Ethical, legal, and social issues related to ingestible, implantable electronic devices and mRNA delivery devices.
Lisa Bero, Natalie Banacos, Christine M Baugh, Peter R Chai, Tiffany R Glynn, Matthew DeCamp, Ben Harnke, Hannah Scotch, Jelena Durdic, Matthew Wynia, Eric G Campbell
Abstract
Open AccessOral delivery systems are being developed to treat disease, including ingestible devices that implant in the gut and deliver electrical stimulation or mRNA therapeutics. The implementation of these devices raises questions about the associated ethical, legal, and social implications (ELSIs). Our scoping review examined 83 scholarly publications published between 1946 and 2024 that investigate ELSI topics around the development and use of these technologies. We highlight the characteristics of the publications, the ethics topics mentioned, and a content analysis to describe ELSI themes. Themes particularly relevant to ingestible, implantable electronics and mRNA delivery devices were data use, invasiveness, and possible impacts on patient-clinician trust. This review suggests solutions to better protect patients from ethical and clinical risks resulting from data misuse and future empirical research engaging clinicians, patients, and researchers in this field.