The governing rules of Telehealth in the kingdom of Saudi

Kingdom of Saudi Arabia

The governing rules of Telehealth in the kingdom

of Saudi Arabia

-Executive rules-

Document version V2.6

Document status Final draft

Document date 21/2/2021

Office of origin National Health Information Center (NHIC)

Approval authority Saudi Health Council (SHC)

2 Nhic.gov.sa The governing rules of Telehealth

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Document Revision History

Regulations Approval Process

Version Date Type of update Prepared/Revised by:

V1.0 April 1st 2018 First Draft National Health Information Center (NHIC)

V1.1 April 13th 2018 Final Draft National Health Information Center (NHIC)

V1.2 May 10th 2018 Final Draft National Health Information Center (NHIC)

V1.3 June 29th 2018 Final Draft National Health Information Center (NHIC)

V2.0 August 22th 2019 Final Draft National Health Information Center (NHIC)

V2.1 September 30th 2019 Final Draft National Health Information Center (NHIC)

V2.2 November 12th 2019 Final Draft National Health Information Center (NHIC)

V2.3 December 3rd 2019 Final Draft National Health Information Center (NHIC)

V2.4 December 22nd 2019 Final Draft National Health Information Center (NHIC)

V2.5 December 22nd 2019 Final Draft National Health Information Center (NHIC)

V2.6 February 21st 2021 Final Draft National Health Information Center (NHIC)

Subject Approved by: Approval date:

The Governing Rules of Telehealth

(Telemedicine) in Saudi Arabia

General director of the NHIC

Scientific committee

Preparatory committee

Board members of SHC

17/3/2019

24/3/2019

30/9/2019

22/12/2019


TABLE OF CONTENTS

1. INTRODUCTION ............................................................................................................................................. 7

1.1 PURPOSE ............................................................................................................................................................... 7

1.2 SCOPE ...................................................................................................................................................................... 7

1.3 STAKEHOLDERS IMPACTED BY THE DOCUMENT ......................................................................... 7

2. TELEHEALTH REGULATIONS AND POLICIES ARTICLES .............................................................. 8

2.1 DEFINITIONS ...................................................................................................................................................... 8

2.2 TERMS DEFINING TELEHEALTH IN SAUDI ARABIA ...................................................................... 9

2.3 CLASSIFICATION (TYPES OF TELEHEALTH ACTIVITIES) .......................................................... 9

2.4 GENERAL CONSIDERATIONS ................................................................................................................... 10

2.5 FUNCTIONS OF THE SAUDI TELEHEALTH NETWORK.............................................................. 11

3. ORGANIZATION ...........................................................................................................................................12

3.1 BEFORE A TELEHEALTH ACTIVITY ....................................................................................................... 12

3.2 DURING A TELEHEALTH ACTIVITY ...................................................................................................... 14

3.3 AFTER A TELEHEALTH ACTIVITY .......................................................................................................... 15

4. CONCLUSION ................................................................................................................................................16


LIST OF ACRONYMS

AI Artificial Intelligence

CBAHI Saudi Central Board for Accreditation of Healthcare Institutions

CCHI Council of Cooperative Health Insurance

HCF Healthcare Facility

HCP Healthcare Professional

ICD International Classification of Diseases

ICT Information and Communication Technology

NHIC National Health Information Center

RPM Remote Patient Monitoring

SCFHS Saudi Commission for Health Specialties

SFDA Saudi Food and Drug Authority

SHC Saudi Health Council

STN Saudi Telehealth Network

TLA Tele-assistance

TLC Teleconsultation

TLD Telediagnosis

TLE Tele-expertise

TLH Telehealth

TLM Telemanagement

TLS Telesurgery

TSeP Telehealth Service Provider

TSoP Telehealth Solution Provider



1. INTRODUCTION

1.1 PURPOSE

This document contains the regulations, policies, and definitions that support the practice of telehealth

(TLH) in the Kingdom of Saudi Arabia. This document is considered as an executive version of the rules

governing telehealth and it is considered a complementary version of the establishing rules.

1.2 SCOPE

1.2.1 In Scope:

The scope of this document is the specification of requirements for telehealth practice in the Kingdom of

Saudi Arabia.

Telehealth should be provided for: a) the purpose of screening, b) medical regulation (triage), c)

consultation, d) diagnostics, e) the requirement of a medical opinion, f) support of the provision of

treatment, and g) monitoring a medical condition.

1.2.2 Out of Scope:

The contents and specifications that are explicitly out of scope for this document are clinical guidelines

and procedures.

1.3 STAKEHOLDERS IMPACTED BY THE DOCUMENT

The stakeholders impacted by the document are as follows: healthcare professionals (HCP), healthcare

facilities (HCF), health administration including, Saudi Food and Drug Authority (SFDA), Council of

Cooperative Health Insurance (CCHI), Saudi Commission for Health Specialties (SCFHS), Saudi Central

Board for Accreditation of Healthcare Institutions (CBAHI), medical licensing department in the ministry

of health (MOH), health insurances, telehealth service and solution providers (TSeP and TSoP).


2. TELEHEALTH REGULATIONS AND POLICIES

ARTICLES

2.1 DEFINITIONS

Term Definition

Telehealth

A remote healthcare practice facilitated by the use of electronic means of

information and communication technology

Telemedicine

A remote medical practice facilitated by the use of electronic means of

information and communication technology.

Telecare

A remote paramedical practice facilitated by the use of electronic means

of information and communication technology.

A telehealth solution

provider (TSoP)

An entity providing a technological tool used to practice telehealth. The

tool may be a hardware and/or a software, and may be a medical device.

A telehealth service

provider (TSeP)

An entity providing a remote clinical health service.

Digital health

The digitalization of health and includes telehealth and non-telehealth

activities.


2.2 TERMS DEFINING TELEHEALTH IN SAUDI ARABIA

2.2.1 Telehealth shall be synchronous (simultaneous transfer of information including

videoconference) or asynchronous (non-simultaneous transfer of information).

2.2.2 Telehealth should be delivered through video, and/or audio, and/or picture, and/or text,

and/or data.

2.2.3 Telehealth should be used for an interaction between a patient and a HCP, or between two

or more HCPs.

2.2.4 Telehealth should be used between a patient site (where the patient is located) and a

remote site (where the remote HCP is located).

2.2.5 Telehealth may be delivered or accessed through mobile health and may involve robots,

connected devices, or artificial intelligence (AI).

2.3 CLASSIFICATION (TYPES OF TELEHEALTH ACTIVITIES)

2.3.1 Teleconsultation (TLC) is a remote consultation between a patient and a HCP.

2.3.2 Remote patient monitoring (RPM) is a remote monitoring of a patient performed by a HCP

based on the patient’s collected and shared health data

2.3.3 Telesurgery (TLS) is a remote surgery or intervention performed by a healthcare

professional (HCP) to a patient.

2.3.4 Tele-expertise (TLE) is a remote expert medical opinion provided by a requested HCP to a

requesting HCP relying on store-and-forward

2.3.5 Telediagnosis (TLD) is a remote diagnosis and/or interpretation performed by a healthcare

professional (HCP) without synchronous interaction with the patient.

2.3.6 Tele-assistance (TLA) is a synchronous remote technical expert support provided by a

requested HCP to a requesting during a technical intervention

2.3.7 Telemanagement (TLM) is the remote complete management of inpatients by remote

HCPs.


2.4 GENERAL CONSIDERATIONS

2.4.1 Telehealth may be practiced by all types of HCPs registered with SCFHS.

2.4.2 All legal requirements applied to a HCP in the Kingdom of Saudi Arabia shall be applied to

the practice of telehealth.

2.4.3 HCPs shall be allowed to practice telehealth across all types of healthcare facilities and shall

not be restricted to public or private sectors.

2.4.4 HCPs not registered in the country’s SCFHS who wish to provide telehealth services for

patients located in KSA shall be registered to provide telehealth services there. HCPs who

do not reside in KSA remain accountable for their competence and actions to the authorities

in the jurisdiction that governs their practice.

2.4.5 Health insurance coverage of telehealth activities shall be applied in accordance with the

regulations on health insurance coverage of the Council of Cooperative Health Insurance

(CCHI) in the Kingdom of Saudi Arabia.


2.5 FUNCTIONS OF THE SAUDI TELEHEALTH NETWORK

2.5.1 STN shall be the national leading department responsible for implementing and updating

the national telehealth regulations and policies.

2.5.2 STN shall coordinate all public and private stakeholders to implement the regulations and

policies.

2.5.3 STN shall monitor and evaluate the implementation of the regulations and policies.

2.5.4 STN shall define, develop and implement all processes and templates required by the

regulations and policies. STN shall be the only entity to be responsible to update the

processes and templates.

2.5.5 STN shall define a process to receive suggestions and comments to improve the processes

and templates.

2.5.6 STN shall publicly share information on TSeP licensed by the licensing authority to the

public.

2.5.7 STN shall coordinate the definition of funding models for telehealth.

2.5.8 STN shall support research and evidence-based practices on telehealth activities conducted

in the Kingdom of Saudi Arabia.

2.5.9 STN shall receive any complaint about a telehealth activity. The procedures to be applied in

case of a complaint shall be defined by STN.

2.5.10 STN shall define, develop, implement and update procedures in case of non-compliance of

the regulations and policies.

2.5.11 STN shall be involved in inspection or audit of telehealth activities.

2.5.12 STN shall provide an annual report of telehealth activities to communicate publicly about

their status of implementation and their impacts in the Kingdom of Saudi Arabia.


3. ORGANIZATION

3.1 BEFORE A TELEHEALTH ACTIVITY

License

3.1.1 A licensed healthcare facility (HCF) shall comply with regulations and policies of the STN

to practice telehealth and shall not apply to a telehealth license.

3.1.2 A TSeP shall apply to a telehealth license to deliver telehealth services.

Accreditation

3.1.3 The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) shall include

a section on telehealth on their accreditation standards.

3.1.4 The Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI) shall define

a process for accreditation of TSeP.

Medical devices

3.1.5 Medical devices used for telehealth activities shall abide by the medical devices regulations

under the umbrella of Saudi Food and Drug Authority.

Contracting and collaboration

3.1.6 Contracting with TSeP or TSoP shall be made after the definition of the medical objectives

and model of care based on criteria defined by the STN.

3.1.7 If two or more HCF provide a collaborated telehealth activity between themselves, written

agreements based on a template provided by the STN shall be signed to formalize the

relationship between both organizations.


Training

3.1.8 HCPs shall be trained on telehealth before practicing telehealth.

3.1.9 HCP training on telehealth may be provided during the initial health education or acquired

with continuous education training accredited by the Saudi Commission for Health

Specialties (SCFHS).

3.1.10 Initial education of a HCP, including the medical residency curriculum, and healthcare

facility manager’s education shall include telehealth content.

Malpractice insurance

3.1.11 The malpractice insurance of HCPs shall include telehealth practice.

Health information

3.1.12 Telehealth activities shall be compliant with the health information exchange policy

(SeHE), including all relevant data security and privacy requirements, and compatible with

the Standards and policies of interoperability.

3.1.13 HCPs shall have sufficient evidence to identify the patient for a telehealth activity.

3.1.14 HCPs shall have access to all relevant patient health and medical information to practice

telehealth, if existing.

Declaration

3.1.15 HCF providing telehealth activities shall declare their activities to the STN before

initiating the activity and shall update this declaration at least annually.

3.1.16 A declaration by a HCF to the STN shall include the description of the objectives,

classification “types of activities” (2.3), model of care, financial model, participating HCPs,

chosen TSeP or TSoP, data management approach, and evaluation protocol based on a

template defined by the STN.


Patient rights

3.1.17 An informed patient consent shall be recorded, preferably online, before any telehealth

activity. The consent template shall be defined by the STN.

3.1.18 Patients may refuse and/or cancel any participation to a telehealth activity, at any time,

without the need to provide justification.

3.1.19 Patients may request for a telehealth activity.

3.1.20 Patients should receive relevant education on telehealth, if needed.

3.1.21 A protocol shall be defined in case of technical incidents stopping an activity.

3.1.22 A protocol shall be defined in case of a medical emergency occurring during an activity.

3.2 DURING A TELEHEALTH ACTIVITY

3.2.1 HCPs practicing telehealth shall respect the following:

3.2.1.1. Their obligations and ethical responsibilities

3.2.1.2. Patient confidentiality

3.2.1.3. Legal requirements for paediatric patients and patients with mental health

conditions.

3.2.2 A HCP practicing telehealth may deliver an online prescription or medical investigation in

accordance with professional responsibility, respecting the medical prescription and

investigation regulations applied in the Kingdom of Saudi Arabia.

3.2.3 A HCP may prepare a referral, which shall be in accordance with regulations on patient

referrals in the Kingdom of Saudi Arabia.

3.2.4 During a tele-expertise, both HCPs shall engage their responsibility based on their

individual contribution. The responsibility of the requested HCP is engaged when an answer

is provided to the requesting HCP. The responsibility of the requesting HCP is engaged


when a request is sent and when a decision is taken based on the answer provided by the

requested HCP.

3.3 AFTER A TELEHEALTH ACTIVITY

3.3.1 All telehealth activities shall be included in the medical record of a patient and shall include

3.3.1.1. HCP identification

3.3.1.2. Location of patient and remote sites

3.3.1.3. Date and time

3.3.1.4. Classification

3.3.1.5. Details of the prescriptions and/or medical investigation provided

3.3.1.6. All technical incidents which may impact the activity

3.3.1.7. All adverse events which may be observed during the activity.

3.3.2 Medical coding, including the International Classification of Diseases (ICD), shall be applied

at the end of each telehealth activity, in accordance with the medical coding regulations in

the Kingdom of Saudi Arabia.

3.3.3 HCP and HCF practicing telehealth may be paid for the practice of telehealth.

3.3.4 HCF may be inspected or audited, at any given time, without prior notice in accordance with

national regulations in the Kingdom of Saudi Arabia.

3.3.5 Declared HCF (including TSeP) shall provide an annual evaluation report to the STN based

on a template defined by the STN.


4. CONCLUSION

This document is considered as the national regulations and policies for telehealth in the Kingdom

of Saudi Arabia and will be updated accordingly if needed.

This document is followed by the general guidelines for the practice of telehealth documents.

Documents

The governing rules of Telehealth in the kingdom of Saudi