Cyber-situational Awareness in Clinical Trials Using Wearable Device Technology
Event Type
Poster Presentation
TimeThursday, April 152:10pm - 2:12pm EDT
LocationDigital Health
DescriptionPurpose/Aims: It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age.

Background: The push for wearable technology integration within clinical trials has been championed by the Office of the National Coordinator for Health Information Technology as a means of supporting interoperability within the virtual care landscape. Wearable devices allow participants to remain home, ameliorating unnecessary travel for brief research visits which can now be replaced for real-time time biofeedback monitoring and health status questionnaires (known as Patient Reported Outcomes). The increasingly permeable boundary between the clinical trial participant and technology has resulted in a lapse of scanning the digital environment for changes or threats that impact decision-making, known as cyber-situational awareness (CSA). Wearable devices require additional security measures, such as encryption and de-identification, which are not easily visible to the participant as an end-user. To promote confidence in wearable device utilization, clinical trial sponsors and organizations must encourage cyber-situational awareness while also fostering means of measuring cyber-situational awareness as a requisite skill for comprehensive informed consent.

Assessment of Findings: Literature findings note the dissonance between traditional situation awareness elements (perceiving changes in environment via senses and cognition) and cyber-situation awareness elements (digital environment changes including passive data collection and passive/active interaction with task completion). For example, a participant may have their steps counted passively via a smart watch with no computerized prompt to input information. However, extraneous movements (typing, for example), may falsely inflate step count, requiring situation awareness on the user as to the technological error by the watch. To ensure accurate data to inform study procedures and results dissemination, clinical trial sponsors and participants benefit from the delineation of tasks associated within wearable devices and how the participant may interact with the device. Assessment and measurement techniques may range from self-rated questionnaires, observer-rated evaluation of CSA as a competency prior to device utilization, and combination assessments. These assessments and evaluations provide insight as to a participant’s level of CSA as well as organizational considerations for enhanced technological security factors and awareness prompts within device design to support task awareness by the participant.

Brief Description of Best Practice: Clinical trial sponsors may integrate elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

Conclusion: As clinical trials shift to more technological components to remove undue participant burdens from participation, critical components of cyber-situational awareness must be considered as a core aspect of informed consent. Device utilization and daily wear are not integral skills particularly when used in an investigational format, and as such must be addressed prior to study procedures. Evaluation and assessment techniques adapted from other industrial specialties (aviation, military) may be leveraged in this unique subset of healthcare delivery.