Cybersecurity challenges of medical wearable devices: Initial empirical results and recommendations.

Wearable and implantable devices, like other “smart” digital devices, can be vulnerable tocybersecurity breaches, potentially impacting the safety and effectiveness of the devices. Thesedevices are small medical appliances embedded inside or attached to the human body. Thesewearable medical devices are connected to the Internet, hospital networks, and other medicaldevices. Subsequently, such medical devices enable continuous and automatic management ofhealth condition. Some examples include implantable cardiac pacemaker, attached continuousglucose monitoring (glucose sensor) system, insulin pump, and morphine infusion pump.Incidents of cybersecurity attacks have been documented by the Food and Drug Administration(FDA) since 2013. For example, in 2017 FDA issued an advisory about a cybersecurityvulnerability and flaws in Medtronics implantable cardiac pacemakers. In 2018 the FDA issues asecond advisory about cybersecurity vulnerabilities identified in Abbott’s implantable cardiacdevice pumps. FDA also issued advisory about cybersecurity vulnerabilities about MedtronicMiniMed Paradigm insulin pump. Fortunately as of now, no patients’ death or injuries have beendocumented. In this innovative research, we are seeking to investigate the awareness ofcybersecurity threats, as well as knowledge sharing among stakeholders, including patients,healthcare professionals, and biomedical engineering students working on developing medicaldevices. Based on feedback collected from 17 Subject Matter Expert (SMEs) using the Delphitechnique, we revised the initial instrument. Following the final results from the participants, weplan to analyze and develop a report that will also be shared with the FDA and key devicemanufacturers.Keywords: Wearable and implantable medical devices, cybersecurity breach, experts panel