Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review (Preprint)

Abstract

BACKGROUND The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Though privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure it meets their needs. Research on patient perspectives on consent is limited to the context of biobanks, registries, and secondary uses. There is limited consent research in the broader context of digital health. OBJECTIVE This state-of-the-art review aims to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives are to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. METHODS A structured literature search was developed and deployed in four electronic databases: Medline, IEEE Explore, Scopus and Web of Science for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they: discussed eConsent or consent, focused on the patient perspective or preference, and related to digital health or digital PHI. Data were extracted using an extraction templated and analyzed through qualitative content analysis. RESULTS Seventy-five articles were included for analysis. Most studies were published within the last five years (58/75, 77.3%), conducted in a clinical care context (33/75, 44.0%), and set in the United States (48/75, 64.0%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33.3%) and participants perceived usability and comprehension of an eConsent notice (25/75, 33.3%). More than half of the studies did not describe the type of consent model used (40/75, 53.3%). A Broad open consent model was the most explored (11/75, 14.7%). Sixty-eight studies (90.7%) found that participants were willing to provide consent; however, their consent behaviours and preferences were context dependent. Common patient consent requirements include clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. CONCLUSIONS There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. The evidence suggests that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical in fostering trust in digital health tools and the innovative uses of data in optimizing health and system outcomes.