Glossary Term
Cybersecurity for Medical Devices
Definition
Cybersecurity for medical devices refers to the processes, technologies, and practices implemented to protect medical devices and associated data from unauthorized access, attacks, and breaches. It ensures the confidentiality, integrity, and availability of data generated or transmitted by medical devices, safeguarding patient safety and privacy.
Relevance to the MedTech Industry
Cybersecurity is critical in the MedTech industry to prevent potential harm caused by cyberattacks, such as data breaches, operational disruptions, or compromised device functionality. As medical devices increasingly integrate with networks, cloud systems, and other technologies, robust cybersecurity measures are essential for maintaining regulatory compliance and patient trust.
Additional Information & Related Terms
Risk Management File Documents cybersecurity risks and mitigations as part of overall device safety planning.
Software as a Medical Device (SaMD) Requires stringent cybersecurity measures due to its reliance on software for functionality.
FDA Premarket Cybersecurity Guidance U.S. regulatory guidance on cybersecurity requirements for medical devices.
Post-Market Surveillance Involves monitoring cybersecurity threats and implementing updates for deployed devices.