The COVID-19 pandemic has led to a significant increase in the use of electronic platforms to provide access to health services. There are various types of platform, but most enable patients to consult with a medical practitioner or solicit responses to health-related questions. Often, these responses are generated through automated mechanisms and algorithms. These platforms seemingly push the legal boundaries of telemedicine.
When providing telemedicine services, health practitioners must comply with the General Ethical Guidelines for Good Practice in Telemedicine, which the Health Professions Council of South Africa (HPCSA) issued under the Health Professions Act (56/1974) in August 2014.
The telemedicine guidelines define 'telemedicine' as:
The practice of medicine using electronic communications, information technology or other electronic means between a healthcare practitioner in one location and a healthcare practitioner in another location. This is for facilitating, improving and enhancing clinical, educational and scientific healthcare and research, particularly to the under serviced areas in the Republic of South Africa.
The telemedicine guidelines apply only to the use of electronic means to carry out acts that fall within the 'practice of medicine', which includes:
- diagnosing a person's physical health status;
- advising a person on their physical health status; and
- administering, selling to or prescribing for a person any medicine or medical treatment.(1)
Only registered medical practitioners – and other registered health professionals, such as nurses, pharmacists and allied health professionals, acting within their own delineated scopes of practice – may carry out the acts that fall within the scope of the medical profession.
This is particularly relevant where platforms use automated responses or AI programmes to generate a diagnosis based on the input provided by patients. In South Africa, the intervention of a medical practitioner registered with the HPCSA (or another registered health professional) is required to diagnose a patient.
It may therefore be said that any platform or medical device that purports to diagnose a patient without a healthcare practitioner physically assessing and/or confirming the diagnosis is prohibited in South Africa under the current legislative framework. However, platforms can freely provide and make available to subscribers or users of a platform health or medical information without the intervention of a healthcare practitioner.
Scope of permissible health platforms and apps
According to the telemedicine guidelines, telemedicine clearly relates to the use of electronic means to facilitate consultations between healthcare practitioners based in different locations, generally to improve practitioners' and patients' access to specialist advice in under-resourced areas. The specificity of this definition suggests that the HPCSA recognises the use of electronic means for consulting or delivering medical services only in the limited context of two or more healthcare practitioners consulting about a patient. However, the fact that nothing in the telemedicine guidelines expressly prohibits the use of electronic means to deliver medical services to patients raises doubts as to the veracity of arguments against this use.
In a March 2020 media statement, the HPCSA stated that:
there are numerous advertisements for doctors to be involved in Telemedicine models that are in contravention of the HPCSA's Ethical Guidelines on Telemedicine. This may result with [sic] patients routinely being serviced by practitioners virtually, that is, directly without the consulting and responsible practitioner's physical presence.(2)
The HPCSA then restated the definition of 'telemedicine' as described above. Although the question of whether healthcare practitioners can use electronic means to provide medical services to patients directly remains ambiguous, this was a clear statement by the HPCSA that face-to-face consultations between healthcare practitioners and patients are required when providing routine services. This suggests that using an electronic platform to deliver medical services to a patient in the absence of a face-to-face consultation is unlikely to be seen as an ethical practice, regardless of whether the actual practice of virtually delivering medical services to a patient falls within the scope of the telemedicine guidelines.
Healthcare practitioners should follow the interpretation that the telemedicine guidelines recognise the use of electronic means to facilitate the delivery of medical services only where two healthcare practitioners in different locations need to consult about a patient. Healthcare practitioners that use telemedicine methods to deliver medical services directly to patients may be putting themselves at risk of a finding of misconduct by the HPCSA should a complaint be made.
The telemedicine guidelines permit healthcare practitioners to use electronic means to provide patients with general medical information or medical information on particular conditions. The telemedicine guidelines also appear to permit the use of electronic means to monitor the progress of a patient's condition following a diagnosis and a physical consultation. However, in the latter case, to comply with the telemedicine regulations, it is recommended that:
- an existing patient relationship be in place;
- the patient consents to the use of an electronic platform to advise on the progress of their condition; and
- effective mechanisms be put in place to ensure the protection and integrity of any personal or health information that is shared on the electronic platform or app.
The HPCSA's views on telemedicine have been criticised as being outdated. However, the core of the debate should be patients' best interests.
Telemedicine during COVID-19
In the same month as the HPCSA issued the above media statement, telemedicine in South Africa took centre stage due to the COVID-19 pandemic. The HPCSA has recognised that the "COVID-19 outbreak constitutes a public health emergency and risk to practitioners, patients and more broadly, the well-being of the South African community".
On 26 March 2020, following the national lockdown announcement, the HPCSA issued guidelines on telemedicine for health practitioners. These indicated that although the telemedicine guidelines discussed above discourage virtual consultations between doctors and patients, the COVID-19 pandemic presents unique challenges. The new guidelines replace 'telemedicine' with 'telehealth', which covers "remote consultations with patients using telephonic or virtual platforms of consultation".
The HPCSA announced that during the COVID-19 pandemic, it will permit the use of telehealth as defined above. Healthcare practitioners can conduct telephonic and virtual consultations with their patients. The HPCSA has limited this exemption to existing healthcare practitioner-patient relationships, effectively discouraging virtual or telephonic consultations between healthcare practitioners and new patients.
On 3 April 2020 the HPCSA released a notice to amend the telemedicine guidelines during the COVID-19 pandemic. The amendment provides that:
Telehealth should preferably be practised in circumstances where there is an already established practitioner-patient relationship. Where such a relationship does not exist, practitioners may still consult using Telehealth provided that such consultations are done in the best clinical interest of patients.
Over the past year, South Africa has seen a rapid development in telehealth. Looking beyond the COVID-19 pandemic, it is hoped that the HPCSA considers patients' best interests and takes decisive action to incorporate national and international telehealth successes in a much-needed revamp of the existing legislative framework.
Although it is uncertain how the end of the COVID-19 pandemic will affect existing telemedicine developments, it would be reasonable to believe that the HPCSA will face significant resistance when the time comes for it to remove the recent amendments to the telemedicine guidelines.
In an open letter protesting the guidelines issued by the HPCSA on the 26 March 2020, the South African Medical Association called on the HPCSA to align its position on telemedicine with international telemedicine regulations.
The COVID-19 pandemic has put the HPCSA, healthcare practitioners and all South Africans in a position to reimagine what access to healthcare services could look like. The future of telehealth in South Africa should support the implementation of Valid and informed consent from patients and adherence to the Ethical Rules of Conduct for Practitioners Registered Under the Health Professions Act should remain salient features when contemplating any telehealth developments in a South African context.
While telemedicine was previously the subject of many divergent views in South Africa, the COVID-19 pandemic has required collaboration in order to protect the best interests of both patients and healthcare practitioners. This will be an important factor when considering the future of telemedicine in South Africa following the pandemic.
Endnotes
(1) See "Regulations defining the scope of the profession of medicine" in the Government Gazette 31958, issued by the minister for health.
(2) See "Guidelines on Telemedicine in South Africa", HPCSA, 9 March 2020.
