Health Insurance Portability and Accountability Act (HIPAA)
Health Insurance Portability and Accountability Act (HIPAA) introduces new standards
for protecting the privacy of individuals’ identifiable health information.
HIPAA regulations apply to investigators who need to use, for research purposes,
individually identifiable health information held by a covered entity or its business
associates. Individually identifiable health information means the identity of the
subject is or may readily be ascertained by the investigator or associated with the
information. Covered entities are defined as: (1) health plans, (2) health care clearing
houses, and (3) health care providers who electronically transmit any health information
in connection with transactions, for which The Department of Health and Human Services
(HHS) has adopted standards (generally, transactions concern billing and payments
for insurance coverage). For example, hospitals, academic medical centers, physicians
who electronically transmit claims transaction information to a health plan.