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Schrödinger's App

Published online by Cambridge University Press:  01 January 2021

Leah R. Fowler
Affiliation:
University of Houston Law Center Health Law & Policy Institute
Stephanie R. Morain
Affiliation:
Baylor College of Medicine Center for Medical Ethics & Health Policy

Abstract

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Type
Articles
Copyright
Copyright © 2020 American Society of Law, Medicine & Ethics Boston University School of Law

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References

1 Mobile Fact Sheet, Pew Research Center (June 12, 2019), https://www.pewinternet.org/fact-sheet/mobile.

3 See Neha Baluni, Mobile Medical Apps: A Game Changing Healthcare Innovation, HealthWorksCollective (Aug. 12, 2018), https://www.healthworkscollective.com/mobile-medical-apps-a-game-changing-healthcare-innovation (“52% of smartphone users collect health-associated information on their cell phones.”).

4 Andy Edwards, mHealth: Healthcare Mobile App Trends in 2019, OrthoLive (Feb. 2, 2019), https://www.ortholive.com/blog/mhealth-healthcare-mobile-app-trends-in-2019.

5 See discussion infra Section II.A.

6 Uri Benoliel & Shmuel I. Becher, The Duty to Read the Unreadable, 60 B.C. L. Rev. 2256, 2260 (“Under the duty to read doctrine, contracting parties are presumed to have read the contract before agreeing to its terms. Failure to fulfill this duty has three main legal implications. First, a party is normally bound by the terms of the contract notwithstanding its failure to read them. Second, refraining from reading the contract does not constitute grounds for voiding the contract. Third, failure to read the contract does not trigger a contractual mistake necessary for contract reformation.”).

7 Katie Gambier-Ross et al., A Mixed Methods Exploratory Study of Women's Relationships with and Uses of Fertility Tracking Apps, 4 Digital Health, 2018, at 2.

8 Sim, Ida, Mobile Devices and Health, 381 New Eng. J. Med. 956, 956 (2019)CrossRefGoogle ScholarPubMed.

9 Higgins, John P., Smartphone Applications for Patients' Health and Fitness, 129 Am. J. Med. 11, 13 (2016)CrossRefGoogle ScholarPubMed.

10 Melody Kramer, The Physics Behind Schrodinger's Paradox, Nat'l Geographic (Aug. 14, 2013) https://www.nationalgeographic.com/news/2013/8/130812-physics-schrodinger-erwin-google-doodle-cat-paradox-science.

11 Gambier-Ross et al., supra note 7, at 1-2.

12 See id.; see also Mary Summer Starling et al., User Profile and Preferences in Fertility Apps for Preventing Pregnancy: An Exploratory Pilot Study, 4 mHealth, no. 21, 2018, at 2.

13 Alexander Freis et al., Plausibility of Menstrual Cycle Apps Claiming to Support Conception, 6 Frontiers in Pub. Health, April 2018, at 2.

14 See Starling et al., supra note 12, at 11-12; see also Richard A. Bretschneider, A Goal- and Context-Driven Approach in Mobile Period Tracking Applications, in Universal Access in Human-Computer Interaction: Access to Learning and Well-Being 279, 280 (M. Antona & C. Stephanidis eds., 2015) (noting that 10% of study participants said they would use a period tracking app as a method of contraception).

15 Bretschneider, supra note 14, at 279–87. Of note, this paper does not draw a clear distinction between apps marketed as period-tracking or those marketed as fertility-tracking. The concepts are used interchangeably, consistent with research that suggests users searching for a fertility app to help prevent pregnancy, most users will look for apps using terms unrelated to pregnancy prevention. Moreover, tracking apps often serve multiple purposes for users over time as their reproductive intentions and behaviors change across the life course.

16 See Duane, Marguerite et al., The Performance of Fertility Awareness-Based Method Apps Marketed to Avoid Pregnancy, 29 J. Am. Board Fam. Med. 508, 508 (2016)CrossRefGoogle ScholarPubMed.

17 See FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy, FDA.Gov (Aug. 10, 2018), https://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-direct-consumer-app-contraceptive-use-prevent-pregnancy. Contraception software is classified as a Class II medical device with special controls, see FDA Reclassifies Contraception Software as Class II (Special Controls), FDA News (Mar. 8, 2019), https://www.fdanews.com/articles/190495-fda-reclassifies-contraception-software-as-class-ii-special-controls.

18 See Scherwitzl, E. Berglund et al., Perfect-use and Typical-use Pearl Index of a Contraceptive Mobile App, 96 Contraception 420, 422-24 (2017)Google Scholar. But see Frank-Hermann, Petra et al., Letter to the Editor: Fertility awareness-based mobile application, 22 European J. Contraception & Reprod. Health Care 396, 396-97 (2017)CrossRefGoogle Scholar (discussing the limitations of the Scherwitzl et al. study).

19 See Victoria Jennings et al., Perfect- and Typical-use Effectiveness of the Dot Fertility App over 13 Cycles: Results from a Prospective Contraceptive Effectiveness Trial, 24 European J. Contraception & Reprod. Health Care 148 (2019).

20 Naomi Kresge et al., Period-Tracking Apps Are Monetizing Women's Extremely Personal Data, Bloomberg (Jan. 24, 2019, 6:00 AM), https://www.bloomberg.com/news/articles/2019-01-24/how-period-tracking-apps-are-monetizing-women-s-extremely-personal-data; see also Ctr. on Media & Human Dev., Nw. U., Teens, Health, and Technology: A National Survey 22-23 (2015), http://cmhd.northwestern.edu/wp-content/uploads/2015/05/1886_1_SOC_ConfReport_TeensHealthTech_051115.pdf (observing that period tracking apps are the fourth most popular app among adults and the second most popular among girls ages 13-18); Levy, Karen E. C., Intimate Surveillance, 51 Idaho L. Rev. 679, 685 (2015)Google Scholar (noting that some fertility tracking apps are designed for men, hoping to empower them with knowledge about when their partner (or partners – there is a discrete feature for those with multiple sexual partners) might be disagreeable based on her upcoming period, or when she might be more amenable to intercourse according to predicted ovulation dates).

21 Duane et al., supra note 16, at 511 (“The majority of fertility apps are neither designed for avoiding pregnancy nor founded on evidence based FABMs.”).

22 Freis et al., supra note 13, at 2.

23 See Duane et al., supra note 16, at 511.

24 See Moglia, Michelle L. et al., Evaluation of Smartphone Menstrual Cycle Tracking Applications Using an Adapted APPLICATIONS Scoring System, 127 Obstetrics & Gynecology 1153, 1154-55 (2016)CrossRefGoogle ScholarPubMed (“Our primary criterion for ongoing inclusion in this study was accuracy. Ninety-nine percent of regular menstrual cycles range from 21 to 35 days, and only one in eight or nine women have 28-day cycles. Because women may not know their average cycle length, we decided that the ability to predict the next menstrual cycle based on averages of past cycles and not on a default (often 28-day) cycle length would be an important element of our accuracy criteria.”).

25 Lunde, Britt et al., An Evaluation of Contraception Education and Health Promotion Applications for Patients, 27 Women's Health Issues 29, 34 (2017)CrossRefGoogle ScholarPubMed (“More than one-third of identified apps were excluded from this review for containing inaccurate information.”); see also Moglia, supra note 24, at 1153-55 (noting that of the 108 apps that fit the study criteria, 88 apps were eliminated due to the inclusion of misinformation and other inaccuracies).

26 See, e.g., Isobel Asher Hamilton, Popular period-tracking apps were found sharing extremely sensitive data to Facebook, including when users last had sex, Business Insider (Sept. 10, 2019, 7:28 AM), https://www.businessinsider.com/period-tracking-apps-found-sharing-highly-sensitive-data-to-facebook-2019-9.

27 Daniel A. Epstein et al., Examining Menstrual Tracking to Inform Design of Personal Informatics Tools, CHI ’17: Proceedings of the 2017 CHI Conference on Human Factors in Computing Systems, May 2017, at 6883 (stating that “some women prefer using a dedicated app because of privacy, including S192: “keeping info in an app instead of written on my calendar gives me greater privacy.”); see also Karlsson, Amanda, A Room of One's Own? Using Period Trackers to Escape Menstrual Stigma, 40 Nordicom Rev. 111, 113 (2019)Google Scholar (discussing the concept of privacy from a feminist perspective).

28 Jerry Beilinson, Glow Pregnancy App Exposed Women to Privacy Threats, Consumer Reports Find, Consumer Rep. (July 28, 2016), https://www.consumerreports.org/mobile-security-software/glow-pregnancy-app-exposed-women-to-privacy-threats.

29 Id.

30 Id.

31 Id. Of note, Glow corrected the vulnerabilities after receiving notification from Consumer Reports.

32 Cooper Quintin, The Pregnancy Panopticon, Electronic Frontier Found. 6-10 (2017), https://www.eff.org/files/2017/07/27/the_pregnancy_panopticon.pdf.

33 Kit Huckvale et al., Assessment of the Data Sharing and Privacy Practices of Smartphone Apps for Depression and Smoking Cessation, JAMA Network Open, Apr. 2019, at 2.

34 Scott Thurm & Yukari Iwatani Kane, Your Apps Are Watching You, Wall Street J. (Dec. 17, 2010), https://www.wsj.com/articles/SB10001424052748704694004576020083703574602 (“The main companies setting ground rules for app data-gathering have big stakes in the ad business. The two most popular platforms for new U.S. smartphones are Apple's iPhone and Google's Android. Google and Apple also run the two biggest services, by revenue, for putting ads on mobile phones.”).

35 See Kresge et al, supra note 20.

36 Kaitlyn Tiffany, Period-Tracking apps are not for Women, Vox (Nov. 16 2018, 12:35 PM), https://www.vox.com/the-goods/2018/11/13/18079458/menstrual-tracking-surveillance-glow-clue-apple-health.

37 Kresge et al, supra note 20.

38 See A. Lange et al., Smartphone fertility app use among couples of reproductive age: potential use of big data to improve fertility care and advance reproductive health research, 108 Fertility & Sterility, Oct. 2016, at e111.

39 The Myth of Moon Phases and Menstruation, Clue (Apr. 16, 2019), https://helloclue.com/articles/cycle-a-z/myth-moon-phases-menstruation.

40 Levy, supra note 20, at 691.

41 See Adam Jacobson, The Risks of Pregnancy-Tracking Apps Risk Mgmt. (Aug. 1, 2019), http://www.rmmagazine.com/2019/08/01/the-risks-of-pregnancy-tracking-apps.

42 Id.

43 Id.

44 Stephanie R. Morain et al., What to Expect When [Your Employer Suspects] You're Expecting, 176 JAMA Intern. Med. 1597 (2016).

45 Jacobson, supra note 41; see also Levy, supra note 20, at 686-87.

46 See Jacobson, supra note 41.

47 Carla Herreria, Missouri Health Director Tracked Planned Parenthood Patients' Periods On Spreadsheet, Huffington Post (Oct. 29, 2019, 11:00 AM), https://www.huffpost.com/entry/missouri-health-official-planned-parenthood-periods_n_5db8a9dbe4b0bb1ea370e116; Rachel Maddow, Trump Admin Tracked Individual Migrant Girls' Pregnancies, MSNBC (Mar. 15, 2019), https://www.msnbc.com/rachel-maddow/watch/trump-admin-tracked-individual-migrant-girls-pregnancies-1459294787849.

48 Some health apps look and act enough like health care that these laws and regulations indeed apply. For example, the FDA regulates some health apps as “mobile medical apps.” This definition includes apps that have device software functionality meeting the definition of a device in section 210(h) of the Food, Drug, and Cosmetic Act and are either intended to be used “as an accessory to a regulated medical device” or “transform a mobile platform into a regulated medical device.” See U.S. Food & Drug Admin., Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff 4-5 (Sep. 27, 2019), https://www.fda.gov/media/80958/download.

49 See Shuren, Jeffrey et al., FDA Regulations of Mobile Medical Apps, 320 JAMA 337, 337 (2018)CrossRefGoogle ScholarPubMed.

50 21st Century Cures Act, Pub. L. No. 114-255, § 3060, 130 Stat. 1130 (2016) (codified as amended at 21 U.S.C. § 360j(o)(1)(B) (2016)).

51 For other apps, FDA is piloting a new pre-certification program with a streamlined review for companies producing software as medical devices that demonstrate “a culture of quality or organizational excellence.” Instead of showing clinical outcomes before release, they are instead subject to post-market performance monitoring of safety and effectiveness, See Sim, supra note 8, at 962.

52 Gambier-Ross et al., supra note 7, at 2.

53 U.S. Dep't Health & Hum. Servs., Guidance for Health IT Developers: Health App Use Scenarios & HIPAA 1 (Feb. 2016), https://hipaaqsportal.hhs.gov/community-library/accounts/92/925889/Public/OCR-health-app-developer-scenarios-2-2016.pdf.

54 Id.

55 Errol Ozdalga et al., The Smartphone in Medicine: A Review of Current and Potential Use Among Physicians and Students, 14 J. Med. Internet Res. e128 (2012).

56 Nicole Martinez-Martin & Karola Kreitmair, Ethical Issues for Direct-to-Consumer Digital Psychotherapy Apps: Addressing Accountability, Data Protection, and Consent, 5 JMIR Mental Health e32 (2018); see also Bakos, Yannis et al., Does Anyone Read the Fine Print? Consumer Attention to Standard Form Contracts, 43 J. Legal Stud. 1, 31-32 (2014)CrossRefGoogle Scholar (“[m]easures that reduce the cost of comprehending the contract terms are likely to be more successful … Thus, a regulatory approach focusing on shortening and simplifying online contracts, standardizing their terms, and providing a standardized summary is more likely to increase readership than an approach focusing on [mandating] disclosure. [This suggests that an important benefit of regulations that mandate disclosure of basic credit terms in a standardized manner and large fonts], such as the “Schumer box” in the U.S. and the “summary Box” in the United Kingdom, [comes from reducing] the cost of reading and comprehending these terms. Simple and plain language requirements can be seen in the same light.”).

57 See generally T.J. Kasperbauer & David E. Wright, Expanded FDA regulation of health and wellness apps, 34 Bioethics 235 (2019).

58 Google, L.L.C., Developer Policy Center, Google Play, https://play.google.com/about/developer-content-policy (last visited Apr. 6, 2020).

59 Apple, Inc., App Store Review Guidelines, Apple Developer, https://developer.apple.com/app-store/review/guidelines (last updated Mar. 4, 2020).

60 See, e.g., California Consumer Privacy Act of 2018, Assemb. B. 375, ch. 55, 2017-18 Leg. (Cal. 2018) (enacted); Att'y Gen. Kamala D. Harris, Cal. Dep't of Just., Privacy on the Go: Recommendations for the Mobile Ecosystem 1-2 (2013), https://oag.ca.gov/sites/all/files/agweb/pdfs/privacy/privacy_on_the_go.pdf.

61 Discussion international laws, such as the GDPR, are relevant to the discussion but outside the scope of this paper.

62 Complaint for Permanent Injunction & Other Equitable Relief at 9-10, FTC v. Aura Labs, Inc., No. 8:16-cv-2147 (C.D. Cal. Dec. 2, 2016), https://www.ftc.gov/system/files/documents/cases/161212_aura_labs_complaint.pdf.

63 Complaint at 4, In re Koby Brown, No. 102-3205, (F.T.C. 2011), https://www.ftc.gov/sites/default/files/documents/cases/2011/09/110908dermappscmpt.pdf.

64 See Nancy S. Kim, Wrap Contracts: Foundations and Ramifications 35-43 (2013). Clickwrap contracts are those that require a consumer to affirmatively select that they agree to the conditions in some form or another, such as by checking a box that says, “I have read and agree to the terms.” A browsewrap contract requires a user to navigate somewhere else – sometimes after clicking a hyperlink provided in a prominent location and other times located in less obvious places. Id. at 42-43. Instead of clicking “I agree,” a user is assumed to have agreed to the terms of a browsewrap contract by using the technology so long as they have notice that the terms exist.

65 See id. at 37-39.

66 See id. at 3-4.

67 See id. at 103.

68 Id. at 138.

69 See id. at 128-29.

70 See id. at 137-39.

71 Id. at 2-4.

72 See, e.g., id. at 1-5.

73 Ali Sunyaev et al., Availability and Quality of Mobile Health App Privacy Policies, 22 J. Am. Med. Inform. Assoc. e28, e31 (2015); see also Bakos et al., supra note 56, at 195 (“We find that only one or two out of 1,000 retail software shoppers choose to access the license agreement and that most of those that do access it [spend too little time to have] read more than a small portion of the text.”); Nili Steinfeld, “I Agree to the Terms and Conditions”: (How) do Users Read Privacy Policies Online? an Eye-Tracking Experiment, 55 Computers in Human Behav. 992 (2016); Kevin Litman-Navarro, We Read 150 Privacy Policies. They Were an Incomprehensible Disaster, N.Y. Times (June 12, 2019), https://www.nytimes.com/interactive/2019/06/12/opinion/facebook-google-privacy-policies.html (last accessed September 11, 2019).

74 Roberts, Jessica L. & Hawkins, Jim, When Health Tech Companies Change Their Terms of Service, 367 Science 745, 745 (2020)CrossRefGoogle Scholar.

75 See Kashmir Hill, What happens when you tell the internet you're pregnant, Jezebel (July 27, 2017), https://jezebel.com/what-happens-when-you-tell-the-internet-youre-pregnant-1794398989.

76 Id.

77 See Thomas, Gareth Martin & Lupton, Deborah, Threats and Thrills: Pregnancy Apps, Risk, and Consumption, 17 Health, Risk & Society 495, 499 (2016)CrossRefGoogle Scholar.

78 Id. (referencing Ovia Pregnancy Tracker, https://www.oviahealth.com).

79 See id. at 499-500.

80 See supra notes 60-62.

81 See Leah R. Fowler et al., Readability and Accessibility of Terms of Service and Privacy Policies for Menstruation-Tracking Smartphone Applications, Health Promotion Practice, Feb. 2020, at 4.

82 But see Huckvale et al., supra note 33, at 2.

83 In a small qualitative study of Danish women's use of period-tracking apps, no interviewee had read the privacy policies or remembered permitting the app for data sharing. However, those interviewed did not perceive the risk of data sharing to be great. Users also erroneously assumed that they could disappear into aggregate data, underscoring the importance of increased scrutiny into privacy protections and the way apps communicate data-handling practices. Karlsson, supra note 27, at 117-19.

84 Hill, supra note 75.

85 See Kim, supra note 64, at 71-76.

86 Canterbury v. Spence, 464 F.2d 772, 783 n.36 (D.C. Cir. 1972).

87 See Ruth R. Faden & Tom L. Beauchamp, A History and Theory of Informed Consent 3 (1986).

88 Berg, Jessica, The E-Health Revolution and the Necessary Evolution of Informed Consent, 11 Ind. Health L. Rev. 589, 594 (2014)Google Scholar.

89 Faden & Beachamp, supra note 87, at 8-9.

90 Whitney, Simon N. et al., A Typology of Shared Decision Making, Informed Consent, and Simple Consent, 140 Annals Internal Med. 54, 55 (2004)CrossRefGoogle ScholarPubMed.

91 Id.

92 Berg, supra note 88, at 590-91.

93 See Wiggins, Andrea & Willbanks, John, The Rise of Citizen Science in Health Care and Biomedical Research, 19 Am. J. Bioethics 3, 7 (2019)CrossRefGoogle Scholar.

94 Martinez-Martin & Kreitmair, supra note 56, at 4.

95 See Fowler et al., supra note 81, at 3.

96 Id.

97 Faden & Beauchamp, supra note 87, at 13.

98 Nir Eyal, Informed Consent, Stan. Encyclopedia of Phil., https://plato.stanford.edu/archives/spr2019/entries/informed-consent (last updated Jan. 16, 2019).

99 Id.

100 See Kim, supra note 64, at 57-59.

101 See Faden & Beauchamp, supra note 87, at 19.

102 Kim, supra note 63, at 71-76.

103 For more on Kantian ethics, see Immanuel Kant, Fundamental Principles of the Metaphysic of Morals (Thomas Kingsmill Abbott trans., CreateSpace Independent Publishing Platform 2016) (1785).

104 See Sugarman, Jeremy et al., A Professional Standard for Informed Consent for Stem Cell Therapies, 322 JAMA 1651, 1652 (2019)CrossRefGoogle Scholar.

105 Urs-Vito Albrecht, Transparency of Health-Apps for Trust and Decision Making, 15 J. Med. Internet Res. e277 (2013).

106 For a detailed review of some of the problems with informed consent as framed by legal standards, see generally Koch, Valerie Gutmann, Eliminating Liability for Lack of Informed Consent to Medical Treatment, 53 U. Rich. L. Rev. 1211, 1219-31 (2019)Google Scholar.

107 Contreras, Jorge, Genetic Property, 105 Geo. L.J. 1, 29 (2016)Google Scholar (“Like clickwrap agreements for computer software, much informed consent documentation has become so lengthy, complex, and turgid that all but the most sophisticated readers have difficulty understanding it.”).

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