Ministry of Health (MOH)

Health ministry; health data is PDPL sensitive data. This page also lists NHIC, Saudi Health Council, SFDA and research ethics instruments.

Health data rules come from several bodies. Health data is sensitive data under the PDPL. Wadira lists their instruments on this page until they have their own.

Ministry of Health (MoH): health policy and public providers. Its Data Governance Policy (v0.1) is an internal MoH policy, not a sector-wide rule.
Saudi Health Council and the National Health Information Center (NHIC): health information standards, including the Saudi Health Information Exchange Policies (IS0303), IS0101 and the Telehealth Application Guidelines.
Saudi Food and Drug Authority (SFDA): drugs, medical devices and clinical trials (clinical trials regulations v4.0; MDS-G010; MDS-G38).
National Committee of Bioethics (NCBE): research ethics under Royal Decree M/59, including rules on sending samples abroad.
Council of Health Insurance (CHI): health insurance. CHI and NPHIES data rules are not yet covered.

Sector rules and the PDPL. Health data is sensitive data under the PDPL, so the registration trigger in draft Art 34 of the October 2026 amendments to the PDPL Implementing Regulation (IR) would capture most health providers. Sector hosting and sample rules (NHIC telehealth, research ethics) apply alongside PDPL transfer rules; a PDPL-compliant transfer does not lift them.

Regulates: Healthcare providers · Health information exchange participants · Clinical trial sponsors · Medical device and drug companies

Protects: Patients · Health records · Research participants

Official website

Instruments issued or administered (8)

Law of Ethics of Research on Living Creatures and its Implementing Regulations · Law
Regulations and Requirements for Conducting Clinical Trials on Drugs (v4.0) · Regulation
Saudi Health Information Exchange Policies (IS0303 v1.0) · Instrument
MoH internal Data Governance Policy (v0.1) · Instrument
Saudi eHealth Security and Privacy Interoperability Specification (IS0101) · Standard
Telehealth Application Guidelines · Guideline
Guidance on AI/ML-Enabled Medical Devices (MDS-G010) · Guideline
Guidance on Pre-Market Cybersecurity of Medical Devices (MDS-G38) · Guideline

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