Authors:
Sreekanth Yalavarthi
Addresses:
Department of Healthcare IT, R&D Engineering, HCL Technologies, Buffalo Grove, United States of America.
The European Union Medical Device Regulation has brought in strict requirements so that the medical device remains cybersecurity-safe. Such devices today are highly software-intensive and have critical functions related to network connectivity. Therefore, they are prone to cyber threats on an unimaginable scale. This paper will discuss the requirements of cybersecurity under EU MDR by focusing on challenges in compliance and prioritizing patients' safety. It underlines one prerequisite: manufacturers should practice the concept of secure-by-design while keeping post-market-market surveillance mechanisms robust. An architecture for cybersecurity management, specifically designed for medical devices, is provided, and its effectiveness is tested through empirical study. The results are evaluated using tools like Python and MATLAB. According to studies, adherence to upgrades brings about massive boosts in the readiness quotient relating to cybersecurity, in addition to enhancing patient safety metrics. However, striking a balance between innovation and regulation is tough. This paper concludes by ending with some limitations and research directions that will ensure that cybersecurity strategies are in consonance with emerging technologies.
Keywords: Cybersecurity and Cyberattacks; Medical Devices; EU MDR; Patient Safety; Cybersecurity Breaches; Healthcare Devices; Health Care Services; Risk Assessment; Medical Systems.
Received on: 19/02/2024, Revised on: 27/04/2024, Accepted on: 11/06/2024, Published on: 05/09/2024
AVE Trends in Intelligent Health Letters, 2024 Vol. 1 No. 3, Pages: 158-167