Hostname: page-component-78c5997874-8bhkd Total loading time: 0 Render date: 2024-11-19T04:06:47.021Z Has data issue: false hasContentIssue false
  • English
  • Français

International mHealth Research: Old Tools and New Challenges

Published online by Cambridge University Press:  01 January 2021

Michael Lang ,
Bartha Maria Knoppers  and
Ma’n H. Zawati
Get access Rights & Permissions [Opens in a new window]

Abstract

In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue S1: Unregulated Health Research Using Mobile Devices , Spring 2020 , pp. 178 - 186
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Barnes, S.J., Pressey, A.D., and Scornavacca, E., “Mobile Ubiquity: Understanding the Relationship between Cognitive Absorption, Smartphone Addiction and Social Network Services,” Computers in Human Behavior 90 (2019): 249-258.CrossRefGoogle Scholar
McGonigle, A.J.S. et al., “Smartphone Spectrometers,” Sensors 18, no. 1 (2018): 223-238.CrossRefGoogle Scholar
Dorsey, R.E. et al., “The Use of Smartphones for Health Research,” Academic Medicine 92, no. 2 (2017): 157-160.CrossRefGoogle Scholar
Pushter, J., “Smartphone Ownership and Internet Usage Continues to Climb in Emerging Economies But Advanced Economies Still Have Higher Rates of Technology Use,” Pew Research Center, available at <http://s1.pulso.cl/wp-content/uploads/2016/02/2258581.pdf> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
The GSMA, “The Mobile Economy 2018,” at 15, available at <https://www.gsma.com/mobileeconomy/wp-content/uploads/2018/05/The-Mobile-Economy-2018.pdf> (last visited October 9, 2019).+(last+visited+October+9,+2019).>Google Scholar
Chib, A. and Lin, S.H., “Theoretical Advancements in mHealth: A Systematic Review of Mobile Apps,” Journal of Health Communication 23, nos. 10/11 (2018): 909-955.CrossRefGoogle Scholar
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
Wiggins, A. and Wilbanks, J., “The Rise of Citizen Science in Health and Biomedical Research,” American Journal of Bio-ethics 19, no. 8 (2019): 3-14.CrossRefGoogle Scholar
45 C.F.R.§ 46.102(l).Google Scholar
Apple, “ResearchKit and CareKit,” available at <https://www.apple.com/ca/researchkit/> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Bot, B.M. et al., “The mPower Study, Parkinson Disease Mobile Data Collected Using ResearchKit,” Scientific Data 3 (2016).CrossRefGoogle Scholar
Webster, D.E. et al., “The Mole Mapper Study, Mobile Phone Skin Imaging and Melanoma Risk Data Collected Using ResearchKit,” Scientific Data 4 (2017).CrossRefGoogle Scholar
Apple, “Apple Announces Three Groundbreaking Health Studies,” 2019, available at: <https://www.apple.com/news-room/2019/09/apple-announces-three-groundbreaking-health-studies/> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Webster et al., supra note 12.Google Scholar
Zens, M. et al., “‘Back on Track:’ A Mobile App Observational Study Using Apple’s ResearchKit Framework,” JMIR mHealth uHealth 5, no. 2 (2017).CrossRefGoogle Scholar
Jardine, J., Fisher, J., and Carrick, B., “Apple’s ResearchKit: Smart Data Collection for the Smartphone Era?” Journal of the Royal Society of Medicine 108, no. 8 (2015): 294-296.CrossRefGoogle Scholar
See Kubben, P., “Mobile Apps,” in Kubben, P., Dumontier, M., and Dekker, A., eds. Fundamentals of Clinical Data Science (Maastricht: Springer, 2019): at 171.CrossRefGoogle ScholarPubMed
Cartwright, J., “Smartphone Science,” Nature 531, no. 7596 (2016): 669-671.CrossRefGoogle Scholar
Moore, S. et al., “Consent Processes for Mobile App Mediated Research: Systematic Review,” JMIR mHealth uHealth 5, no. 8 (2017).CrossRefGoogle Scholar
Carter, A. et al., “Mobile Phones in Research and Treatment: Ethical Guidelines and Future Directions,” JMIR mHealth uHealth 3, no. 4 (2015).CrossRefGoogle Scholar
Doerr, M. et al., “Formative Evaluation of Participant Experience with Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study,” JMIR mHealth uHealth 5, no. 2 (2017).CrossRefGoogle Scholar
Wilbanks, J., “Design Issues in E-Consent,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 110-118.CrossRefGoogle Scholar
Doerr, M., Suver, C., and Wilbanks, J., “Developing a Transparent, Participant-navigated Electronic Informed Consent for Mobile-mediated Research,” 2016, Sage Bionetworks, available at <https://ssrn.com/abstract=2769129> (last visited February 28, 2020).CrossRef+(last+visited+February+28,+2020).>Google Scholar
Zawati, M.H. et al., “Barriers and Opportunities in Consent and Access Procedures in Low- and Middle-Income Country Biobanks: Meeting Notes from the BCNet Training and General Assembly,” Biopreservation & Biobanking 16, no. 3 (2018): 171-178.CrossRefGoogle Scholar
Grundy, Q. et al., “Data Sharing Practices of Medicines Related Apps and the Mobile Ecosystem: Traffic, Content, and Network Analysis,” British Medical Journal 364, no. 1 (2019).Google Scholar
Id. See also O’Loughlin, K. et al., “Reviewing the Data Security and Privacy Policies of Mobile Apps for Depression,” Internet Interventions 15 (2019): 110-115.CrossRefGoogle Scholar
See, e.g., Moore et al., supra note 19.Google Scholar
Hamine, S., “Impact of mHealth Chronic Disease Management on Treatment Adherence and Patient Outcomes: A Systematic Review,” Journal of Medical Internet Research 17, no. 2 (2015): e52.CrossRefGoogle Scholar
Global Newswire, “mHealth (Mobile Health) Ecosystem Market 2017-2030 - $23 Billion Opportunities, Challenges, Strategies & Forecasts,” available at <https://www.globenews-wire.com/news-release/2017/03/02/930109/0/en/mHealth-Mobile-Healthcare-Ecosystem-Market-2017-2030-23-Billion-Opportunities-Challenges-Strategies-Forecasts.html> (last visited March 18, 2020).+(last+visited+March+18,+2020).>Google Scholar
Spector-Bagdady, K. et al., “Encouraging Participation and Transparency in Biobank Research,” Health Affairs 37, no. 8 (2018): 1313-1320.CrossRefGoogle Scholar
Caulfield, T. and Murdoch, B., “Genes, Cells, and Biobanks: Yes, There’s Still a Consent Problem,” PLoS Biology 15, no. 7 (2017): 1-9.CrossRefGoogle Scholar
Sheikh, Z. and Hoeyer, K., “‘That Is Why I Have Trust’: Unpacking What ‘Trust’ Means to Participants in International Genetic Research in Pakistan and Denmark,” Medicine, Health Care, and Philosophy 21, no. 4 (June 2018): 169-179.CrossRefGoogle Scholar
Holloway, K. and Herder, M., “A Responsibility to Commercialize? Tracing Academic Researchers’ Evolving Engagement with the Commercialization of Biomedical Research,” Journal of Responsible Innovation 6, no. 3 (2019): 263-283.CrossRefGoogle Scholar
Humphreys, K., Trafton, J. and Wagner, T.H., “The Cost of Institutional Review Board Procedures in Multicenter Observational Research,” Annals of Internal Medicine 139, no. 77 (2003).CrossRefGoogle Scholar
Wiggins and Wilbanks, supra note 8.Google Scholar
Dove, E.S., Knoppers, B.M., and Zawati, M.H., “Towards an Ethics Safe Harbor for Global Biomedical Research,” Journal of Law and the Biosciences 1, no. 1 (2014): 3-51.CrossRefGoogle Scholar
Id.Google Scholar
Department of Health and Human Services, Office for Human Research Protections, International Compilations of Human Research Standards (2019 ed.), available at <https://www.hhs.gov/ohrp/sites/default/files/2019-International-Compilation-of-Human-Research-Standards.pdf> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Department of Health, Republic of South Africa, eHealth Strategy for South Africa (2012).Google Scholar
Ministère des Affaires Sociales et de la Santé, “Stratégie Nationale e-santé 2020: Le Numérique au Service de la Modernisation et de l’efficience du Système de Santé,” available at <https://solidarites-sante.gouv.fr/IMG/pdf/strategie_e-sante_2020.pdf> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Health Sciences Authority, Medical Devices Branch, “Regulatory Guideline for Telehealth Products,” available at <https://www.hsa.gov.sg/docs/default-source/hprg-mdb/regulatory-guidelines-for-telehealth-products-rev-2-1.pdf> (last visited March 18, 2020).+(last+visited+March+18,+2020).>Google Scholar
World Health Organization, “mHealth: Use of Appropriate Digital Technologies for Public Health,” EB142/20 available at <https://apps.who.int/gb/ebwha/pdf_files/EB142/B142_20-en.pdf> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Crico, C., “mHealth and Telemedicine Apps: In Search of a Common Regulation,” eCancer 12, no. 853 (2018).CrossRefGoogle Scholar
Bradway, M. et al., “mHealth Assessment: Conceptualization of a Global Framework,” Journal of Medical Internet Research mHealth 5, no. 5 (2017): e60.Google Scholar
Carlson, R.V., Boyd, K.M., and Webb, D.J., “The Revision of the Declaration of Helsinki: Past, Present and Future,” British Journal of Clinical Pharmacology 57, no. 6 (2004): 695-713.CrossRefGoogle Scholar
Puhan, M.A. et al., “A Digitally Facilitated Citizen-science Driven Approach Accelerates Participant Recruitment and Increases Study Population Diversity,” Swiss Medical Weekly 148 (2018): w14623.Google Scholar
World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (64th WMA General Assembly, Fortaleza: 2013) § 26.Google Scholar
Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), International Ethical Guidelines for Health-related Research Involving Humans (Geneva: 2016): at Guideline 9.Google Scholar
United Nations Special Rapporteur on the Right to Privacy — Task Force on Privacy and the protection of Health Data, “Draft Recommendation on the Protection and use of Health-Related Data” (Strasbourg: 2019), available at <https://rm.coe.int/draft-recommendation-on-the-protection-and-useof-health-related-data/1680943beb> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Id.Google Scholar
World Medical Association, supra note 47.Google Scholar
Id.Google Scholar
OECD-HARVARD Global Health Institute Workshop, Mobile Technology-Based Services for Global Health and Wellness: Opportunities and Challenges (Boston: 2016), available at <https://www.oecd.org/sti/ieconomy/Summary-Mobile-Health-Oct2016.pdf> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Id.Google Scholar
CIOMS Guidelines, supra note 48.Google Scholar
World Medical Association, supra note 47, § 12.Google Scholar
CIOMS Guidelines, supra note 48, at Guideline 1.Google Scholar
OECD, supra note 53, at 9–10.Google Scholar
World Medical Association, supra note 47, § 23.Google Scholar
CIOMS Guidelines, supra note 48, at Guideline 23.Google Scholar
Id.Google Scholar
Glaser, A., “Apple Is a Tech Regulator,” Slate, June 3, 2019, available at <https://slate.com/technology/2019/06/apple-wwdc-sign-in-facebook-google.html> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
World Medical Association, supra note 47.Google Scholar
Id.Google Scholar
Id.Google Scholar
Lang, M. and Zawati, M.H., “The App Will See You Now: Mobile Health, Diagnosis, and the Practice of Medicine in Quebec and Ontario,” Journal of Law and the Biosciences 5, no. 1 (2018): 143-173.CrossRefGoogle Scholar
European Commission, “Green Paper on Mobile Health (mHealth),” available at <https://eu-ems.com/event_images/Downloads/GreenPaperonmobilehealth-1.pdf> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar
Ikemoto, L.C., “DIY Bio: Hacking Life in Biotech’s Backyard,” University of California Davis Law Review 51, no. 2 (2018): 539-568.Google Scholar
DIY Bio, “Codes,” available at <https://diybio.org/codes/> (last visited February 28, 2020).+(last+visited+February+28,+2020).>Google Scholar