HIPAA Overview

Public Health Disclosures

lMandated reporting of contagious diseases

lDisclosure regarding an FDA regulated activity

lRegistries

–Government, academic and non-profit

–Required by law, IRB waiver, authorization, limited data set

–Development of registry for research is “research”


	All such disclosures should be in keeping with “minimum necessary standard”

	Registries do not have to be government sponsored. Academic and non-profit registries qualify.

	Currently can use data in registry for research with IRB approval (and approval of the registry holder). Need patient authorization or waiver etc. under HIPAA.

	FDA – Disclosures related to safety, quality and effectiveness of an FDA regulated product – adverse events, product recalls, post marketing surveillance

	Does not include disclosure to drug companies for marketing purposes.

	Minimum necessary