The completion of the Human Genome Project opened new doors for business enterprise. One such activity is direct-to-consumer (DTC) genetic testing, or genetic testing offered on a service-driven basis, without the need for a clinician or other intermediary. DTC genetic testing has been, and continues to be, a burgeoning market and source of genetic data for original research that has produced new insights and discoveries in human ancestry and health.
PROJECT NARRATIVE Consumer protections are of rising importance to the sustainability of personal genomics and mobile health industries and realization of precision health, yet the extent of consumer protections available from the Federal Trade Commission (the primary federal agency in the United States responsible for ensuring online privacy and data security beyond medical settings, for the prevention of unfair and deceptive trade practices of companies that might not be governed by HIPAA, and for promoting innovation) are poorly characterized and have received surprisingly little ELSI re
The incorporation of genetics and genomics into medical care and the public domain raises new challenges for how we understand privacy and identity, concepts that have long been closely linked in American discourse.
Healthcare institutions are implementing artificial intelligence (AI) at a rapid pace. The hope is that AI will improve the quality of care and reduce costs in the long run. However, the deployment of AI in healthcare settings also presents new ethical and legal challenges. For example, AI can reproduce health disparities and pose a risk to patients if human factors, like implicit or explicit bias, are present in the training data set or it lacks representation from population subgroups. AI also raises challenges for regulators like the U.S. Food and Drug Administration (FDA).
PROJECT NARRATIVE Consumer protections are of rising importance to the sustainability of personal genomics and mobile health industries and realization of precision health, yet the extent of consumer protections available from the Federal Trade Commission (the primary federal agency in the United States responsible for ensuring online privacy and data security beyond medical settings, for the prevention of unfair and deceptive trade practices of companies that might not be governed by HIPAA, and for promoting innovation) are poorly characterized and have received surprisingly little ELSI re