The Private Healthcare Facilities Ordinance (PHFO) set in law a new regulatory regime for private healthcare premises in Hong Kong. Along with it, a new role, the Chief Medical Executive (CME) was established. By now there will be many clinicians already in this position, but there may be others who are understandably apprehensive of taking on this position or concerned about the risks it may bring onto them as individuals.
The Private Healthcare Facilities Ordinance (Cap. 633) was officially gazetted in November 2018 and regulates all private healthcare facilities. This new regulatory regime aims to protect patient safety and patient rights and is implemented by the Department of Health’s Office for Regulation of Private Healthcare Facilities.
It requires all private hospitals, day procedures, clinics and health services establishments to hold a license, or, where applicable, a letter of exemption. Its implementation was phased in with licensing for private hospitals commencing in July 2019, day procedure centres in January 2020, and clinics in October 2025, with exemption arrangements for small practice clinics who are eligible. The relevant licensing provisions with regard to health service establishments have not yet been brought fully into operation.
If considering a CME position, it is well worth reviewing the Codes of Practice relevant to the type of PHF issued by the Department of Health, which sets out the standards and obligations required of the licensee and the CME. With the Codes for private hospitals being well over 100 pages, this may seem a daunting task.
Under the PHFO, the licensee is responsible for the operation of the facility and for appointing the CME, with the CME being responsible for the day-to-day administration. The CME is also responsible for ensuring that clinical staff are appropriately qualified, trained, and working within their competence.
There are different requirements for CME eligibility in terms of experience depending on the type of facility, but they must be of integrity and good character, and physically and mentally fit to operate a PHF. It is the CME who is responsible for the implementation of the rules, policies and procedures in the facility, and ensuring that these are consistent with Medical Council of Hong Kong’s Code of Professional Conduct or the Code of Professional Discipline for the Guidance of Dental Practitioners in Hong Kong of the Dental Council. It is therefore crucial for CMEs to be familiar with the requirements of both the DOH and the Medical/Dental Council Codes.
To offer an example, a CME would have their own obligations to ensure that patient data is kept secure in their own handling of information, but also would be responsible for ensuring that the policies around data protection for the facility is in line with data protection laws, i.e. the Personal Data (Privacy) Ordinance (Cap. 486), as well as the regulations in the MCHK’s Code. The CME must look at policies, staff and training to demonstrate efforts made for staff to be aware of their requirements in their own practice.
Non-compliance with the regulations of the PHFO can lead to regulatory actions, which are decided based on the level of risk to patient safety, and range from the lesser sanctions of advice or requirement notice, to more serious consequences such as suspension or cancellation of the facility’s license. (ORPHF - Regulation of Private Healthcare Facilities - Regulatory Actions)
The PHFO established a two-tier system for complaints management against private healthcare facilities. The first tier is local resolution, i.e. the complaint is handled by the facility itself.
It is for the CME to implement a mechanism for complaints handling at the local level, which includes procedures for receiving, managing and responding to the complainant, as well as ensuring that patients and carers are aware of the procedure for lodging a complaint and the complaint process itself.
If the complainant is dissatisfied with the response, then a complaint can be made to the Committee on Complaints against Private Healthcare Facilities or the ‘Complaints Committee’. (Committee on Complaints against Private Healthcare Facilities - Complaints Handling Procedures)
It is for the CME to ensure that any replies and results of investigations are provided to the Complaints Committee within the stipulated timeframe, and that any advice any from them on improvement measures are implemented.
If a complaint is substantiated then it is referred to the ORPHF of the DOH, or other regulatory bodies. The Complaints Committee does not have jurisdiction over the professional conduct and judgement of registered healthcare professionals as individuals, however concerns can be passed on to the relevant regulatory bodies, such as the MCHK.
The importance of a robust complaints handling process cannot be understated. Many cases at Medical Protection involve an initial complaint, which, when handled in an empathic, robust and timely manner, can avoid escalation into an MCHK complaint or a claim in clinical negligence.
The PHFO requires timely reporting and investigation of patient safety incidents. It is the CME who is responsible for the incident management and reporting system and must review all incident reports, as well as the subsequent reviews and remedial or quality improvement actions taken. There is also a requirement for policies to be in place for proper disclosure of adverse events to patients or their next of kin.
The CME should ensure that any sentinel event or serious untoward event is reported to the Director of Health within 24 hours following identification, with a full report required within four weeks. Sentinel events include procedures involving the wrong patient or body part, retained instruments and medication errors resulting in major permanent loss of function or death, and serious untoward events include medication errors which could have led to death or permanent harm.
Medical professionals are bound by the professional obligations outlined by the MCHK in the Code of Professional Conduct, regardless of whether their role is clinical or non-clinical in nature, and even in their personal life. Actions and omissions as a CME could result in investigation by the MCHK. Although it has been possible for complaints about clinicians to be made directly to the Medical Council by patients/families, colleagues, employers and the public, there is now an additional pathway via the new complaints system, as outlined above.
The new Ordinance aims to strengthen the governance of the private healthcare sector and the Chief Medical Executive plays a key role in this. Taking on a crucial role such as the Chief Medical Executive will undoubtedly increase the risk of exposure to medicolegal issues, however with it comes an opportunity to influence the clinical care and performance of the facility. If taking on a role as CME, you can take the following steps to best reduce risk to yourself, the facility and patients:
If processes surrounding the management of risk, quality, incidents and complaints are robust, this can lead to improvements in both patient safety and patient satisfaction.