Cybersecurity, Data Protection, and Artificial Intelligence in Medical Devices

This chapter gives an overview of the current cybersecurity issues in medical devices, risks concerning the personal data use, and regulatory recommendations for medical devices with artificial intelligence (AI) technologies. First sections describe general cybersecurity principles, cybersecurity pre- and post-market actions, responsibilities among healthcare stakeholders, and the importance of cybersecurity information disclosure. Data protection subsection provides current regulations on the use of personal health data. Subsection on AI-based medical devices explains the current trends in regulatory approvals for software as medical devices (SaMD) that use artificial intelligence and machine learning (ML) methods. Presented are the regulatory proposals concerning the modifications of medical devices to mitigate operating vulnerabilities and potential patient harm.