Health data

Health data rules and standards from the Ministry of Health, the Saudi Health Council and NHIC, the SFDA and the National Committee of Bioethics. Health data is PDPL sensitive data.

8 instruments in this framework.

Primary law: niẓām (Royal Decree M/…)

Law of Ethics of Research on Living Creatures and its Implementing Regulations · Royal Decree M/59; Implementing Regulations v3 (2025); in force (reported)

Implementing & executive regulation

Regulations and Requirements for Conducting Clinical Trials on Drugs (v4.0) · SFDA, version 4.0, 10 May 2026; current

Rules, controls & standards

Saudi Health Information Exchange Policies (IS0303 v1.0) · v1.0; NHIC copy issued by the Saudi Health Council (21 April 2016); original MoH eHealth (
MoH internal Data Governance Policy (v0.1) · Version 0.1, marked Confidential, undated; published on moh.gov.sa
Saudi eHealth Security and Privacy Interoperability Specification (IS0101) · Saudi Health Council, version 1.0, 21 April 2016; technical standard

Guidelines & circulars

Telehealth Application Guidelines · NHIC; undated; current
Guidance on AI/ML-Enabled Medical Devices (MDS-G010) · SFDA, 3 January 2023; guidance
Guidance on Pre-Market Cybersecurity of Medical Devices (MDS-G38) · SFDA, version 1.0, 18 June 2019; guidance

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