Regulatory Regime for Private Healthcare Facilities
Hong Kong's healthcare system runs on a dual-track basis comprising both the public and private sectors.
Before the commencement of the Private Healthcare Facilities Ordinance (Cap. 633), regulation of private healthcare facilities (PHFs) in Hong Kong was limited to a narrow set of facilities drawn up decades ago, mainly covering private hospitals and non-profit-sharing medical clinics. The Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165) and the Code of Practice for Private Hospitals, Nursing Homes and Maternity Homes set out the regulatory framework for private hospitals, nursing homes and maternity homes. The Medical Clinics Ordinance (Cap. 343) and the 
Code of Practice For Clinics Registered Under The Medical Clinics Ordinance (Cap. 343), on the other hand, set out the regulatory framework for non-profit-sharing medical clinics. Under the Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165) and the Medical Clinics Ordinance (Cap. 343), the Department of Health (DH) registered PHFs subject to conditions relating to accommodation, staffing and equipment, and inspects the registered institutions.
Other PHFs, such as ambulatory medical centres and clinics operated by medical groups or individual (or jointly by several) medical practitioners, were not subject to direct statutory control beyond the regulation of individuals' professional practice.
Review of Regulation
In 2012, the Steering Committee on Review of the Regulation of Private Healthcare Facilities (Steering Committee) was set up to conduct review on the Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165) and the Medical Clinics Ordinance (Cap. 343). The Steering Committee has put forward recommendations on the regulatory approach and scheme for PHFs, taking into account views from various sectors of the society.
In December 2014, a three-month public consultation on the regulation of PHFs was conducted with the proposal that under the new regulatory regime, three categories of facilities (hospitals, facilities providing high-risk medical procedures in ambulatory setting and facilities providing medical services under the management of incorporated bodies) should be regulated. Details of the consultation can be found in the Consultation Document and the subsequent Consultation Report.
In preparation for the new regulatory regime, the Project Steering Committee on Standards for Ambulatory Facilities (PSC) was set up by the DH and the Hong Kong Academy of Medicine (HKAM) in April 2015, co-opting members from the medical faculties of local universities, private hospitals and practitioners' associations. The terms of reference of the PSC are: (1) to steer the development and promulgation of standards for ambulatory facilities providing high-risk medical procedures; (2) to make recommendations on the procedure-specific standards and, where appropriate, on the essential core standards for ambulatory facilities for the legislative review; and (3) to steer the conduct of impact assessment survey for regulatory control of ambulatory facilities. Eight Task Forces were formed under the PSC by nomination of the HKAM and its constituent Colleges, comprising members who practised in hospitals and/or ambulatory settings and from both the public and private sectors.
The DH also conducted a survey on PHFs to collect information on PHFs providing ambulatory medical and dental services and their modes of operation.
Price transparency is one of the key elements in the new regulatory regime for PHFs. In October 2016, the Government together with the Hong Kong Private Hospitals Association rolled out a pilot programme for enhancing price transparency for private hospitals. All the private hospitals in Hong Kong have participated voluntarily in the pilot programme in respect of the three price transparency measures, namely, budget estimates, fee schedules and historical bill sizes statistics. Starting from August 2018, private hospitals can submit relevant data to the DH through an electronic platform named e-Licensing.
Private Healthcare Facilities Ordinance
In June 2017, the Private Healthcare Facilities Bill was introduced into the Legislative Council, and was passed by the Legislative Council on 15 November 2018. The Private Healthcare Facilities Ordinance (Cap. 633) was gazetted on 30 November 2018.
The Private Healthcare Facilities Ordinance (Cap. 633) protects patient safety and rights through the introduction of a new regulatory regime for PHFs. Four types of PHFs are subject to regulation, namely hospitals, day procedure centres, clinics and health services establishments. The Office for Regulation of Private Healthcare Facilities is implementing the regulatory regime in phases based on the types of PHFs and their risk levels.
Applications for hospital and day procedure centre licences commenced on 2 July 2019 and 2 January 2020 respectively. Hospital licences and the first batch of day procedure centre licences under the Private Healthcare Facilities Ordinance (Cap. 633) took effect on 1 January 2021. The Private Healthcare Facilities Ordinance (Cap. 633) replaced the Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165) to provide a new regulatory regime for private hospitals from the same day onward. Healthcare institutions registered under the Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165) are regulated under different new regulatory regimes. The DH will start to accept applications for clinic licences and requests for letters of exemption for small practice clinics on 13 October 2025.
The Advisory Committee for Regulatory Standards for Private Healthcare Facilities was established in accordance with the Private Healthcare Facilities Ordinance (Cap. 633) on 1 September 2020.
The Committee on Complaints against Private Healthcare Facilities was established in accordance with the Private Healthcare Facilities Ordinance (Cap. 633) with effect from 1 December 2020.
