Artificial Pancreas Implantables -- How Healthcare Professionals May Deal With DIY Bio Cases
For healthcare professionals, this paper identifies emerging risks and governance gaps in handling DIY artificial pancreas systems, though it is primarily a conceptual analysis without empirical data.
The paper examines how clinicians encounter patients using DIY artificial pancreas systems outside regulatory control, highlighting legal and clinical uncertainties when patients assume manufacturer roles. It analyzes cyberbiosecurity risks across both regulated and DIY automated insulin delivery systems.
Automated insulin delivery (AID) and artificial pancreas systems increasingly serve as safety-critical cyber-physical technologies in clinical care, integrating sensors, algorithms, software, and insulin-delivery hardware to automate a life-sustaining therapy. While regulated commercial systems are supported by formal approval pathways, manufacturer governance, and post-market surveillance, clinicians are also encountering patients who rely on do-it-yourself (DIY) artificial pancreas systems that operate outside conventional regulatory and institutional control structures. This paper examines how routine clinical handling practices intersect with cyberbiosecurity risk across both regulated and DIY AID systems. When insulin delivery systems are fundamentally reconfigured into a bespoke AID system, with the patient-user becoming the primary threat vector by assuming manufacturer-level roles without mandated governance, the entire ecosystem of stakeholders is placed in legal and clinical uncertainty.