Telemedicine – medicolegal issues and answers: an update article

Leon G Tong 唐力安, Billy CF Chiu 趙志輝, David KF Kan 簡錦輝

HK Pract 2021;43:96-101

Summary

Many countries have been adversely affected by the on-going COVID-19 pandemic to the extent of having to endure complete or major lockdowns of their medical services for various periods and durations, including the closing of their local community clinics. In those places, Telemedicine was not merely just an alternative choice, but often has become the only means of consultation for patients with their doctors.

In contrast, Hong Kong which is primarily an urban locale with excellent and easy physical access to both Private and Public clinics. It has been fortunate in not having to undergo complete or major lockdowns due to the COVID-19 pandemic, and that most doctors’ offices have remained open throughout this period. The hope is that this will remain the case despite recent surges.

Even so, Telemedicine (or interest in it) may be on the ascendant, due to various factors. Telemedicine has many advantages; it will be useful in cross-border situations, especially when travel restrictions are in place. Telemedicine will help to reduce cross-infection, and many doctors are terrified that their offices may be forced to close if a patient or staff is deemed as positive or a “close contact”. Patients have also been reluctant to attend in person to doctors’ offices due to the fear of being exposed, so having at least the option of being able to offer patients telemedicine services is certainly something to know about. This can be done using the doctor’s own or other public platforms, or perhaps less desirably, patronising commercial or business companies offering brokered services who supply their own list of patients.

摘要

許多國家因受到持續全球性COVID-19大流行影響，需要暫停包括社區醫療等各種服務。在這些地區，遙距醫療不僅是另類選擇，而是與病人診症的唯一途徑。相比其他地區，香港具備優良的交通網絡，病人可以輕易地前往私人或公營診所求診。幸好，香港未因疫情而需要全面或大規模封城。多數醫生仍然繼續應診。冀望這種情況不會受到近日確診人數上升而改變。即使如此，遙距醫療（或對它的興趣）可能會由於不同因素而漸趨普及。對誇境人士而言 ，尤其是當交通往來受到限制時，遙距診症變得至為重要。遙距診症亦有助減低交叉感染風險。很多執業醫生害怕其病人或同事一旦被確診或界定為“緊密接觸者”時，他們的醫務所會被強制停診。亦有病人擔心受到感染而不願親身前往診所求診。無論如何，我們至少已意識到為病人提供遙距醫療服務的可能性。醫生可以使用自己的平台或在其他公共平台操作。或較為欠理想的，可為一些商營中介公司所提供的病人服務。本文簡列一些家庭醫生在開拓遙距醫療服務時需要考慮的問題。

Introduction

A webinar¹ focusing on the practicaland medicolegal aspects of Telemedicine was hosted in October 2020 by The Hong Kong College of Family Physicians (HKCFP) in partnership with the Medical Protection Society (MPS). This topic was chosen due to a perceived rise in interest in telemedicine as evidenced by a rise in enquiries to MPS on this topic, its increased use overseas and the start-up of a few commercial telemedicine platforms in Hong Kong (HK). The objective was not to promote nor discourage the role of telemedicine but to discuss the medicolegal implications of its use in relation to our MPS & HKCFP members.

Panel members included the Medical Director of MPS, and the current authors of the article, in their roles as MPS affiliated legal professionals and moderators from the HKCFP Board of Education

An opinion poll¹ was conducted amongst the participants and many interesting questions were raised. This article summarises and elaborates on points discussed by the panel during the webinar, and also provides additional information that was not covered during the webinar.

(1)  Participant polls¹:

The webinar audience had a rather high 75% participation rate of having done any form of telemedicine in their practice. This could have been as basic as conducting a consultation by telephone up to perhaps a full remote video interview.

• 60% responded that they felt sufficiently comfortable to practice more telemedicine.
• 74% had prescribed medication after a teleconsultation.

However, in contradiction to the above, 95% of respondents believed that more telemedicine training was required, and 88% wanted regulatory updates on the rules and regulations of telemedicine, showing that there was certainly room for improvement in training and advice.

(2)  Are there local guidelines on telemedicine?

The Medical Council of Hong Kong (MCHK) published a timely “Ethical guidelines on practice of telemedicine” in their December 2019 MCHK Number 26 Newsletter which was sent out to registered practitioners.² It should be noted that these are guidelines to what the expected standard is, and not rules set out in stone, which is an appropriate approach to address this rapidly evolving area.

With regards to the issue of jurisdiction, a doctor must comply with the law governing the practice of medicine in the jurisdiction where the patient receives the medical services.² If necessary, the doctor may consider liaising with a local doctor where the patient is situated to overcome this problem.³

(3)  What is the definition and scope of telemedicine?

The MCHK guideline has adopted the World Medical Association (WMA) definition of telemedicine and such definition was amended in the October 2018 WMA Statement²:

“…the practice of medicine over a distance, in which interventions, diagnoses, therapeutic decisions, and subsequent treatment recommendations are based on patient data, documents and other information transmitted through telecommunication systems.”

Furthermore ,in the MCHK Guideline², telemedicine included but was not limited to:

“(a) tele-treatment of patients within the definition of WMA;
(b) collaboration between doctors and/or with other healthcare professionals through telecommunication systems;
(c) monitoring of patients through telecommunication systems; and
(d) dissemination of service information and/ or health education to the public (including patients) through telecommunication systems.”

Therefore, the scope of telemedicine embraces a wide spectrum of activities which medical practitioners should be familiar with before using it in their clinical practice.

(4)  What technology is appropriate to conduct telemedicine?

The technology must be fit for its purpose including system stability and encryption for data protection.

In the MCHK guideline² : “telecommunication systems include telephone, email, social media (e.g. SMS, WhatsApp, Facebook, internet forum & etc.); and other means of electronic communication between two or more people in different locations, at least one of which is within Hong Kong.”

All doctors should receive proper training in the operation of whichever application is being used.

(5)  What should I (the doctor) explain to the patient if I (the doctor) want to obtain an informed consent?

The patient needs to be given a full explanation on how telemedicine works, its limitations, suitable alternatives, privacy concerns, the possibility of technological failure including confidentiality breaches, prescribing policies and the coordination of care with other healthcare professionals⁵ .

Although a doctor may rely on implied consent, it is advisable to obtain an express consent from the patient and incorporate the documentation into the process of telemedicine delivery. The process includes the patient’s understanding on the reason for an online instead of a face-to-face consultation, their agreement to proceed with that particular mode or platform, and identity of all parties, as well as how privacy will be safeguarded.⁵ A standardised form, perhaps to be formulated in the future, would facilitate this process.

(6) What should be documented in my (doctor’s) records after a teleconsultation?

The minimal content requirement would be the same as in a face-to-face consultation, and additional information will need to be documented⁴. This includes:

(a) A proper record on the information received and advice delivered.
(b) The clinical history and other information received including video observations and investigation results.
(c) A detailed documentation of the options discussed, including an option of no treatment or refusal to proceed, should be carefully explained. If there is a termination of a teleconsultation and a conversion to a face-to-face appointment, this must also be recorded.
(d) Furthermore, it is vital to record a safety net if the patient’s condition does not show improvement, with a clear written instruction for further assessment and follow-up care.
(e) If video recording is considered, documentation of a patient’s agreement is required.
(f) Obviously, in addition to written records, a video recording of the consultation would provide additional support to demonstrate that a proper consultation was conducted.
(g) The reasons as to why a face-to-face consultation was not done as the first choice.⁹

(7) Can I (the doctor) prescribe medicine after a teleconsultation with a patient in HK?

The doctor must evaluate if all required clinical information obtained through the teleconsultation satisfies his/her usual criteria for prescription and that such practice is comparable to the doctor’s face-to-face consultation.² Furthermore, the doctor will need to fulfil the clinic nurse’s or the hospital pharmacist’s role in explaining and documenting the patient’s understanding of the instructions for administration of the medicine.

(8) Can a patient’s representative pick up the medicine at the clinic on behalf of the patient?

A common scenario is that of a patient requesting a proxy or representative such as a relative to pick up their medicine at the clinic on the patient’s behalf. There is no such express provision or regulation in Hong Kong, and it is recommended that medicine is issued only if the doctor is satisfied with the representative's identity, by way of an authorisation letter and keeping a record of the representative's HKID or other identification in the patient's records. If the doctor decides to allow a representative to pick up a patient’s “Dangerous Drug”, extra-vigilance, say, in the way of a recorded confirmation with the patient when the representative arrives at the clinic is advisable.

(9) Can I electronically send a prescription to the patient to obtain the medicine from a community pharmacy?

If a doctor is satisfied with the teleconsultation and decides to prescribe to the patient, the doctor may send a copy of the prescription by fax or email in advance, but the patient must provide the originally signed prescription upon picking up the medicine at the community pharmacy.

(10) Should I entertain the patient’s requests for the delivery of medicine to the patient’s home?

For delivery of medicine, again there is no express provision for or against this method by an intermediary. The doctor should ensure the integrity of the delivered medicine, so that there are no mix-ups, and to ensure that the quality of the medicine is not adversely affected. Delivery of Dangerous Drugs by an intermediary must be avoided.

(11) What if the patient is based in Mainland China or Macau, can I dispense and supply medicine?

Regarding delivery or supplying medicine to patients outside of Hong Kong, currently, there is a special scheme initiated by the Government of Hong Kong Special Administrative Region (HKSAR) to deliver prescription medicine to HK residents with urgent needs in Guangdong and Fujian⁸ .

Apart from this scheme, repeating a prescription to an existing patient suffering from a chronic condition should be acceptable provided that the patient’s condition has been stable and the previously mentioned jurisdictional issues are taken into account. It is probably not advisable to provide a large supply of medicine and the doctor will need careful documentation.

(12) In the event of a complaint or claim from an international patient following a telemedicine services, in which jurisdiction is it likely to be pursued? And am I protected by the MPS?

In order to satisfy the MCHK dual jurisdictions’ licensing guideline, a doctor must have a valid practicing license in both countries (e.g. both in Hong Kong and the People’s Republic of China), if he intends to undertake the consultation solely on his/her own

When a Hong Kong doctor without dual licensing provides a second opinion service in a joint consultation with the patient and his/her Mainland doctor, the Hong Kong doctor must clearly document their role of interpreting the limited clinical information of the patient. In the case of an adverse event, the patient may proceed to make a complaint or claim against a doctor either in Hong Kong or the People’s Republic of China.

It has been the experience of the MPS that claims are usually brought to and made in the jurisdiction in which the doctor is domiciled (i.e. lives in and usually practises), as this is most likely where a judgement can be enforced against the doctor, but this is not a given. MPS will support its members based on the rules and regulations of the member’s domicile location (i.e. where he is listed as a member) and will be protected in a claim made to the member in HK.

(13) What are the considerations for a doctor when participating in a Commercial or Business entity telemedicine platform, which advertises an online doctor’s service?

The COVID-19 pandemic has accelerated the development of mobile Apps as online platforms for new patients to remotely ask questions about their symptoms. Given the clinical context, is the doctor satisfied that there will be proper evaluation? It is advisable that the patient has had prior in-person consultation, such that the doctor already has knowledge of the patient's identity, medical history and access to previous medical records.⁹

It is important that the patient is not "short-changed” due to the doctor only having incomplete or inaccurate information. If physical examination is likely to add critical information, then the doctor should not proceed until an examination can be arranged.10 A doctor is recommended to consider his/her participation as a “Panel Doctor” with caution. He/she must understand the circumstances in which a new patient is referred, the risk of breaching practice promotion (advertising) rules and possible improper financial transactions. It is of the utmost importance to remember that the online service companies simply act as business brokers or middle-men between the doctors and their patients, and that it is ultimately the doctors themselves who are held professionally accountable and answerable to the Medical Council.

(14) Which type of patients are appropriate for practicing telemedicine?

As discussed above, it is advisable that the patient is an existing known patient of the doctor. Doctors must be aware that a “doctor-patient relationship” is the cornerstone of providing patient care. Due diligence is needed to ensure that the true identity of both the doctor and patient can be verified to all parties during a remote consultation, such as by providing photo identification at the time of a video consultation.

Otherwise it really depends on the circumstances of the consultation. Telemedicine can be especially useful where it is difficult or inadvisable for the patient to attend to the doctor in-person, whether to minimise infection risks or due to other factors such as poor mobility¹⁰. Documentation is needed as to the reason a face-to-face consultation is inappropriate⁹

Note that the MCHK still views that the Standard of Care that is given during a person-to-person consultation must apply equally to a Telemedicine consultation. Obviously, telemedicine is appropriate only if the medical condition can be managed without needing a full “hands-on” physical examination. Generally, follow-ups of chronic or established conditions will be easier to manage remotely than compared to, say, new, undiagnosed or undifferentiated symptoms.

However, the correct interval between remote visits until the time an in-person consultation becomes necessary will depend on factors such as whether any significant change in clinical condition is expected, or if there will be a significant change in medication or dosage, and will rely on each doctor’s individual clinical judgement. There may even be added benefits for some specialties such as rheumatology patients for whom it may be inconvenient to travel to the clinic, whereby the doctor can observe functional ability of the patient in real time in his home environment. From previous Hospital Authority experience, geriatric and psychiatric services may also be amenable to telemedicine follow up.

(15) How should I follow up with the patient after a teleconsultation?

This is one of the commonest “weakest links” in medico-legal cases.⁹ The doctor must clarify with the patient as well as with other healthcare professionals involved what their respective roles and follow-up responsibilities are for a successful continuity of care of the patient.⁸ Written instruction should be given to the patient on what warning symptoms to look out for, how and when the doctor can be contacted later, and the steps the patient should take if he/she is unsuccessful in contacting the doctor.

(16) How can I manage the medicolegal risks of patients’ remote monitoring?

In the World Medical Association definition, “Monitoring of patients through telecommunication systems”, is a form of telemedicine. The ability to remotely monitor their patient’s urgent medical data and events is an area of increasing interest to primary care physicians. This can range from simple tasks such as having patients taking and reporting their own periodic blood pressures or serum glucose levels to more complex methods such as Telemetric Holter ECG

Furthermore, the COVID-19 pandemic has driven the global adaptation of remote monitoring to triage patients with chronic disease to their appropriate least frequent interval of face-to-face follow-up. Despite research showing higher patient satisfaction and quality of life after using telemedicine11, many doctors are reluctant to adopt Remote Patient Monitoring (RPM) because of the fear of liability. Possible pitfalls include the continual alerts, calls or failed contacts that may not be properly handled by clinic staff despite their best efforts.

Finally, the issues of data accuracy and security cannot be overlooked⁶ . Therefore, good clinic protocols and policies of how to interpret and handle incoming data from RPM will need to be established, before RPM can be used for effective and accurate patient care.

(17) Finally, what are the major areas of pitfalls in Telemedicine that one should remember?

To recap, the issues in general that require particular attention are:

(i) adequate verification of identity of both parties;
(ii) increased difficulty in establishing a trustful doctor-patient relationship;
(iii) possible inherent problems with technology relating to its use, storage and privacy;
(iv) a remote physical examination may be less comprehensive and reliable than a “hands-on” examination; and
(v) lastly, whatever problems and requirements that apply to person-to-person consultations will also apply to consultations made by telemedicine.

Conclusion

In conclusion, it seems there is an urgent need to establish an appropriate telemedicine training programme locally for Hong Kong doctors in order increase their confidence level, even if they may have already adopted it or have decided to do so in the future. There are numerous medicolegal pitfalls in telemedicine, and it is only by having a critical understanding and review of the issues at the heart of this matter so that a doctor will be able to navigate safely through these challenges.

The MPS is delighted to be in continuous conversation with the HKCFP in order to pique our doctors’ interest towards adopting Telemedicine by providing educational articles such as this one, or perhaps by implementing a future training programme for the benefit of our respective members and fellows. For those who may be interested, several webinars on Telemedicine may additionally be viewed on the MPS’ website.¹²

The authors welcome further discussions on this topic.

Disclaimer: This article presents material that has been prepared in good faith by the current authors and members of the webinar panel which included the Medical Director of the Medical Protection Society (UK), lawyers from one of the MPS’s appointed legal practices in HK, MPS’s HK Medicolegal Consultant and moderators from the HKCFP Board of Education. However, the material must not be taken as definitive legal advice and readers are advised to obtain specific legal advice from their respective medical defense organisations or legal professionals if necessary.