. In addition, given the content of this CFF’s resolution, several new activities will be enabled in an easy, quick and safe way, such as (i) the issuance of clinical reports, (ii) expert assessments based on tests carried out in the pharmacy, in addition to, consequently, (iii) greater interaction between patients, doctors and pharmacists.

Additionally, considering the Brazilian public health system ("SUS") exclusively, the Brazilian Ministry of Health’s Ordinance n. 1,348/2022 sets forth the terms for provision of telehealth services at the public health system level.

The new Brazilian Telehealth regulation (i.e., Federal Law n. 14,510/2022) revoked the Law n. 13,989/2020, which temporarily and provisionally permitted telemedicine services while the fight against COVID-19 was ongoing – given that many methods of epidemiological surveillance were adopted at that time to control the spread of the disease in the country, such as social isolation, quarantine measures (i.e., lockdown), contact tracing etc., what contributed to the encouragement of telehealth as an effective form of remote care to help maintain social distancing.

It is also important to mention that before the pandemic, from a legislative and legal perspective, since 2007 there have been several ordinances issued by the Ministry of Health providing for telehealth services exclusively within the scope of the Brazilian public health system (SUS). However, there was no law specifically disciplining the matter – a fact that undoubtedly generated legal uncertainty, especially for the private sector. As for the Professional Board of Medicine’s Resolution n. 1,643/2002, the provisions on telemedicine were also extremely vague and not supportive of the development of telehealth business models in Brazil, a reason why nobody operating in the private sector previously considered telehealth services as an interesting way of doing business in Brazil.

This mindset changed in the country based on the strong evidence supporting the use of telehealth for the provision of remote clinical and non-clinical health services, and attention is finally being paid in Brazil to this type of healthcare assistance.

No regulations.

Telehealth is defined and regulated differently from province to province in Canada. Colleges in Canada’s provinces and territories set the standards of care for the practice of medicine, including telehealth / telemedicine.

For example, in Ontario, the College of Physicians and Surgeons of Ontario (the "CPSO") defines "telemedicine" as "both the practice of medicine and a way to provide or assist in the provision of patient care (which includes consulting with and referring patients to other health-care providers, and practising telemedicine across borders) at a distance using information and communication technologies such as telephone, email, audio and video conferencing, remote monitoring, and telerobotics."

Additionally, each province’s respective health insurance plan dictates whether telehealth services will be reimbursed by the province. Further, for those services not covered by provincial health insurance plans, they may be covered by private health insurance plans (i.e. dental services) – each respective private health insurer’s plan will dictate whether telehealth services will be reimbursed.

• Political Constitution of the Republic: The constitutional text establishes as the duty of the Chilean State the protection of the free and equal access to actions of promotion, protection and recovery of health and rehabilitation of the individuals.
• Decree with force of Law No. 1 of 2005: This regulation establishes the responsibility of the Ministry of Health of guaranteeing the right to access to healthcare, as well as to coordinate, control and execute such actions, where appropriate and regulates public health agencies.
• Law No. 20,584, enacted in 2012 and Decree No. 41, both issued by the Ministry of Health, which regulate the rights and duties of individuals in relation to actions related to their health care.
• Law No. 19,628, enacted in 1999 on Protection of Private Life. This law regulates the processing and treatment of persona data. It contains regulation of sensitive data, which is defined as personal data that refer to the physical or moral characteristics of persons or to facts or circumstances of their private life or intimacy, such as personal habits, racial origin, ideologies and political opinions, religious beliefs or convictions, physical or psychological health conditions and sexual life.
• National Program for Telehealth of 2018: This program, part of the digital transformation plan fostered by the Chilean Government, considers telehealth as a strategy based on the Model of Integrated Family and Community Healthcare, in the context of Integrated Health Services Networks. It aims to generate the technical, technological, administrative, organizational and financial conditions for the provision of telehealth services in both the public and private sectors. This program also sets forth the principles, objectives and strategies for the implementation of telehealth services throughout the country.
• Memorandum A15 No. 04995 (2013) and Memorandum A15 No. 0223 (2015), both issued by the Ministry of Health: These documents define the concept of telemedicine (in similar terms as those introduced by the WHO), explain the reasons why telemedicine is relevant for the provision of healthcare services, especially for patients living in remote areas, define in broad terms the professional liability standard, and provide precise obligations for telemedicine consultations in accordance to the legal standards (i.e., classify telemedicine as a non-invasive medical procedure with no relevant risks for patients).
• Resolution No. 277 of 2011: This resolution establishes technical and administrative rules applicable to certain agents of the Chilean public health system. Some general rules regarding telehealth or telemedicine are established through this Resolution, such as the following:
  • The healthcare institution is responsible for ensuring that the healthcare practitioner provides this service in a private and dedicated environment. It is prohibited to perform it in places of public access where the privacy of the beneficiary may be compromised.
  • The healthcare institution is responsible for ensuring that the service is provided personally by the practitioner chosen by the patient.
  • The healthcare institution must take all information security measures so that the direct doctor-patient interaction is carried out in a safe manner, taking care of the privacy of the patient and maintaining the safety and registration of their clinical records.
  • The healthcare institution must provide the patient with a list of available hours and doctors specialized in this modality, as well as remind the beneficiaries of the limitations of this modality.
  • In case of requiring the issuance of an electronic medical prescription, the professional will do so through electronic means declared by the provider at the time of registration.

Finally, it should be noted that this resolution was modified and updated by:

• Resolution No. 54/2020, which incorporated a definition of teleconsultation into the technical-administrative rules governing the free-choice tariff of the National Health Fund ("Fonasa") and included certain telemedicine services, including teleconsultation in dermatology, psychiatry, neurology, among others;
• Resolution No. 204/2020 of the Undersecretariat of Public Health, which introduced measures aimed at expanding and regulating public health insurance coverage for remote care during the COVID-19 pandemic. In this regard, a list of first medical consultations and follow-up consultations was included in the public health insurance. The Resolution also specified the duty of healthcare providers to take all information security measures to ensure that when telemedicine is provided, the direct interaction between the physician and the beneficiary is carried out in a secure manner, taking care of the patient's privacy;
• Resolutions Nos.226//2020, 227/2020, 351/2020 and 220/2021, which incorporated new medical care codes under the telemedicine modality; and
• Resolution No. 436/2021, which incorporated definitions for teleconsultation, telerehabilitation and synchronous care, among other amendments.The Regulation will cover matters including:
  • the minimum technological standards that platforms must have when providing telehealth services;
  • the conditions that must be followed to ensure confidentiality of patient data;
  • the information that telehealth service providers must provide to patients; and
  • how patient clinical records ought be accessed and safeguarded.

In the context of the COVID-19 pandemic, the following regulations have also been issued:

• Decree 22/2019 of the Undersecretariat of Health Care Networks, which approved Explicit Health Guarantees ("GES") of the General Regime of Health Guarantees, and can now be granted by means of telemedicine, teleconsultation and other digital health uses according to the Technical, Medical and Administrative Regulations.
• Ordinary A15 N°2448/2020 of the Undersecretariat of Public Health, on the use of information and communication technologies in the health sector. This regulation established strategic guidelines on telemedicine in synchronous and asynchronous modalities, teleconsultation, telephone contact, development of remote care, administrative and registration aspects, and the rights of patients.
• Oficio Circular N°7/2020 of the Superintendence of Health. This regulation established certain criteria regarding the rights of patients in terms of general and financial information, physical space where remote care will take place, the development and timeliness in which medical care will be provided, the due safeguarding of patient privacy, and the duty of confidentiality.
• Oficio Circular 49/2020 of the Superintendence of Health, which establishes the issuance of electronic medical licenses in authorized remote medical consultations.

A series of administrative rules were promulgated on July 17, 2018 by PRC National Health Commission and National Administration of Traditional Chinese Medicine pursuant to PRC State Council’s Opinion to Promote "Internet Plus Healthcare" promulgated on April 25, 2018. These administrative rules include the following:

• Administrative Measures for Internet Diagnosis and Treatment (For Trial Implementation);
• Administrative Measures for Internet Hospitals (For Trial Implementation); and
• Good Administrative Practice for Remote Medical Services (For Trial Implementation).

In addition, on February 8, 2022, PRC National Health Commission and National Administration of Traditional Chinese Medicine further promulgated Rules for the Supervision of Internet Diagnosis and Treatment (For Trial Implementation).

Currently there is no law or administrative regulation, which has greater legal authority than administrative rules, enacted to specifically govern telehealth or internet health.

Telehealth is governed by Law 1419 of 2010, which allows the provision of health services in this manner, and Resolutions 2654 and 3100 of 2019, issued by the Ministry of Health. These rules set out specific requirements and standards to be fulfilled in order to provide telehealth. These requirements are related to the compliance with data protection regulation, as well as the security and reliability of the platforms (ICT) used for telehealth (see below).

As any other health services, the provision of telehealth requires the prior authorisation of the local authority. For this purpose, the provider is required to demonstrate that it complies with the minimum standards in relation to infrastructure, management of clinical records, human resources, medicine and medical devices, among others. However, as a result of the COVID-19 pandemic, through Decree 538 of 2020, authorised health services providers can request transitory authorisation from the Ministry of Health to provide services in different conditions or new services that they were not previously authorised to provide (e.g., telemedicine).

These laws and requirements are in addition to the applicable laws and regulations that govern the authorisations necessary to provide health services generally.

According to Articles 5 and 35 of the Telemedicine Ordinance, healthcare institutions, healthcare workers, companies performing healthcare activities and private healthcare workers performing telehealth activities in the Republic of Croatia must (i) obtain a four-year Telemedicine Center Approval issued by the Croatian Institute of Emergency Medicine (Hrvatski zavod za hitnu medicinu – "Institute"); and (ii) be included in the Network of Telemedicine Centres (Mreža telemedicinskih centara). This network has been established under the Croatian Decision on the Adoption of the Newtwork of Telemedicine Centers adopted by the Croatian Minister of Health ("Network Of Telemedicine Centers Decision"). It is noted that, in relation to the approval from the Institute, the applicant must comply with the various infrastructure, equipment, and software requirements imposed by Articles 28 et seq. of the Telemedicine Ordinance.

Pursuant to Article 3 of the Telemedicine Ordinance, a telemedicine centre can be of two types:

• A telemedicine access centre, being an institution where one can receive telehealth (telemedicine) services; or
• A telemedicine specialist centre, being an institution where one can receive and be provided with telemedicine services according to specialties.

Pursuant to Article 3 (4) of the Telemedicine Ordinance, a telemedicine centre may be stationary and / or mobile, and, moreover, allowed to be performed either with direct interaction of participants (i.e., real-time communication between the service seeker, the service recipient and the teleconsultant), or without direct interaction of participants (see Article 4 (6), (7), and (8) of the Telemedicine Ordinance).

The applicable legislation does not specify the ways telehealth services may be provided. However, the legislation stipulates that telehealth services are provided through a network communication system that forms a common health basis for secure data exchange and interoperability tools (technical standards, classifications and network communication infrastructure). The purpose of such a network is to ensure the connectivity and interoperability of registers and information systems in the public health system of Croatia and to provide common elements for interaction with citizens or other users.

Further, the Healthcare Act provides that the medical and public health data can be collected through the mobile healthcare platform mZdravstvo (in English: mHealth) which involves the use of mobile communication devices for the collection of general and clinical health data, the transfer of health information to physicians, researchers and patients, and remote monitoring of medical parameters of the patient.

The Act on electronization of healthcare introduces a comprehensive legal framework for the basic infrastructure of electronic healthcare and defines roles and responsibilities of entities in the electronic healthcare system. The new legislation has a split effect, with the first part of the act came into force on 1 January 2022, other parts coming into force during 2023 and 2024, and the full act should then come into force on 1 January 2026.

In Denmark there are no specific laws relating to telehealth. Instead, telehealth is regulated by the health legislation in Denmark in general.

The Danish Healthcare Act (LBKG 2019-08-26, nr. 903) regulates main aspects of the Danish healthcare system including patients’ rights, the use and processing of personal health data and the maintenance of and responsibility for a collective digital infrastructure.

Furthermore, the Danish Ministry of Health has adopted the Danish Requirements for Security of Network – and Information Systems Within the Healthcare Sector Act. The Act implements parts of Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 and aims to secure a high level of protection of such systems to secure the operation of a functional healthcare system.

Existing legislation does not currently comprehensively address the issue of telehealth or telemedicine services. The Act on the Electronic Processing of Client Data in Healthcare and Social Welfare (784/2021), which in 2021 repealed the prior version of the Act, sets out the general requirements for all data systems and their suppliers as well as for healthcare service providers. Furthermore, the Act on Electronic Services and Communication in the Public Sector (2003/13) sets out requirements on the rights, duties and responsibilities of the authorities and their customers in the context of electronic services and communication. The Private Healthcare Act (152/1990), the Private Healthcare Decree (744/1990) and the Private Healthcare Decree issued by the Ministry of Social Affairs and Health (7/2006) sets out certain requirements for private healthcare providers. The Act on the Status and Rights of Patients (785/1992) applies to the status and rights of patients in health care and medical care. The Act on Health Care Professionals (559/1994) applies to health care professional and promotes safety of patients and improves the quality of health care services.

The National Supervisory Authority for Welfare and Health (Valvira) has issued guidance for telehealth services including a list of requirements for telehealth providers. In addition to Valvira, also the Finnish Medical Association has issued recommendations for telehealth.

Furthermore, all online services (websites) offered in the public sector must be accessible. This means that online services must be easily accessible to all users, especially those with disabilities. The accessibility of digital services is governed by the Act on the Provision of Digital Services (306/2019). The requirements laid down in this Act also apply to Kanta Services, in which patient data is shared between healthcare organisations, pharmacies and citizens. It should be noted, that the requirements of accessibility will be applied to mobile services in June 2021.

The Regional State Administrative Agency ("AVI") supervises the enforcement of accessibility. For example, Web Content Accessibility Guidelines 2.1 ("WCAG") developed by the World Wide Web Consortium covers a wide range of recommendations for making Web content more accessible. According to the instructions given by the supervisory authority (the AVI) the WCAG will make the content more accessible to a wider range of people with disabilities.

In France, telehealth (“télémédecine”) has been formally introduced in the French Public Health Code (“FPHC”) since the adoption of Law No. 2009-879 of July 21, 2009 on hospital reform and relating to patients, health, and territories (Art. L. 6316-1 et seq. and R. 6316-1 et seq. of the FPHC).

In particular, the use of telehealth is subject to the following:

• Appropriate training and qualification of professionals resorting to telehealth;
• Respect of the patients’ fundamental rights (information and consent);
• Appropriate patient’s training or preparation to use the telehealth device, if needed;
• Requirements in terms of authentication and identification of healthcare professionals and patients on the telehealth device or platform;
• Access of medical professionals to medical records;
• Requirements related to health data hosting and other data protection rules.

French authorities have further published guidelines to facilitate the implementation of telehealth. In particular:

• the French National Health Authority (Haute Autorité de Santé, the “HAS”) published a set of guidelines and specific information memo (e.g., a memo intended for professionals on teleconsultation and tele-expertise, a good practice guide on teleconsultation and tele-expertise, a good practice guide on tele-care, information sheet intended for patients regarding teleconsultation and tele-care);
• The French National Health Insurance (Assurance Maladie) published a Charter of teleconsultation good practices.

Please note that further requirements apply for the reimbursement of certain telehealth procedures by social security schemes.

In Germany, the requirements of telehealth are not regulated in one specific law, but rather in a patchwork of different laws, regulations and directives.

Essential aspects of telehealth, e.g. remote treatment, prescription, reimbursement, documentation and informed consent requirements, are regulated, inter alia, in the new German Patients Data Protection Act (“PDSG”), the German Social Code Book V ("SGB V"), the German Federal Framework Agreement for Physicians ("BMV-Ä"), the German Drug Act ("AMG"), the German Act on Drug Advertising ("HWG"), the Model Professional Code for Physicians in Germany ("MBO-Ä") and the Model Professional Code for Psychological Psychotherapists and Child and Youth Psychotherapists ("MBO-P").

In addition, in December 2019, the German Digital Healthcare Act ("DVG") entered into force, introducing digital health apps as a new category of medical benefits which may be prescribed by doctors and have to be reimbursed by the Statutory Health Insurers ("SHI" – "GKV") subject to further requirements according to Sec. 33a of the SGB V.

Telehealth is regulated by virtue of article 66 par. 16 of Law 3984/2011 (A’ 150), which reads as follows:

Telehealth services are provided if possible and under the responsibility of the treating doctor who is dealing with each case. The doctor, for the purposes of the protection of personal data, is responsible to request from the patient, or if this is not possible from a relative of first degree, the signed approval for the use of telehealth services. If this is not possible, then doctor shall offer telehealth services at his / her own discretion. The instructions of the hospitals and health units, which provide telehealth services are offered for advisory purposes and they are under no circumstances mandatory.

There is no legislation or regulation governing telemedicine in Hong Kong. The Guidelines issued by the Medical Council are not binding and not exhaustive. The Guidelines state that they are to be read in conjunction with the WMA Statement on the Ethics of Telemedicine, however, the provisions of the Guidelines shall prevail if those set out in the latter are different (Guidelines, page 2, para. 8).

Telemedicine includes a wide range of activities, including but not limited to the following four principal areas:

1. Tele-treatment of patients within the definition of WMA;
2. Collaboration between doctors and / or with other healthcare professionals through telecommunication systems;
3. Monitoring of patients through telecommunication systems; and
4. Dissemination of service information and / or health education to the public (including patients) through telecommunication systems.

(The Guidelines focus on the first three areas. Doctors practising in Hong Kong are therefore advised to familiarise themselves with the requirements under Part B of the Code of Professional Conduct issued by the Medical Council before carrying out any activities falling under the fourth area (Guidelines, pages 1, para. 4).)

The Guidelines do not constitute a legal document, however, contravention of the Guidelines may render doctors liable to disciplinary proceedings. The Guidelines are not intended to be applied to overseas-qualified doctors who practise telemedicine on patients in Hong Kong (Guidelines, page 2, para. 7). The Medical Council, however, may report any unregistered medical practitioners practising telemedicine on patients in Hong Kong to the relevant professional body and / or law enforcement agency.

Health Minister Decree no. 60/2003 sets out the minimum requirements for the provision of general healthcare services listing specifically healthcare services that can be performed via telemedicine. Followed by the COVID-19 pandemic regulations the scope of permissible telehealth activities in Hungary has been extended significantly. As a result, telehealth services shall be permissible in all forms of patient care, where this is practically possible and reasonable from a medical perspective, the latter to be decided by the physician and supervised by the healthcare regulatory authorities.

Further Act 144 of 1997 on Health Care provides for the general application of telemedicine services. The Act says that Healthcare service providers shall be able to provide healthcare services fit for telemedicine where facial identification is prescribed necessary stemming from the unique characteristics of the treatment and due to medical reasons - by means of information and communication infrastructure capable of transmitting video and audio signals with facilities for facial recognition.

In summary, the current legislative changes have made it possible to deliver almost all out-patient healthcare services via telehealth services, provided that the technology background is given (at both ends) and that the patient need is both reasonable and medically justifiable to be fulfilled via telehealth services.

Telehealth is not regulated specifically in Ireland, and there is a lack of legislation and regulatory schemes specific to digital health IT and eHealthcare.

However, there are several legislative and regulatory schemes which apply to the practice of virtual medicine, such as consumer and data protection by way of general application, and tailored legislation for medical professionals.

In respect of the provision of health services, the Health Act 2004 and the Health Act 2007 apply to medical services. Healthcare practitioners involved in telehealth will be subject to the applicable regulations and codes of practice for their profession, for example, doctors providing medical services via telehealth are required to be registered with the Medical Council, as is required when providing services via traditional means. Doctors providing telemedical services must also comply with the standards of good practice, and the ethical guide deals specifically with telemedicine and reiterates that doctors must be satisfied that the telehealth services being provided are safe and suitable. It is important that all healthcare providers comply with the relevant codes of conduct, regardless of the means by which the services are provided, and these guides may also specifically address the provision of telehealth.

On 3 April 2020, the following regulations came into force (S.I. No. 98/2020 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2020 and S.I. No. 99/2020 - Misuse of Drugs (Amendment) Regulations 2020) to facilitate the electronic transfer of prescriptions from a prescriber to a pharmacy and to allow further supplies of existing prescriptions by pharmacists to patients during the COVID-19 pandemic. Although intended to be temporary to deal with the Covid 19 emergency, these Regulations are still in force to ensure continued care and treatment for patients (see here for the guidance for prescribers and pharmacists on the legislation changes).

In addition, the National COVID-19 Telehealth Steering Committee has mandated a Remote Patient Monitoring Working Group to examine international evidence for use of remote patient monitoring solutions and to develop guiding principles for their implementation. As a result, operational guidance for telehealth implementation has been developed (see here for the guidance for acute hospitals; and here for guidance for community services).

In respect of the information processed in order to provide telehealth, there is a robust legislative framework in Ireland in respect of data protection. The General Data Protection Regulation is implemented in Ireland by the Data Protection Act 2018, and supplemented by the Data Protection Act 2018 (Health Research) Regulations 2018. In terms of cybersecurity, at an EU level, the Network and Information Systems Directive 2016/1148 governs regulation round cybersecurity and the protection of information.

eHealth Ireland is an independent body, set up by the Health Services Executive, which leads strategy and guides the implementation of telehealth. eHealth Ireland liaises with key stakeholders in this area and has developed several strategic programmes leading eHealth developments in Ireland. Guidance produced by eHealth Ireland recommends that all eHealth systems should be patient-centric, and there should be an emphasis on efficiency, transparency, and ease of access.

Any contractual engagement entered into in relation to the provision of telehealth services may be governed by Irish law, and a patient may have rights under Irish law to bring a case for any tort, negligence or breach of contract.

The Health Service Executive (HSE) has operational responsibility for the public provision of healthcare, including telehealth. The Data Protection Commission (DPC) is the national authority in Ireland with oversight over the management and processing of data. The Health Products Regulatory Authority (HPRA) has a regulatory role to monitor the safety of medical devices in Ireland after they are placed on the market, including mobile applications for diagnosing a disease or medical condition. The Global Observatory for eHealth of the World Health Organization defines Mobile Health (mHealth) as “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices.” This includes mobile devices including smartphones and tablets, as well as devices that provide real-time patient monitoring like FitBits and other wearables.

From an intellectual property perspective, there are laws regarding copyright and database rights, and the processing of sensitive data is a highly regulated area.

In 2014, the Italian Ministry of Health ("MoH") issued specific guidelines which, although not binding, provide useful indications on how telehealth services should be performed in Italy ("MoH Guidelines"). The MoH Guidelines substantially reflect the definition of telehealth provided by the WHO, i.e., the delivery of healthcare services using ICT for the exchange of information, in situations where patients and providers (or two or more providers) are separated by distance.  The rules and principles applicable to traditional healthcare services also apply to telehealth services, to the appropriate extent. In this sense, the MoH Guidelines clarify that Article 8-ter of Italian Legislative Decree 502/1992, which establishes the obligation to obtain authorization to provide healthcare services, also applies to telehealth. However, it must be noted that the MoH Guidelines do not consider telehealth services as a substitute for traditional healthcare services, but rather as an additional tool to enhance the efficacy and efficiency of the Italian National Health System (“NHS”).

In March 2016, the MoH issued a decree establishing the National Centre for Telehealth (Centro nazionale per la telemedicina e le nuove tecnologie assistenziali) within the Italian National Health Institute (Istituto Superiore di Sanità – "ISS"), to promote and coordinate research on telehealth.

The Covid-19 pandemic boosted the use of telehealth.  In 2020:

• The Italian Medicines Agency (AIFA) adopted several measures to cope with the COVID-19 pandemic, including the remote performance of certain activities by HCPs and third-party providers in the context of clinical trials;
• The ISS issued specific guidelines for the provision of telehealth services during the COVID-19 pandemic;
• The MoH updated the MoH Guidelines.

Moreover, telehealth became one of the pillars of the Italian National Recovery and Resilience Plan (“PNRR”).  The PNRR is part of the Next Generation EU (NGEU) program, the EUR 750 billion program that the European Union negotiated in response to the Covid-19 pandemic, and envisages six (6) missions.  Mission 6 of the PNRR is dedicated to healthcare and allocates a total of EUR 18.5 billion for the modernization and digitalization of the Italian NHS. 

Accordingly, after the launch of the PNRR Italian authorities adopted several guidelines and regulations on telehealth:

• On 6 August 2021, the Ministry of Economy and Finance issued a decree that, in the context of the PNRR, allocates EUR 1 billion to the improvement of telehealth in Italy;
• The MoH adopted several decrees, including:
  • Decree of 23 May 2022, which provides indications on the use of telehealth for homecare services;
  • Decree of 21 September 2022, which approved the requirements for the implementation of telehealth services at the regional level;
  • Decree of 30 September 2022, which establishes the procedures to approve projects on telehealth at the regional level.

Moreover, on 11 October 2022 the Italian National Agency for Regional Health Services (“Agenas”) launched a bidding process for the implementation of the National Telehealth Platform (piattaforma nazionale di telemedicina).  The National Telehealth Platform will serve as the central infrastructure to ensure uniformity in the delivery of telehealth services across Italian regions and autonomous provinces.  On 8 March 2023, the Agenas and the company that was awarded the tender signed the agreement for the design, implementation, and management of the National Telehealth Platform.

Telehealth is regulated under the following regulations:

• Regulation of Minister of Health of the Republic Indonesia Number 20 of 2019 regarding the Organisation of Telemedicine Services through Health Service Facilities;
• Circular Letter of the Minister of Health No. 2 of 2020; and
• Indonesian Doctors Association Regulation No. 74 of 2020.

In Japan, telehealth is generally subject to the Medical Practitioners’ Act (the "Act") and various guidelines issued by the Minister of Health, Labour and Welfare (the "MHLW") and other government agencies.

Under Article 20 of the Act, medical practitioners cannot provide medical care or issue a medical certificate or prescription without personally performing a "medical examination". Under the guideline issued by the MHLW ("Guideline 1"), telehealth is not considered a "medical examination" under the Act unless the relevant medical institutions, medical practitioner, patients, and any other relevant person comply with the following requirements:

• Each medical practitioner shall enter into an agreement regarding telehealth with each patient after providing sufficient information to the patient;
• The first examination of each patient is conducted face to face to collect accurate information from such patient;
• Medical institution / practitioner shall prepare and preserve the treatment plan of each patient;
• Confirmation of both parties’ IDs at the beginning of each telehealth meeting, such as doctor’s license and patient’s driver license;
• Accurate management of the pharmaceutical drugs each patient has taken before or during the telehealth treatment;
• Setting up a system which allows medical practitioners to obtain the same information from the patient as in the case of face-to-dace examination;
• Medical practitioner needs to provide telehealth services from a location so that he / she can obtain sufficient and accurate information about the patient’s physical and mental condition, such as an isolation room in a hospital;
• Medical practitioners need to attend a training prescribed by MHLW before providing telehealth service;
• A patient receives telehealth services from a location so that his / her privacy is secured, such as his / her home; and
• Medical practitioners institutions, and any other relevant person need to set up security systems to protect patient’s personal information and any other important information.

However, in response to the COVID-19 pandemic, the MHLW issued a new guideline ("Guideline 2"). Under Guideline 2, telehealth can be conducted for the first examination of a patient as long as the medical institutions, medical practitioners, patients, and any other relevant person comply with following extra requirements in addition to the requirements discussed above:

• The medical practitioner shall collect accurate information about the patient based on some documents such past medical reports of the patient;
• The medical practitioner shall not prescribe any high risk pharmaceutical drug such as narcotics and psychotropics; and
• The medical institution shall submit reports regarding the telehealth services they provide as requested by the MHLW to local authorities every month.

However, under Guideline 2, it is not necessary for medical practitioners (excluding dentists) to attend the training prescribed by the MHLW before providing telehealth service.

Section 104 of the Health Act empowers the Cabinet Secretary for Health to ensure the enactment of legislation that provides for, among other things, health service delivery through m-health, e-learning and tele-medicine. However, the Cabinet Secretary has not yet published any Rules or Regulations on telehealth. At present, Kenya has a National eHealth Policy and Guidelines for mHealth Systems.

The Kenya National eHealth Policy (2016-2030) was developed with the aim to improve the availability and quality of healthcare services through the use of ICT. The objectives of the Policy are: enhancing interaction between client and health service provider; accelerating achievement of universal health coverage; and enhancing electronic exchange of health data and information.

The Kenya Standards and Guidelines for mHealth Systems were published in April 2017 and are applicable to the health sector at all levels of healthcare and health management both at the national and county government levels to support service delivery and facilitate referral mechanisms utilizing mobile technologies. The Guidelines contain the requirements that should be considered in the development, implementation, support and maintenance of mHealth systems. They also set out the standards for electronic consultation and prescription.

The Health Information System Policy (2010-2030) was also developed with the aim of improving health information products and health services, to enhance the application and use of ICT to improve access and quality of health care and improve the privacy, confidentiality, and security of information sharing and use.

Telehealth is covered under Medical Practice Law No. 70 of 2020.

There are no specific laws regulating telehealth.

The Luxembourg government issued specific rules relating to teleconsultation in the context of the COVID-19 pandemic and a code of conduct on the organisation of the health system during the COVID-19 pandemic (both are in French language).

These guidelines provide that health professionals (i.e., physicians regardless of their specialty, dentists and midwives) are free to decide whether or not to use teleconsultation. However, the health professional must have met the patient beforehand. Ideally a physical consultation must have taken place in the last 12 months prior to the teleconsultation but in order to avoid unnecessary patient travel, exceptions may be allowed. In addition, the government recommends that health professionals ensure patients understand all the information given to them, as well as all recommendations and prescriptions made.

Furthermore, teleconsultation is a medical act and thus, it must meet all the regulatory and ethical requirements normally applicable to the different health professionals respectively.

There are no specific laws that relate to, and / or regulate, telehealth.

After an initial project from December 2015 till 27 April 2018 – being the Mexican Official Standard "PROY-NOM-036-SSA3-2015 for the regulation of distance medical attention" ("NOM Project"), which established regulation of procedures for healthcare personnel conducting remote healthcare services – the Mexican Government has taken the approach that telehealth is an activity integrated in health services and therefore, the laws and regulations (such as the General Health Law and the Regulations of the General Health Law in Matters of the Provision of Health Care Services) applicable to general healthcare services, shall apply to telehealth too.

Telehealth is mainly regulated by a Decree in Morocco. This being said, Law no. 131-13 on the practice of medicine introduced in 2015 telehealth as a practice of medicine to be regulated by Decree.

Decree no. 2-18-378 on telehealth (‘the Decree’) was published in mid-2018 to regulate all telehealth services, which include the following services:

• Remote medical consultation;
• Remote medical expertise;
• Remote medical monitoring; and
• Remote medical assistance.

The Decree subjects service providers to a prior authorization process and provides for obligations upon telehealth service providers which should be complied with and maintained for the duration of the provision of the relevant telehealth services.

There is no specific regulation of telehealth in Namibia.  Telehealth therefore falls under the general regulatory framework for the provision of health services.

There are no specific regulations regarding telehealth, but an array of regulations which healthcare should be compliant with, such as the qualification criteria of the HCP, the informed consent of, and agreement with the patient, and data protection.

This includes among others the Healthcare Quality, Complaints and Disputes Act (in Dutch: Wet kwaliteit klachten en geschillen in de zorg (Wkkgz)). Further, the Health and Youth Care Inspectorate, who supervises healthcare and youth care services in the Netherlands, created frameworks for telehealth. These frameworks set out the relevant standards and criteria based on applicable laws and regulations. This concerns for example the “Inzet van e-health door zorgaanbieders” and “Telemonitoring van volwassenen thuis” (only available in Dutch).

There are no specific laws regulating telehealth in Nigeria outside the law governing the provision of healthcare services in general i.e. the National Health Act 2014 and its subsidiary legislations, directives, guidelines etc. Other supporting laws include:

• National Information Technology Development Agency (2007), the Nigeria Data Protection Regulation (2019) and the Nigeria Data Protection Implementation Framework (2020).
• Medical and Dental Practitioners Act, Cap M8, Laws of the Federation of Nigeria, 2004.
• Nigerian Communications Commission Guidelines.
• Code of Medical Ethics 2008.
• Standards Organization of Nigeria Act of 2015.
• National Agency for Food and Drug Administration and Control 2004.
• Federal Competition and Consumer Protection Act 2018.

There are no specific laws in New Zealand that govern telehealth.

The regulatory framework under which health practitioners are required to operate is silent on whether a practitioner located overseas and providing services from overseas is required to be registered in New Zealand.

There are standards and guidelines that apply broadly to the provision of telehealth in New Zealand, including:

• Telehealth guidelines and position statements issued by professional bodies, such as the Medical Council of New Zealand, The Royal New Zealand College of General Practitioners, and the Dental Council New Zealand.
• Te Whatu Ora Health New Zealand Health Information Standards Organisations relating to video-conferencing and Health Information Security Framework.

Telehealth is not specifically regulated (yet, see Anticipated reforms), but must comply with the general legislation on providing healthcare services, including protection of sensitive personal data (see Fields of healthcare).

Telehealth development is primarily handled by two public bodies. The Norwegian Directorate of eHealth coordinates eHealth by cooperating with e.g. regional health authorities and local authorities, as well as develops and administers digital solution for the improvement and simplification of the healthcare sector. The Norwegian Health Network is a state-owned enterprise, owned by the Ministry of Health and Care Services, whose task is to develop, manage and operate national e-health solutions and infrastructure.

There is no regulation for telehealth as the Omani Laws were silent about it. However, the telehealth as a practice is permitted. The only two points that we need to highlight are 1) In general, practicing the medical and pharmaceutical activities in Oman required license from Ministry of Health based on article 7 of the Royal Decree (22/96) Regulating the practice of human medicine and dentistry. 2) Finding any way for diagnosis, treatment and rehabilitation of the patient are not permitted without license based on the article (17) of the same Royal decree.

There is no comprehensive domestic regulation on telehealth – telemedicine is regulated fragmentarily in a few acts of law. Act of 5 December 1996 on the Professions of Physician and Dentist provides a general possibility of rendering the telemedical services. Some other acts regulate certain aspects of telemedical services.

Recently a new the Regulation of the Minister of Health of 12 August 2020 on the organisational standard of teleporting in primary healthcare entered into force and sets forth rules on providing telemedical services within primary care.

There are relevant rules (e.g. The Order of Physicians Ethics Code – "Código Deontológico da Ordem dos Médicos"), Dispatches of the Deputy Secretary of State of the Minister of Health and normative rulings from the Health General Directorate (Direção Geral da Sáude)   regulating the use of telehealth in the scope (and outside the scope) of the National Healthcare System ("SNS"). Establishments providing healthcare services, notably, telehealth equipment and units are subject to National Health Regulatory Authority (ERS) regulation, in particular, to mandatory registration before ERS.

There are currently no specific laws that regulate telehealth in Qatar. Telehealth has been introduced to patients by the Qatar Ministry of Public Health ("MoPH") in collaboration with key stakeholders and as part of Qatar’s E-Health and Data Management Strategy. The MoPH has activated channels to healthcare services at Qatar’s Primary Healthcare Corporation ("PHCC"), Qatar’s State healthcare provider Hamad Medical Corporation ("HMC"), and TASMU Smart Qatar, Ministry of Communications and Information Technology (previously, Ministry of Transport and Communication) (“MoCIT”)(an initiative aligned to the MOCIT that aims to transform Qatar into a world class smart city that has the latest digital solutions to increase the standard of living and increase Qatar’s competitiveness internationally).

Government Emergency Ordinance no. 196/2020, which entered into force on 19 November 2020 (“GEO no. 196/2020”), represents the general legal framework regulating telehealth.

GEO no. 196/2020 is implemented through Government Decision no. 1133/2022 regarding the approval of the Methodological Norms for the implementation of the provisions of the Government Emergency Ordinance no. 196/2020 for the amendment and completion of Law no. 95/2006 on healthcare (”GD no. 1133/2022”). GD no. 1133/2022 regulates the medical specialties and the list of services that are the object of telehealth services, the conditions for the organization and operation of telemedicine.

Before GEO no. 196/2020 was adopted, there was limited legislation regarding specific types of telehealth, such as telehealth targeted at rural areas.

In addition, specific legislation relating to temporary general telehealth rules was applicable in the context of the COVID-19 pandemic.

Telehealth is regulated mainly as a medical service under Russian law.

Russian law refers to telehealth as involving "telemedicine technologies". "Telemedicine technologies" are defined under the Health Protection Law as information technologies enabling the remote interaction between healthcare professionals and patients (or the legal representatives of minor patients) relating to the conduct of consultations and medical observations of the patient. Accordingly, telehealth is understood as providing medical services on a remote basis.

A state medical licence is required to perform telehealth. However, initial consultations cannot be made through remote technologies and must be performed on an in-person basis.

Beyond licensing requirements, the structure of Russia’s telehealth rules is that these rules will apply only to "medical assistance" (which is defined by the Health Protection Law to mean a complex of actions aimed at maintenance or restoration of health, including the provision of medical services) provided on a remote basis. Therefore, if a service is provided not specifically for medical assistance, the rules for telehealth will not be applied. Nevertheless given the breadth of the definition of "medical assistance", most consultations, observations or follow ups could be expected to fall within the regulatory framework.

The relevant authorities in KSA have issued decisions, procedures and guidelines to regulate the use of telehealth in KSA. This includes but is not limited to the following:

• Minister of Health Decision No. 7/88 dated 25/04/1441H, the official instrument approving the Regulation Governing Telehealth (Telemedicine) in KSA; and
• The Regulation Governing Telehealth (Telemedicine), issued by the National Health Information Centre ("NHIC") ("Telehealth Regulation").

The Telehealth Regulations provide that a government agency shall be created to regulate and monitor telemedicine and shall be named the Saudi Telemedicine Unit of Excellence, which will operate within the NHIC of the Saudi Health Council.

South Africa has no single piece of primary legislation that specifically governs telehealth. However, certain aspects of telehealth services are regulated by  general health legislation such as the National Health Act 61 of 2003 ("National Health Act") and the Health Professions Act 56 of 1974 ("Health Professions Act").

In terms of the Health Professions Act, no person shall practice any health profession within South Africa unless the person is registered with the HPCSA. Only practitioners who have been deemed competent and who are registered in their respective professions are authorised to participate in telehealth practice in South Africa. Furthermore, the Guidelines provide that, where telehealth services are provided across South African borders, practitioners serving South African patients should be registered with the regulating bodies in their original states as well as with the HPCSA. In effect, a doctor in Spain cannott provide telehealth services to a person within South Africa unless that doctor is registered with the relevant regulatory body in Spain and with the HPCSA in South Africa in terms of the Health Professions Act. However, "bots" that provide telehealth services don't have to register in terms of the Health Professions Act.

Registered healthcare professionals have to abide by the Guidelines that have been published by the HPCSA together with the other ethical guidelines published by the HPCSA. While the Guidelines are not considered as law, misconduct could result in the deregistration of a healthcare provider's licence.

There is currently no over-arching legislation governing telehealth in Singapore, although we highlight that the telemedicine sector is intended to be regulated by the Healthcare Services Act 2020 ("HCSA"). While parts of the HCSA have taken effect from 3 January 2022, the legislation and provisions relating to telehealth are expected to be rolled out over the course of 2023 which will bring telehealth and telemedicine services under the licensing regime applicable to traditional medical services providers. The public consultation for the telehealth provisions recently concluded in end 2022 and it is expected that the relevant phases of legislation and provisions will be introduced from end June 2023 onwards.

The proposed new regime intends to regulate the provision of medical service via the ‘remote’ method of service delivery. This refers to the provision of a medical service via technological means (including but not limited to telephone, internet-based video, email, and/or similar electronic-based communications) and where the service provider and the patient are not physically in the same location. It however excludes (a) companies that only operate telemedicine platforms or provides software as a service, but do not otherwise provide medical services or direct patient care, such as third-party telemedicine applications; (b) tele-support services, such as mobile applications that provides educational information to patients on diseases and medication; or (c) tele-collaboration services, such as online platforms that facilitate information sharing among doctors for peer consultation purposes.

While the finalised language of the legislation amendments have not yet been published, under the proposed regime, among others:

• telemedicine service providers will need to be specifically licensed before such services can be offered;
• licensees will have to appoint a clinical governance officer to provide clinical governance and technical oversight. The clinical governance officer must be a registered medical practitioner with the Singapore Medical Council under the Medical Registration Act 1997 of Singapore and hold a valid practising certificate with the appropriate number of years of experience. Such officer must also complete the prescribed telemedicine e-training;
• licensees will have to establish and implement guidelines to assist medical practitioners in determining whether a particular medical condition may be managed remotely. Such guidelines must take into consideration: (i) the patient’s medical condition and medical history; (ii) the patient’s ability to use the teleconsultation function effectively (for example based on their technological literacy); and (iii) the medical practitioner’s training and scope of practice;
• licensees will have to ensure that the patient or caregiver is provided with alternative arrangements for such patient to receive medical care if the medical practitioner deems that the patient’s condition cannot be remotely managed in a proper, effective and safe manner. For example, the patient requires a physical examination or when ancillary services need to be provided;
• real-time two-way interactive audio-visual communications should be used as the primary means of remote medical service delivery when medical service is provided remotely;
• real-time, two-way interactive audio-visual communications must be used whenteleconsulting is carried out with new patients using the licensee’s medical service for the first time and there are no earlier patient records and medical history with the relevant licensee;
• medical practitioners providing medical service remotely should complete the prescribed telemedicine e-training; and
• doctors providing remote medical services will need to abide by good professional practices and conduct defined under the Singapore Medical Council (SMC)’s Ethical Code and Ethical Guidelines (ECEG).

For completeness, telehealth in Singapore is currently regulated through various codes, guidelines and regulations, including the following:

• National Telemedicine Guidelines;
• Singapore Medical Council’s Ethical Code and Ethical Guidelines and Handbook on Medical Ethics;
• Regulatory Guidelines for Telehealth Products by the Singapore Health Sciences Authority (Medical Devices Branch);
• Health Products (Licensing of Retail Pharmacies) Regulations and Telepharmacy Guidelines; and
• Singapore Dental Council’s Ethical Code and Ethical Guidelines.

These generally regulate the telehealth products (including software and mobile applications), and medical professionals providing such telehealth services.

In Slovakia, telehealth is regulated by Act No. 576/2004 Coll. on Health Care and on Services related to Health Care, as amended (hereinafter referred to as the "Act on Health Care"). According to Section 49k of the Act on Health Care, during a crisis situation, a general practitioner or a specialised physician is entitled to provide the consultation to the patient via electronic communication without the patient‘s presence in the clinic after verifying the identity of the patient and the insurance relationship with his / her respective health insurance company. This consultation via electronic communications must be recorded by the physician in the patient’s medical records.

First and foremost it shall be noted that a comprehensive legal framework regulating telehealth in Slovenia has not yet been adopted.

Telehealth is, however, partially regulated by several legal acts.

Telemedicine

For instance, Article 3 (3) ZZDej sets out that Telemedice services shall be carried out according to the rules of medical doctrine. Furthermore, apart from the data protection aspects (discussed in detail below), the said Article also transposes the relevant parts of the Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 by stipulating that in the case of Telemedicine, healthcare shall be deemed to be provided in the country in which the healthcare provider providing the Telemedicine is established.

Additionally, when determining the legal framework pertainig to Telemedicine, the Slovenian Patients’ Rights Act (Zakon o pacientovih pravicah – "ZPacP") shall be considered. In particular, a potential challenge for the provision of Telemedicine services represents Article 20 (2) ZPacP which stipulates that it is a patient’s right to have the doctor provide explanations / relevant information in a direct fashion.

Telepharmacy

According to Article 6 (1) no 6 ZLD-1, Telepharmacy is recognized as a regulated pharmacy activity.

Moreover, Article 19 (2) no 16 of the Slovenian Regulation on the Conditions for Conducting Pharmacy Activities (Pravilnik o pogojih za izvajanje lekarniške dejavnosti) and Article 8 (3) no 13 of the Slovenian Regulation on the Provision of Pharmacy Services in a Hospital Pharmacy (Pravilnik o izvajanju storitev lekarniške dejavnosti v bolnišnični lekarni) set forth the requirements regarding recordkeeping pertaining to Telepharmacy activities.

Other aspects

A further legal act regulating the realm of telehealth in Slovenia is the Slovenian Healthcare Databases Act (Zakon o zbirkah podatkov s področja zdravstvenega varstva – "ZZPPZ"). ZZPPZ sets forth different requirements in relation to health data processing and the Slovenian web portal "eZdravje", described below.

Spain does not have a national telehealth policy or strategy, except for the Royal Decree 81/2014 (transposing Directive 2011/24/UE) on the application of patients’ rights in cross-border healthcare which provides rules for facilitating the access to safe and high-quality healthcare between countries (including telemedicine) and promoting cooperation on healthcare within Member States.

The National Board of Health and Welfare (Sw: Socialstyrelsen) has issued the guidance "Digital care. Overarching principles for treatment and care" ("Digitala vårdtjänster Övergripande principer för vård och behandling") regarding when provision of treatment and care digitally is suitable, available (only in Swedish) here.

Strama, the Swedish strategic programme against antibiotic resistance, has also issued certain recommendations, available (only in Swedish) here.

Furthermore, the Swedish Regions and County Councils (Sw. Sveriges regioner och kommuner (SKR)) has issued certain recommendations regarding digital healthcare services, available (only in Swedish) here, as well as recommendations on marketing of such services, available (only in Swedish) here.

Currently, there are very limited guidelines and regulations available in relation to "telemedicine". The relevant guidelines and regulations include the following.

TMC Notification

The Notification No. 54/2563 (2020) issued by The Medical Council of Thailand effective from 21 July 2020 ("TMC Notification") defines "telemedicine" as "the transmission or communication of data on modern medicine from a medical practitioner, including from a health facility, in the public and / or private sector, from one place to another place by electronic means in order to provide advice, recommendations to other medical practitioners, or any other person, for a medical procedure within the scope of the medical profession, according to the condition, nature and existing circumstances under responsibility of the person who transmits or communicates such medical data.

The TMC Notification only governs the act of medical practitioners and not third party health facility or patients. Therefore, the TMC Notification is aimed at the action and ethical conduct of physicians and the limits of their practice.

According to the TMC Notification, the provision of telemedicine shall be in compliance with other regulations issued by the TMC, such as the Professional Standards for Medical Practitioner B.E. 2555 (2012), the Medical Competency Assessment Criteria for Licensing to Practice as a Medical Practitioner B.E. 2555 (2012) and its amendment B.E. 2563 (2020)) and other criteria or guidelines determined by the TMC within the scope of the medical profession law.

Similarly, there are also regulations governing the nursing profession in the provision of telemedicine services and these are issued by The Nursing and Midwifery Council of Thailand ("TNMC"). Generally, the nurses who provide telenursing will need to comply with the Professional Nursing and Midwifery Act B.E. 2528 (1985) (as amended) and other regulations issued by the TNMC such as in relation to ethical conduct.

TTMC Notification

Like the TMC Notification, the Thai Traditional Medical Council (“TTMC”) issued a Notification dated 8 February 2022 (“TTMC Notification”), governing the provision of Thai traditional telemedicine and Applied Thai Traditional telemedicine services. The definition of “Thai traditional telemedicine” is similar to the definition of “telemedicine” given under TMC Notification but applicable to “Thai traditional medicine” and “Thai traditional medical practitioner” instead of modern medicine and medical practitioner.

Under the TTMC Notification, the provision of Thai traditional telemedicine and Applied Thai Traditional telemedicine services shall be in compliance with other regulations issued by the TTMC, such as the Professional Standards for Thai Traditional Medical Practitioner B.E. 2563 (2020), the Professional Standards for Applied Thai Traditional Medical Practitioner B.E. 2560 (2017), the Medical Competency Assessment Criteria for Licensing to Practice as a Thai Traditional Medical Practitioner B.E. 2557 (2014) and its amendments, the Medical Competency Assessment Criteria for Licensing to Practice as an Applied Thai Traditional Medical Practitioner B.E. 2557 (2014) and its amendments, and other criteria or guidelines determined by the TTMC within the scope of the Thai traditional medical profession law.  

MOPH Notification

Previously there were concerns regarding the standard, quality and safety of services provided through telemedicine. Therefore, through the MOPH Notification, the MOPH regulates the provision of telemedicine service provided via telemedicine systems. In other words, the MOPH Notification assists in ensuring that receivers of telemedicine services are provided with standardised services performed by qualified practitioners.

The MOPH Notification defines "telemedicine service" as "medical and public health services of medical facilities provided to service receivers by practitioner via telemedicine in order to exchange information that is beneficial for consultation, examination, diagnosis, treatment, nursing, prevention, health reinforcement and recover and beneficial for continuous education of medical and public health personnel" and "telemedicine system" as "systems using digital platforms for providing medical and public health services to those who are in different places by transmitting visual and audio information or other methods".

Under the MOPH Notification, a medical facility who wishes to operate telemedicine services as an additional service must obtain permission from the MOPH. Likewise, medical facilities who wishes to operate telenursing must first obtain approval from the MOPH. Therefore, it can be understood that only existing medical facilities, as approved by the Medical Facilities Act B.E. 2541 (as amended), are able to provide such telemedicine services. Once the approval is granted, the medical facility must also comply with other obligations stated in the MOPH Notification such as ensuring that there are proper registration and recording systems in place, the medical facility is sufficiently staffed with skillful and experienced practitioners, appropriate telecommunication devices are used and the service recipients are provided with all necessary details of the processes prior to the provision of telemedicine services.

In light of the above, we view that this area of law is new and developing. Therefore, we can expect to see additional guidelines and standards in the future.

At a federal level, the annex to Cabinet Decision No. 40/2019 On the Implementing Regulation of Federal Decree-Law No. 4/2016 on medical liability ("ICT Health Law"), entitled "Controls and Conditions of Providing Remote Health Services" ("Federal Telehealth Regulations") expressly covers a range of telehealth services including:

• Remote medical consultation;
• Remote medical prescription;
• Remote diagnosis;
• Remote medical monitoring; and
• Remote medical intervention.

At an Emirate level the Abu Dhabi Department of Health ("AD DOH") Standards for the Provision of Tele-Monitoring Services in the Emirate of Abu Dhabi ("AD DOH Standards") apply in Abu Dhabi, and the Dubai Health Authority ("Dubai HA").

Standards for Telehealth Services ("Dubai HA Standards") are the key pieces of regulation / policy to be referred to.

There are also regulations which apply specifically to providers located within the Dubai Healthcare City ("DHCC") free zone in the UAE, specifically Health Data Protection Regulation No 7 of 2013 ("DHCC Regulation").

Each law places extensive obligations upon telehealth service providers which should be considered carefully in advance applying for the relevant licence(s) to ensure that compliance can be demonstrated to the regulator(s) and maintained for the duration of the provision of the relevant telehealth services.

Generally speaking, there are no specific laws regulating telehealth. Instead, healthcare professionals will be subject to the usual legislation, licensing and registration obligations, and professional codes of conduct which are specific to their particular field, in the same way that they would be should the service be provided in a face to face setting.

In November 2019 a jointly agreed ‘high level principles for good practice in remote consultations and prescribing’ were published by a range of co-authors, including (but not limited to) the Care Quality Commission ("CQC"), the General Dental Council, the General Pharmaceutical Council, and General Medical Council. The key principles include to make patient safety the first priority and to understand how to identify vulnerable patients, and take appropriate steps to protect them.

It has been recognised by regulators that the provision of healthcare via telehealth means could potentially create an additional level of risk to patients, which will need to be managed by the healthcare provider (for example, in August 2021 the General Pharmaceutical Council’s Director of Insight, Intelligence and Inspection wrote to organisations representing pharmacies and pharmacy professionals to highlight serious patient safety concerns relating to online prescribing services). A number of regulators and trade bodies in the UK have therefore sought to issue guidance to the professionals they regulate. By way of some examples:

• The General Pharmaceutical Council issued guidance in April 2019 on providing online pharmacy services, detailing the steps that pharmacists could take to ensure that they continues to meet the standards expected of them. This guidance was updated in March 2022to provide further clarity around identity checking of people using the service, and to align the guidance with other guidance produced by themselves and others.
• The General Medical Council issued guidance in response to the COVID-19 pandemic, to assist doctors in providing remote consultations and steps they could take to manage patient safety.
• The British Medical Association, and trade union and professional body for doctors in the UK, has also issued guidance on how to run remote consultations with patients.

In addition, NHS England have developed guides on video consultations (produced in partnership with the University of Oxford). These include for example the ‘Guide to adopting remote consultations for people with skin conditions’ and ‘Guide to adopting remote consultations in adult musculoskeletal physiotherapy services’.

For any healthcare professional looking to use telehealth in the UK, they should ensure that they have the appropriate licence and registration for the healthcare services they provide (in 2022 an online doctor’s service was ordered to pay £13,670 after pleading guilty to providing services without being registered with the Care Quality Commission ("CQC")), as well as review any available and applicable guidance issued on best practice for the provision of remote services.

A study was published by Europe Economics in January 2018, which was commissioned by the General Medical Council to review regulatory approaches to telemedicine around the world. In this study, it was noted that the CQC, the regulator of private healthcare providers in the UK, had particular concerns with telemedicine, including lack of access to patients’ records, identification of the patient and their key characteristics (i.e. gender, sex, weight), and healthcare not being provided in real time and on a text basis. The CQC provided an update on its website in September 2019 stating that the online provision of health and care services challenges the existing regulatory landscape by transforming how care is delivered, where and by whom. It noted that it was working with other regulators and adopting a coordinated approach to address regulatory gaps and help improve the quality and safety of services for people in the UK.

It is possible that guidance will continue to be issued by the regulators, and legislation regulating healthcare providers updated, to address any regulatory gaps.

As noted above, the practice of telehealth is regulated at the state level, either by statute or by regulations or professional guidelines passed by state professional licensing bodies such as the Board of Medicine. In addition to the different definitions of telehealth, states may have varying requirements and standards including informed consent, permitted communication methods, what constitutes an appropriate examination, supervision requirements (for example, of telehealth delivered by nurses), mental health services, remote prescribing, and coverage requirements in both state Medicaid programs and through private commercial insurance. Further, as noted above, federal law impacts the practice of telehealth through the DEA’s requirements for prescribing certain medications through telehealth. Lastly, there are also federal and state laws (as described in more detail below), that impact the privacy and data security of health information received via telehealth.

Many state licensing boards have released policies or codes relating to the practice of telehealth. For example, the Federation of State Medical Boards, which does not have any regulatory authority but generally supports the licensing policies and efforts of the various state medical and osteopathic licensing boards, released a Policy on the Appropriate Use of Telehealth, which includes informed consent requirements.  In addition, many states have informed consent requirements for the provision of telehealth services, including specific language that must be in such consents.

Further, nearly all of the major professional trade associations have adopted policies on telehealth (e.g., American Medical Association, American Hospital Association, American Dental Association, etc.). While these trade associations do not have any regulatory authority, their guidance and policies generally guide the conduct of the professionals in their industry sectors.

There are currently no laws – including statute or bylaws – that regulate telehealth. Medical practitioners and caregivers have generally accepted the overall medical ethics in the admission of telehealth services.  In so far as regulation of the provision of such services is concerned, it has not been a topical issue. Perhaps, for the simple reason that telehealth service in Zambia is, by default of unsophistication, restricted to consultation, appointment and basic medical advice in person.

The law that governs medicinal practice is the Health Professions Act [Chapter 27:19] ( the” Act”). The Act regulates healthcare professionals generally and limits the provision of medical services to Zimbabwean registered practitioners. In terms of section 29 of The Act, the Medical and Dental Practitioners Council of Zimbabwe (“MDPCZ”) is the regulating body of the medical and dental professions in Zimbabwe.

Telehealth is regulated by the policies and guidelines issued by the MDPCZ. The most recent telehealth policies are the Policy on International Telemedicine PCC/35/14 and the Policy on Telemedicine of July 2022.

These laws are applied widely by the Ministry of Health and Child Care (the “Ministry’) and the Postal and Telecommunications Regulatory Authority of Zimbabwe (“POTRAZ”) as well.