The Turkish Ministry of Health (“Ministry”) has recently issued the Regulation on Telemedicine Services (“Regulation”), determines the procedures and principles regarding the scope of telemedicine services, the permissions for the provision of telemedicine services, registration of telemedicine information systems, and inspection of healthcare facilities within this scope. The Regulation aims to serve the provision of healthcare regardless of location and geography and based on contemporary medical technology. Accordingly, the Regulation covers all healthcare facilities that provide telemedicine services, all healthcare professionals involved in telemedicine services, telemedicine information system developers, and natural persons desiring to receive healthcare services remotely.
Operating License and Registration Requirements
Pursuant to the Regulation, telemedicine information system is defined as a secure software that enables written, audio, or video communication, which may be developed by the Ministry or its use for provision of telemedicine services is approved by registration by the Ministry. With this respect, developers other than the Ministry shall follow the minimum standards determined by the Ministry. Accordingly, changes to be made in the minimum standards determined by the Ministry should also be reflected in the telemedicine information system software within the period determined by the Ministry.
It is obligatory to register with the Ministry’s system as the unregistered telemedicine information systems cannot be used for the provision of telemedicine services as per the Regulation. With the Regulation, it has been stipulated that the procedures and principles of registration will be determined by the General Directorate of Health Information Systems and announced on the official website of the Ministry. It is required that the telemedicine information system is developed in such a way that it allows the notification and transfer of the transactions made within the scope of telemedicine services and determined by the Ministry to the information management system of the relevant health facility that has been authorized to provide telemedicine services by the Ministry in accordance with the Regulation.
Accordingly, it has been regulated that a telemedicine service operating license shall be issued by the Ministry if the health facility that wishes to provide telemedicine services meets the necessary conditions. In this context, the procedure to be followed for the telemedicine service operating license is also specified under the Regulation. For the healthcare facilities affiliated to the Ministry, the Ministry shall be able to grant telemedicine service operating license ex officio. Additionally, it is also regulated that healthcare facilities that have received international health tourism authorization certificates may provide telemedicine services within the scope of international healthcare tourism and tourist health within the framework of the relevant legislation. Healthcare facilities providing telemedicine services must obtain a telemedicine operating license until August 19, 2022.
Moreover, the health facilities that have been authorized to provide telemedicine services by the Ministry in accordance with the Regulation shall provide the necessary infrastructure and technical equipment for the healthcare professionals to be able to connect to the healthcare information system remotely. According to the Regulation, the criteria related to issues such as infrastructure and technical equipment required for telemedicine service provision are to be determined by the Ministry.
The Regulation also specifies the healthcare services that can be provided remotely, provided that they are suitable to be practices remotely. For example, the patients who request telemedicine services may be examined to the extent that the telemedicine service allows, diagnosed diseases may be controlled, medical advice may be provided, consultation or secondary opinion may be requested, or when necessary, it may be suggested that the patient to apply to a health institution physically. Also, for the remote evaluation of diseases, clinical parameters such as blood glucose levels and blood pressure may be evaluated and monitored, and treatment and drug management may be provided. With wearable technologies and other medical devices, the health data of the person requesting telemedicine may be measured and tracked remotely; during endemic or epidemic outbreaks, necessary medical procedures may be carried out to protect the health of people in line with national guidelines; healthcare services may be provided to protect and monitor health, to support a healthy life, and to provide psychosocial support services. In addition, the authorized health facilities may provide telemedicine services to the patients requesting healthcare services from another health facility, if they acquire the operating license in the same branch regarding telemedicine.
The regulation also stipulates issues such as informing the patient, verification of identity, the obligations of the parties providing or benefiting from telemedicine services, protection of personal data, registration, notification and track records, and also restrictions regarding provision of telemedicine services:
i. Informing the patient
The persons who will receive telemedicine services should be informed before starting the telemedicine service and to the extent that it is suitable for the nature of the service to be provided. For example, the identity and expertise of the healthcare professional who will provide telemedicine services, the differences between telemedicine services and applied treatments, the nature and results of the healthcare service should be mentioned. Such information should be conveyed in plain language. that can be understood by the person requesting the health service.
ii. Identity verification
The health facility should take the necessary measures to verify the identity of the person receiving the telemedicine services. In this context, an additional secondary authentication infrastructure or tool can be used by the healthcare facility. The Regulation exemplifies that the healthcare professional may request the person receiving telemedicine service to show their official identity card over the camera and may also request that they verify their identity in case of doubt And if this request is not fulfilled, provision of telemedicine services may be denied or terminated.
iii. Obligations of the parties
Moreover, if there is a third person present who can see and/or hear the conversation of the patient and the healthcare professional during the provision of telemedicine service, the parties are obliged to inform the other party regarding the presence of a third party.
Another obligation stipulated by the Regulation is that the persons receiving telemedicine service shall explain the requested information about their medical history and health status to the healthcare professional in an accurate, comprehensible, and detailed manner.
iv. Protection of personal data
Pursuant to the Regulation, the healthcare facility and healthcare professional are responsible for the protection of privacy and personal data of the patients in the provision of telemedicine services. In this regard, data controller and data processor shall process the personal data obtained through the telemedicine services within the scope of the Regulation as well as the Law on the Protection of Personal Data numbered 6698 and its secondary legislation. In addition, it is required to take all kinds of technical and administrative measures to ensure the security of personal data and to fulfill the obligation to inform the data subjects. Visual or audio records may not be obtained without the explicit consent of both parties.
v. Restrictions regarding provision of telemedicine services
The Regulation prohibits health facilities to provide telemedicine services without the operating license in a determined branch of health. However, consultation or second opinion services of health facilities affiliated to the Ministry or state universities are excluded. With the Regulation, telemedicine services shall not be provided by healthcare professionals who are not authorized to perform their profession in Turkey. Another important point is that the healthcare professional and/or healthcare facility shall not force patients to receive healthcare services remotely. In this context, appointment schedules should not be arranged in such a way as to complicate or prevent the physical access to the health facility. Another restriction worth a mention is that the Regulation prohibits telemedicine service recipients in Turkey to use any medical devices other than those registered by the Turkish Medicines and Medical Devices Agency.
Simge Kılıç, Esra Temur