Foundations for Meaningful Consent in Canada’s Digital Health Ecosystem: Retrospective Study (Preprint)
Authors: Shen Nelson , Kassam Iman , Zhao Haoyu , Chen Sheng , Wang Wei , Wickham Sarah , Strudwick Gillian , Carter-Langford Abigail 
Published: June 2021

BACKGROUND

Canadians are increasingly gaining web-based access to digital health services, and they expect to access their data from these services through a central patient access channel. Implementing data sharing between these services will require patient trust that is fostered through meaningful consent and consent management. Understanding user consent requirements and information needs is necessary for developing a trustworthy and transparent consent management system.

OBJECTIVE

The objective of this study is to explore consent management preferences and information needs to support meaningful consent.

METHODS

A secondary analysis of a national survey was conducted using a retrospective descriptive study design. The 2019 cross-sectional survey used a series of vignettes and consent scenarios to explore Canadians’ privacy perspectives and preferences regarding consent management. Nonparametric tests and logistic regression analyses were conducted to identify the differences and associations between various factors.

RESULTS

Of the 1017 total responses, 716 (70.4%) participants self-identified as potential users. Of the potential users, almost all (672/716, 93.8%) felt that the ability to control their data was important, whereas some (385/716, 53.8%) believed that an <i>all or none</i> control at the data source level was adequate. Most potential users preferred new data sources to be accessible by health care providers (546/716, 76.3%) and delegated parties (389/716, 54.3%) by default. Prior digital health use was associated with greater odds of granting default access when compared with no prior use, with the greatest odds of granting default access to digital health service providers (odds ratio 2.17, 95% CI 1.36-3.46). From a list of 9 information elements found in consent forms, potential users selected an average of 5.64 (SD 2.68) and 5.54 (SD 2.85) items to feel informed in consenting to data access by care partners and commercial digital health service providers, respectively. There was no significant difference in the number of items selected between the 2 scenarios (<i>P</i>&gt;.05); however, there were significant differences (<i>P</i>&lt;.05) in information types that were selected between the scenarios.

CONCLUSIONS

A majority of survey participants reported that they would register and use a patient access channel and believed that the ability to control data access was important, especially as it pertains to access by those outside their care. These findings suggest that a broad <i>all or none</i> approach based on data source may be accepted; however, approximately one-fifth of potential users were unable to decide. Although vignettes were used to introduce the questions, this study showed that more context is required for potential users to make informed consent decisions. Understanding their information needs will be critical, as these needs vary with the use case, highlighting the importance of prioritizing and tailoring information to enable meaningful consent.