1. Regulation of Private healthcare facilities in hong kong
Office for Regulation of Private Healthcare Facilities
Department of Health
The Government of the Hong Kong Special Administration Region

2. Organisation chart of Department of Health
Director of Health
Consultant in-charge, Dental Service
Controller, Regulatory Affairs
Office for Regulation of Private Healthcare Facilities
Other regulatory affairs, including:
- Drug Office
- Radiation Health Unit
- Medical Device Control Office
- Boards and Councils
- Chinese Medicine Division
Controller, Centre for Health Protection
Deputy Director of Health

3. Dual-track healthcare system in Hong Kong
Inpatient service (number of bed days)
Private ~10%
Public ~90%
Public ~30%
Private ~70%
Outpatient service(number of attendances)

4. Current Regulation of Private Healthcare Facilities
Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165)
Medical Clinics Ordinance
(Cap. 343)
Private Hospitals and Maternity Homes
(N=12)
Nursing Homes
(N=66)
Non-profit-sharing medical clinics
(N=87)

5. Regulation of private hospitals and nursing homes
Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165)
Enacted in 1936
Does not include any hospital maintained by the Government, any military hospital or any public hospital within the Hospital Authority Ordinance
Registration requirements：
Accommodation
Staffing
Equipment

6. Code of Practice Sets out the regulatory standards
General
Corporate governance (e.g. organization, human resource, information management)
Clinical governance (e.g. quality management, risk management, complaints, clinical research)
General management (e.g. facility management, healthcare engineering, infection control)
Clinical services (e.g. patients’ right, care of patient, telemedicine, specific service requirements)
Supporting services
Price transparency
De-registration
Compliance to CoP is one of the conditions of registration

7. Registration Inspection Sentinel Event Complaint handling
New application
Annual registration
new applications / change in hospital services
Inspection
Unannounced
At least twice a year
Theme of ad-hoc inspection based on the risk identified
Sentinel Event
11 reportable events
Conduct root cause analysis
Annual Patient Safety Digest to share lesson learnt
Complaint handling
Monitor the compliance of licensing requirements

8. Reportable events Sentinel event Serious untoward event
Surgery / interventional procedure involving the wrong patient or body part
Retained instruments or other material after surgery / interventional procedure
ABO incompatibility blood transfusion
Medication error resulting in major permanent loss of function or death
Intravascular gas embolism resulting in death or neurological damage
Death of an in-patient from suicide (including home leave)
Maternal death or serious morbidity associated with labour or delivery
Infant discharged to wrong family or infant abduction
Other adverse events resulting in permanent loss of function or death (excluding complications)
Serious untoward event
Medication error which could have led to death or permanent harm or carries a significant public health risk
Patient misidentification which could have led to death or permanent harm

9. Regulation of Medical Clinics
Medical Clinics Ordinance (Cap. 343)
Enacted in 1963
Regulate non-profit sharing clinics
Does not include the following clinics:
Premises maintained by the Government, Hospital Authority, universities
Private consulting rooms used by registered medical practitioners, not bearing the word ‘clinic’ or ‘polyclinic’
Premises used by dentists, Chinese medical practitioners, pharmacists, physiotherapist, optometrist, etc
Registration requirements：
Accommodation
Staffing
Equipment
Non-profit sharing

10. Code of Practice Sets out the regulatory standards
Human Resources Management
Accommodation and Equipment
Rights of Patients
Medical Records
Drug Dispensing
Fire Safety & Occupational Health
Infection Control
Reporting to the Department of Health
Compliance to CoP is one of the conditions of registration

11. Private Healthcare Facilities Ordinance (Cap 633)
Passed in November 2018
Provides for a new regulatory regime for private healthcare facilities (PHFs), for premises where registered medical practitioners and/or dentist practise
Key licensing requirements:
Appointment of Chief Medical Executive
Complying with the requirements of the Ordinance, Conditions of Licence and Code of Practice issued by the Director of Health
Putting in place a Complaints Management System
Price Transparency measures

12. Regulation under the new Private Healthcare Facilities Ordinance
Hospitals
Day Procedure Centres (DPCs)
Clinics
Exempted Clinics (small practice clinics, i.e. those
involving only solo or small group
practice)
Risk
Level

13. Scheduled Medical Procedures
Scheduled medical procedures that can be performed in day procedure centres but not in clinics
Include the following eight classes of specialized services –
Endoscopic procedure
Chemotherapy
Haemodialysis
Interventional radiology and lithotripsy
Radiotherapy
Surgical procedure
Anaesthetic procedure (such as general anaesthesia and deep sedation)
Dental procedure

14. Group of ≥ 4 clinics operated
Requirements on CME
Hospital
DPC
Clinic
Group of ≥ 4 clinics operated
by the same licensee
General
Must possess the necessary qualifications and experience
Must be physically and mentally fit to administer a PHF 
Must be of integrity and good character
Qualification
Registered medical practitioner
Medical practice: Registered medical practitioner
Dental practice: Registered dentist
Combined medical and dental practices: Registered medical practitioner (with a registered dentist appointed to assist CME)
Experience
(Registered in HK)
≥ 15 years
≥ 6 years
≥ 4 years
≥ 8 years

15. Validity of licences Hospital Clinic Day Procedure Centre
Small Practice Clinic
Renewal of exemption not required
Clinic
Up to 5 years
Day Procedure Centre
Up to 3 years
Hospital
Up to 2 years

16. Thank you