Sage Journals: Discover world-class research

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.

Get full access to this article

View all access options for this article.

References

S.J.

Barnes ,

A.D.

Pressey , and

Scornavacca , “Mobile Ubiquity: Understanding the Relationship between Cognitive Absorption, Smartphone Addiction and Social Network Services,” Computers in Human Behavior 90 (2019): 249-258.

A.J.S.

McGonigle

et al., “Smartphone Spectrometers,” Sensors 18, no. 1 (2018): 223-238.

R.E.

Dorsey

et al., “The Use of Smartphones for Health Research,” Academic Medicine 92, no. 2 (2017): 157-160.

Pushter

, “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).

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).

Chib and

S.H.

Lin , “Theoretical Advancements in mHealth: A Systematic Review of Mobile Apps,” Journal of Health Communication 23, nos. 10/11 (2018): 909-955.

M.A.

Rothstein ,

J.T.

Wilbanks , and

K.B.

Brothers , “Citizen Science on Your Smartphone: An ELSI Research Agenda,” Journal of Law, Medicine & Ethics 43, no. 4 (2015): 897-903.

Wiggins and

Wilbanks , “The Rise of Citizen Science in Health and Biomedical Research,” American Journal of Bio-ethics 19, no. 8 (2019): 3-14.

45 C.F.R.§ 46.102(l).

10.

Apple, “ResearchKit and CareKit,” available at <https://www.apple.com/ca/researchkit/> (last visited February 28, 2020).

11.

B.M.

Bot

et al., “The mPower Study, Parkinson Disease Mobile Data Collected Using ResearchKit,” Scientific Data 3 (2016).

12.

D.E.

Webster

et al., “The Mole Mapper Study, Mobile Phone Skin Imaging and Melanoma Risk Data Collected Using ResearchKit,” Scientific Data 4 (2017).

13.

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).

14.

Webster et al., supra note 12.

15.

Zens

et al., “‘Back on Track:’ A Mobile App Observational Study Using Apple’s ResearchKit Framework,” JMIR mHealth uHealth 5, no. 2 (2017).

16.

Jardine ,

Fisher , and

Carrick , “Apple’s ResearchKit: Smart Data Collection for the Smartphone Era?” Journal of the Royal Society of Medicine 108, no. 8 (2015): 294-296.

17.

See

Kubben

, “Mobile Apps,” in

Kubben ,

Dumontier , and

Dekker , eds. Fundamentals of Clinical Data Science (Maastricht: Springer, 2019): at 171.

18.

Cartwright

, “Smartphone Science,” Nature 531, no. 7596 (2016): 669-671.

19.

Moore

et al., “Consent Processes for Mobile App Mediated Research: Systematic Review,” JMIR mHealth uHealth 5, no. 8 (2017).

20.

Carter

et al., “Mobile Phones in Research and Treatment: Ethical Guidelines and Future Directions,” JMIR mHealth uHealth 3, no. 4 (2015).

21.

Doerr

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).

22.

Wilbanks

, “Design Issues in E-Consent,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 110-118.

23.

Doerr ,

Suver , and

Wilbanks , “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).

24.

M.H.

Zawati

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.

25.

Grundy

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).

26.

Id. See also

O’Loughlin

et al., “Reviewing the Data Security and Privacy Policies of Mobile Apps for Depression,” Internet Interventions 15 (2019): 110-115.

27.

See, e.g., Moore et al., supra note 19.

28.

Hamine

, “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.

29.

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).

30.

Spector-Bagdady

et al., “Encouraging Participation and Transparency in Biobank Research,” Health Affairs 37, no. 8 (2018): 1313-1320.

31.

Caulfield and

Murdoch , “Genes, Cells, and Biobanks: Yes, There’s Still a Consent Problem,” PLoS Biology 15, no. 7 (2017): 1-9.

32.

Sheikh and

Hoeyer , “‘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.

33.

Holloway and

Herder , “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.

34.

Humphreys ,

Trafton and

T.H.

Wagner , “The Cost of Institutional Review Board Procedures in Multicenter Observational Research,” Annals of Internal Medicine 139, no. 77 (2003).

35.

Wiggins and Wilbanks, supra note 8.

36.

E.S.

Dove ,

B.M.

Knoppers , and

M.H.

Zawati , “Towards an Ethics Safe Harbor for Global Biomedical Research,” Journal of Law and the Biosciences 1, no. 1 (2014): 3-51.

37.

Id.

38.

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).

39.

Department of Health, Republic of South Africa, eHealth Strategy for South Africa (2012).

40.

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).

41.

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).

42.

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).

43.

Crico

, “mHealth and Telemedicine Apps: In Search of a Common Regulation,” eCancer 12, no. 853 (2018).

44.

Bradway

et al., “mHealth Assessment: Conceptualization of a Global Framework,” Journal of Medical Internet Research mHealth 5, no. 5 (2017): e60.

45.

R.V.

Carlson ,

K.M.

Boyd , and

D.J.

Webb , “The Revision of the Declaration of Helsinki: Past, Present and Future,” British Journal of Clinical Pharmacology 57, no. 6 (2004): 695-713.

46.

M.A.

Puhan

et al., “A Digitally Facilitated Citizen-science Driven Approach Accelerates Participant Recruitment and Increases Study Population Diversity,” Swiss Medical Weekly 148 (2018): w14623.

47.

World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (64th WMA General Assembly, Fortaleza: 2013) § 26.

48.

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.

49.

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).

50.

Id.

51.

World Medical Association, supra note 47.

52.

Id.

53.

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).

54.

Id.

55.

CIOMS Guidelines, supra note 48.

56.

World Medical Association, supra note 47, § 12.

57.

CIOMS Guidelines, supra note 48, at Guideline 1.

58.

OECD, supra note 53, at 9–10.

59.

World Medical Association, supra note 47, § 23.

60.

CIOMS Guidelines, supra note 48, at Guideline 23.

61.

Id.

62.

Glaser

, “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).

63.

World Medical Association, supra note 47.

64.

Id.

65.

Id.

66.

Lang and

M.H.

Zawati , “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.

67.

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).

68.

L.C.

Ikemoto

, “DIY Bio: Hacking Life in Biotech’s Backyard,” University of California Davis Law Review 51, no. 2 (2018): 539-568.

69.

DIY Bio, “Codes,” available at <https://diybio.org/codes/> (last visited February 28, 2020).

International mHealth Research: Old Tools and New Challenges

Abstract

Get full access to this article

References