HIPAA, the “Health Insurance Portability and Accountability Act of 1996,” provides federal protection of patient health information. You will be receiving weekly messages to help you understand the topic and how it impacts your job. Today’s HIPAA message examines when quality assurance becomes research.
Questions:
1.How is research defined under HIPAA?
2.When does Quality Assurance (QA) become research?
Answers:
1.HIPAA adopted the common rule definition of research:
- a systematic investigation;
- designed to develop or contribute to generalizable knowledge.
2.Quality Assurance is defined as quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines.
Quality Assurance is part of healthcare operations under HIPAA; however, when you intend to communicate results outside the organization in publications, lectures and other community forums, then you are contributing to generalizable knowledge and are conducting research. Contact the Institutional Review Board (IRB) if you have questions.
If you’re a manager, please ensure all of your employees are informed of the contents of these messages and how it applies to your work area. Some ways of sharing the information include discussions during staff meetings, printing and posting this message or asking your employees if they have any further questions.