How Could Commercial Terms of Use and Privacy Policies Undermine Informed Consent in the Age of Mobile Health?

Granular personal data generated by mobile health (mHealth) technologies coupled with the complexity of mHealth systems creates risks to privacy that are difficult to foresee, understand, and communicate, especially for purposes of informed consent. Moreover, commercial terms of use, to which users are almost always required to agree, depart significantly from standards of informed consent. As data use scandals increasingly surface in the news, the field of mHealth must advocate for user-centered privacy and informed consent practices that motivate patients' and research participants' trust. We review the challenges and relevance of informed consent and discuss opportunities for creating new standards for user-centered informed consent processes in the age of mHealth.

[1]  Cicely Marston,et al.  Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK , 2015, Int. J. Medical Informatics.

[2]  Scott R. Peppet Regulating the Internet of Things: First Steps Toward Managing Discrimination, Privacy, Security & Consent , 2014 .

[3]  Nadir Weibel,et al.  Reimagining Human Research Protections for 21st Century Science , 2016, Journal of Medical Internet Research.

[4]  Eric J Topol,et al.  Can mobile health technologies transform health care? , 2013, JAMA.

[5]  Xiaoqian Jiang,et al.  iCONCUR: informed consent for clinical data and bio-sample use for research , 2016, AMIA.

[6]  C. Suver,et al.  Developing a Transparent, Participant-Navigated Electronic Informed Consent for Mobile-Mediated Research , 2016 .

[7]  Stacey Pereira,et al.  Do privacy and security regulations need a status update? Perspectives from an intergenerational survey , 2017, PloS one.

[8]  Hetan Shah Use our personal data for the common good , 2018, Nature.

[9]  Ali Sunyaev,et al.  Availability and quality of mobile health app privacy policies , 2015, J. Am. Medical Informatics Assoc..

[10]  J. Tyson,et al.  Randomized n-of-1 Trials: Quality Improvement, Research, or Both? , 2016, Pediatrics.

[11]  Mark A. Rothstein,et al.  Citizen Science on Your Smartphone: An ELSI Research Agenda , 2015, Journal of Law, Medicine & Ethics.

[12]  Scout Calvert,et al.  Opportunities and challenges in the use of personal health data for health research , 2016, J. Am. Medical Informatics Assoc..

[13]  C. Suver,et al.  Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study , 2017, JMIR mHealth and uHealth.

[14]  Barbara J. Evans,et al.  Barbarians at the Gate , 2016, American Journal of Law & Medicine.

[15]  Matthew J. Bietz,et al.  Privacy Attitudes among Early Adopters of Emerging Health Technologies , 2016, PloS one.

[16]  Tom Rodden,et al.  Consent for all: revealing the hidden complexity of terms and conditions , 2013, CHI.

[17]  Matthew J. Bietz,et al.  Privacy Policies for Apps Targeted Toward Youth: Descriptive Analysis of Readability , 2018, JMIR mHealth and uHealth.

[18]  Nadir Weibel,et al.  Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives , 2017, AJOB empirical bioethics.

[19]  “Common Rule,et al.  Federal Policy for the Protection of Human Subjects. Final rule. , 2017, Federal register.

[20]  R. D. de Vries,et al.  Moral concerns and the willingness to donate to a research biobank. , 2015, JAMA.

[21]  J. Kerr,et al.  Engaging research participants to inform the ethical conduct of mobile imaging, pervasive sensing, and location tracking research , 2016, Translational behavioral medicine.

[22]  S. Cummings,et al.  Informed Consent. , 2017, The New England journal of medicine.

[23]  Eric J. Topol,et al.  The emerging field of mobile health , 2015, Science Translational Medicine.

[24]  Eric J. Topol,et al.  A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors , 2015, bioRxiv.

[25]  Mobile Health and Fitness Apps: What Are the Privacy Risks? , 2017 .