Medical Device Cybersecurity
3.0
creditsAverage Course Rating
In an increasingly connected healthcare landscape, medical devices have effectively become IT endpoints, often running general-purpose operating systems like Windows or Linux, incorporating cloud microservices, and integrating artificial intelligence to detect, prevent, and improve patient health outcomes. Protecting these devices from cyber threats is not just a technical challenge—it's a matter of patient safety. A security breach in medical devices like pacemakers or infusion pumps can have life-threatening consequences. National and international regulatory bodies, such as the FDA and EU National Competent Authorities (NCAs) and Medical Device Regulation (MDR), know the implications and have provided prescription and guidance emphasizing stringent cybersecurity measures throughout a device's lifecycle, from design and development to postmarket surveillance. The result is a heightened awareness of medical device security and its impact on healthcare delivery, requiring cybersecurity risk management. In particular, focusing on threat modeling, cybersecurity risk assessment, secure design, secure coding practices, vulnerability management and monitoring, software bill of materials, cybersecurity transparency, user labeling, penetration testing, and more. Recommended background: computing systems, operating systems, machine learning & AI.
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