The regulatory rules for telemedicine services have been developed based on the Royal Order (No. 47455) dated 9/8/1441 AH, which includes the amendment of Article Thirteen of the Health Professions Practice Law, allowing healthcare practitioners to conduct examinations or treatment through telemedicine services and at home or workplaces according to the regulations set by the Ministry of Health.

1- The following words and phrases shall have the meanings indicated next to them unless the context of the text requires otherwise:

• (a) Appropriation: It is the official recognition of the qualifications of the healthcare practitioner after verifying and evaluating them for the purpose of providing healthcare.

• (b) Healthcare facilities: It is an institution or organization licensed to provide diagnostic and healthcare services within the Kingdom of Saudi Arabia.

• (c) Healthcare practitioner: Any individual licensed to practice health professions, which include the following categories: medical doctors, dentists, specialist pharmacists, and healthcare technicians in (radiology, nursing, anesthesia, laboratory, pharmacy, optics, epidemiology, prosthetics, physical therapy, dental care and installation, computed tomography, nuclear medicine, laser devices, and surgeries), as well as psychologists, social workers, nutritionists, public health professionals, midwives, paramedics, speech and hearing therapists, occupational therapy, medical physics, and other officially recognized health professions.

• (d) Ministry: It is the Ministry of Health in the Kingdom of Saudi Arabia.

• (e) Telemedicine services: These are services provided as a digital health service within the scope of the facility's license and include clinical services.

• (f) Franchise: It refers to the authorities granted by the relevant administrative agency to provide healthcare in specialized and qualitative practices for the healthcare practitioner, based on registration and licensing according to the health professions practice system.

• (g) Remote assistance: It is the use of modern communication means to provide support or treatment to a patient or another healthcare practitioner, including remote medical support provided by a healthcare practitioner to assist another healthcare practitioner in delivering medical services.

• (h) Remote consultation: It is the use of modern communication means to meet with a doctor specifically trained to provide consultation to the patient or other doctors regarding a disease or treatment, and it includes a remote medical opinion requested by the patient from a healthcare practitioner seeking a medical opinion different from a previous medical opinion provided by another healthcare practitioner.

• (i) Remote diagnosis: It is the use of modern communication means to determine the nature of the disease or any other problem by examining the symptoms.

• (j) Remote health: It is the use of modern communication means to provide health-related services and information that support patient care, administrative activities, and health education.

• (k) Center: It is the Center of Excellence for Digital Health at the Ministry of Health.

• (l) Remote monitoring: It is the remote medical monitoring of the patient based on the medical and health data collected by the patient, healthcare specialist, or electronic device.

• (m) Remote testing: It is the use of modern communication means to conduct tests or examinations to detect the disease or injury of the patient.

• (n) Remote treatment: It is the use of modern communication means to treat a person for a disease or injury.

• (o) Remote triage: It is the use of modern communication means to prioritize urgent cases of injuries, wounds, and diseases to determine the order of treatment for a large number of patients or injured individuals.

(1) These regulations aim to establish standards for telemedicine services and to monitor the compliance of healthcare facilities and healthcare practitioners in the field of healthcare within the Kingdom of Saudi Arabia.

(1) The regulatory regulations apply to all health facilities and health practitioners licensed by the Ministry of Health to provide telemedicine services through both public and private health facilities.

(2) The regulatory regulations are effective until Sha'ban 1443 AH, corresponding to March 2022 AD.

(1) Telemedicine services may only be provided by a healthcare facility licensed by the Ministry of Health in the Kingdom of Saudi Arabia.

(2) All healthcare facilities should have telemedicine services according to their capabilities.

(3) Healthcare facilities must comply with all laws and regulations issued by the Ministry of Health.

(4) An entity not licensed as a healthcare facility in the Kingdom of Saudi Arabia that provides telemedicine services must obtain a license allowing it to practice telehealth from the Center of Excellence for Digital Health.

(5) All legal requirements applicable to healthcare facilities apply to any entity providing telemedicine services.

(1) The establishment operating in the field of telemedicine services must meet the requirements of the Ministry of Health regarding the license and other necessary requirements for its operation, and licenses shall be granted as follows:

• A- Public Sector: Prior permission must be obtained before activating telemedicine services from the Center of Excellence for Digital Health.

• B- Private Sector: Licenses to practice telemedicine services are granted by the Licensing Department at the Ministry of Health after alignment with the conditions and requirements of the Center of Excellence for Digital Health for practicing telemedicine.

(2) The healthcare establishment shall redistribute the minimum number of doctors to provide telemedicine services in accordance with the Ministry of Health's policy regarding the licensing of healthcare establishments.

(3) The healthcare facility must equip the establishment with devices, equipment, and technologies approved by the Ministry of Health, necessary for providing remote health services, including software and peripheral/terminal/appurtenance devices.

(4) Each healthcare establishment partnering with another healthcare establishment to provide telemedicine services must enter into a written contract that includes the provision of those services.

(5) The contract must detail the roles and responsibilities of each party and be in compliance with the laws and regulations of the Kingdom of Saudi Arabia.

(6) The healthcare facility maintains a record of all doctors and other healthcare specialists working in digital health services.

(7) The healthcare establishment is responsible for informing the partner healthcare establishment, which is not subject to the jurisdiction of the Kingdom of Saudi Arabia, of all applicable laws, regulations, and rules in the Kingdom of Saudi Arabia that govern telemedicine services, and ensuring the partner facility's compliance with them.

(8) The healthcare establishment must have policies regarding the description of telemedicine services and the scope of available services, patient identification, selection, risk assessment, and patient consent.

(1) Telemedicine services related to diagnosis and medical treatment are provided by a physician.

(2) Telemedicine services may be practiced by all types of licensed healthcare workers and specialists in the health field.

(3) All legal requirements applicable to healthcare workers practicing their profession within the jurisdiction of the Kingdom of Saudi Arabia apply to telemedicine practitioners.

(4) Healthcare practitioners are permitted to provide telemedicine services in all types of healthcare facilities in the Kingdom of Saudi Arabia.

(5) Healthcare practitioners providing telemedicine services may charge a fee for delivering this service.

(1) The practice of telemedicine is limited to healthcare practitioners who possess qualifications to practice the profession within the jurisdiction of the Kingdom of Saudi Arabia.

(2) Physicians, nurses, and contracted healthcare practitioners must hold the license and privileges granted to provide telemedicine services in accordance with the requirements of the Ministry of Health.

(3) Telemedicine services must comply with the laws and regulations of the Kingdom and operate within the scope of their license, specialization, and granted privileges.

(4) Healthcare practitioners providing telemedicine services must adhere to the requirements of professional licensing.

(5) Nurses and other healthcare specialists may provide telehealth services related to diagnosis and treatment under the supervision of the attending physician.

(6) A healthcare facility licensed by the Ministry of Health to provide telemedicine services may grant its employees the privilege to offer telemedicine services according to their specialization, and document this in the employees' records.

(7) The healthcare facility providing telemedicine services must be accredited by an internationally recognized organization for telemedicine services within 18 months or within the timeframe that may be determined by the center from the date telemedicine services commence.

(1) The insurance coverage must include telemedicine services.

(2) Private health insurance must provide coverage for telemedicine services and at least the general coverage.

(1) Telehealth services that involve two or more healthcare practitioners, each healthcare practitioner shall be responsible based on their individual contribution.

(2) Responsibility shall be determined after the completion of the necessary investigation in each case individually.

(3) The healthcare facility shall ensure the existence of malpractice insurance throughout the duration of the telemedicine service.

(4) Telemedicine services provided by the healthcare practitioner must be covered by insurance against medical errors.