Ethical Issues in mHealth: What is Good Enough?

With around 5 billion mobile phone users globally, opportunities for mobile technologies to play a formal role in health services, particularly in low- and middle-income countries, are undeniable. The use of wearable and deployable sensors, portable electronic devices and software applications (‘apps’) to provide interventions and therapies, health services, and to manage personal and patient information has exploded into all of our lives. Smart phone‘apps’ are proliferating beyond games and information gathering.

How good are these technologies?
 Are they safe? Functional? Privacy-protected?
 Who is monitoring them?
 What is good enough?
 Do all players/stakeholders define ‘good enough’ in the same way?
 This blog is here to kick up the discussion.

Mobile Health (mHealth) offers elegant solutions to problems that health care – both prevention and treatment arms – have faced since their inception: How to get the right information where and when it is needed, how to conquer the obstacles presented by time (who has any?) and geography, how to access remote populations and help health workers in the field. mHealth offers the promise (or maybe we should say, the hope) of persistent, pervasive healthcare services that can be delivered anytime, anywhere. And mHealth also offers a new arsenal of potentially effective ways to intervene, manage and treat in health care that will actually lead to behavior change and improved health outcomes. With the rapid increase in smart phone ownership, particularly in low-income populations, phone-based interventions have brought positive results in many groups, including low socioeconomic status and minority populations. Technology has become a part of our everyday lives – and it has high potential for improving health by assisting with (remote) clinician-patient communications, (self) monitoring, behavior modification and disease self-management. There are a number of ethical implications in this new connectivity and fast-paced technology development. I would like to focus on three, one blog at a time.

These are:

1.  How do we know which apps and technologies are ‘good’ (i.e. collect data reliably and validly, provide data feedback that is reliable and valid, and provide adequate protection of your privacy)?
2. Who should own & control the data that your apps are collecting? Who cares about privacy, are the regulations too cumbersome to even be considered in full? What are we willing to share in order to get valued ‘goods’ – like a fast, personalized search?
3. mHealth technologies collect and store vast amounts of data. What ARE we going to do with all that data? And what is the availability of all that data for an unspecified amount of time doing to us? What does it mean to live in a world where our past, medical and otherwise is etched like a tattoo into our digital skins?

This is the blog about #1. How do we know which ‘apps’ are ‘good’ – and what is good enough? Happtique is a company that has taken it upon themselves to “curate all of the medical and healthcare apps under the sun.” That’s a pretty tall order. But there is no question that there is a need for some kind of quality control. The proliferation of apps and technologies that could impact people’s health has spilled over into the consumer world without very much oversight. What if a technology doesn’t do what it says it will do, doesn’t measure what it claims to measure, what if it fails while monitoring your heart rate or digitally transfers your information through insecure webs and portals? And where do we draw the line – which seems pretty fuzzy – between health, medicine, and play? Do apps like “Affirmations for a Stress Free Life” qualify as mHealth? These are questions that, arguably, should be the terrain of careful research, to which any other medical/health device has been required to undergo in the past. But mHealth technologies are moving at lightening speed. The 5-year, or even 2-year research cycle isn’t fast enough to keep up with the developments. By the time that you have ‘tested’ your technology, it is obsolete. And note that Happtique doesn’t offer to test these technologies. They very cleverly have aimed to curate and certify them – not the same as validate or test –  and are hammering out a process that seems to combine expert panels and crowdsourcing – very clever. iMedicalApps offers a similar service. Here, physicians, health professionals, and mHealth analysts provide reviews, some research, and experientially-based commentary on mobile technologies, with the possible advantage that iMedicalApps  don’t make or sell apps themselves. Both approaches are more nimble than, say, the Federal Trade Commission, or the Food and Drug Administration. There are interesting discussions on the pros and cons of FDA regulation of mHealth, for instance by Bradley Merrill Thompson and David L. Scher.

So Happtique is stepping up to the plate in an important situation where it might not be ideal for-profit corporation to take the lead. Why not? Partially because they are a ‘for-profit’. Happtique also sells mHealth apps. Including “Affirmations for a Stress Free Life”, by the way. So the conflict of interest issue looms large, although, like I said up front, the need for some kind of quality control is obvious, and the angle that Happtique has taken is creative. However, possibly life-saving technologies and apps that have not undergone rigorous, evidence based development and testing pose tough problems. What we have here is an area where government agencies, funders, researchers, and industry need to find a way to come downstairs together.  Agile software development forms a triumvirate between developers, business people and customers, leaving science and regulation out of the picture. We need fresh ideas on how to tackle the tension between the glacial progress of science and the lightning speed of technological development. I am hoping some of you readers will post them here or on my blog at http://uscethics.net/!

Donna Spruijt-Metz, MFA, PHD, is Associate Professor, Department of Preventive Medicine, University of Southern California. Her research focuses on childhood obesity. She has a deep interest in harnessing mobile health (mHealth) technologies and new media modalities to bring researchers and researched systems into interaction, to engage people in their own data, and to bring about lasting change in obesity through changes in societal norms, built and perceived environments, and behavior. She is also Director, Responsible Conduct in Research for the Keck School of Medicine at USC. Her ethics blog is here: http://uscethics.net/, and her research website is here: http://metzlab.net/. She is interested in the ethical issues surrounding mHealth technologies.