ABSTRACT

In the evolving landscape of medical device cybersecurity, ensuring patient safety during technological advancements is paramount. The FDA and other regulatory bodies play pivotal roles in setting guidelines and standards to mitigate risks associated with interconnected medical devices. Through frameworks like ISO, IEC, and HIPAA, manufacturers are mandated to integrate robust cybersecurity measures throughout the device lifecycle, from design and production to post-market surveillance. Recent updates require manufacturers to adopt a proactive approach, conducting thorough risk assessments and implementing advanced security features such as encryption and AI-driven threat detection. Collaboration among stakeholders-manufacturers, healthcare providers, and cybersecurity experts—is emphasized to fortify device resilience against emerging threats like phishing and ransomware. Continuous updates and adherence to best practices ensure that medical devices remain secure and reliable in the face of modern cybersecurity challenges. It provides a comprehensive understanding of the regulatory landscape, recent updates, and common challenges medical device manufacturers face in achieving cybersecurity compliance. Keywords: Cybersecurity, Medical devices, FDA, ISO, IEC, Cybersecurity updates
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9581.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9581