Ingestible electronic sensors are a promising technology for improving health outcomes that may, for example, be useful in monitoring and promoting the taking of medication. However, these sensors also raise ethical and legal challenges that need to be considered by all stakeholders—notably, the creators of such products—at the earliest stages of the development process. Here, we examine selected ethical and legal issues related to ingestible electronic sensors. We first briefly describe sensors that are already available on the US and European markets as well as potential future sensor combinations. We then focus on ethical aspects, discussing patient, provider, and social issues. Finally, we provide a comparative analysis of legal regulation of ingestible electronic sensors in the US and Europe.
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The research for this contribution was supported by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme in Biomedical Innovation Law (grant agreement no. NNF17SA027784).
I.G.C. has served as a consultant for Otsuka Pharmaceutical on their Abilify MyCite product. The company neither funded the preparation of this Perspective nor played a role in its drafting or review.
Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Gerke, S., Minssen, T., Yu, H. et al. Ethical and legal issues of ingestible electronic sensors. Nat Electron 2, 329–334 (2019). https://doi.org/10.1038/s41928-019-0290-6
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