Exploring the Risks of Digital Health Research: Towards a Pragmatic Framework

By Dr. John Torous

Image courtesy of Flickr user Integrated Change

We often hear much about the potential of digital health to revolutionize medicine and transform care – but less about the risks and harms associated with the same technology-based monitoring and care. “It’s a smartphone app … how much harm can it really cause?” is a common thought today, but also the starting point for a deeper conversation. That conversation is increasingly happening at Institutional Review Boards (IRBs) as they are faced with an expanding number of research protocols feature digital- and smartphone-based technologies.

In our article, ‘Assessment of Risk Associated with Digital and Smartphone Health Research: a New Challenge for IRBs” published in the Journal of Technology and Behavioral Science [1], we explore the evolving ethical challenges in evaluating digital health risk, and here expand on them. While risk and harm in our 21^st century digital era are themselves evolving topics that change with both technology and societal norms, how do we quantify them to help IRBs in making safe and ethical decisions regarding clinical research?

A first step is to consider what is the baseline risk of any online or connected technology. Take for example privacy. In countries like the United States, internet service providers can now legally collect and sell users’ web browsing history without consent [2]. Popular websites such as Facebook may at times track users even when logged out or sometimes even without them ever having signed up [3]. The uses of this digital data can range the gamut from targeted advertising to police subpoenas of Fitbit and smartphone data for criminal prosecution [4]. With so much personal data already being collected in everyday life as the price of admission for use of today’s online services, what qualifies as high or low risk digital data collection in a clinical study or even everyday life? In Europe, this question has led to the new General Data Protection Regulation (GDPR) that took effect on May 25^th 2018 [4] and set new strict and enforceable standards for online privacy, the right to be forgotten, data portability, data access, and breach notifications. Whether other countries will follow and pass legislation similar to the GDPR remains to be seen, but until then the question of assessing risks around privacy remains challenging for IRBs, researchers, and the public.

Image courtesy of Pixabay

While privacy is the chief risk considered today with online-, sensor-, and smartphone-based research, as these tools develop so does their potential to create new risks. Three other types of risks that are important to consider are physical, psychological, and financial. In the published literature, there are surprisingly few cases of physical harm resulting from smartphone-based research studies which may in part reflect that most studies today focus on monitoring or lowering risk lifestyle interventions. There is also a paucity of data on psychological harms from smartphone-based studies or how people may react to being closely monitored, for example via GPS on their smartphone, etc. Likewise, there has been little reported on financial risks associated with inadvertent disclosure of digital data collected by sensors and smartphones. This is not to say these risks are minimal, but rather that as a field we need to better study and quantify these risks and their magnitude of harm. Without good data, it is challenging for IRBs to make informed decisions about studies - and equally challenging for research participants to make informed decisions about joining that study.

Further considerations that are more unique to digital health studies include assessing technology literacy and bystander risk. While words like ‘GPS,’ ‘anonymized data,’ and ‘hashing’ are frequently used in informed consent documents for smartphone studies, it is important to ensure that those signing informed consent actually understand what these words mean. Do you know the difference between de-identified and anonymized data? There is some research suggesting that those with lower health literacy may also be vulnerable to assuming health technologies like smartphone apps, etc. are safer and more secure than they actually are [6]. This raises the issue of a new digital divide not based on access to technology, but rather on understanding risks and equitable utilization. Yet another risk to consider that does not often occur in classical clinical research but more frequently with digital technology studies is bystander risk. Voice recordings may capture other voices in the nearby vicinity, Bluetooth monitoring will record information about nearby smartphones, and cameras may capture an entire scene with others in it.

Image courtesy of Wikimedia Commons

Putting it all together, the model below seeks to guide IRBs through considering the different types of risk as well as ways to mitigate them. While this model is not designed to be comprehensive or thorough for every type of digital health study for every type of clinical population, hopefully the basic themes and examples provided may help guide informed decision making.

Recognizing risks in digital health studies is not an exercise in hindering research, but rather the pathway to mitigate risk and help ensure safer and better studies. For example, the largest risk factor of privacy is actually often the easiest to mitigate with appropriate encryption and security protocols. Ensuring that informed consent language is appropriate for those who are less technology-literate can help them better understand the study and be more interested in meaningfully participating. Communities like the Connected and Open Research Ethics (CORE) offer free and easy access to support and online forums for researchers, IRBs, and anyone to ask questions and receive answers on digital health ethics. The Neuroethics Blog you are reading right now also offers a wealth of relevant posts to help guide ethical decision making in this digital era. But perhaps the best resources of all remains an open mind willing to explore not only the benefits of digital technology, but also ponder the risks in order to bring both sides together for more informed decision making.

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John Torous MD is director of the digital psychiatry division at Beth Israel Deaconess Medical Center at Harvard Medical School. As a board-certified psychiatrist with a background in computer sciences and clinical informatics, his research on smartphone apps and sensors for predicating relapse in serious mental illnesses like schizophrenia bridges engineering and clinical care. In 2017, Dr. Torous was awarded the Carol Davis Ethics Award by the American Psychiatric Association, an annual award for ethics and mental health work. 



References

1. Torous J, Roberts LW. Assessment of Risk Associated with Digital and Smartphone Health Research: a New Challenge for Institutional Review Boards. Journal of Technology in Behavioral Science. 2018:1-5.



2. FCC releases proposed rules to protect broadband consumer privacy (2016). Federal Communications Commission. https://www.fcc.gov/document/fcc-releases-proposed-rules-protect-broadband-consumer-privacy. 




3. https://www.buzzfeed.com/alexkantrowitz/heres-how-facebook-tracks-you-when-youre-not-on-facebook?utm_term=.loGrdzO1g#.eiED5XZR2



4. https://www.washingtonpost.com/local/public-safety/commit-a-crime-your-fitbit-key-fob-or-pacemaker-could-snitch-on-you/2017/10/09/f35a4f30-8f50-11e7-8df5-c2e5cf46c1e2_story.html?noredirect=on&utm_term=.a4acd2fba4ea



5. https://www.eugdpr.org/



6. Mackert M, Mabry-Flynn A, Champlin S, Donovan EE, Pounders K. Health literacy and health information technology adoption: the potential for a new digital divide. Journal of medical Internet research. 2016 Oct;18(10).

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Torous, J. (2018). Exploring the Risks of Digital Health Research: Towards a Pragmatic Framework . The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2018/07/exploring-risks-of-digital-health.html

Neuroscience and Human Rights

Last month, I had the privilege of attending the International Neuroethics Society Meeting in Washington, DC, made possible by a travel award from the Emory Neuroethics Program. This year's meeting featured panelists from diverse backgrounds: government, neuroscience, ethics, law, engineering, public health, and others. Each participant and attendee offered her unique perspectives on topical issues in neuroethics.



As I listened to many thought-provoking presentations and discussions, a question kept arising in my mind: to what extent should scientists engage with issues of social justice if their research findings support changes in public policy? As a "war on science" continues to be waged by members of the U.S. Senate and Congress (see Senator Coburn's 2014 "Wastebook," and the recent NPR Science Friday response by targeted scientists) and the American public lags in scientific literacy (A NSF report this year found that 1 in 4 Americans think the sun orbits the earth), this question carries a particular sense of urgency. Isn't science supposed to support human flourishing and maximize our well-being, as the American Association for the Advancement of Science puts it, "for the benefit of all people?" How accountable should scientists be in ensuring that this actually happens, beyond the scope of their laboratories?



My reflections on these questions were ignited by a fascinating example of how neuroscience can inform policy, provided by Katy de Kogel of the Dutch Ministry of Justice. Dr. de Kogel spoke of recent shifts in Dutch criminal law that reflect neuroscientific consensus: the neural substrates that support decision-making are not fully "online" in the developing, adolescent brain. In contrast to United States legal code, which specifies that individuals above the age of 18 be prosecuted as adults, thus barring them from legal protections offered to minors, Dutch courts have incorporated scientific understanding of neurodevelopment into their criminal code by advancing the age at which individuals are tried as minors: from 18 to 22 years of age. Criminal research findings support this change, as minors housed in adult detention centers tend to have higher rates of recidivism than those detained in juvenile centers. In my view, this is a refreshing and somewhat unexpected example of how society can benefit from advancements in neuroscience. We often think of science producing technological or medical innovations that improve our lives, rather than ancillary benefits like this that are impossible to foresee at the outset of a project.

Katy de Kogel of the Dutch Ministry of Justice (Courtesy of Dr. Gillian Hue)

The next panel discussion, themed "Neuroscience and Human Rights," provided another example of how neuroscience and society can intersect. One of the participants, Dr. Mariana Chilton of Drexel University, presented her research on food insecure communities here in the United States. Food insecurity is defined by the USDA as "a household-level economic and social condition of limited or uncertain access to adequate food." Dr. Chilton's talk highlighted the striking prevalence of food insecurity among American children: an astonishing 21.6%, according to a 2014 report by the non-profit organization, Feeding America. She continued by pointing out overwhelming epidemiological evidence linking early-life malnutrition and its associated psychosocial stressors to adverse health outcomes in adulthood. These negative outcomes include, but are certainly not limited to, impairments in social skills, language development, emotional self-regulation, and problem-solving abilities derived from neurodevelopment deficits that come along with macro- and micronutrient deficiencies. With billions of dollars spent annually on psychiatric medications and innumerable losses in productivity due to mental health issues such as Attention Deficit Hyperactivity Disorder (ADHD) and depression, I wondered whether the rising prevalence of childhood malnutrition could be a key mechanism by which our national public mental health crisis has arisen? (For context on the American mental health crisis, the CDC estimates that only 17% of US adults are considered to be in a state of optimal mental health.)



Dr. Chilton's presentation continued with a neuroethically-minded suggestion that inadequate US policies to support childhood nutrition and healthcare constitute a human rights violation. First off, she cites the 1989 United Nations Convention on the Rights of the Child (UNCRC), which asserts that "the child, by reason of his physical and mental immaturity, needs special safeguards and care, including appropriate legal protection, before as well as after birth," which support the child's right "to the enjoyment of the highest attainable standard of health," as outlined in Article 24 of the Convention. Secondly, Chilton points out that contemporary findings from developmental neuroscience and maternal and child health epidemiology unequivocally demonstrate that nutritional deficiencies do not support the "highest attainable standard of health" for children, as advocated by the UNCRC. The implication is that with such a large proportion of American children undernourished, publicly-funded programs such as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), the Supplemental Nutrition Assistance Program (SNAP), and the National School Lunch Program (NSLP), may be inadequate to fully address their needs. Therefore, the inalienable human rights of the child to flourish are, in my estimation, jeopardized by US policy (or lack thereof). As an aside, I was astonished to learn that of the 194 United Nations member states to sign the treaty, only 3 countries have failed to ratify it: Somalia, South Sudan, and the United States.

Dr. Mariana Chilton speaking at the "Neuroscience and Human Rights" Panel (Courtesy of Dr. Gillian Hue)

By suggesting that human rights can serve as a rationale for changes in US social policy, Dr. Chilton contributes a novel and persuasive approach to political arguments around issues like access to food, housing, and early education. Arguments against empirically-validated government programs that support childhood nutrition and health often helicopter around the respective economic and political views of their proponents, with both sides of the political divide overlooking human rights concerns. One example of this is the justification provided by Rep. Paul Broun (R-GA) in 2011 for his proposed 10% cut in federal funding for WIC, by suggesting that the measure would "save us from spending hundreds of millions of dollars we don't have," and that WIC is "seemingly designed to hold a section of the population in limbo rather than helping them grow out of poverty." I concede Rep. Broun's obvious point that budget cuts would save money; however, there is extensive empirical support for the beneficial effects of the WIC program on short- and long-term health outcomes. While more efficient approaches to support childhood nutrition may exist, such as reducing healthcare costs for families and increasing the federal minimum wage, political rhetoric and discourse on public health policies should consider their implications for human rights.



Returning to my original question on the extent to which scientists should engage in conversations with policymakers and the public, I would argue that they do in fact have an ethical responsibility to do so. While it may not be the responsibility of scientists to advocate for specific policies per se, I personally think that they and their academic institutions have an ethical responsibility, as publicly-funded entities, to communicate their research findings and particularly its broader implications to the public. Unfortunately, one of the biggest obstacles that even the most well-intentioned, socially-engaged scientist faces is the lack of time or incentive to get involved. As NIH and NSF pay-lines continue to decline, scientists spend more of their valuable time competing for grant funding, and the institutions within which scientists serve continue to weigh a researcher's "success" by grant and publication record, rather than activities like civic engagement. I challenge colleges and universities to refine their science faculty evaluation to be more in accord with the goals of the AAAS. For example, how has Dr. X "provided a voice for science on societal issues," or "promoted the responsible use of science in public policy?" I think most scientists would support such a change.



As Dr. Chilton demonstrated at INS 2014, neuroscientific research findings can be incorporated into human rights arguments for updating US social policies and legal statutes. Knowing what they know about human health and disease, some scientists may be particularly well-positioned to advocate for social change. It is incumbent upon the public and their elected officials to honestly ask themselves, for example, whether they are taking adequate measures "to combat disease and malnutrition…through the provision of adequate nutritious foods and clean drinking-water," as stated in the UNCRC. Whether these discussions are initiated by neuroscientists who understand that the adolescent neocortex is underdeveloped and therefore lacks impulse control, or those who understand that early-life deprivation has profound, persistent effects on the human capacity to flourish, someone must speak and act for members of society who are not empowered to do so for themselves.

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Kohn, J. (2015). Neuroscience and Human Rights. The Neuroethics Blog. Retrieved on

, from http://www.theneuroethicsblog.com/2015/01/neuroscience-and-human-rights.html