Feature: Medical electronics
Medical device cybersecurity F
essential information on the effectiveness of various treatments, thereby making meaningful contributions to ongoing efforts to improve patient outcomes. Such advantages are driving the significant growth of connected medical technology, alongside efforts to expand access to healthcare services to remote areas and support the increased demand for home healthcare solutions for patients with chronic health problems. However, the expanding use of connected technologies in the delivery of healthcare services also introduces a number of potentially significant cybersecurity risks. Like other data sets, health-related
data includes confidential information that could be misused when accessed by those with malicious intent. Names
34 March 2023
www.electronicsworld.co.uk
By Joe Lomako, Business Development Manager (IoT), TÜV SÜD and addresses of patients, medical conditions and diseases, prescribed drugs and therapies, as well as details about insurance coverage, are just some examples of sensitive data collected by connected medical devices that could be vulnerable to cybersecurity threats and breaches. Unfortunately, cyberattacks against
ew recent innovations have done more to transform healthcare than the use of connected technologies. Over time, connected devices and the data they generate provide
connected medical devices are becoming all too common. According to a 2020 survey conducted by Swedish soſtware company
ir.deto, at least 82% of medical device manufacturers experienced at least one cyberattack on one or more of their products in the previous 12 months. With the anticipated growth in the deployment and use of connected medical devices, the number of cyberattacks is only likely to increase.
Cybersecurity requirements for medical devices Amidst this growing threat landscape, regulators in major jurisdictions are increasingly aware of the need to provide
the industry with clearer and more direct regulations and guidance on developing connected medical devices that can help secure them from the most likely cyber threats. Evidence of the growing concern among regulators is perhaps best exemplified by the evolution of the European Union’s (EU) regulations that are applicable to medical device cybersecurity considerations: • 1993 – Te Medical Device Directive (93/42/EEC) includes a single sentence that indirectly refers to cybersecurity- related concerns.
• 2017 – Te Medical Device Regulation (MDR) includes six paragraphs in Annex I that directly address cybersecurity considerations.
• 2019 – Te Medical Device Coordination Group (MDCG) issues its “Guidance on Cybersecurity for Medical Devices”. Tis provides detailed descriptions of basic cybersecurity concepts, secure design and manufacturing practices, documentation and instructions for use, as well as post-
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