Medical Device Regulation and Cybersecurity: Achieving ‘Secure by Design’ for Regulatory Compliance

Abstract

The rapid evolution of information technology over the past 50 years is transforming our healthcare institutions from paper-based organizations into smart hospitals, a term now used by European Union Agency for Cybersecurity (ENISA). These changes are also associated with the systematic reliance on medical devices by both patients and healthcare providers. While these devices have the potential to advance personalized health solutions and improving the quality and efficacy of care, they nevertheless present significant security risks and challenges throughout the healthcare sector.