1. How is research defined under HIPAA?
2. When does Quality Assurance (QA) become research?
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.
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