Proactive Role of Clinical Engineering in the Adoption of ISO/IEC 80001-1 within Healthcare Delivery Organization

The integration of medical device systems and general hospital information technology (IT) infrastructure creates a medical device-IT network that requires patientoriented cybersecurity risk management to ensure patient safety. This study discusses the roles of clinical engineering in taking initiatives in the implementation of the ISO/IEC 80001-1 risk management framework in a hospital environment. Further, we present lessons learned and clinical engineering opportunities in managing medical device cybersecurity, which include development of an integrated systems test lab.Clinical Relevance— This paper highlights Clinical Engineering’s leadership role in implementing an effective risk management system for integrated medical device systems to reduce cybersecurity risks to enhance patient care and safety.