The PHFO mainly regulates premises where registered medical practitioners and/or registered dentists practise. Under the PHFO, four types of PHFs are subject to regulation, namely hospitals, DPCs, clinics, and health services establishments. Operators of the above four types of PHFs need to obtain a relevant licence or a letter of exemption in order to continue their operation. Please refer to Part 1 of the PHFO for definitions of the four types of PHFs.

Hospital licences under the PHFO are required for operating private hospitals. For premises where registered medical practitioners and/or registered dentists practise and provide medical services without lodging, the premises will either need a DPC licence if scheduled medical procedures defined under the PHFO are provided, or a clinic licence if such procedures are not provided. Please refer to section 2 and Schedule 3 to the PHFO for the definition of scheduled medical procedures.

Under the PHFO, a clinic that falls under the meaning of an SPC may request for a letter of exemption. For details, please refer to Question A2.

Health services establishments encompass new modes of operation or delivery of healthcare services that entails a significant level of risk. Facilities for conducting clinical trials as described in Schedule 9 to the PHFO are to be regulated as health services establishments.

The definition of an SPC is stipulated in section 41 of the PHFO. An SPC must be operated only by registered medical practitioner(s) and/or registered dentist(s). The operation may be in the form of a sole proprietorship, a partnership or a company. Moreover, the following three conditions must also be met.

1. Number of medical practitioners or dentists:
1. If the SPC is operated under a sole proprietorship, the sole proprietor must be a registered medical practitioner or a registered dentist;
2. If the SPC is operated under a partnership or a company, there can only be a maximum of five partners or company directors, and all partners or company directors must be registered medical practitioners or registered dentists.
2. The right to use the premises:
1. The sole proprietor of the sole proprietorship; at least one partner of the partnership; or at least one director of the company shall have exclusive rights to use the premises forming the SPC; in other words, except for the operator(s) and locum arrangements, other doctors or dentists are not allowed to practise in the clinic; and
2. No matter whether the SPC is operated as sole proprietorship, partnership or a company, the operators of the SPC cannot employ other registered medical practitioners or registered dentists (except for locum arrangements).
3. Locum arrangement:
1. For every registered medical practitioner or registered dentist operating the SPC, the total number of locum days for which another registered medical practitioner or registered dentist takes up the duties of the individual must not exceed 60 days in a calendar year;
2. In addition, the aggregate number of locum days for all the partners or directors operating the clinic must not exceed 180 days in a calendar year.

Each registered medical practitioner or registered dentist may operate up to three SPCs with valid exemption at the same time. Please refer to Part 4 of the PHFO for details.

The PHFO was gazetted on 30 November 2018.

The Government has been implementing the PHFO in phases based on the risk level of various types of PHFs. Applications for hospital and DPC licences have commenced since 2 July 2019 and 2 January 2020 respectively. Applications for exemption of scheduled nursing homes commenced on 2 January 2020 and ended on 30 April 2020. For clinics, the arrangements of application for licence and request for letter of exemption will be announced in due course.

Penalty provision pertaining to the operation of a hospital and a DPC without a licence has commenced on 1 January 2021 and 30 June 2022 respectively. Any person operating a hospital without a licence commits an offence and is liable on conviction to a fine of HK$5,000,000 and to imprisonment for five years; any person operating a DPC without a licence commits an offence and is liable on conviction to a fine of HK$100,000 and to imprisonment for three years.

The Government is now actively taking forward the regulatory work on clinics. Based on the current plan, the Government intends to submit the Gazette Notice on the announcement of the effective date of relevant sections of the PHFO to the Legislative Council in the first half of 2025, with a view to start accepting clinic licence application and request for letter of exemption in the fourth quarter of 2025. In accordance with its usual arrangement, the Department of Health will announce the application arrangements in a timely manner to allow sufficient preparation time for the industry. Prior to accepting clinic licence application and request for letter of exemption, the Government will conduct a series of publicity. The commencement of penalty provision pertaining to the operation of a clinic without a licence will be announced later. Please check out the latest announcements on our website.

The PHFO provides transitional arrangements for DPCs and clinics. The provisional licences allow the DPCs/clinics to continue to operate during the transitional period under the new regulatory regime before being qualified for full licences.

Under the transitional arrangements, operators of DPCs which were in operation on 30 November 2018 have already been issued with provisional licences. Applications for DPC provisional licences had already ceased on 30 April 2020. The first batch of DPC licences (including both full and provisional licences) came into effect on 1 January 2021.

Operators of clinics which were in operation on 30 November 2018 are eligible to apply for a provisional licence. Please refer to Division 4 under Part 9 of the PHFO for details.

The Secretary for Health will appoint by notice published in the Gazette the date on which the transitional arrangements expire. A provisional licence issued to a licensee will expire on the appointed date, or when the licensee's application for the full licence is approved, withdrawn or rejected. In order to provide sufficient preparation time for the trade, the expiry date of the transitional arrangements will be at least one year after the date on which the notice is published.

Operators of clinics which came into operation or were moved to another premises after 30 November 2018 need to comply with the requirements under the PHFO and apply for a full licence.

All PHFs must hold a licence or a letter of exemption in order to legally operate. The provisional licences of DPCs or clinics allows those which were already in operation on 30 November 2018 to continue to operate during the transitional period under the new regulatory regime before they are qualified for a full licence. A PHF will be issued a full licence only when the PHF conforms to all licensing requirements and standards. When the transitional period comes to an end, these PHFs must be covered by a full licence.

The PHFO regulates premises of PHFs where registered medical practitioners and/or registered dentists practise. Irrespective of the frequency or duration of such practice, the operator is required to apply for a licence or request for a letter of exemption. In addition, the operator shall ensure the premises complies with other prevailing legislations relevant to the operation, such as the Medical Registration Ordinance, the Radiation Ordinance, etc.

Moreover, the licensee of a PHF must appoint a chief medical executive (CME) to take charge of the day to day administration of the facility. Please also refer to FAQ Section B for more information on the requirements on governance of PHFs.

Premises where registered medical practitioners and/or dentists practise are subject to regulation and licensing under the PHFO. If the services provided by Chinese medicine practitioners and allied health professionals are provided in the same premises where registered medical practitioners and/or registered dentists practise, such services will also be covered by the licences issued under the PHFO. The PHFO, however, does not cover premises where only Chinese medicine practitioners and allied health professionals practise. These Chinese medicine practitioners and allied health professionals will continue to be regulated under the applicable legislations and codes of practice.

Under the PHFO, any PHF where registered medical practitioners and/or registered dentists practise must be covered by a licence or a letter of exemption, regardless of whether they work part-time or full time.

Moreover, the licensee of a PHF must appoint a CME to take charge of the day to day administration of the facility. Please also refer to FAQ Section B for more information on the requirements on governance of PHFs.

Under the PHFO, any PHF that is covered by a licence or an exemption shall:

• be a distinct and exclusive unit that is able to perform its functions independently, and is physically separated from any premises that serve a purpose not reasonably incidental to the type of facility for which the licence is issued or specified in the letter of exemption; and
• has a direct and separate entrance.

Except during the transitional phase in clinics where a provisional licence is issued, all operators must ensure that the facility they operate has a direct and separate entrance not shared with any other premises.

For further details, please refer to Question B9.

Under the PHFO, any PHF where registered medical practitioners and/or registered dentists practise must be covered by a licence or a letter of exemption. Any premises (including premises claiming to be providing "beauty services") that provide medical services (e.g. carrying out medical procedures) require a licence or a letter of exemption depending on the nature of medical services or procedures they provide. Licensed PHFs are subject to licensing conditions imposed by the Department of Health and the relevant codes of practice. Applicants should pay attention to the requirements on distinct premises, direct and separate entrance, and relevant transitional arrangements as set out in the PHFO. Please also refer to Question B12 for more information on differentiating medical procedures from beauty services.

The Department of Health conducts inspection to licensed PHFs to ensure compliance with the PHFO and the relevant codes of practice.

The licensing periods for different types of PHF licences are as follows:

• Hospital licence: two years
• DPC licence: three years
• Clinic licence: five years
• Licence of scheduled clinics listed in Schedule 6 to the PHFO: one year

The Department of Health has been announcing the details of the new licensing regime in phases according to the implementation schedule and organising briefings for respective stakeholders. Please check out the latest announcements on our website.

Under the PHFO, the licensee of a hospital must be a legal person, i.e. a company, or other body corporate, operated by a board of directors, which must include a person who is not a registered medical practitioner, a registered dentist, nor an employee of the hospital. Apart from the scheduled clinics listed in Schedule 6 to the PHFO, the licensee of other PHF may be a legal or natural person, i.e. an individual, a partnership, a company, a body corporate other than a company, or a society.

The CME of a DPC shall be a registered medical practitioner or a registered dentist who has been registered in Hong Kong for not less than six years, and the CME of a clinic shall be a registered medical practitioner or a registered dentist who has been registered in Hong Kong for at least four years. If a DPC or clinic provides medical services, the CME must be a registered medical practitioner; if only dental services are provided, the CME must be a registered dentist; if a DPC or clinic provides both medical and dental services, the CME must be a registered medical practitioner, and the licensee must also appoint a registered dentist to assist the CME in carrying out the day to day administration of the dental practice.

If a licensee who operates a group of four or more clinics has established for this group of clinics a Medical Advisory Committee (MAC) (refer to Question B6) and appointed for each clinic in the group, according to the type of practice, a registered medical practitioner or a registered dentist who is serving at the clinic, to assist the CME in carrying out the day to day administration of the clinic, the licensee may appoint a single CME for this group of clinics. This appointed CME for the group of clinics will have to be a medical practitioner or dentist who has been registered in Hong Kong for not less than eight years, and is not serving at the same time as the CME of another PHF.

It is the duty of the licensee to appoint a CME and it is an offence if he/she fails to do so. Please refer to section 49 of the PHFO for more details.

Under the PHFO, the licensee of a PHF is wholly responsible for the operation of the facility. The licensee's responsibilities include ensuring the facility's compliance with the PHFO, conditions of licence, codes of practice, etc.; appointing a CME for the PHF; setting up and enforcing rules, policies and procedures relating to the quality of care for, and the safety of, patients in the PHF; making available to the public information about the prices of chargeable items and services provided in the PHF; and putting in place complaints handling procedures.

The appointed CME is to take charge of the day to day administration of the facility. The CME's responsibilities also include adoption and implementation of rules, policies and procedures concerning healthcare services provided in the facility.

The licensee of a hospital must be a legal person, while the licensee of other PHFs can be a legal person or a natural person. As such, the licensee of PHFs other than hospitals may be appointed as the CME for the same PHF.

The above requirements for licensees and CMEs do not apply to SPCs with exemption in force.

Under the PHFO, the CME of a PHF is responsible for the day to day administration of the facility, and the adoption and implementation of rules, policies and procedures concerning the healthcare services provided in the facility. The CME of a hospital (registered medical practitioner only) must not serve at the same time as a CME of another PHF. Furthermore, a registered medical practitioner or a registered dentist must not serve at the same time as the CME of:

• more than two DPCs;
• more than three clinics; or
• more than one DPC and one clinic.

However, if four or more clinics are operated at the same time by the same licensee, the licensee may appoint a single CME for that group of clinics provided that the licensee:

• has established a Medical Advisory Committee for that group of clinics; and
• has appointed for each of the clinics under that group a medical practitioner, or a dentist, who is serving the clinic to assist the CME in carrying out the day to day administration of the clinic.

For requirements on qualification of a CME in different types of PHFs, please refer to Part 5 of the PHFO.

A registered medical practitioner or a registered dentist who operates, or intends to operate, an SPC may ask the Director of Health for a letter of exemption for the clinic, regardless of whether he or she is serving as a CME of other PHF(s). However, each registered medical practitioner or registered dentist may only operate up to three exempted clinics at the same time. Please refer to Part 4 of the PHFO for details.

The operator of a PHF refers to the licensee of any licensed PHF. The PHFO does not require the licensee to be doctors or dentists. For SPC, the operators of an exempted clinic must be registered medical practitioners or registered dentists.

The licensee of a hospital is required, in addition to appointing a CME, to establish and maintain an MAC. For a licensee who operates a group of four or more clinics at the same time, if an MAC is established and maintained for this group of clinics, and, for each of the clinics, a registered medical practitioner or registered dentist who is serving the specific clinic is appointed to assist the CME in carrying out the day to day administration of that clinic, the licensee may appoint a single CME for this group of clinics.

If the PHF is a medical practice or a combined medical and dental practice, the chairperson of the MAC must be a registered medical practitioner. If the PHF is a dental practice, the chairperson of the MAC must be a registered dentist. The number of members of the MAC is to be decided by the licensee, but at least half of the members must be registered medical practitioners or registered dentists, including at least one registered medical practitioner who is not employed by, or practising in, the concerned PHF.

If there is a change of the CME, the licensee must, before the expiry of 14 days after the change has occurred, notify the Director of Health in writing of the change. It is the duty of the licensee to notify such change and it is an offence if he/she fails to do so. Please refer to section 49 of the PHFO for more details.

Under the PHFO, the premises of licensed PHFs and exempted clinics must

1. be a distinct and exclusive premises, physically separated from any premises that serves a purpose not reasonably incidental to the facility, and
2. have a direct and separate entrance.

The transitional arrangement for clinics with a provisional licence on the above requirements is provided under the PHFO. During the validity period of a provisional licence, such clinics are not required to comply with the requirements on separate entrance, subject to certain conditions. This transitional arrangement is not applicable to DPCs and SPCs. Please refer to section 138 of the PHFO for details. Moreover, operators of exempted clinics are required to have the exclusive rights to use the premises forming the SPC.

Under the PHFO, premises in relation to a PHF are interpreted as places if they are:

• physically connected by internal access among themselves; or
• physically attached or in close proximity to, or adjoining one another; and
• forming a distinct whole for the facility to function as a single entity.

If a PHF has several units in the same building, and these units have internal access among themselves, or adjoining to each other, such that they operate as a single entity, these units will be considered as part of the premises of the PHF.

Following are some scenarios for a DPC or clinic premises to be covered by one licence:

• a DPC/clinic occupying two or more units connected with internal access
• a DPC/clinic occupying two or more adjoining units
• a DPC/clinic occupying two or more units within the same building

In a PHF, services such as those provided by dietitians and physiotherapists may in principle fall within the scope of being reasonably incidental to the services of a medical clinic, subject to any specific circumstances pertaining to those practices in individual cases. Services such as beauty services (e.g. haircut, manicure) are expected to be not reasonably incidental to the intended practice. The operator of any PHF must ensure that the premises of the facility are physically separated from any premises that serve a purpose not reasonably incidental to the type of facility/practice as specified on any licence/letter of exemption. The operator has the responsibility to justify the reasonableness of any incidental service to be provided in the facility. In general, conducting sales promotion of medical insurance, providing catering services and selling daily necessities are not considered as being reasonably incidental to the medical or dental practices in a DPC, clinic or SPC.

In 2013, the Steering Committee on Review of Regulation of Private Healthcare Facilities published the "Report of the Working Group on Differentiation between Medical Procedures and Beauty Services". The report has made recommendations that the following four categories of procedures should be performed by registered medical practitioners or registered dentists:

• cosmetic procedures that involve injections;
• procedures that involve the mechanical/chemical exfoliation of the skin below the epidermis;
• hyperbaric oxygen therapy; and
• dental bleaching.

Please refer to the "Report of the Working Group on Differentiation between Medical Procedures and Beauty Services" for details.

Operators of DPCs should observe the relevant requirements of the PHFO, the "Code of Practice for Day Procedure Centres", and the "Guidance notes for application for Day Procedure Centre licence". Operators should also ensure that premises are distinct and separate with separate entrance for the DPC, and a CME with relevant qualifications is appointed.

Applications for DPC provisional licences had already ceased on 30 April 2020.

The various codes of practice for PHFs are standards and specifications issued by the Director of Health under the PHFO.

The "Code of Practice for Day Procedure Centres" is available here.

Operators of PHFs are advised to make reference to the relevant codes of practice to ensure compliance.

The PHFO is a premises-based legislation. Hence, if both scheduled medical procedures and minor medical procedures are performed in the premises, the operator of that PHF would only need to apply for a DPC licence.

The PHFO provides transitional arrangements for clinics.

Under the transitional arrangements, operators of clinics which were in operation on 30 November 2018 can apply for a provisional licence. The specified period for applications for provisional and full licences for clinics will be announced in due course. The provisional licence allows the clinics to continue to operate during the transitional period under the new regulatory regime before being qualified for a full licence. Please refer to section 136 under Part 9 of the PHFO for details.

The Secretary for Health will appoint by notice published in the Gazette the date on which the transitional arrangements expire. A provisional licence issued to a licensee will expire on the appointed date, or when the licensee's application for the full licence is approved, withdrawn or rejected. In order to provide sufficient preparation time for the trade, the expiry date of the transitional arrangements will be at least one year after the date on which the notice is published.

Operators of clinics which came into operation or were moved to another premises after 30 November 2018 need to comply with the requirements under the PHFO and apply for a full licence.

All PHFs must hold a licence or a letter of exemption in order to legally operate. The provisional licence of clinics allows those which were already in operation on 30 November 2018 to continue to operate during the transitional period under the new regulatory regime before they are qualified for a full licence. A PHF will be issued a full licence only when the PHF conforms to all licensing requirements and standards. When the transitional period comes to an end, these PHFs must be covered by a full licence.

In line with the development of digital government, the Department of Health will make the application procedures for clinic licence fully electronic. The Department of Health is upgrading the website of the Office for Regulation of Private Healthcare Facilities (ORPHF) to facilitate the clinic licence applicants to submit their applications via e-Licensing when the application procedures for provisional and full clinic licences commence. Details will be announced in due course.

The application procedures for clinic provisional or full clinic licences will be announced in due course.

Pursuant to section 99 of the PHFO, the Advisory Committee for Regulatory Standards for Private Healthcare Facilities (Advisory Committee) was established in 2020 to devise, review and update the standards of regulation for PHFs. The "Standards for Clinics" (the Standards) are developed by the Advisory Committee in consultation with relevant stakeholders and are intended to apply to all medical and dental clinics to be licensed under the PHFO when the relevant provisions are in force. The Standards comprise standards in respect of governance, physical conditions, service delivery and care process, infection control, risk management and contingency, and other matters related to the operation of a clinic. The "Code of Practice for Clinics" will be drawn up with reference to the Standards and published in due course.

The PHFO regulates premises where registered medical practitioners and/or registered dentists practise. Any premises with medical and/or dental practice are required to be covered by a licence or a letter of exemption.

The Government is now actively taking forward the regulatory work on clinics. Based on the current plan, the Government intends to submit the Gazette Notice on the announcement of the effective date of relevant sections of the PHFO to the Legislative Council in the first half of 2025, with a view to start accepting clinic licence application and request for letter of exemption in the fourth quarter of 2025. In accordance with its usual arrangement, the Department of Health will announce the application arrangements in a timely manner to allow sufficient preparation time for the industry.

Although the PHFO allows an SPC to be exempted from the requirement of a licence, the operator(s) must apply to the Director of Health for a letter of exemption. Under the PHFO, operators need to obtain a relevant licence or a letter of exemption in order to continue the operation of the PHFs.

Operator(s) of a clinic that falls under the meaning of an SPC can choose to apply for a clinic licence or a letter of exemption. For details on applying for a clinic licence, please refer to the relevant webpage.

The operator(s) of any clinic that does not fall under the meaning of an SPC must apply for a clinic licence in order to operate. Please refer to the relevant webpage for the requirement on clinic licence.

An SPC can only be operated by registered medical practitioner(s) and/or registered dentist(s). As stipulated in section 42 of the PHFO, any individual, a partnership or a company that operates or intends to operate an SPC may ask the Director of Health for a letter of exemption for the clinic.

As stipulated in section 41 of the PHFO, a registered medical practitioner who is qualified to operate an SPC is a person whose name is included in Part I of the General Register kept under section 6(1) of the Medical Registration Ordinance (Cap. 161).

According to section 43(1) of the PHFO, none of the individuals signing the request can, for the time being, in the capacities as the sole proprietor of an exempted clinic, a partner of a partnership operating an exempted clinic, or a director of a company operating an exempted clinic (in whatever combination) for three or more other exempted clinics.

In other words, each registered medical practitioner or registered dentist may operate up to three SPCs with valid exemption at the same time. If you are operating three exempted clinics at the same time, you will have to apply for a clinic licence for the fourth or subsequent clinics.

As far as the operation of an SPC is concerned, locum arrangement refers to the situation where another registered medical practitioner or registered dentist takes up the duties of a registered medical practitioner or registered dentist who is entitled to the relevant letter of exemption at the SPC during the latter's absence. The two persons would not provide medical services at the SPC concerned at the same time. Any locum period within a calendar day will be taken as one locum day.

For every registered medical practitioner or registered dentist operating the SPC, the total number of locum days for which another registered medical practitioner or registered dentist takes up the duties of the individual, must not exceed 60 days in a calendar year. In addition, the aggregate number of locum days for all the partners or directors operating the clinic must not exceed 180 days in a calendar year.

Part-time employment of any registered medical practitioner(s) or registered dentist(s)_ to provide medical services in the presence of the registered medical practitioner(s) or registered dentist(s) who is/are issued with the relevant letter of exemption at the SPC concerned is not allowed.

In line with the development of digital government, the Department of Health will make the procedures for requesting letter of exemption for SPC fully electronic. Operator(s) of SPC can submit the request and relevant document(s), check the request progress and receive the letter of exemption through the e-Licensing system. If the operator(s) is unable to use the electronic system, he or she may also submit a paper request form. The details of the arrangement will be released in a timely manner.

Requesting for a letter of exemption for an SPC is free of charge.

Operators of exempted clinics must comply with all relevant requirements for an SPC and its operation under the PHFO. If there are any intended changes of the clinic, or intended cessation of the clinic’s operation, the operator(s) must give the Director of Health not less than 14 days' advance notice in writing. The operator(s) may have to request for another exemption or apply for a licence.

Unless the clinic is relocated, no longer falls under the meaning of an SPC, or the exemption is revoked by the Director of Health, the letter of exemption for an exempted clinic will remain valid.

In order to facilitate the public to identity whether the premises providing medical services have been issued with a valid licence or an exemption, the Department of Health has established the Private Healthcare Facilities Register (the Register) to record all exempted clinics and PHFs with valid licence. Relevant information of exempted clinics will be uploaded to the Register. The Register will be uploaded to the website of ORPHF and will be available in ORPHF office for public inspection. Furthermore, exempted clinic are provided with letter of exemption as well as a QR code to facilitate the public to obtain the information of the SPC on our website. Public may ask the SPC for more details