Regulatory regimes and procedural values for health-related motion data in the United States and Canada. Issue 3 (September 2022)

• Record Type: Journal Article
• Authors: Boyer, Philip; Donia, Joseph; Whyne, Cari; Burns, David; Shaw, James
• Is Part Of: Health policy and technology. Volume 11:Issue 3(2022)
• Publication Date: 2022-09
• Subjects: Motion data -- Wearable technologies -- Digital health -- Health Technology -- Policy regimes -- Procedural -- Values -- Artificial -- Intelligence; Medical policy -- Periodicals; Medical technology -- Periodicals; Medical policy; Medical technology; Health Policy -- Periodicals; Biomedical Technology -- Periodicals; Technology Assessment, Biomedical -- Periodicals; Periodicals; 362.105
• DOI: 10.1016/j.hlpt.2022.100648
• Languages: English
• ISSNs: 2211-8837

Abstract

Highlights: Wearable digital health technologies are subject to limited regulation in California and Ontario. Wearable apps can infer information about a user's health but are often not classified as medical devices. Motion data are not typically required to adhere to the protections reserved for health care data. Value-based gaps in policy regimes warranting further investigation include inconsistent regulatory implications, lack of trustworthy practices, and diverging definitions of reasonableness. Greater consideration of procedural values in policymaking could help ameliorate the risks of motion data from wearables. Abstract: Objectives: Digital health technologies often have minimal regulatory oversight if the perceived risk to users is low. This is especially relevant to motion data captured from wearable devices, which are increasingly used across sectors and in clinical settings. The aim of this research is to identify gaps in procedural values embedded in two policy regimes for the governance of health-related motion data. Methods: This paper examines the policy regimes of the state of California in the United States and the province of Ontario in Canada with respect to digital health applications and the use of motion data, and demonstrates how three example technologies would be regulated under these regimes. This is followed by a gap analysis of procedural values within the two policy regimes. Results: Applications that are categorized as health and wellness or are not classified as medical devices under these regimes are not typically required to adhere to the strict guidelines of data usage, application standards and accountability reserved for health care, despite collecting and distributing data that may be used to infer information about a user's health. The values-based gaps in these policy regimes illustrate three crucial issues for research and policy on this topic: Inconsistent regulatory implications for different entities, a lack of trustworthy practices, and challenges over the definition of "reasonableness". Conclusion: Greater consideration of procedural values embedded in policies could better advance the goal of ameliorating the risks of motion data collected by wearable devices and applications. Public Interest Summary: Digital applications that use movement data from wearable devices are appearing more frequently throughout society. They are even used in many health care settings. Movement data and applications are usually considered relatively low risk to users, and as such often bypass health data and medical device regulatory protections. However, these data can be used to generate information about a person's health, and may in some cases influence treatment decisions. This paper provides an overview of the regulatory environments for digital health applications and motion data for the state of California in the United States and the province of Ontario in Canada. We demonstrate how three example digital health applications would be regulated in these jurisdictions, and use them to highlight the need for policies that better protect the public from the potential risks of health-related motion data collected by wearable devices.