ÃÛ¶¹ÊÓƵ

Cybersecurity Risk Management for ÃÛ¶¹ÊÓƵs

Medical device connectivity creates significant benefits for patients and healthcare organizations, but it also expands the potential attack surface for cybersecurity threats. This article emphasizes the importance of addressing cybersecurity during device design and development, rather than treating it as a late-stage consideration. Vulnerabilities that remain unresolved before market launch can provide entry points into healthcare networks and potentially compromise data confidentiality, data integrity, device performance, and patient safety.

A strong cybersecurity strategy begins with secure by design principles and clearly defined security requirements. Manufacturers should incorporate cybersecurity expertise into the design process, identify vulnerabilities across diverse technologies and infrastructure, and apply risk-based controls to address potential threats. Protective systems that can detect, respond to, and recover from threats provide an additional layer of risk control, while labeling and instructions represent a less robust form of mitigation.

Cybersecurity must also be managed throughout the medical device lifecycle. Legacy operating systems, supply chain dependencies, emerging vulnerabilities, and evolving threats can create new risks after commercialization, making ongoing monitoring, patching, and security updates essential. The article highlights resources including IMDRF guidance, AAMI TIR57 and TIR97, the NIST Cybersecurity Framework, OWASP resources, and FDA cybersecurity recommendations as tools manufacturers can use to establish and maintain effective cybersecurity risk management.

Read the full article: