Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

Authors

• Mark A. Rothstein
• John T. Wilbanks
• Laura M. Beskow
• Kathleen M. Brelsford
• Kyle B. Brothers
• Megan Doerr
• Barbara J. Evans
• Catherine Hammack-Aviran, Belmont University College of LawFollow
• Michelle L. McGowan
• Stacey A. Tovino

Document Type

Article

Publication Date

2020

Abstract

The rapid expansion of mobile health (mHealth) technologies has enabled large-scale collection of health-related data outside traditional clinical research environments. This article examines ethical and regulatory challenges posed by “unregulated” health research conducted through mobile applications, wearable devices, and consumer digital platforms. Drawing on legal analysis and ethical scholarship, the authors explore gaps in the U.S. regulatory framework, particularly where research activities fall outside the scope of the Common Rule or other human-subject protections. The paper identifies key ethical risks, including inadequate informed consent, privacy vulnerabilities, unclear data governance, and limited accountability for commercial entities conducting research. To address these challenges, the authors propose policy reforms and oversight strategies aimed at improving transparency, participant protections, and ethical governance while maintaining flexibility for innovation in digital health research.

Recommended Citation

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations, 48 J. L. Med. Ethics S.1: 196-226 (2020) (with Mark Rothstein, John Wilbanks, Laura Beskow, Kathleen Brelsford, Kyle Brothers, Megan Doerr, Barbara Evans, Michelle McGowan & Stacey Tovino).