The ubiquity and use of smartphones, sensors, devices, and wearables that monitor,
diagnose, and improve health behaviors is exploding. We track our health habits by
strapping wearables to our wrists, attaching patches to our skin, and even ingesting
sensing pills that transmit signals to our health care providers (Topol, Steinhubl,
& Torkamani, 2015). Deluges of data are analyzed for insights at lightning speed.
These personalized health technologies (PHTs) produce completely new categories of
data that make precision medicine both a reality and potentially cost-effective. The
voluminous data trails these smartphones, sensors, devices, and wearables leave behind
also open new doors for misuse and harm by well-intentioned innovators and malevolent
characters. Innovation of PHT is several laps ahead of ethical, legal, and social
(ELS) considerations that are needed to allay legitimate concerns of prospective users
and their health care providers. Is this personal health data accurate, reliable,
and trustworthy? Is it wise to share publically on social networks or privately with
health care providers? Are companies reusing the data for marketing or advertising
purposes? Is it protected from cybercriminals? Uncertainty in these areas may limit
the quality, acceptability, uptake, and potentially revolutionary benefits of PHT.
Collective action by varied stakeholders is needed to eliminate ELS barriers of PHT
use for individual and societal benefit.
Ethical, Legal, and Social Implications of Personalized Health Technology
Innovations from scientific discoveries may not be publically accepted because of
ethical or legal concerns, or because of their failure to meet societal needs. For
example, discrepancies in the global uptake of genetically modified foods persist,
primarily due to insufficient investment throughout their development in understanding
what is required for society to consider them to be safe. On the other hand, the Human
Genome Project's proactive approach to addressing ELS implications led to broad acceptance
of genetic and genomic research. President Obama's Precision Medicine Initiative may
not lead to public benefit unless it explores pressing ELS implications.
Technological advances with ethical dimensions necessitate robust science. Weak or
insufficient evidence can fuel judgments based on ideology, or subjective perceptions
of benefit or risk. The relative newness of PHT reflects an evidence base in its infancy
with modest research demonstrating its effectiveness. Studies on how to improve health-related
behaviors with these technologies are increasingly including proven principles of
behavioral economics or behavior change techniques (Michie et al., 2013; Volpp, Asch,
Galvin, & Loewenstein, 2011). Nonetheless, much more evidence about the use of PHT
to promote behavior change must be generated, synthesized, and presented in ways that
enable decision-makers to understand its value.
Legal concerns may also hinder progress in PHT. The President's Council of Advisors
on Science and Technology (2014) concluded: “Only in some fantasy world do users actually
read [privacy] notices and understand their implications before clicking to indicate
their consent.” Insufficient attention to how privacy is protected or how personal
health data from PHTs is used may result in unanticipated or irrevocable consequences
for companies and consumers. Concerns exist about whether personal health data is
being used by companies in ways that consumers do not expect, including sharing information
with undisclosed third parties or with entities in countries that might have different
rules with respect to data privacy and use. Designing PHTs with privacy considerations
“baked in” through approaches like “privacy by design” may help mitigate if not avoid
these legal issues (Cavoukian & Jonas, 2012).
Social concerns may further impede the uptake of PHTs and their potential health gains.
Different groups profit unequally from innovation. At present, many PHTs benefit the
younger and affluent “worried well” rather than high-risk and marginalized populations;
digital divides continue to widen as new and often expensive PHTs enter the marketplace.
Poor health literacy and numeracy further inhibit interpretation and use of PHT data
to support informed health decision-making. These issues must be taken into account
in the design of PHTs if they are to have widespread impact on individual and public
health.
ELS challenges are often perceived as impediments to progress, but this need not be
the case. A responsible approach to innovation engages society in considerations of
the ELS implications of technology through the entire development process. Responsible
innovation anticipates and evaluates the potential implications and societal expectations
of technology in ways that are democratic, equitable, and sustainable (European Commission,
2013).
Consultation for Collective Action: Guidelines for Personalized Health Technology
To advance consideration of ELS implications of PHT, we hereby launch a global public
consultation on a draft set of Guidelines for Personalized Health Technology (Vitality
Institute, 2015). The guidelines include six recommendations: (1) Ensure PHTs use
principles of evidence-based approaches to health behavior improvement, such as behavior
change techniques and behavioral economics; (2) Design PHTs with the aim of promoting
utility and equitable accessibility across diverse populations; (3) Integrate approaches
like privacy by design in the development and management of PHTs and supporting systems;
(4) Advance user-centered design of PHTs; (5) Enable evidence on PHTs demonstrating
validity, reliability, and other key performance metrics; and (6) Facilitate transparency
with respect to data stewardship.
These guidelines are intended to serve as a set of principles for the responsible
development of PHTs and stewardship of their associated data. Their impact demands
input from the full range of stakeholders in PHT: health care professionals, payers,
academic researchers, public policymakers, designers and developers of PHT, and concerned
consumers. The Vitality Institute, an action-oriented and evidence-based health promotion
and chronic disease prevention research organization, will pilot these guidelines
with these stakeholders. The uptake and utility of these guidelines will be assessed
using independent evaluators. Based upon this evaluation, the guidelines will be revised
and promoted as a self-regulatory framework for the PHT industry that can help assure
that PHTs have a sustained positive impact on the health of the public.