Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Findings from a Pan-Canadian Survey (Preprint)

BACKGROUND Patients are increasingly gaining online access to digital health services and expect to access their data from various sources through a central patient access channel. For digital health services to connect and mutually share data, it is critical to understand patient consent preferences to meet the privacy needs of Canadians. Understanding user consent requirements and information needs is necessary in developing a trustworthy and transparent consent management system to support patient access channels. OBJECTIVE The objective of this study was to understand (1) data control preferences, (2) information needs for consent, and (3) how preferences and needs may vary by different user characteristics. METHODS A secondary analysis of a national survey was completed using a retrospective descriptive study design. The cross-sectional survey, conducted in October 2019, used a series of vignettes and consent scenarios to develop a deeper understanding of Canadians’ privacy perspectives and preferences for consent management. Non-parametric tests, and logistic regression analyses were conducted to identify differences and associations between the various factors. RESULTS Of the 1017 total responses, 70.4% (716/1017) of participants self-identified as potential users. Almost all (672/716, 93.8%) felt the ability to control their data was important, while 53.8% (385/716) believed an “all or none” control at data source level was adequate. Most users prefer new data sources to be accessible by healthcare providers (546/716, 76.3%) and delegated parties (389/716, 54.3%) by default. Users with positive healthcare privacy experiences were more likely than users with poor experiences to grant default access to healthcare providers (OR 2.78, 95%CI 1.34-5.74) and less likely to grant access to no-one (OR 0.31, 95%CI 0.14-0.72). From a list of nine information elements found in consent forms, users selected an average of 5.70 (SD 2.66) and 5.63 (SD 2.84) items to feel informed in consenting to data access by care partners, and commercial digital health service providers respectively. There were significant differences (p<0.05) in information needs between the scenarios. CONCLUSIONS Many survey participants would register and use a patient access channel and believe the ability to control data access is important, especially as it pertains to access by those outside their care. Positive healthcare experiences were a significant factor in this decision, signaling the importance of providing positive healthcare privacy experiences in both physical and digital environments. These findings suggest broad “all-or-none” approach by data source may be accepted; however, approximately one-fifth of users were unable to decide. Although vignettes were used to introduce the questions, this study showed that more context is required for users to make an informed decision. Understanding their information needs will be critical, as these needs varied with use case, highlighting the importance of prioritizing and tailoring information to enable meaningful consent.