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

Abstract

The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although 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 that it meets their needs. Consent for research in the context of digital health is limited.

This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were 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.

A structured literature search was developed and deployed in 4 electronic databases—MEDLINE, IEEE Xplore, 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 electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis.

In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants’ willingness to share PHI (25/75, 33%) and participants’ perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured.

There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting 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 for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.