An ad hoc committee will plan and conduct a public workshop to explore the effect of regulatory requirements on the production of health literate communications, both written and oral. The workshop will feature invited presentations and discussions of regulatory requirements for health care providers and researchers, using the topic of informed consent as a way to illustrate the practical effect of these requirements on health literate practices. The topic may encompass consent to care, diagnostics, treatment, and clinical research. It will also include the interaction between the patient and provider or researcher as well as documents provided to the patient. The workshop will feature the presentation of a commissioned paper that will frame the issue by providing a broad overview of the regulatory landscape that may include some review of best practices or practices to avoid. The committee will define the specific topics to be addressed, develop the agenda, select and invite speakers and other participants, and moderate the discussions. An individually-authored summary of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.