Implementing Regulation of the Law of Private Health Institutions

Article 1

Article 2

  • 1/2 The following conditions must be met for licensing a private clinic:

    • 1. The owner of the clinic must be a Saudi doctor classified and registered with a valid professional registration with the Saudi Commission for Health Specialties.

    • 2. The clinic must have a licensed nurse or nursing staff authorized to practice the profession, and clinical assistants or health assistants may be utilized instead of the nurse according to the clinic's specialty.

  • 2/2 It is required to appoint a full-time Saudi medical supervisor who specializes in the nature of the work of the medical complex, laboratory, radiology center, or day surgery center in the following cities: Riyadh, Makkah, Madinah, Jeddah, Dammam, and Khobar. Other cities are exempt from the nationality requirement if a Saudi technical supervisor is not available. The owning or partnering doctor or professional in the health institution may serve as the technical supervisor, provided that they specialize in the nature of the health institution's work.

  • 3/2 The requirements for the technical supervisor of health institutions are:

    • 1. Must hold a bachelor's degree or its equivalent in one of the medical specialties related to the nature of the health institution's work, and must be classified and registered with a valid professional registration with the Saudi Commission for Health Specialties.

    • 2. Must have at least one year of experience in the nature of the health institution's work.

  • 4/2 The following conditions apply to the position of medical director in the hospital:

    • 1. Must be a Saudi doctor holding a bachelor's degree in medicine and surgery and must be classified and registered with a valid professional registration with the Saudi Commission for Health Specialties.

    • 2. Must have at least three years of experience in an administrative position in a health institution or hold an accredited certificate in one of the administrative specialties.

    • 3. The medical director of the hospital is considered the technical supervisor.

    • 4. A dentist may hold the position of medical director in specialized dental hospitals.

  • 5/2 It is required that the administrative director in health institutions be a Saudi national holding a bachelor's degree.

Article 3

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Article 4

  • 1/4 The License to open hospitals, addiction treatment and rehabilitation centers, and independent fertility centers is granted with the approval of the Assistant Agency for Health Investment Development, provided that the Health Affairs Directorates in the regions and governorates issue and renew all licenses for health institutions.

  • 2/4 The licensing for opening emergency transport service centers is conditional upon compliance with the terms and specifications according to Annex No. (6).

  • 3/4 The health institution may, based on the Ministry's approval, contract with a company or institution specialized in operating health institutions, provided that this company or institution is qualified and accredited by the Ministry according to Annex No. (7).

  • 4/4 The application for the License to open the health institution is submitted to the relevant Health Affairs Directorate according to the procedures outlined in Annex No. (8), and the inspection committee from the Licensing Department will examine the building and equipment within ten days of submitting the license application.

  • 5/4 The Ministry grants immediate licenses on the condition that the minimum number of health practitioners for the health institutions listed in Annex No. (9) is provided.

Article 6

  • 1/6 Health institutions are classified according to the standards set by the Committee for Classifying Healthcare Providers.

  • 2/6 The Ministry publishes the classification results periodically.

Article 7

  • 1/7 The healthcare institution shall publish the prices approved by the Licensing Departments of the Health Affairs Directorates electronically on its website or in a printed copy.

  • 2/7 The written consent of the patient must be obtained or an invoice issued (indicating the name of the treating physician and the therapeutic service provided) before providing the service, and it must be included in the patient's medical record, except in emergency cases that require immediate intervention.

  • 3/7 The healthcare institution is obligated to provide a free follow-up for the patient within at least fourteen days for the same condition diagnosed in the initial examination.

  • 4/7 Discounts on service prices or promotional offers may not be made by any advertising means without the approval of the Ministry (attached number 10).

Article 8

  • 1/8 The Ministry grants a license to practice the profession based on the conditions stated in the Health Professions Practice System and its executive regulations, provided that the health institution commits to suspending the practitioner from work upon the expiration of their license until the license is renewed.

  • 2/8 The health institution may not employ a health practitioner who has a license to practice in another health institution except through the following:

    • A- Secondment between health institutions according to the following requirements:

      • 1. The licenses of both health institutions must be valid.

      • 2. The health practitioner must hold a valid license to practice.

      • 3. The secondment may be within or outside the jurisdiction of the health affairs directorate where the health institution is located.

      • 4. Approval must be obtained from the health affairs directorates of the regions or governorates to which both health institutions belong before the health practitioner commences work at the requesting entity, ensuring that this does not disrupt the minimum number of health practitioners in both institutions.

      • 5. The duration of the secondment must not exceed one hundred and eighty days (continuous or intermittent) within one year, provided that the license of the seconded health practitioner is valid during the secondment period.

      • 6. Health practitioners working in the health institution are allowed to work in other health institutions owned by them, and the institution must maintain records to document the movement of health practitioners between institutions without disrupting the required minimum of health practitioners.

      • 7. The license of the health institution to which the health practitioner is seconded must match their specialty.

    • B- Regarding the work of the Saudi consultant physician or the first deputy physician, it is conducted according to the following rules:

      • 1. A consultant physician or first deputy physician holding a valid registration and classification from the Saudi Commission for Health Specialties may work in a maximum of three health institutions, and they are not permitted to work in another health institution in the same activity if they are licensed in a day surgery center, but they may work in the outpatient clinics of another hospital or medical complex.

      • 2. It is required to obtain licenses to practice in the health institutions where they will work without disrupting the minimum number of required health practitioners in each health institution.

      • 3. It is required to provide the health affairs in the region or governorate with their working hours in each health institution, and the health affairs must be notified when they cease working to cancel the health practitioner's license to practice.

  • 3/8 Health practitioners may be licensed to practice through recruitment companies and the Ajir service in the name of the health institution they will work for after fulfilling the following:

    • 1- The required conditions in the Health Professions Practice System and the Private Health Institutions System.

    • 2- A copy of the contract for the health practitioner's services between the health institution and the recruitment company, specifying the name of the health practitioner, passport number, residency number, classification and registration number with the Saudi Commission for Health Specialties, and the start and end dates of work in the health institution.

    • 3- When licensing new health institutions, the duration of contracts for health practitioners in Ajir must not be less than six months and may be renewed as needed.

    • 4- The health institution must comply with what is stated in Article (41) of the Health Professions Practice System issued by Royal Decree No. (M/95) dated 4/11/1426 AH.

  • 4/8 The health institution must cancel the health practitioner's license upon the termination of the contractual relationship with them.

  • 5/8 Private hospitals and medical complexes prepared for the specialty and capabilities of the visiting physician may request the recruitment of visiting physicians according to the rules specified in Article Three of the Health Professions Practice System and its executive regulations.

  • 6/8 The hospital is obligated to grant clinical privileges and authorities to the health practitioner according to the following standards:

    • 1. Hospitals must establish an internal committee called the Clinical Privileges and Credentials Committee responsible for reviewing the qualifications and experiences of health practitioners at the hospital to ensure they have the necessary education, training, experience, and skills.

    • 2. The committee shall be chaired by the medical director and include heads of essential departments such as surgery, internal medicine, emergency, intensive care, the human resources manager, and a representative from the hospital management, with the classification of physicians not less than consultant, and the committee shall approve and grant all privileges and authorities to health practitioners within the hospital in accordance with the classification of the Saudi Commission for Health Specialties.

    • 3. The committee shall have written policies and procedures that define responsibilities in granting, denying, canceling, or suspending any clinical privileges.

    • 4. The committee must consider the availability of health practitioners and hospital facilities when issuing a decision to grant clinical privileges and authorities.

    • 5. The committee issues a decision to grant clinical privileges and authorities to health practitioners in the hospital to provide medical care services to patients within the hospital according to Annex (No. 11).

  • 7/8 Other health institutions must prepare written policies and procedures for the schedules of clinical privileges and authorities for all physicians in all departments and specialties by forming an internal committee to approve clinical privileges according to Annex (No. 11).

  • 8/8 Health practitioners and health institutions must adhere to the policy document and procedures for the schedule of clinical privileges and authorities for each category of dentists according to Annex (No. 12).

  • 9/8 Compliance with the guideline for clinical privileges and authorities for the most practiced medical specialties in health institutions according to Annex (No. 13) is required.

Article 10

  • 1/10 The hospital is obligated to provide the minimum number of healthcare practitioners as follows:

    • 1- Fulfillment of the conditions stated in paragraphs (4-5) of Article Two of the Law.

    • 2- Appointment of a head of nursing with a classification of at least Specialist.

    • 3- Appointment of a number of consultant physicians, residents, and interns in outpatient clinics and inpatient departments as per the attachment (No. 14).

    • 4- Provision of the minimum number of specialists, technicians, and nursing staff to ensure coverage of medical services, and clinical assistants and health assistants may be employed to work in outpatient clinics only instead of nursing as per the attachment (No. 14).

    • 5- Provision of a list of on-call physicians available 24/7.

Article 11

  • 1/11 Hospital Sections and Services:

  • The hospital must be equipped with the following sections: 

    • 1. Outpatient Clinics.

    • 2. Inpatient Wards: A negative pressure isolation room for airborne infectious diseases must be provided, compliant with Ministry specifications, equipped with a separate bathroom at a rate of one room for every 25 inpatient beds, with a minimum of one room in the inpatient department.

    • 3. Emergency Department: A resident physician in emergency medicine or one of the hospital's main specialties and two nurses for every ten beds in the emergency department must be available around the clock according to the facility (Annex No. 14) with adherence to the following regulations:

      • A- A fully equipped isolation room.

      • B- Provision of a modern ambulance, not older than five years prior to the date of application for the final license or ten years for renewal.

      • C- Existence of policies for patient transfer.

      • D- The number of emergency beds must not be less than 10% of the total number of beds and is not counted among the hospital beds.

    • 4. Laboratory Department (according to Article (1/15).

    • 5. Radiology Department (according to Article (2/15).

    • 6. Operating Room with established policies and procedures for the department.

    • 7. Intensive Care Unit:

      • A- The hospital must provide intensive care beds that match the size and activity of the hospital at a rate of one intensive care bed for each operating room, or 10% of the hospital's bed capacity, whichever results in a higher number of intensive care beds.

      • B- At least one negative pressure isolation room must be provided for every six intensive care beds, compliant with Ministry specifications.

      • C- The intensive care unit must be equipped with necessary furniture and equipment (ventilators, intubation devices, a rapid response cart equipped with a defibrillator, emergency medications and equipment, blood oxygen and heart rate monitors, blood transfer devices and pumps, blood gas analysis and measurement devices).

    • 8. Hospitals with maternity wards must meet the following requirements:

      • A- They must include at least two rooms equipped for natural childbirth with privacy, providing midwives for the active phase of labor, an operating room equipped for cesarean sections, a room for newborns, and a room for premature infants, comprising no less than 20% of the total beds in the maternity department, and all mothers must be allowed companions during childbirth with continuous emotional and physical support.

      • B- Compliance with Ministry standards for cesarean sections, episiotomy, and the rate of vaginal births after cesarean sections according to the facility (Annex No. 15).

      • C- Provision of a clinic for breastfeeding support staffed by a healthcare practitioner trained in breastfeeding counseling to support pregnant or breastfeeding mothers, in compliance with the system for the distribution of breast milk substitutes issued by Royal Decree No. (M/49) dated 21/09/1425H.

      • D- Compliance with the provisions of Article Nine of the Prevention of Acquired Immunodeficiency Syndrome (AIDS) and the rights and duties of the infected issued by Royal Decree No. (M41) dated 16/04/1439H.

      • E- Compliance with the requirement to conduct screening for Hepatitis C virus infection for all cases admitted for childbirth as part of the national program for the elimination of Hepatitis C virus, with all cases that test positive referred to the Ministry of Health for registration and initiation of treatment.

    • 9. Support services in hospitals as stated in Article (No. 4/15) or additional activities according to Article (No. 5/15).

    • 10. Administrative services in hospitals as follows:

      • A- An administration department with offices for the hospital director and assistants, and for administrative and accounting staff.

      • B- Reception and appointment office.

      • C- Medical records department, taking into account the provisions of Article (3/3). 

      • D- Department for electronically registering births and deaths within the systems regulated by the Ministry according to the facility (Annex No. 16).

      • E- The hospital must retain patient files for ten years, including the last visit of the patient, and upon destruction after this period, a summary of the medical condition must be retained for a similar duration for reference when needed.

      • F- Provision of paper or electronic prescription pads that can be printed upon request from the patient or inspection committees.

    • 11. Nutrition Department:

      • A- The hospital is obligated to provide a nutrition system that aligns with the regulations and guidelines issued by the Ministry in the field of nutrition.

      • B- A clinical nutrition specialist must be provided.

      • C- The kitchen must meet all health and technical conditions for food preparation, preservation, and serving to patients according to Hazard Analysis and Critical Control Points (HACCP) standards, and the hospital may contract with a specialized nutrition company.

    • 12. Laundry Department: The hospital must have a dedicated department equipped with all devices and machines that ensure the cleaning, washing, and ironing of clothes and linens, or secure these services from outside the hospital by contracting with a specialized company according to technical and health standards.

    • 13. Sterilization Department: The hospital must have a dedicated department equipped with all devices that ensure safe sterilization according to technical and health standards, and may contract with a specialized company.

    • 14. Morgue: The hospital must have a morgue for preserving bodies according to recognized medical methods, with no less than one unit for every 25 beds.

    • 15. Internal Pharmacy: Managed by a licensed pharmacist with consideration of the provisions of the Pharmaceutical Facilities and Products Regulation issued by Royal Decree No. (M/31) dated 1/6/1425H and its executive regulations, it is required to appoint a Saudi pharmacist or a Saudi pharmacy technician responsible for the custody of narcotic substances and psychotropic substances, and the head of nursing or their delegate in the hospital's internal department is responsible for the custody of narcotic substances and psychotropic substances, with a secure, locked place designated for storing narcotic substances and psychotropic substances according to the Narcotic Drugs and Psychotropic Substances Control Regulation issued by Royal Decree No. (M/39) dated 8/7/1426H according to Annex No. (17).

  • 2/11 Cleanliness: A good level of cleanliness must be maintained in every section of the hospital, with independent cleaning services designated for the operating, maternity, and intensive care departments, and the hospital may contract with a specialized cleaning company.

  • 3/11 The hospital is obligated to implement the essential safety requirements (ESR) referred to in the standards of the Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI).

  • 4/11 Staff working in the kitchen, laundry, cleaning, and sterilization must have health certificates proving their free status from infectious diseases.

  • 5/11 Hospitals without a blood bank must secure blood units and components from other health sectors free of charge, and a separate section within the laboratory must be equipped to conduct blood type testing and compatibility tests and store blood units and components, which must include (blood bank refrigerator, deep freezer for plasma, and platelet incubator). The hospital is obligated to conduct the above tests and provide medical supervision for blood transfusions according to the service pricing approved by the Ministry.

  • 6/11 A licensed security company must be contracted for 24-hour security services or provide a sufficient number of security personnel in the hospital.

  • 7/11 Extended medical care and rehabilitation hospitals may be opened according to the conditions and regulations as per Annex (No. 18).

  • 8/11 Specialized hospitals for the treatment and rehabilitation of addicts may be opened or a permit obtained to add a department for the treatment and rehabilitation of addicts in existing hospitals according to Annex (No. 19).

Article 12

  • 1/12 Every healthcare institution must notify the Ministry of infectious diseases, adhering to all instructions and preventive procedures established by the Ministry as per the attachment (No. 20). The private healthcare institution is also obligated to provide the Ministry with any statistical data it requests.

  • 2/12 Every healthcare institution must report serious health incidents occurring within it through the notification mechanism approved by the Ministry as per the attachment (No. 21).

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