Research and HIPAA Privacy Protections

Questions and Answers

What are HIPAA's protections for health information used for?

Research purposes

What does PHI stand for?

Protected health information

When is more detailed information required in a HIPAA disclosure accounting?

For disclosures that involve fewer than 50 subject records

What does HIPAA include in its definition of 'research'?

Activities related to the development of generalizable knowledge Signup and view all the answers

When is a 'disclosure accounting' required under HIPAA?

For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets Signup and view all the answers

What characteristic does a HIPAA authorization have?

Uses 'plain language' that the data subject can understand Signup and view all the answers

What is 'retrospective research' under HIPAA?

Research that generally requires either an authorization or meeting one of the criteria for a waiver of authorization Signup and view all the answers

Study Notes

HIPAA and Research

HIPAA enhances protections for health information used in research in addition to the Common Rule and FDA regulations.
Research activities under HIPAA aim to develop generalizable knowledge, extending beyond clinical trials.

Protected Health Information (PHI)

PHI is defined as identifiable health information created or held by covered entities and their business associates.
PHI must be adequately protected when used in research settings to ensure privacy and compliance.

Disclosure Accounting

When providing information to a data subject regarding HIPAA disclosure accounting, further detail is necessitated for cases involving fewer than 50 records from subjects.
A "disclosure accounting" is mandatory for all human subjects research that utilizes PHI without prior authorization, with the exception of limited data sets.

HIPAA Authorization Characteristics

A HIPAA authorization must be written in "plain language" to ensure the data subject fully understands it, similar to informed consent documents.

Retrospective Research Requirements

Retrospective research, also known as data mining, that involves PHI is classified as research under HIPAA and requires either authorization or fulfillment of waiver criteria.

Description

This quiz covers key concepts related to HIPAA privacy protections, particularly in the context of health information used for research purposes. Familiarize yourself with terms such as protected health information (PHI) and the relationship between HIPAA and other regulations like the Common Rule and FDA. Test your knowledge and understanding of these important privacy regulations.