The Covid-19 pandemic has in many ways ramped up the migration of healthcare services and solutions into the technological realm. Government’s aim to vaccinate 67% of the population by the end of the year will be strongly reliant on the capturing and storage of personal information via the Electronic Vaccination Data System (EVDS). The Covid Alert SA track-and-trace application which two million people have installed on their mobile devices is another platform that manages millions of complex, interlinked geolocation networks in real time. As well as preoccupation with the functionality of technological advancements in the healthcare space, it is critical to keep sight of the legal requirements that guide and govern their usage.

This is the age of exciting possibilities for both healthcare providers and developers intent on harnessing technology to enhance health care. But as technological innovation leapfrogs to bring dramatic change, legislation must play catch-up. In practice this is uncharted terrain, requiring a mix of caution and insight before jumping in headlong.

Whether the healthcare technology seeks to address new complexities, such as robotics used in surgical interventions, or simply streamline existing methods, such as the digital management of practitioner consulting rooms, this will likely require the use of at least one broad technology. Such technologies include artificial intelligence (AI), big data (the systematic analysis and extraction of data most often residing in the cloud), machine learning (such as the use of algorithms) and digital- or e-health care (generally electronic processes and communication). 

While technological advancements seek to swiftly change the face of health care, the legislative framework in which they operate lags behind. Consider that globally there is no accepted legal definition of “AI”. South Africa has no legal definition for “digital health care” and “big data” as a concept is not specifically regulated. (The Department of Health has adopted the WHO definition for digital health, which is “the field of knowledge and practice associated with any aspect of adopting digital technologies to improve health, from inception to operation.”)

Although there is no explicit framework for the governance of these concepts, other relevant laws and codes, when read together with the laws governing medicine (including the Medicines Act, the National Health Act and the Health Professions Act, 1974 (Act No. 56 of 1974)), enable an understanding of the legal terrain in which healthcare technology operates.

As data – including its capture, storage, analysis and use – plays a pivotal role in the previously-mentioned technologies, the Promotion of Access to Information Act (PAIA) and the Protection of Personal Information Act (POPI) No. 4 of 2013 are significant legislation. Under POPI, health data is represented as “special personal information”, and is subject to more protections than personal data. Special personal information may not be processed unless one of the general authorisations set out in section 27, 32 of 33 of POPI exists; or where the Information Regulator has authorised it (Pienaar and Shacksnovis, 2021).

Further to this, algorithms constitute “computer programs” which are governed under the Copyright Act and technological medical devices under Patent Law. Technology developers and service providers are bound by contract law.

Inherent challenges

Using technologies such as AI in health care which replace the “human aspect” can raise legal and ethical questions around accountability, transparency and consent. An article in The National Law Review  notes that when “complex, deep-learning algorithm AI” is used in the diagnosis of patients, the doctor may not fully understand the diagnoses and subsequently fail to adequately explain to the patient. This makes it difficult to establish accountability should errors occur in the diagnosis. Additionally, AI is not immune to algorithmic biases, which could lead to a diagnosis based on gender, race or other factors that do not have a causal link to the diagnosis.

The moral status of “artificial agents” also raises complexities in terms of who is in control of the technology. Currently there is no existing case law in South Africa to add clarity to the matter.

In the absence of express laws for healthcare technology, it is important to scrutinise the disparate laws that will govern and inform their use. It is also important to understand where laws may overlap in order to identify which would take precedence in the event of a dispute.

Healthcare providers and practitioners need to be keenly aware of the potential risks and challenges that could constrain the immense potential in adopting healthcare technologies. To avoid unintentional non-compliance and unnecessary litigation, they are advised to seek professional guidance when charting a path through the complex legal terrain.

Bishop Fraser is a boutique firm with offices in Johannesburg and Cape Town, specialising in commercial, mining and environmental law, with the ability to provide counsel across numerous practice areas. Bishop Fraser’s multi-disciplinary team of experts provides bespoke, practical and cost-effective solutions to complex legal challenges.