Page 73 - DP-2-2

Design+ Meaningful digital consent: A VSD study

1. Introduction decision-making. This study uses a value-sensitive design
(VSD) approach to identify how socio-technological
The ongoing digitalization of mental health care is factors may be incorporated into notice design.
1
changing how it is accessed and delivered. Despite the
transformative potential of digital mental health tools 2. Theoretical approach and conceptual
and artificial intelligence (AI), there are many challenges framework
to patient acceptance of their use to support mental
health care. A common barrier to acceptance is patient While human-centered design is an increasingly adopted
perceptions of privacy risks and their understanding of approach in developing digital health tools, it primarily
data practices (e.g., data collection, use, and disclosure). 2-5 focuses on the needs, preferences, and experiences of
individual users. It has been argued that VSD may better
Privacy notices (herein referred to as “notices”) are the capture the ethical, societal, and political aspects of
typical mechanism for informing digital health users about design. VSD offers a theoretically grounded and holistic
16
the data practices of an organization. The digital health approach that fills the gap by “frontloading” ethical and
marketplace operates on a “notice and choice” paradigm, socio-technical considerations early in the design process
which assumes users can make an informed choice based by designing for values. Within this context, values are
on the available notice, implying consent. An express defined as a set of guiding principles of what people
6
consent approach requires users to opt into the terms consider to be most important in life, focusing on ethics
outlined in the notice (i.e., “click to accept”). These models and morality. Given that the concept of informed consent
17
fail to achieve informed consent as notices are often long, is deeply rooted in philosophy and ethics, 17,18 this study
jargon-heavy, and written at a college level, if available. will use a VSD approach in exploring the design of digital
7
“Notice and consent” creates a problematic dynamic, mental health privacy notices. VSD consists of a “tripartite
where consent is uninformed and provides app vendors methodology” to inform design: conceptual, empirical,
with legitimate power over data uses. This is particularly and technological investigations. 17
concerning with digital mental health tools due to the
sensitive nature of the data they collect. The opacity of 2.1. Conceptual investigation
8,9
data practices contributes to a growing sense of mistrust Conceptual investigations comprise analytically,
among users and raises critical questions about the ethical theoretically, or philosophically informed explorations
use of data in digital mental health. 10,11
of values relevant to stakeholders and technology. This
The concept of meaningful consent was intended process explores how these values are defined, prioritized,
to address the opacity by emphasizing the need for and potentially come into tension with one another. This
organizations to enable comprehension of the notices, phase often involves philosophical analysis and ethical
where consent is only valid “if it is reasonable to expect reasoning to ensure a comprehensive understanding of the
that your customers will understand the nature, purpose, values at stake. 17
and consequences of the collection, use or disclosure of This investigation explores meaningful consent through
their personal information.” Guidance on implementing two perspectives: the user and the privacy notice. The user
12
meaningful consent suggests that literacy gaps need to be is a direct stakeholder since they will be engaging with the
bridged, and patient preferences should be included in its privacy notices to decide whether they want to use the app
development. 13
and share their data. They will also be experiencing any
A recent review found mixed evidence on how to privacy implications. Drawing on actor-network theory
implement notices and consent forms, where some studies (ANT), notices are treated as direct stakeholders as they
19
supported brevity, and others supported more detailed are active “actors” that mediate relationships, negotiate
information. 13,14 This finding suggests that notice design power, and translate values, laws, and user agreements.
preferences are highly context-dependent, shaped not Notices also embody the legal/regulatory requirements
only by the user experience and interface (UX/UI) but and interests of the other direct and indirect stakeholders.
also by broader social factors (e.g., literacy, expectations, Much like in-person interactions, a privacy notice provides
relationships, and norms). This context-dependency cues for people to interpret, act upon, and reinforce or
15
creates a challenge in designing notices and requires challenge power dynamics between individuals. This
20
further guidance to support meaningful consent. Without conceptual investigation explores the interaction between
nuanced and specific recommendations for designing a potential digital mental health user and the notice of a
meaningful consent, organizations may struggle to ensure hospital-based application, which is based on the insights
that individuals fully understand the implications of data derived from workshops with digital health privacy
collection and use, potentially undermining informed regulators and decision-makers. 13

Volume 2 Issue 2 (2025) 2 doi: 10.36922/dp.8158