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Private Healthcare Facilities Ordinance

Frequently Asked Questions



Q1 : When will the Private Healthcare Facilities Ordinance commence and come into operation? What are the arrangements for submitting applications for licences?
   
Q2 : What kind of facilities will be regulated under the Private Healthcare Facilities Ordinance?
   
Q3 : How will existing private clinics transit to the new licensing regime?
   
Q4 : What documentation will operators of day procedure centres and clinics be required to provide to prove their eligibility for a provisional licence?
   
Q5 : What kind of clinics may be exempted from operating with a licence under the Private Healthcare Facilities Ordinance?
   
Q6 : Under the new regime, are private healthcare facilities required to have distinct premises and separate entrances?
   
Q7 : Are services provided by Chinese medicine practitioners and allied health professionals (e.g. physiotherapists) subject to regulation under the Private Healthcare Facilities Ordinance?
   
Q8 : What are the responsibilities of licensees and chief medical executives (CMEs) under the new regime? Can the licensee of a private healthcare facility (PHF) be appointed as the CME of the PHF?
   
Q9 : Can the chief medical executive (CME) be appointed part-time? Can a CME appointed by a private healthcare facility (PHF) operate another small practice clinic with an exemption?
   
Q10 : What are the content of the codes of practices in respect of day procedure centres and clinics?
   
Q11 : Does a beauty parlour which provides medical procedures need a licence under the new licensing scheme?
   
Q12 : How can members of public and operators of private healthcare facilities obtain latest information on implementation of the new regime?

Q1 : When will the Private Healthcare Facilities Ordinance commence and come into operation? What are the arrangements for submitting applications for licences?

A1 :

The Private Healthcare Facilities Ordinance ("the Ordinance") was gazetted on 30 November 2018.

The Government will implement the Ordinance in phases based on the risk level of various types of PHFs. According to the current plan, applications for licences for private hospitals will commence in mid-2019 and those for day procedure centres are anticipated to commence in 2020. For clinics, applications for licences and letters of exemption are anticipated to commence in 2021 at the earliest.

The Department of Health will announce the details of the licensing scheme and organise briefings in the coming months. Please check out the latest announcements at the webpage of the Office for Regulation of Private Healthcare Facilities under the Department of Health (https://www.dh.gov.hk/english/main/main_orphf/main_orphf.html).

   
Q2 : What kind of facilities will be regulated under the Private Healthcare Facilities Ordinance?

A2 :

The Private Healthcare Facilities Ordinance ("the Ordinance") mainly regulates premises where registered medical practitioners and registered dentists practise. Under the Ordinance, there are four types of private healthcare facilities (PHFs) subject to regulation, namely hospitals, day procedure centres, clinics and health services establishments. Under the new regime, operators of the above four types of PHFs will need to obtain licences or letters of exemption.

Hospital licences under the Ordinance will be required for the 12 private hospitals currently registered under the Hospitals, Nursing Homes and Maternity Homes Registration Ordinance to continue their operation. For a premises where registered medical practitioners or dentists practise and provide medical services without lodging, it will either need a day procedure centre licence if “scheduled medical procedures” defined under the Ordinance are provided, or a clinic licence if such procedures are not provided. A small practice clinic may apply for exemption under the Ordinance, please refer to QA5 for details. Please refer to section 2 of and Schedule 3 to the Ordinance for the definition of “scheduled medical procedures”.

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

Please refer to Part 1 of the Ordinance for the definitions of the four types of PHFs.

   
Q3 : How will existing private clinics transit to the new licensing regime?

A3 :

The Private Healthcare Facilities Ordinance ("the Ordinance") provides for transitional arrangements for day procedures centres and clinics only. Under the transitional arrangement, an operator of a day procedure centre or a clinic in operation on 30 November 2018 will be issued with a provisional licence upon application for a full licence, provided that the below conditions are met –
  1. the operator is a fit and proper person to exercise control over or operate the day procedure centre/clinic;
  2. the person to be appointed as the chief medical executive for the day procedure centre/clinic is a fit and proper person to administer the centre/clinic; and
  3. the operation of the day procedure centre/clinic by the operator would not be contrary to the public interest.

The provisional licence allows the day procedure centre or clinic concerned to continue to operate during the transitional period under the new regulatory regime before it is qualified for a full licence. Please refer to Division 4 under Part 9 of the Ordinance for details.

For operators who start operating day procedure centres and clinics after 30 November 2018, they will need to comply with requirements under the new regulatory regime and aim to apply for full licences or letters of exemption in accordance with the arrangements announced by the Department of Health and requirements stipulated under the Ordinance.

The Department of Health will announce the details of the regulatory regime and organise briefings in the coming months. Please check out the latest announcements on the webpage of the Office for Regulation of Private Healthcare Facilities under the Department of Health (https://www.dh.gov.hk/english/main/main_orphf/main_orphf.html)

   
Q4 : What documentation will operators of day procedure centres and clinics be required to provide to prove their eligibility for a provisional licence?

A4 :

On submitting their applications for licences, applicants will be required to provide documentary proof to show that the day procedure centre or clinic concerned was in operation and provided medical services as stated in the application on 30 November 2018. Examples of documentary proof are -
  1. copy of Business Registration Certificate showing that medical services concerned were carried out at the premises by the applicant;
  2. records of procurement or maintenance of drugs and medical equipments;
  3. other licence(s) relating to the provision of medical services concerned (e.g. licence issued under the Radiation Ordinance (Cap. 303) for radioactive substances and irradiating apparatus); and
  4. records of employment / appointment of healthcare staff.

Applicants may be required to provide other supporting documents such as booking records if necessary.

The DH will announce the details of the licensing scheme and organise briefings in the coming months. Please check out the latest announcements on the webpage of the Office for Regulation of Private Healthcare Facilities under the Department of Health (https://www.dh.gov.hk/english/main/main_orphf/main_orphf.html)

   
Q5 : What kind of clinics may be exempted from operating with a licence under the Private Healthcare Facilities Ordinance?

A5 :

Under the new regime, operators of a small practice clinic may ask the Director of Health for a letter of exemption to operate the small practice clinic without a licence. Under the Private Healthcare Facilities Ordinance (“the Ordinance”), a small practice clinic refers to a clinic which –
  1. is operated by –
    1. a registered medical practitioner or registered dentist as a sole proprietor;
    2. a partnership having not more than 5 partners, each of whom is a registered medical practitioner or a registered dentist; or
    3. a company having not more than 5 directors, each of whom is a registered medical practitioner or a registered dentist;
  2. except the sole proprietor/partners/directors, no other registered medical practitioners or registered dentists practise in the clinic; and
  3. the sole proprietor/partner(s)/director(s)/company has/have the exclusive right to use the premises forming the clinic.

Under the new regime, each registered medical practitioner or registered dentist may operate at most three small practice clinics with valid exemption at the same time. Please refer to Part 4 of the Ordinance for details.

   
Q6 : Under the new regime, are private healthcare facilities required to have distinct premises and separate entrances?

A6 :

Under the Private Healthcare Facilities Ordinance ("the Ordinance"), the premises of licensed private healthcare facilities 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.

Transitional arrangement for licensed clinics on the above requirements is provided under the Ordinance. During the validity period of a provisional clinic licence, clinics with a provisional licence are not required to comply with the requirements on separate entrance, subject to certain conditions. This transitional arrangement is not applicable to day procedure centres and small practice clinics with valid exemption. Please refer to section 138 of the Ordinance for details.

   
Q7 : Are services provided by Chinese medicine practitioners and allied health professionals (e.g. physiotherapists) subject to regulation under the Private Healthcare Facilities Ordinance?

A7 :

A premises where registered medical practitioners and dentists practise is subject to regulation and licensing under the Private Healthcare Facilities Ordinance (“the Ordinance”). If the services provided by Chinese medicine practitioners and allied health professionals are provided in the same premises where registered medical practitioners and dentists practise, such services will also be covered by the licences concerned. The new regime does not cover premises where only allied health professionals practise. These health professionals will continue to be regulated under the relevant laws and codes of practice.

   
Q8 : What are the responsibilities of licensees and chief medical executives (CMEs) under the new regime? Can the licensee of a private healthcare facility (PHF) be appointed as the CME of the PHF?

A8 :

Under the new regime, 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 licence conditions, codes of practice, etc.; and setting up and enforcing relevant rules, policies and procedures. The licensee must also appoint a CME for the facility.

The CME is to take charge of the day-to-day administration of the facility. The CME of a PHF is responsible for the adoption and implementation of rules, policies and procedures concerning the healthcare services provided in the facility.

Under the new regime, 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 does not apply to small practice clinics with exemption in force.

   
Q9 : Can the chief medical executive (CME) be appointed part-time? Can a CME appointed by a private healthcare facility (PHF) operate another small practice clinic with an exemption?

A9 :

Under the new regime, CME of a PHF is responsible for the day-to-day administration of the facility, the adoption and implementation of rules, policies and procedures concerning the healthcare services provided in the facility. A registered medical practitioner or a registered dentist may only serve as a CME of one of the below items–
  1. one private hospital;
  2. two day procedure centres;
  3. three clinics; or
  4. one day procedure centre and one clinic.

For requirements on qualification of a CME in different types of PHFs, please refer to Part 5 of the Private Healthcare Facilities Ordinance ("the Ordinance").

A registered medical practitioner or a registered dentist that operates, or intends to operate, a small practice clinic 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). Please refer to QA5 and Part 4 of the Ordinance for the definition of small practice clinic and the arrangement for exemption.
   
Q10 : What are the content of the codes of practices in respect of day procedure centres and clinics?

A10 :

For day procedure centres, the Hong Kong Academy of Medicine (HKAM) and the Department of Health (DH) have promulgated a set of Core Standards, which applies to all day procedure centres and Procedure-specific Standards for day procedure centres providing the following procedures –
  1. anaesthesia and sedation;
  2. chemotherapy;
  3. interventional radiology and lithotripsy;
  4. surgery, anaesthesia and sedation;
  5. endoscopy;
  6. dental procedures; and
  7. haemodialysis.

The above promulgated standards are accessible at DH’s website.

The draft standards applicable to clinics under the new regime is also accessible at DH’s website.

The above-mentioned standards will form the codes of practice for day procedure centres and clinics respectively when the relevant sections of the Private Healthcare Facilities Ordinance ("the Ordinance") come into operation. Operators of existing day procedure centres and clinics are advised to make reference to the above-mentioned standards as soon as possible, so as to ensure compliance with the Ordinance when it comes into operation.

   
Q11 : Does a beauty parlour which provides medical procedures need a licence under the new licensing scheme?

A11 :

The Private Healthcare Facilities Ordinance (“the Ordinance”) mainly regulates premises where registered medical practitioners and registered dentists practise. Any premises (including premises claimed to be providing “beauty services”) that provide medical services (e.g. carrying out medical procedures) require day procedure centre or clinic licences depending on the nature of medical services or procedures they provide. These premises are also 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 Ordinance.

The Department of Health will conduct inspection to licensed private healthcare facilities to ensure compliance with the Ordinance and the relevant codes of practice.

   
Q12 : How can members of public and operators of private healthcare facilities obtain latest information on implementation of the new regime?

A12 :

The Department of Health will announce the details of the licensing scheme and organise briefings in the coming months. Please check out the latest announcements on the webpage of the Office for Regulation of Private Healthcare Facilities under the Department of Health (https://www.dh.gov.hk/english/main/main_orphf/main_orphf.html).

   

 



Last Revision Date : 25 Apr 2019