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 Private Healthcare Facilities Ordinance, regulation of private healthcare facilities (PHFs) in Hong Kong, however, was limited to a narrow set of facilities drawn up decades ago mainly covering private hospitals and non-profit-sharing medical clinics. The Hospital, 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 Medical Clinics Ordinance, on the other hand, set out the regulatory framework for non-profit-sharing medical clinics. Under Cap. 165 and 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 regulation of individuals' professional practice.
Review of Regulation
In 2012, the Steering Committee on Review of the Regulation of Private Healthcare Facilities was set up to conduct the review on Cap. 165 and Cap. 343. The Steering Committee has put forward recommendations on the regulatory approach and scheme for private healthcare facilities, taking into account views from various sectors of society.
In December 2014, a three-month public consultation on the regulation of private healthcare facilities 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 are formed under the PSC by nomination of the HKAM and constituent Colleges, comprising members who practise in hospital and/or ambulatory settings and from both the public and private sectors.
The DH also conducted a survey on private ambulatory facilities 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 (HKPHA) 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 hospital can submit relevant data to the Department of Health through an electronic platform namely 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) has been gazetted on 30 November 2018.
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 ORPHF is implementing the regulatory regime in phases based on the types of PHFs and their risk levels.
Applications for hospital licence and day procedure centre licence were commenced on 2 July 2019 and 2 January 2020 respectively. Hospital licences and the first batch of day procedure centre licences under Cap. 633 took effect on 1 January 2021. 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 Cap. 165 are regulated under different new regulatory regimes. Details on application for clinic licences and request for letters of exemption in terms of small practice clinics will be announced in due course.
The Advisory Committee for Regulatory Standards for Private Healthcare Facilities was established in accordance with Cap. 633 on 1 September 2020 for a term of three years.
The Committee on Complaints against Private Healthcare Facilities was established in accordance with Cap. 633 with effect from 1 December 2020 for a term of three years.
