Thailands New Regulation on Telemedicine Service Standards in Medical Facilities

Thailand's New Regulation on Telemedicine Service Standards in Medical Facilities Lexology

Thailands New Regulation on Telemedicine Service Standards in Medical Facilities
1. Background Telemedicine services have become one of the alternative care options for patients during the COVID-19 pandemic. More and more services are being offered by private hospitals and clinics with support from digital healthcare applications. Now, anyone can access healthcare services at the touch of their finger. Previously, telemedicine services were not specifically regulated. Hence, issues concerning healthcare service safety, standards and quality have arisen, which demand discussion on the solutions to such issues by the relevant authorities. In our previous article “Launch of the Practical Guideline on Telemedicine in Thailand” in NO&T Thailand Legal Update No. 4 (August 2020) (please click here), we provided an update in respect of the Telemedicine Guidelines, which focused on the guidelines for licensed medical practitioners to provide telemedicine services and briefly mentioned a draft Notification of Ministry of Public Health Re: Standard of Service in respect of Medical Facility via Telemedicine System from the Ministry of Public Health to further regulate and legalize the telemedicine business in medical facilities. Earlier this year, the Ministry of Public Health published the Notification Re: Standards of Service in respect of Medical Facility via Telemedicine System dated 18 January 2021 in the Royal Gazette (the “Telemedicine Notification”), which came into force on 2 February 2021, further legalizing telemedicine in Thailand. 2. Key Takeaways of the Telemedicine Notification Principally, the Telemedicine Notification prescribes the standards for private medical facilities that use telemedicine systems as part of their services to ensure the safety of healthcare receivers in such medical facilities under the Medical Facility Act of 1998. The key takeaways are as follows. The Telemedicine Notification applies to i) telemedicine services and ii) telemedicine service systems, which are defined as follows: 1) “ telemedicine services” means the medical and public health services of medical facilities provided to service receivers by practitioners via telemedicine services in order to exchange information that is beneficial for consultation, examination, diagnosis, treatment, nursing, prevention, health reinforcement and recovery and beneficial for continuous education of medical and public health personnel; 1 and 2) “telemedicine service systems” means 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 2 . In order to operate a telemedicine business via a medical facility, the licensee 3 and the medical facility operator (manager) 4 shall have: 1) a sufficient number of practitioners who possess skills, education and training meeting the relevant standards in their particular fields for providing telemedicine services without affecting main medical service operations, i.e., offline medical services, pursuant to the list of available practitioners submitted thereby to the Bureau of Sanatorium and Art of Healing, Department of Health Service Support; 5 and 2) a telemedicine service system that has telecommunication devices and technology that a service provider and a service receiver can use to clearly communicate in relation to telemedicine services as well as standards on information security measures. 6 . Regarding the results of providing telemedicine services, the licensee, the medical facility operator and the medical practitioner providing the services to service receivers shall be liable for any results that may occur due to the provided services 7 . The Telemedicine Notification shall not apply to any consultations between medical practitioners that do not involve service receivers. Such internal consultations shall not be deemed to constitute telemedicine services under the Telemedicine Notification 8 . This is because information exchanges between medical practitioners, i.e., teleconsultations, are not for the purpose providing telemedicine services under the Telemedicine Notification. If the licensee and the medical facility operator wish to provide additional telemedicine services, the licensee and the medical facility shall: 1) submit an application to add telemedicine services to the Bureau of Sanatorium and Art of Healing, Department of Health Service Support; 9 2) ensure that systems for registrations, data records, service reports, inspections and verification processes in respect of telemedicine are sufficiently applied in every step; 10 3) ensure that practitioners who provide telemedicine services in medical facilities comply with laws relating to such practitioners’ practices and other relevant laws; 11 4) provide service receivers with clarification in respect of all of the processes in detail before providing the services, the results that may occur due to the provided services in every aspect and the risks thereof; 12 and 5) provide sufficient and appropriate technology systems, medical devices and communication devices, including risk management and error controls in technology communications according to the relevant laws13, e.g., the Personal Data Protection Act of 2019, Electronic Transaction Act of 2001, Medical Device Act of 2008, Act Governing Commission of Offences Relating to Computers of 2007, etc. Medical facilities that already provided telemedicine services prior to the effective date of the Telemedicine Notification shall submit an application for additional services following this notification within 90 days from the effective date thereof. 3. Our Remarks The Telemedicine Notification sets out stricter standards for private medical facilities regardless of the size and type thereof to ensure the safety and security of telemedicine services as well as boost confidence in medical standards required by laws for digital platforms. It should be noted that the Telemedicine Notification is only applicable to private medical facilities, i.e., private hospitals and clinics. As a result, public medical facilities are not subject to the Telemedicine Notification. However, public medical facilities who wish to provide telemedicine services still need to comply with their own standards. The Telemedicine Notification clearly indicates that telemedicine services shall be provided by specifically licensed practitioners in healthcare fields and shall be provided under the supervision of a licensed medical facility, which means stand-alone healthcare applications can no longer provide telemedicine services without being partnered with a licensed medical facility . If the licensee and the medical facility operator fail to comply with the Telemedicine Notification, such failure may be considered a violation of Section 65 of the Medical Facility Act of 1998, which may result in the licensee and the medical facility operator being punished by imprisonment not exceeding one year and/or a fine not exceeding 20,000 THB. In addition, the penalties under the relevant laws may be imposed on violators on a case-by-case basis. Currently, the relevant authorities for each professional practice field are now preparing specific regulations in relation to telemedicine services in accordance with the principles of the Telemedicine Notification. As of now, telemedicine-related regulations are comprised of the Telemedicine Guideline from the Medical Council of Thailand, the Notification of the Medical Technology Council Re: Standards of Tele-Medical Labs Services of 2020 dated 8 October 2020, the Notification of the Pharmacy Council of Thailand No. 56/2020 Re: Prescription Standards and Processes for Providing Tele-Pharmacy of 2020 dated 2 June 2020, and the Notification of Physical Therapy Council Re: Standards of Tele-Physical Therapy of Medical Facilities of 2020 dated 3 March 2021. Further telemedicine-related regulations are expected within this year and we will provide you with updates on the latest progress thereof.