Regulating telemedicine in South Africa

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Both established and start-up businesses are competing for pole position in developing innovative and disruptive new technologies, software, platforms and solutions to capture the healthcare market in South Africa and around the world. However, buy-in from healthcare practitioners, patients, funders and regulators is required.

Rural underserviced communities, the elderly and patients requiring treatment for chronic conditions have greatly benefited from telemedicine solutions. which provide improved access to healthcare services, lower costs and positive outcomes.

It is against this backdrop that the Health Professions Council of South Africa (HPCSA) developed, approved and published the General Ethical Guidelines for Good Practice in Telemedicine (Guidelines) in August 2014.

The stated objective of the South African Telemedicine System, as per the guidelines, is to deliver healthcare services at a distance to South African communities in underserved areas and alleviate the human resource crisis currently experienced, as well as to improve links and communication between developed healthcare facilities and underdeveloped rural areas.

The guidelines recognise that telemedicine may be provided through email, teleconferencing, videoconferencing or similar forms of technology, which enable healthcare practitioners to replicate the interaction of traditional face-to-face consultations with patients. Technologies that enable real-time monitoring of vital signs, taking x-rays and administering hearing tests, to name a few, are being developed and used by healthcare practitioners to assist with the treatment of patients from a distance.

Three parties

Three parties will generally be involved in the provision of telemedicine services - a requesting patient, a consulting healthcare practitioner and a servicing healthcare practitioner.

The consulting healthcare practitioners and servicing healthcare practitioners are held to the same standards of medical practice as healthcare practitioners that conduct face-to-face consultations. Treatments, including writing prescriptions, based solely on online questionnaires will not constitute an acceptable standard of care, and are not permitted in terms of the guidelines.

Consulting healthcare practitioners will conduct face-to-face interviews or examinations with requesting patients and will refer patient information to a remote location for further advice or intervention. Ultimately, the consulting healthcare practitioners will remain responsible for the treatment of requesting patients, the decisions and other recommendations given to requesting patients, as well as for keeping detailed records of the requesting patients' conditions and the information transmitted and received from servicing healthcare practitioners.

The servicing healthcare practitioners will advise consulting healthcare practitioners or intervene in the treatment of requesting patients from a remote location, and the former's obligations include the keeping of detailed records of the advice provided, as well as the information received, and ensuring that the advice or treatment suggestions given were understood by the relevant consulting healthcare practitioner or requesting patient.

Informed consent is imperative in order to engage in telemedicine, and the guidelines require that the requesting patient be informed regarding the purpose of the telemedicine services, the cost of the services and the implications thereof.

Legislative compliance

Compliance with legislation such as the Consumer Protection Act, the Protection of Personal Information Act, the Electronic Communications and Transactions Act, the Health Professions Act, and the Medicines and Related Substances Act will become relevant when the solutions and the devices to be used in the provision of telemedicine services are selected and developed.

As telemedicine services develop, mature and become more widely adopted in South Africa, regulators such as the HPCSA and the South African Health Products Regulatory Authority, national government, and the legislature will have to ensure that laws, regulations, policies and guidelines addressing telemedicine services, healthcare practitioners, medical devices, reimbursement practices and data protection rules, are developed and refined in such a manner that innovative and new solutions are encouraged, and at the same time ensuring patient safety and positive outcomes.