Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability , and Informed Consent, and the Way to Move Forward

Digital Home Health During the COVID-19 Pandemic Challenges to Safety, Liability , and Informed Consent, and the Way to Move Forward
Faculty Books
Sara Gerke
Dickinson Law Idea, 2022
Open Access
Introduction
Artificial intelligence (AI) and other digital health products, such as smart pills, are rapidly entering clinical practice. We live in the age of big data, where massive amounts of data are collected and used to develop or update digital health products and are shared with third parties for research or commercial purposes. Moreover, we can already see a shift in health care from hospitals to people’s homes, for example through the use of medical apps, Fitbits, and other wearables. This line between clinic and home will likely become more and more blurry in the near future. According to one estimate, the smart home health care market size is projected to grow from $6.1 billion in 2018 to over $30 billion in 2025. In particular, the COVID-19 pandemic has propelled the adoption of health AI and digital health across multiple applications. For example, the development and use of digital home health products have been expedited to reduce exposure to the coronavirus SARS-CoV-2, such as through remote patient monitoring, and to better control its spread, such as through exposure-notification apps. At the same time, the regulation of medical devices is more flexible during the public health emergency. However, the acceleration of launching new digital home health devices on the US market combined with less regulatory oversight also raises some challenges, including post-pandemic questions. In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.