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Abstract: The human microbiome is rapidly emerging as a major factor in human disease and wellness, as the microbes in or on our bodies are central to our health, informing medical decisions relating to disease risk, prognosis, diagnosis, treatment, and preventative measures. With the rapid growth of microbial science and medicine, a number of novel legal issues associated with microbiomics are also emerging. These legal issues include: regulatory pathways for living microorganisms as disease therapeutics or wellness aids, forensic applications, privacy implications, informed consent requirements, return of results, intellectual property, and diversity of samples and subjects. This article surveys and describes these legal issues and provides an agenda for the legal community to respond to the challenge posed by the rapidly emerging science of microbiomics.
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