Cybersecurity Informed Consent for Medical Devices

The Medical Device Cybersecurity Awareness Gap

Patients and clinicians frequently lack awareness of the network vulnerabilities, update lifecycles, and remote tampering risks inherent to implanted and connected medical devices.

The Cybersecurity Informed Consent Framework

A multidisciplinary team of clinicians, ethical hackers, and bioethicists formulated a structured framework to transparently disclose cybersecurity risks during clinical consent procedures.

Advisory Collaboration and Scenario Modeling

A thirty-person advisory board modeled real-world clinical scenarios, evaluating legal precedents and regulatory requirements to craft accessible consent disclosures.

Clinical Implementation and Assessment

The project transitions to clinical pilot testing to evaluate whether standardized cybersecurity disclosures improve patient trust without deterring adoption of life-saving therapies.