Introduction

Hong Kong has been one of the most well-established destination for medical tourism in Asia. With the recent introduction of the jurisdiction’s very first Photon Therapy Centre in Hong Kong (bringing one of the world’s most advanced radiation technologies into Hong Kong), Hong Kong continues to stand as the crown jewel of quality medical centres in the region.

In face of the coronavirus pandemic, whilst the medical profession is known for being largely immune to economic downturns (the sick will always need care regardless of their wealth status), it is also faced with many novel challenges due to the nature of COVID-19. In turn, healthcare providers have increasingly began to turn to digital healthcare and medical technology or MedTech as solutions to circumstances.

For example, since the COVID outbreak, the use of virtual medical consultations, digital scans and imaging and remote provisions of medical services through medical devices have become much more widespread.

While technological adaptation of MedTech (as opposed to technological resistance) will invariably bring in greater opportunities for all parties involved, healthcare providers are also quickly finding themselves running into uncertain regulatory landscape. As such, it is important for healthcare workers to be mindful of various legal and regulatory issues which relates to the field of MedTech in the course of embracing the same.

1.    Virtual medical consultations

In the wake of COVID-19, the need to maintain social distancing had resulted in a surge for the demand for virtual medical care services across the globe. This is equally so for both private and public hospitals and clinics have been offering telemedicine as an alternative means to provide medical care or advice to patients.

For example, some public hospitals in Hong Kong have recently started to provide telemedicine services to psychiatric patients and those in need of occupational therapy and physiotherapy. At the same time, private healthcare providers have also offered telemedicine such that patients can consult doctors online and order medicine to be delivered directly to their home from clinics.

The benefits of remote healthcare are readily apparent, service disruption due to suspension of physical services during the various waves of COVID are mitigated while patient can also safely obtain the help they desperately require without the need of exposing themselves to nosocomial infection in the process of obtaining treatment.

In this connection, practitioners of virtual medical consultation should remain mindful of the Ethical Guidelines on Practice of Telemedicine which had been published by the Medical Council of Hong Kong in December 2019 (the “Guidelines”).

The Guidelines laid out some generic principles for medical practitioners who substitutes telemedicine for traditional modes of delivery of medical care and/or advice. Pursuant to the Guidelines, doctors are reminded to, when practising telemedicine, remain fully responsible for meeting all legal and ethical requirements and should adhere to well-established principles and standards for:

1.        guiding privacy and security of records;

2.        informed consent;

3.        safe prescribing; and

4.        other key areas of medical practice.

These are the same set of standards as set out in the Code of Professional Conduct of the Medical Council of Hong Kong.

In particular, the doctor must be satisfied that the patient is suitable for a telemedicine interaction and that the standard of care delivered via telemedicine is reasonable considering the specific context. It is also specified that a doctor may prescribe medicines for a patient via electronic means only when he has adequate knowledge of the patient’s health, and is satisfied that the medicine serves the patient’s needs.

It is also recommended that before prescribing any medicine for the first time to the patient, the doctor should still have an in-person consultation with that patient. Thus, the Guidelines places the bulk of the emphasis on the doctor’s role and responsibility in deciding whether telemedicine should be adopted.

In the course of providing telemedicine, practitioners should:

1.        strengthen patient data security by controlling system access, authenticating users and encrypting data whenever possible;

2.        request patients to sign consent and risk disclosure forms before providing telemedicine services; and

3.        collaborate with pharmacies or deliver prescriptions to patients directly to prevent abuse of e-prescription.

2.    Health information privacy and data protection

In Hong Kong, patients’ health records amount to personal data, which is protected under the Personal Data (Privacy) Ordinance (Cap. 486) (“PDPO”).  PDPO protects the privacy right of data subjects in respect of their personal data and governs all data users and in view of the change in global privacy landscape, legislative amendments to PDPO have been proposed.

When health and patient data are collected and stored in medical devices and databases, the data users must comply with the six data protection principles in the collection, holding, accuracy, retention period, security, privacy policy and access to and correction of personal data pursuant to PDPO. Thus, data users should take steps to comply with the principles, for example, data users may provide patients with a “Personal Information Collection Statement” and a “Privacy Policy Statement” before the provision of medical services electronically.

Also, healthcare providers as data users should make sure the duration of retention of the data is reasonable considering the purpose of retention and use of the data is in line with the original purpose consented by the patients. In light of COVID-19, the Privacy Commissioner for Personal Data has reminded the healthcare sector to balance privacy against technological functionalities and social benefit.

In 2016, the Government launched the Electronic Health Record Sharing System (“eHRSS”) in Hong Kong. It is an electronic sharing platform which enables authorised healthcare providers in the public and private sectors to access and share participating patients' electronic health records for healthcare purposes. To regulate the collection, sharing, use and safekeeping of data shared via the eHRSS, the eHRSS Ordinance (Cap. 625) was enacted. Practitioners should put in place policies and measures to enhance data security and ensure compliance with the eHRSS Ordinance. For example, practitioners should:

1.        obtain patients’ consent before uploading and sharing any data;

2.        monitor access logs and accounts closely and report suspicious accesses; and

3.        comply with the eHRSS Data Retention Policy.

3.    Artificial intelligence (“AI”) and
machine learning in healthcare

A topic relevant to the accumulation in electronic medical data and records is the application of AI and machine learning, which is the use of algorithms and software, on the interpretation, and comprehension of such data, which may then assist with diagnosis of diseases, preventing human mistakes, analysing CT imagery during COVID-19 pandemic, and so on. 

Although no laws or regulations specifically targets AI in Hong Kong, there are some relevant laws and regulations that AI developers in the medical field have to comply to. As mentioned, PDPO governs all data uses and their collection and usage of personal data, including medical data, which will be directly relevant to the use of AI in the medical field.

Another two pieces of legislature which are of relevance are the Copyright Ordinance (Cap. 528) and the Patents Ordinance (Cap. 514), which is going to affect the ownership and usage of intellectual property rights generated by AI. Although it is unclear whether works generated by AI is currently protected by copyright in Hong Kong, such issue may arise in the Hong Kong courts in the near future.

A relevant area of interest is the issue of liability for misdiagnosis by AI. There are no local cases which address this issue. However, in other jurisdictions such as the UK, there are suggestions that AI is merely viewed as a tool used by the medical practitioner. As such, the medical practitioner has control over whether or not to follow the diagnosis made by the AI and any misdiagnosis should be dealt with as a medical negligence claim.

To mitigate the risks while reaping the benefits of AI, practitioners should:

1.        post risk disclosure statements and disclaimers on possibility of system errors;

2.        conduct continuous monitoring of quality of AI-system to identify risks; and

3.        obtain medical liability insurance.

4.    Regulation of Medical Devices

Currently, there is no legislation which specifically regulates the manufacture, import, export and sale of medical devices in Hong Kong except for those containing pharmaceutical products or radioactive substances, which may be regulated by existing legislation such as the Pharmacy and Poisons Ordinance (Cap 138), the Radiation Ordinance (Cap 303), and the Telecommunications Ordinance (Cap 106).

However, the Government recognises that there is a need to develop an appropriate regulatory system for medical devices in Hong Kong and this is being developed by the Government to ensure the conformity with the requirements on safety, quality, performance and efficacy before medical devices are allowed to be placed on the local market. Pending the enactment of legislation, since November 2004, the Government has launched the voluntary Medical Device Administrative Control System which includes both a listing system for different classes of medical devices and an adverse incident reporting system.

In recent years, the Government has been actively pushing for the enactment of legislature for pre-market control and post-market control of medical devices and had made a briefing on the legislative proposal to the Legislative Council. Interested parties including manufacturers, importers and distributors of medical devices are thus encouraged to follow the developments closely and participate in future public consultations on the issue.

While making use of medical devices, healthcare providers and users should:

1.        make sure users receive training and have sufficient knowledge of the device;

2.        conduct and record regular maintenance of the device; and

3.        report any adverse incidents through the Medical Device Administrative Control System.

Conclusion

In the age of COVID-19, while we can see a pressing need to utilize technology to improve access to healthcare and assist with the prevention, forecasting the spread of diseases, there is yet to be a clear and comprehensive legal framework relating to medical technology in Hong Kong. However, the medical technology sector still has to stay vigilant to comply with the existing laws and regulations and to keep an eye on the developments closely.