Telehealth Regulation

How is telehealth regulated?

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.

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

Is the use of telehealth permitted?

Yes, the use of telehealth is permitted in the Kingdom of Saudi Arabia ("KSA").

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

How is telehealth regulated?

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.

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

Are there specific fields of healthcare in relation to which telehealth services are currently available, and do they involve the use of proprietary technology or platforms?

The Telemedicine Regulations define telemedicine as "a remote medical practice using information and communication technology", which should be utilised either as an interaction between a patient and a healthcare practitioner ("HCP") or between two or more HCPs. The interaction shall take place between two different sites and may involve robots or artificial intelligence.

Telemedicine is available for screening, triage, consultation, diagnostics, obtaining a medical opinion from an HCP, treatment support, and the monitoring of medical conditions. Teleconsultations can either be between a patient and a HCP or between two or more HCPs and must involve a video consultation (teleconsultations cannot be solely audio) but need not be synchronous.

Telemedicine may be practiced by any KSA accredited HCP within either the public or private sector. Telemedicine undertaken by an HCP outside KSA must be undertaken under the supervision of a KSA based HCP. All legal requirements and protocols that are applied to an HCP in physical practice in KSA apply equally to the practice of telemedicine.

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

Does the public health system include telehealth services, and if so, are such services free of charge, subsidised or reimbursed? Where the public health system does not include telehealth services, are such services covered by private health insurance?

"Seha" is the Saudi e-health App issued by the Ministry of Health and is free of charge. The App provides visual medical consultations and allows all citizens anywhere to have face to face medical consultations with their doctors across KSA.

The Seha application is designed to enable audio-video communication during specific timings during weekdays and weekends.

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

Do specific privacy and/or data protection laws apply to the provision of telehealth services?

The practice of telemedicine must be compliant with the Saudi Health Information Exchange Policies ("SeHE"), including all relevant data security and privacy requirements, and must be compliant with interoperability frameworks and / or the US Health Insurance Portability and Accountability Act. The SeHE is a comprehensive document outlining various policies that govern, amongst others, the manner in which a patient’s health information must be protected and instances where such information is permitted to be disclosed.

HCPs, as per the Telehealth Regulation, are permitted access to a patient’s health information for the purposes of conducting telemedicine activities.

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

How should the cross-border transfer of personal information collected and processed in the course of telehealth services be carried out to ensure compliance with applicable privacy laws?

See Privacy and data protection.

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

Are there any currently applicable codes of conduct on the use of telehealth systems and/or security of telehealth data in your jurisdiction?

Yes, see Regulation of Telehealth.

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia

Are any specific laws, regulations, or self-regulatory instruments expected to be adopted in the near future?

N/A

Last modified 17 May 2021

Saudi Arabia

Saudi Arabia