First: Requirements for Initial Approval
This stage aims to verify the investor’s eligibility and the suitability of the headquarters before starting the setup works.
- Legal Documents:
- Commercial Registration: The facility’s commercial registration must be valid and include the activity "Remote Care and Telemedicine Center".
- Title Deed or Lease Agreement: Provide a copy of the title deed or lease for the administrative office that will serve as the center’s headquarters.
- Site and Plans:
- Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing for the site.
- Preliminary Engineering Plans: Submit preliminary engineering plans for the administrative office, certified by an engineering office. The plans must show:
- Administrative offices.
- Rooms for healthcare practitioners.
- Technical equipment areas.
Second: Requirements for Final Operating License
After obtaining initial approval and completing the setup, this stage is for obtaining the final operating license.
- Technical and Administrative Requirements:
- Digital Platform: The center must have a licensed and approved digital platform or application by the Ministry of Health and the National Health Information Center, ensuring patient data confidentiality and security.
- Documentation System: The platform must be capable of documenting all consultations, including patient identity, type of technology used, date and time of the consultation, and medical recommendations.
- Data Security: All medical data and information must be fully encrypted and stored securely within the Kingdom of Saudi Arabia.
- Infection Control System: A written protocol must exist to ensure sterilization and hygiene when using any medical tools.
- Specialized Staff:
- Technical Director: The center’s technical director must be a physician in a specialty relevant to the type of consultations provided, with a valid professional classification from the Saudi Commission for Health Specialties.
- Healthcare Practitioners: All healthcare practitioners working in the center (physicians, pharmacists, specialists) must hold a valid professional classification from the Saudi Commission for Health Specialties.
- Facilities and Equipment:
- Administrative Headquarters: The administrative office must be fully equipped and include rooms dedicated for healthcare practitioners to conduct consultations.
- Technical Equipment: Provide computers, cameras, and high-quality audio systems to ensure effective communication with patients.
- Additional Requirements:
- Insurance Certificate: Obtain malpractice/medical errors insurance.
- Accreditation: Obtain accreditation from the Saudi Center for Accreditation of Healthcare Institutions (CBAHI), which is mandatory for operation.
- Clear Policies: The center must have clear policies and guidelines for handling emergency cases and informing patients about health conditions that require an in-clinic or hospital visit.
- Prior Consent: Obtain prior consent from the patient before any remote medical consultation, preferably electronically.