Genetic database software as medical devices.

This article provides a primer on medical device regulations in the United States, Europe, and Canada. Software tools are being developed and shared globally to enhance the accessibility and usefulness of genomic databases. Interactive software tools, such as email or mobile alert systems providing variant classification updates, are opportunities to democratize access to genomic data beyond laboratories and clinicians.

Bridging stem cell research and medicine: a learning health system.

Stem cells may not systematically obey traditional Phase I-IV clinical translation models. In response, various actors have suggested that stem cell-based medical innovation models could catalyze translation instead. Accordingly, calls were made to adopt more permissive approaches to stem cell translation.

Disease Resistance and the Definition of Genetic Enhancement.

Recent gene editing experiments carried out in human embryos have raised the question of whether interventions like the introduction of a CCR5-Δ32 deletion, which could provide heritable resistance to HIV infection, ought to be considered enhancements. Many authors have used the term "enhancement" in different ways, some based on patients' biomedical outcomes and others on their social context. These classifications are often considered overly imprecise.