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Who Are the People in Your Neighborhood? Personas Populating Unregulated mHealth Research

Published online by Cambridge University Press:  01 January 2021

Megan Doerr  and
Christi Guerrini
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Abstract

A key feature of unregulated mHealth research is the diversity of participants in this space. Applying an approach drawn from user experience design, we describe a set of archetypal unregulated mHealth researcher “personas,” which range from individuals who seek empowerment or have philanthropic objectives to those who are primarily motivated by financial gain or have misanthropic objectives. These descriptions are useful for evaluating policies applicable to mHealth to understand how they will impact various stakeholders.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue S1: Unregulated Health Research Using Mobile Devices , Spring 2020 , pp. 37 - 48
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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References

Rothstein, M.A., Wilbanks, J.T., and Brothers, K.B., “Citizen Science on Your Smartphone: An ELSI Research Agenda,” Journal of Law, Medicine & Ethics 43, no. 4 (2015): 897-903.CrossRefGoogle Scholar
Cooper, A., The Inmates Are Running the Asylum (Indianapolis: Macmillan Publishing Co., Inc., 1999): at 123.Google Scholar
45 C.F.R. part 46.Google Scholar
21 C.F.R. parts 50, 56.Google Scholar
15 U.S.C. ch. 2, subch. I.Google Scholar
Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. No. 104-191, 110 Stat. 1936 (codified as amended in scattered sections of 18 U.S.C., 26 U.S.C., 29 U.S.C., and 42 U.S.C.).Google Scholar
Health Information Technology for Economic and Clinical Health Act, Pub. L. No. 111-5, tit. XIII, 123 Stat. 115, 226-79 (2009) (codified as amended in scattered sections of 42 U.S.C.).Google Scholar
Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq.)..Google Scholar
Alaska Stat. Ann.§ 18.13.010(a)(2); Colo. Rev. Stat. Ann.§ 10-3-1104.7(1)(a); Fla. Stat. Ann.§ 760.40(2)(a).Google Scholar
For example, a biohacker named Josiah Zayner was under investigation in California for allegedly practicing medicine without a license in violation of state laws that govern medical practice. Hsu, R., “Is Biohacking ‘the Practice of Medicine?’: Regulators Might Think So,” Baylor College of Medicine PolicyWise Blog, July 19, 2019, available at <https://blogs.bcm.edu/2019/07/19/is-biohacking-the-practice-of-medicine-regulators-might-think-so/> (last visited January 13, 2020).Google Scholar
Sahin, C., “Rules of Engagement in Mobile Health: What Does Mobile Health Bring to Research and Theory?” Contemporary Nurse 54, nos. 4-5 (2018): 374-387.CrossRefGoogle Scholar
Coravos, A. et al., “Digital Medicine: A Primer on Measurement,” Digital Biomarkers 3, no. 2 (2019): 31-71.CrossRefGoogle Scholar
45 C.F.R. § 46.102(l).Google Scholar
See infra Part III.4-5.Google Scholar
Eitzel, M.V. et al., “Citizen Science Terminology Matters: Exploring Key Terms,” Citizen Science: Theory and Practice 2 (2017): 1-20; Ceccaroni, L., Bowser, A., and Brenton, P., “Civic Education and Citizen Science: Definitions, Categories, Knowledge Representation,” in Ceccaroni, L. and Piera, J., eds., Analyzing the Role of Citizen Science in Modern Research (Hershey, PA: IGI Global, 2017): at 1-23. The definition is also associated with its own ethical concerns. Guerrini, C.G. et al., “Biomedical Citizen Science or Something Else? Reflections on Terms and Definitions,” American Journal of Bioethics 19, no. 8 (2019): 17-19.Google Scholar
Guerrini, C.J. et al., “Donors, Authors, and Owners: How Is Genomic Citizen Science Addressing Interests in Research Outputs?” BMC Medical Ethics 20, no. 84 (2019).CrossRefGoogle Scholar
National Academies of Sciences, Engineering, and Medicine, “Mapping the Landscape,” in Learning through Citizen Science: Enhancing Opportunities by Design (Washington, D.C.: The National Academies Press, 2018): at 27-52.Google Scholar
See Rothstein, Wilbanks, and Brothers, supra note 1.Google Scholar
“The #WeAreNotWaiting Diabetes DIY Movement,” Health-line, available at <https://www.healthline.com/health/diabetesmine/innovation/we-are-not-waiting#1> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Rao, A. and Cunnane, M., “Diabetes Hacking 101,” WNYC Studios, April 22, 2016, available at <https://www.wnyc.org/story/diabetes-hacking-with-ben-west/> (last visited January 13, 2020).Google Scholar
OpenAPS.org, available at <https://openaps.org/> and <https://www.youtube.com/watch?v=kgu-AYSnyZ8> (both last visited January 13, 2020).+and++(both+last+visited+January+13,+2020).>Google Scholar
See “#WeAreNotWaiting Diabetes DIY Movement,” supra note 19.Google Scholar
Six Until Me, “We Are Not Waiting: CGM in the Cloud (Part 1),” July 10, 2014, available at <https://sixuntilme.com/wp/2014/07/10/cgm-cloud-part/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Id.Google Scholar
YouTube, “MoleMapper,” October 15, 2015, available at <https://youtu.be/iAvw-gCGPI98> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
ResearchKit, available at <http://researchkit.org/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
MoleMapper, available at <https://molemapper.org/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
See OpenAPS.org, supra note 21.Google Scholar
Facebook, CGM in the Cloud, available at <https://www.facebook.com/groups/cgminthecloud/> (last visited January 13, 2020; login required).+(last+visited+January+13,+2020;+login+required).>Google Scholar
See MoleMapper, supra note 27.Google Scholar
Crohnology, available at <https://crohnology.com/> (last visited September 23, 2019).+(last+visited+September+23,+2019).>Google Scholar
Families of Children with Rare Disease Fuel Gene Therapy Research,” The Scientist, April 30, 2018, available at <https://www.the-scientist.com/features/families-of-children-with-rarediseases-fuel-gene-therapy-research-64279> (last visited January 20, 2010).+(last+visited+January+20,+2010).>Google Scholar
BioCurious, “Silicon Valley’s Hackerspace for Biology,” available at <http://biocurious.org/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Nelson, S.C. and Fullerton, S.M., “‘Bridge to the Literature’? Third-Party Genetic Interpretation Tools and the Views of Tool Developers,” Journal of Genetic Counseling 27, no. 4 (2018): 770-781.CrossRefGoogle Scholar
Id.Google Scholar
Grant, A.D., Wolf, G.I., and Nebeker, C., “Approaches to Governance of Participant-led Research: A Qualitative Case Study,” BMJ Open 9 (2019): e025633.CrossRefGoogle Scholar
Greshake, B. et al., “openSNP — A Crowdsourced Web Resource for Personal Genomics,” PLoS ONE 9, no. 3 (2014): e89204; Haeusermann, T. et al., “Open Sharing of Genomic Data: Who Does It and Why,” PLoS ONE 12, no. 5 (2017): e0177158.CrossRefGoogle Scholar
Tandy-Connor, S. et al., “False-Positive Results Released by Direct-to-Consumer Genetic Tests Highlight the Importance of Clinical Confirmation Testing for Appropriate Patient Care,” Genetics in Medicine 20, no. 12 (2018): 1515-1521; Moscarello, T. et al., “Direct-to-Consumer Raw Genetic Data and Third-Party Interpretation Services: More Burden Than Bargain?” Genetics in Medicine 21, no. 3 (2019): 539–541CrossRefGoogle Scholar
See Grant et al., supra note 36.Google Scholar
Allen, C.G. et al., “The Impact of Raw DNA Availability and Corresponding Online Interpretation Services: A Mixed-methods Study,” Translational Behavioral Medicine 8, no. 1 (2018): 105-112.CrossRefGoogle Scholar
Guerrini, C.G. et al., “Who’s on Third? Regulation of Third-Party Genetic Interpretation Services,” Genetics in Medicine 22, no. 1 (2020): 4-11.CrossRefGoogle Scholar
Murphy, E., “Law and Policy Oversight of Familial Searches in Recreational Genealogy Databases,” Forensic Science International 292 (2018): e5-e9.CrossRefGoogle Scholar
Popper, B., “Cyborg America: Inside the Strange New World of Basement Body Hackers,” The Verge, August 8, 2012, available at <https://www.theverge.com/2012/8/8/3177438/cyborg-america-biohackers-grinders-body-hackers> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Id.Google Scholar
The DIY Cyborg,” VICE, October 31, 2013, available at <https://www.vice.com/en_us/article/7b79kx/diy-cyborg> (last visited January 13, 2010).+(last+visited+January+13,+2010).>Google Scholar
Robbins, R., “A Cyborg Magician Explains Why She Implanted 26 Microchips and Magnets in Her Body,” STAT, September 6, 2019, available at <https://www.statnews.com/2019/09/06/acyborg-magician-explains-why-she-implanted-26-microchipsand-magnets-in-her-body/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Hines, A., “Magnet Implants? Welcome to the World of Medical Punk,” New York Times, May 12, 2018, available at <https://www.nytimes.com/2018/05/12/us/grindfest-magnet-implants-biohacking.html> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Warwick, K. et al., “The Application of Implant Technology for Cybernetic Systems,” JAMA Neurology 60, no. 10 (2003): 1369-1373.Google Scholar
Bouton, C.E. et al., “Restoring Cortical Control of Functional Movement in a Human with Quadriplegia,” Nature 533, no. 7602 (2016): 247-250.CrossRefGoogle Scholar
Russell, M., “Body Modifier Brendan Russell to Stand Trial Over Woman’s Snowflake Implant Death,” News.com.au, July 19, 2019, available at <https://www.news.com.au/national/nsw-act/courts-law/body-modifier-brendan-russell-to-stand-trial-over-womans-snowflake-implantdeath/news-story/ca3b-047c9a9b426fedca8d08a0550464> (last visited January 13, 2020).Google Scholar
Id.Google Scholar
23AndMe, “About Us,” available at <https://mediacenter.23andme.com/company/about-us/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Open Humans, available at <https://www.openhumans.org/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
CoverUS, available at <https://coverus.health/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Hu-manity.co, available at <https://hu-manity.co/who-is-humanity-co123-2/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Hu-manity.co, “Frequently Asked Questions,” available at <https://hu-manity.co/faqs/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Sterckx, S. et al., “‘Trust is Not Something You Can Reclaim Easily’: Patenting in the Field of Direct-to-Consumer Genetic Testing,” Genetics in Medicine 15, no. 5 (2013): 382-387.CrossRefGoogle Scholar
Id.Google Scholar
Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. 7149, 7180 (January 19, 2017) (codified at 45 C.F.R. part 46).Google Scholar
Sage Bionetworks, available at <www.sagebionetworks.org> (last visited January 13, 2020). We note that one of the authors (Doerr) is employed by Sage Bionetworks.+(last+visited+January+13,+2020).+We+note+that+one+of+the+authors+(Doerr)+is+employed+by+Sage+Bionetworks.>Google Scholar
Comstock, J., “Partners’ Engagement Engine and 7 More RWJF-Backed Digital Health Projects,” MobiHealth News, March 25, 2015, available at <https://www.mobihealthnews.com/41768/part-ners-engagementengine-and-7-more-rwjf-backed-digital-health-projects> (last visited January 13, 2020).Google Scholar
Odwazny, L., “Finding Flexibility in the Federal Regulations-Fear Not the Feds!” (2014), available at <https://www.nwabr.org/eventsprograms/2014-ohrp-research-community-forum-irbeducation-conference/conference-presentation> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Children’s Hospital of Philadelphia Research Institute, “Federalwide Assurance (FWA): Compliance with Federal Regulatory Requirements and Guidelines,” available at <https://irb.research.chop.edu/federalwide-assurance-fwa> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period, 83 Fed. Reg. 28,497 (June 19, 2018).Google Scholar
Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. at 7181.Google Scholar
Changes to Human Subject Research Rules Impact Studies Funded Non-Federally, Fox Rothschild, LLC, February 11, 2019, available at <https://www.foxrothschild.com/publications/changes-to-human-subject-research-rulesimpact-studies-funded-non-federally/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Metcalf, J., Moss, E., and Boyd, D., “Owning Ethics: Corporate Logics, Silicon Valley, and the Institutionalization of Ethics,” Social Research: An International Quarterly 82, no. 2 (2019): 449-476..Google Scholar
Chambers, C., “Facebook Fiasco: Was Cornell’s Study of ‘Emotional Contagion’ an Ethics Breach?” The Guardian, July 10, 2014, available at <https://www.theguardian.com/science/head-quarters/2014/jul/01/facebook-cornell-study-emotional-contagion-ethics-breach> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
TREND Community, available at <https://trend.community/> (last visited September 23 2019).+(last+visited+September+23+2019).>Google Scholar
Id.Google Scholar
Strava Business, available at <https://business.strava.com/> (last visited September 23 2019).+(last+visited+September+23+2019).>Google Scholar
Gulley, A., “Strava’s Plan to Revolutionize Commuting,” Outside Online, May 15, 2014, available at <https://www.out-sideonline.com/1923291/stravasplan-revolutionize-commuting?source=post> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Robb, D., “Building The Global Heat Map,” Medium, November 1, 2017, available at <https://medium.com/strava-engineering/the-global-heat-map-now-6x-hotter-23fc01d301de> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Chappell, B., “Pentagon Reviews GPS Policies After Soldiers’ Strava Tracks Are Seemingly Exposed,” National Public Radio, January 29, 2018, available at <https://www.npr.org/sections/I-way/2018/01/29/581597949/pentagon-reviews-gps-data-after-soldiers-strava-tracks-are-seemingly-exposed> (last visited January 13, 2020).Google Scholar
Lumb, D., “After Exposing Secret Military Bases, Strava Restricts Data Visibility,” engadget, March 13, 2018, available at <https://www.engadget.com/2018/03/13/after-exposing-secret-military-bases-strava-restricts-data-visi/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Personal communication from Blair Van Brunt to author (MD) (August 29, 2019).Google Scholar
Anjunwa, I., Crawford, K., and Schultz, J., “Limitless Worker Surveillance,” California Law Review 105, no. 3 (2017): 735-776.Google Scholar
Mateescu, A. and Nguyen, A., “Explainer: Workplace Monitoring & Surveillance,” Data & Society, February 6, 2019, available at <https://datasociety.net/wp-content/uploads/2019/09/DandS_WorkplaceMonitoringandSurveillance-.pdf> (last visited January 13, 2020); O’Donovan, C., “Walmart’s Newly Patented Technology for Eavesdropping on Workers Presents Privacy Concerns,” BuzzFeed News, July 11, 2018, available at <https://www.buzzfeednews.com/article/carolineodonovan/walmart-just-patented-audio-surveillance-technology-for> (last visited January 13, 2020).Google Scholar
Yeginsu, C., “If Workers Slack Off, the Wristband Will Know. (And Amazon Has a Patent for It.),” New York Times, February 1, 2018, available at <https://www.nytimes.com/2018/02/01/technology/amazon-wristband-tracking-privacy.html> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Schencker, L., “Would You Wear a Fitbit for Work?,” Chicago Tribune, November 11, 2016, available at <https://www.nytimes.com/2018/02/01/technology/amazon-wristband-tracking-privacy.html> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Rowland, C., “With Fitness Trackers in the Workplace, Bosses Can Monitor Your Every Step — and Possibly More,” Washington Post, February 16, 2019, available at <https://www.washingtonpost.com/business/economy/with-fitness-trackers-in-the-workplace-bosses-can-monitor-your-every-step--and-possibly-more/2019/02/15/75ee0848-2a45-11e9-b011-d8500644dc98_story.html> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Holley, P., “Wearable Technology Started by Tracking Steps. Soon, It May Allow Your Boss to Track Your Performance,” Washington Post, June 28, 2019, available at <https://www.washingtonpost.com/technology/2019/06/28/wearable-technology-started-by-tracking-steps-soon-it-may-allow-your-boss-track-your-performance/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Ajunwa, Crawford, and Schultz, supra note 77; Delgado, A., “Employee Privacy at Stake as Surveillance Technology Evolves,” CBS News, August 14, 2018, available at <https://www.cbsnews.com/news/employee-privacy-surveillance-technology-evolves/ (last visited September 23, 2019).Google Scholar
Lazzarotti, J.J., “Wellness Programs Continue to Face Compliance Challenges,” Jackson Lewis Benefits Law Advisor, February 7, 2019, available at <https://www.benefitslawadvisor.com/2019/02/articles/employeehealth-welfare-plans/wellness-programs-continue-to-facecompliance-challenges/> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Boodman, E., “White Nationalists are Flocking to Genetic Ancestry Tests. Some Don’t Like What They Find,” STAT, August 16, 2017, available at <https://www.statnews.com/2017/08/16/white-nationalists-geneticancestry-test/> (last visited January 13, 2020).Google Scholar
Vincent, J., “1.5 Million Affected by Hack Targeting Singapore’s Health Data,” The Verge, July 20, 2018, available at https://www.theverge.com/2018/7/20/17594578/singapore-health-data-hack-sing-health-prime-minister-lee-targeted (last visited September 23, 2019); “Hackers are Stealing Millions of Medical Records — and Selling Them on the Dark Web,” CBS News, February 14, 2019, available at <https://www.cbsnews.com/news/hackers-steal-medical-records-sell-them-on-dark-web/> (last visited September 23, 2019).+(last+visited+September+23,+2019).>Google Scholar
Biohacking Village Device Lab Registration Form, DEF CON 2019 (on file with authors).Google Scholar
Woods, B., Coravos, A., and Corman, J.D., “The Case for a Hippocratic Oath for Connected Medical Devices: Viewpoint,” Journal of Medical Internet Research 21, no. 3 (2019): e12568.CrossRefGoogle Scholar
Wicklund, E., “FDA Issues Recall For Medtronic mHealth Devices Over Hacking Concerns,” mHealth Intelligence, June 28, 2019, available at <https://mhealthintelligence.com/news/fda-issues-recall-for-medtronic-mhealth-devices-over-hacking-concerns> (last visited January 13, 2020).+(last+visited+January+13,+2020).>Google Scholar
Guerrini, C.J., Spencer, G.E., and Zettler, P.J., “DIY CRISPR,” North Carolina Law Review 97, no. 5 (2019): 1399-1462, available at <https://scholarship.law.unc.edu/nclr/vol97/iss5/17> (last visited January 13, 2020).Google Scholar