ABSTRACT
The connected at-home healthcare device industry is booming. Wearable health trackers alone constituted a $21 billion market in 2020, anticipated to grow to $195 billion by 2027. At-home devices now purportedly make it possible to diagnose and monitor health conditions such as sleep apnea, diabetes, and fertility automatically, immediately, and discreetly. By design, these devices produce a wealth of data that can inform patients of their health status and potentially even recommend life-saving actions. But patients and their healthcare providers often lack access to this data. Manufacturers typically design connected at-home devices to store data in cloud services run by the manufacturers themselves, requiring device owners to register accounts and accept terms of use and limitations that the manufacturers impose …
Duan, Charles and Morten, Christopher, Patient Access to Health Device Data: Toward a Legal Framework (March 8, 2023) in I Glenn Cohen, Daniel B Kramer, Julia Adler-Milstein and Carmel Shachar (eds), Digital Health Care Outside of Traditional Clinical Settings: Ethical, Legal and Regulatory Challenges and Opportunities, Cambridge University Press (forthcoming 2024).
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