The World Health Organization (“WHO”) has described the term ‘Telemedicine’ as the delivery of healthcare services, where distance is a critical factor, by all healthcare professionals, using information and communication technologies for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of healthcare providers. Examples are: (i) patient-to-healthcare provider communication via webcam or mobile application, (ii) healthcare provider-to-healthcare provider communication via webcam, or mobile application, (iii) store-and-forward telemedicine or the collection of clinical data and sending it electronically to another healthcare provider for evaluation.
Before the arrival of the COVID-19 pandemic in Thailand, telemedicine was rather viewed as an optional path to physical contact with healthcare professionals and patients. Since then, telemedicine has reached a level of unprecedented growth owing to the necessity of having ‘contactless’ safety requirements and overcoming ‘long-distance’ obstacles. This article provides the latest legal update and trends in relation to the said medical technology business.
Practical Guideline on Telemedicine
Owing to the previously unregulated business of telemedicine in Thailand, issues concerning professional ethics and legal liability have arisen. There are many obstacles and exposures which a hospital or clinic, as a health facility, and a doctor, as a healthcare provider, should be aware of while providing telemedicine services. For example, there could be unlicensed persons claiming to provide telemedicine services, which will affect the standard and quality of healthcare. Further, there could be medical negligence and error of judgment should doctors rely solely on telemedicine without physical treatment.
On 21 July 2020, the Medical Council of Thailand issued the Notification of the Medical Council on Guideline in respect of Telemedicine and Online Clinics No. 54/2563 dated 21 July 2020 (“Telemedicine Guideline”). The Guideline shall come into effect 90 days after its date of issuance of 21 July 2020, i.e. 20 October 2020. This Telemedicine Guideline is considered as a pioneering official guideline for the telemedicine business in Thailand and aims to set standards – particularly safety and professional standards for healthcare providers and healthcare receivers.
Key concepts of the Telemedicine Guideline are as follows:
“Telemedicine” is defined 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 state and existing circumstances of such medical data.
- “Healthcare Provider” is limited to licensed medical practitioners, and they shall also be responsible for any negative effect occurring from such Telemedicine service, while “Healthcare Receiver” can be anyone who receives a Telemedicine service.
- In order to provide a Telemedicine service, Healthcare Provider shall be subject to the professional medical standards as prescribed by the Medical Council of Thailand, i.e. the Professional Standards for Medical Practitioners of 2012, Criteria of Knowledge and Skills for Assessment of License to Practice as Medical Personnel of 2012 (as amended in 2020) and other criteria or guidelines stipulated pursuant to the Medical Profession Law. Given the foregoing, Healthcare Provider must strictly adhere to all criteria above and is advised to learn all necessary techniques as well as limitations of Telemedicine technology to ensure patient safety.
- Provision of a Telemedicine service is subject to certain technological and electronic limitations, and therefore Healthcare Provider and Healthcare Receiver are to be informed of their certain rights:
- A patient has the right to know information concerning their medical treatment, e.g. any medical facts concerning the treatment provided under the Telemedicine service as well as any other subsequent medical facts, e.g. expert opinion from other medical schools;
- Both Healthcare Provider and Healthcare Receiver must be made aware that not all diseases or conditions are fit for Telemedicine, i.e. face to face treatment would be more efficient;
- Both Healthcare Provider and Healthcare Receiver are entitled to reject the use of Telemedicine; and
- In the case of the use of Artificial Intelligence (AI) with the Telemedicine, the Telemedicine must comply with specific laws, e.g. medical device laws and pharmaceutical laws.
- To mitigate the risks from telecommunication or from technical error, Telemedicine shall be conducted under a safe IT system standard that conforms with international standards and shall be materially available and ready for inspection, including the following procedures:
- Identification and confirmation as regards the Healthcare Provider’s being a licensed practitioner and providing his or her Telemedicine service under an IT system standard in respect of hospitals or health facilities pursuant to the specific laws;
- Identification and confirmation in respect of the Healthcare Receiver’s existence according to the IT system standard as stipulated by the responsible authorities; and
Confirmation that the IT system used for Telemedicine complies with the standards set out in
- the Electronic Transactions Act of 2001 and the Personal Data Protection Act of 2019 (“PDPA”).
- “Online Clinic” is also recognized by the Telemedicine Guideline as being health facilities as prescribed by the laws. Provision of an Online Clinic and Telemedicine under the Telemedicine Guideline shall be conducted only from/via a licensed health facility which belongs to the public and/or private sector and is established pursuant to the relevant laws. As a result, once the Telemedicine Guideline comes into force, private sector enterprises such as startup companies who are currently engaging in the business of Healthcare Provider providing Telemedicine services outside a heath facility, may no longer freely operate a Telemedicine business.
- The Telemedicine Guideline shall not apply to any consultation among licensed medical practitioners or other public health personnel who have already been regulated specifically by other regulations. This is because communication via electronic means among medical practitioners, other public health practitioners, or nurses can – of its nature – be regular communication for the purpose of information exchange and is not communication directly to the Healthcare Receiver.
Further Legislative Developments
Recently, the Department of Health Service Support, of the Ministry of Public Health, one of the emerging regulators of the Telemedicine field, began preparing a draft Notification of Minister of Public Health re: Standard of Service in respect of Health Facility via Telemedicine System. This draft aims to further regulate the Telemedicine business such that any health facility wishing to operate a Telemedicine business may have to apply for a license prior to operating. This draft, once finalized and promulgated, could drastically affect Telemedicine business operations in general. We will keep you informed of further developments once it is legislated.
This Telemedicine Guideline issuance represents a pivotal point for further legislative reform by other supporting mechanisms of Telemedicine, which would require multi-disciplinary efforts from both public and private sectors, i.e. health insurance and medical practitioner license for Telemedicine. We expect that there will be future regulations to support insurance claim and coverage for Telemedicine. Moreover, Telemedicine may ideally lead to future relaxation of medical practitioner license requirements regionally and/or globally, ensuring that doctors in Thailand can assist other countries’ patients in need of healthcare. This overseas service would require international level of co-operation among the governments to overcome the practical barriers and ensure that patients can access quality healthcare at
affordable price in a timely manner through Telemedicine. This would contribute to further growth in the usage and popularity of Telemedicine, domestically and globally.
Prior to the issuance of this Telemedicine Guideline, a lack of regulations for Telemedicine meant that many problems had been caused in terms of security, safety and quality of healthcare services, which was likely to endanger patients. Further, since there were many laws that did not directly address the Telemedicine business, legal implementation and enforcement was rather inconsistent and fragmented.
The Telemedicine Guideline constitutes a set of initial guidelines and criteria to supervise Telemedicine business, in order to prevent legal loopholes in relation to the Telemedicine business and to ensure patients are given a high quality of healthcare. Although the Telemedicine Guideline prescribes no direct penalty against Telemedicine business operators, such operators might be subject to the penalties under other relevant laws and regulations, e.g. Medical Profession Act of 1982; Public Health Act of 1992; Health Facilities Act of 1998; Electronic Transactions Act of 2001; National Heath Act of 2007; Medical Device Act of 2008; Computer Crimes Act of 2007; PDPA, etc. Apart from the aforementioned laws, failure to comply with the Telemedicine Guideline may lead to the imposition, by the Medical Council of Thailand, of disciplinary actions against healthcare providers for legal and/or ethical breaches, on a case by case basis.
It is anticipated that the regulations in respect of Telemedicine will have to keep up with the borderless nature of Telemedicine and ensure patients are treated safely and securely. In the near future, telemedicine could soon become the ‘new normal’ form of medical and health services, with less traveling and waiting time, as well as the lowering of costs to patients.