Establishing Meaningful Informed Consent: Challenges in mHealth

The role of mobile health (mHealth) technologies, including smartphone applications and wearable sensors that enable real-time health monitoring, has become more prevalent in medicine within the last decade. According to authors of an AMA Journal of Ethics article, the inner workings of these technologies have become increasingly complex, and the simple act of collecting, transmitting, and storing these health data carry substantial risks to patient privacy, as well as consent.

Mobile health applications have become increasingly used in health monitoring and clinical practice; many patients can easily incorporate these technologies into their everyday life. Unfortunately, the potential for health data to be shared or accessed by health companies has posed a significant risk to patient privacy. According to the authors, these risks include insurance discrimination, access to health data by family members, and political manipulation.

Obtaining informed consent from mobile health users has also been difficult, primarily because of the arbitrary rules and definitions set forth for doing so. Reconciling commercial terms of use with informed consent, the researchers stated, represents the largest challenge in this field of health technology. They suggest that “the principles that underlie informed consent should guide professionals who adopt mHealth technology as they seek to maintain transparency and protect the interests of mHealth participants and patients.”

An initiative in the European Union, the General Data Protection Regulation, is an approach that will hopefully tackle the difficulty in obtaining meaningful informed consent among patients using mobile health platforms. In commercial situations, the GDPR necessitates that “consent be legible and accessible, that the purpose of collecting data be stated, and that consent be obtained at the point of data collection and be easy to withdraw.” Potentially, these criteria will hopefully inform uniform guidelines across nations, depending on the technology and the environment in which the technology is to be used.

“Leaders in health care and research who seek to leverage mHealth technologies should draw upon the strength of informed consent as they face the challenge of managing unique privacy risks to users,” the researchers wrote. “Informed consent can strengthen trust in relationships across research and clinical practice, and therefore research and health care institutions should seek opportunities to promote and develop better systems of consent and oversight in the age of mHealth.”

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Reference

Schairer CE, Rubanovich CK, Bloss CS. How could commercial terms of use and privacy policies undermine informed consent in the age of mobile health? AMA J Ethics. 2018;20(9):E864-E872.

This article originally appeared on Medical Bag