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Zayenha Health
AI assistant for physicians and healthcare providers in Saudi Arabia
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Zayenha Health helps you craft professional, trustworthy health content: consultation summaries in the globally adopted SOAP format, informed consent forms aligned with the Declaration of Helsinki, and patient education content in clear language that respects patient rights and privacy. Every output reflects Saudi regulatory awareness: health data's classification as sensitive under the Personal Data Protection Law, and SFDA requirements for digital health products and AI-based medical devices, while distinguishing general educational content from individual consultations requiring professional licensing. Built for practitioners and health teams, not a diagnostic substitute.
Example tasks it handles
Knowledge base reference
Reference material the assistant draws on. We review the content periodically and keep it accurate, but official sources remain the authority.
Best Practices
The IMDRF Risk Framework for SaMD: The Basis of SFDA's Regulation of Smart Health Tools
In 2014, the International Medical Device Regulators Forum (IMDRF) published 'SaMD: Possible Framework for Risk Categorization,' which classifies SaMD risk using two criteria: the significance of the information the software provides to a healthcare decision (inform/drive clinical management/diagnose or treat directly), and the criticality of the targeted health situation (non-serious/serious/critical), across 4 risk categories (I through IV). SFDA explicitly adopted this framework (via MDS-G010 and subsequent guidance) as the basis for regulating AI-based medical devices. Any tool within a health assistant that generates recommendations tied to a treatment decision should be provisionally placed on this scale before launch, even if it lands in the lowest risk category.
WHO's Ethics Framework for AI in Health: Six Governing Principles
On 28 June 2021, WHO published 'Ethics and Governance of Artificial Intelligence for Health,' the first comprehensive global framework of its kind, following 18 months of work by an international expert group of 20 specialists. It sets out 6 governing principles: (1) protect human autonomy, (2) promote human well-being, safety, and the public interest, (3) ensure transparency and explainability, (4) foster responsibility and accountability, (5) ensure inclusiveness and equity, and (6) promote responsive and sustainable AI. Any health AI tool — including a content-generation assistant — should be measured against these six principles before being considered ready for use in an actual care context.
Glossary
Glossary: Software as a Medical Device (SaMD) — Where 'Education' Ends and 'Diagnosis' Begins
SaMD stands for 'Software as a Medical Device' — standalone software (not required to be part of a physical medical device) designed for one or more medical purposes: investigation, detection, diagnosis, monitoring, or treatment/management of a health condition. Any tool inside a digital health assistant that provides a preliminary diagnosis, interprets an individual's specific lab result, or recommends a particular treatment decision may fall under this classification — requiring review against SFDA's requirements (MDS-G010/MDS-G-027) before being offered as an actual diagnostic service. The practical dividing line: 'a general explanation of what a test means' is education; 'your specific result means X, so do Y' is individual diagnosis requiring licensing.
Regulations & Laws
SFDA MDS-G-027 (August 2025): The Latest Guidance on Digital Health Product Classification
SFDA issued MDS-G-027 (version 1.0) dated 11 August 2025 — the most current guidance for classifying and registering digital health products for Medical Devices Marketing Authorization (MDMA). Its scope covers Software as a Medical Device (SaMD), mobile health (mHealth) apps, Digital Therapeutics (DTx), and telemedicine. Any digital product or tool falling into these categories — including a health AI assistant producing content used in an actual treatment decision — needs to review the appropriate licensing pathway under this guidance before launching as a diagnostic or therapeutic service rather than a purely educational tool.
SFDA MDS-G010: When an AI Tool Counts as a 'Medical Device'
SFDA issued guidance MDS-G010 (version 1.0, dated 29 November 2022) for AI/ML-based medical devices seeking Marketing Authorization (MDMA) in the Kingdom. It defines regulated devices as those that diagnose, manage, or predict diseases by analyzing medical data, requiring demonstrated clinical association plus analytical, technical, and clinical performance validation, along with AI-specific risk management. The guidance explicitly builds on IMDRF's international risk-categorization frameworks. Any health AI tool that moves beyond 'general education' into individual diagnosis or treatment recommendation falls, in principle, within this guidance's scope.
MOH Licensing Requirements for Telehealth Centers
Obtaining an MOH license for 'telehealth and tele-consultation centers' requires: a valid commercial registration, a Ministry of Investment license (for foreign investors), a Ministry of Municipal and Rural Affairs license, and compliance with the executive regulation for private health institutions (facilities and staffing). The service fee is SAR 1,000 plus platform and health-coding certificate fees, with 3-5 business days processing. This facility license is entirely separate from an individual practitioner's professional practice license; any digital platform offering individual remote consultations — not merely general educational content — needs both licenses together.
Council of Health Insurance (CHI): The Correct Current Name of the Regulator
The 'Cooperative Health Insurance Council' (CCHI) was established under Article 4 of Council of Ministers Resolution No. 71 dated 27/4/1420H (11 August 1999). On 12 September 2021, it was officially renamed the 'Council of Health Insurance' (CHI), dropping 'Cooperative' from the official name. Any health content addressing health insurance or insured-patient claims in Saudi Arabia should reference the authority under its current name, CHI, rather than the outdated CCHI — a common naming error still found in unupdated content.
PDPL: Health Data Is 'Sensitive Data' with Heightened Penalties
The Personal Data Protection Law (PDPL) was issued by Royal Decree No. (M/19) dated 16 September 2021 and came into full effect on 14 September 2024 after a full one-year transitional period. The law classifies 'health data' as 'sensitive data,' triggering stricter processing and consent controls than ordinary data. Penalty for disclosing sensitive data with intent to harm or for personal gain: up to 2 years imprisonment and/or a fine up to SAR 3 million; other violations can reach a fine of SAR 5 million (doubled on repeat violation). Supervising authority: SDAIA. Any digital health tool collecting or processing patient data must treat it as sensitive under the full legal classification.
Law of Practicing Healthcare Professions: The Legal Foundation for Health Practice in Saudi Arabia
The Law of Practicing Healthcare Professions was issued by Royal Decree No. (M/59) dated 4/11/1426H (6 December 2005) and officially published on 28/11/1426H (30 December 2005). It sets the licensing requirements for practicing any health profession in the Kingdom, defines a practitioner's obligations toward patients and facilities, and imposes explicit penalties for impersonating professional titles (such as 'physician' or 'consultant') or practicing without a valid license. Its executive regulation (3rd edition, 1440H/2019 is the latest known) later detailed licensing and disciplinary procedures. Any health content attributed to a practitioner or facility should implicitly assume a valid license under this law.
Ready Templates
Informed Consent Structure per the Declaration of Helsinki: Four Mandatory Elements
The 'Declaration of Helsinki,' issued by the World Medical Association since 1964 (with subsequent substantive revisions), is the most globally recognized ethical reference for medical research on humans. It defines core informed consent elements: (1) informing the participant of the procedure's aims and methodology, (2) clarifying anticipated benefits, (3) full disclosure of potential risks, and (4) the right to refuse participation or withdraw at any time without reprisal — requiring a legally authorized representative's consent where the participant cannot consent themselves. Any informed consent template produced by a health assistant should include these four elements as a baseline, phrased in language an ordinary patient can understand, not complex legal wording.
The Patient Bill of Rights and Responsibilities (MOH)
Saudi MOH officially publishes the 'Patient Rights and Responsibilities Document' on its site. It covers the patient's right to high-quality care, informed consent before any procedure, respect for the privacy and confidentiality of their health information, and the right to understand their diagnosis and treatment plan in language they can understand rather than complex medical terminology — balanced against their responsibilities: providing accurate information about their condition and adhering to the agreed treatment plan. This document is a foundational reference for any patient-communication content produced by a health assistant, whether a consent form, an educational message, or a results summary.
The SOAP Note: The Global Standard for Clinical Documentation Since 1968
American physician Lawrence Weed developed the 'SOAP' format as part of the Problem-Oriented Medical Record system, publishing it in 'Medical Records that Guide and Teach' in the New England Journal of Medicine on 21 March 1968. The format splits a medical visit into 4 ordered sections: Subjective (the patient's complaint in their own words), Objective (exam findings and measurements), Assessment (evaluation/differential diagnosis), and Plan (treatment and follow-up plan). This four-part structure is the world's most widely used clinical documentation standard and forms a direct structural basis for any 'consultation summary' template produced by a health AI assistant — provided it remains a documentation/summarization aid, not a substitute for clinical judgment.
Ready prompts in this field
Human-vetted, ready-to-use prompts.
Patient-Friendly Medical Consultation Summary
Summarize what the doctor said in patient-friendly language with a clear action plan and red flags requiring immediate return.
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EHR Clinical Note (for physicians)
Draft a professional SOAP-format clinical note for EHR (CBAHI-compliant).
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Annual Screening Schedule by Age & Gender
Annual preventive screening schedule for men and women at 30+/40+/50+, based on USPSTF and Saudi MoH guidelines.
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Pediatric Vaccinations Schedule (Saudi MoH Mandatory & Recommended)
Pediatric vaccinations from birth to 18 years per Saudi MoH guidelines, mandatory and recommended.
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Ramadan Preparation Plan for Patients with Chronic Conditions
Ramadan fasting preparation plan for chronic patients (diabetes, hypertension, cardiac, renal) based on IDF-DAR and Fiqh Council guidelines,…
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Health Literacy Content Strategy — Making Medical Information Accessible to Arabic-speaking Patients
Systematic guide for transforming technical medical content into culturally appropriate, plain-language health information for Arabic-speaki…
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Hajj/Umrah Health Preparation Protocol — Physical Readiness, Vaccination, and Medication Management
Comprehensive medical guide for Hajj/Umrah health preparation covering pre-travel physical assessment, mandatory and recommended vaccination…
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Oncology Patient Communication Guide — Breaking Difficult News in Saudi Cultural Context (Family-centered Disclosure)
Comprehensive communication protocol for delivering oncology diagnoses and difficult news in the Saudi cultural and family context, combinin…
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Hospital Patient Experience Improvement Plan — JCI, CBAHI Standards and KFSH&RC Reference
Operational framework for elevating patient experience in Saudi hospitals, drawing on JCI and CBAHI accreditation standards with 90-day impl…
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Nutrition Label Reading Guide — Teaching Saudi Consumers to Interpret Food Labels (SFDA Regulations, Arabic Labels)
Educational guide teaching Saudi consumers to read and interpret food labels per SFDA regulations, covering nutrition facts panels, ingredie…
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Genomic/Precision Medicine Patient Counseling Script — Communicating Genetic Test Results to Saudi Patient and Family
Genetic counseling protocol for communicating genomic test results to Saudi patients and families, combining scientific accuracy with cultur…
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Health App Engagement Strategy — Increasing Saudi Patient Adherence to Digital Health Tools (Nomo, Seha, Dawi Apps)
Strategic framework for increasing usage and adherence to Saudi digital health apps, built on user behaviour science and local health contex…
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The content above is informational and intended for professional reference. It is not formal legal, tax, or professional advice. Please consult official sources and specialists before taking any action.