south african medical technology industry association
advancing innovation responsibility


Archived News
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01 October 2019
Cyber-security in the connected MedTech world

In the digital segment, wireless devices and mobile apps, nanotechnology, data analytics, automation and 3D printing are reshaping the delivery of healthcare.

Anyone would be excited by the opportunities that augmented and virtual reality can bring. As a principle, SAMED is a keen supporter of such innovations, which can unlock new diagnostic and treatment options and support predictive, preventive, personalised and participatory medical care.
For example, recently a patient in the United States used these technologies to travel inside his body and see the effect of treatment on his cancer cells.

South Africa may still have a way to go in catching up with other more digitalised and connected healthcare environments. This gap is also an opportunity to be mindful about the advantages and potential risks and challenges that smart MedTech products bring to the field.

All innovations have pros and cons

Improving the use of resources, laser-precision targeting during diagnosis or treatment, helping patients deal with their condition are important benefits that come from smart devices.

But technology requires varying levels of inter-operability between the patient, their home and the healthcare facility. End-users need to have certain IT capabilities and infrastructure that can handle and process connections and data. And in an always-on world, the security of connections and data access and use must also always be on.

Critical infrastructure and regulatory and reimbursement factors

While we must continue to keep up with technological advancement and strengthen legislation, the current South African regulatory framework already does much to prevent cyber breaches and reduce the risk of exposing patients to related risks.

Device companies are aware that there is no product which can 100% avoid misuse or being tampered with. Therefore they extensively test products prior to bringing them to the market, and continually monitor applications.

Patients, healthcare providers and physicians using such technologies need to ensure they have the IT capabilities and infrastructure to process such data, including security measures. In this regard, the Protection of Personal Information Act is relevant for all.

SAHPRA - The South Africa Health Products Regulatory Agency – follows the International Medical Device Regulatory Forum, which works closely with the US regulator, the Food and Drug Administration (FDA) and other international regulatory agencies. The cybersecurity principles for medical device and technology companies compiled by the Global Medical Technology Alliance is a useful resource, and can be accessed here.

`Contact the
Medical Device Code Hotline

Free call:

0800 00 04 68

E-mail: accompanied by completed complaint form.

Emails must be accompanied by the complaint lodging form. This will assist SAMED to investigate the complaint