Ethical Considerations When Creating Evidence from Real World Digital Health Data

BackgroundPersonal health data (PHD) are collected using digital self-tracking technologies and present opportunities to increase self-knowledge and, also biometric surveillance. PHD become "big" data and are used in health-related research studies. We surveyed consumers regarding expectations regarding consent and sharing of PHD for biomedical research. MethodsData sharing preferences were assessed via an 11-item survey. The survey link was emailed to 89539 English-speaking Withings product users. Responses were accepted for 5 weeks. Descriptive statistics were calculated using Excel and qualitative data were analyzed to provide additional context. ResultsNearly 1640 people or 5.7% of invitees responded representing 62 countries with 80% identifying as Caucasian, 75% male with 78% being college educated. The majority were agreeable to having their data shared with researchers to advance knowledge and improve health care. Participants responding to open ended items (N=247) appeared unaware that the company had access to their personal health data. ConclusionsWhile the majority of respondents were in favor of data sharing, individuals expressed concerns about the ability to de-identify data and associated risks of re-identification as well as an interest in having some control over the use of "their" data. Given consumer misconception about data ownership, access and use, efforts to increase transparency when interacting with individual digital health data must be prioritized. Moreover, the basic ethical principle of "respect for persons" demonstrated via the informed consent process will be critical in advancing the adoption of digital technologies that create real-world evidence and advance opportunities for N-of-1 self-study.