title: Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety.
abstract: The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Sackner-Bernstein
mesh_terms: D016494:Computer Security / Q000592:standards; D003920:Diabetes Mellitus / Q000188:drug therapy*; D030881:Disclosure; D004869:Equipment Safety / Q000592:standards; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: FDA regulation; cybersecurity; diabetes; hack-resistant; insulin pumps