Podcast
Questions and Answers
Recruiting into research can qualify as an activity 'preparatory to research' under which circumstances?
Recruiting into research can qualify as an activity 'preparatory to research' under which circumstances?
What type of information does HIPAA protect?
What type of information does HIPAA protect?
Under HIPAA, when is a 'disclosure accounting' required?
Under HIPAA, when is a 'disclosure accounting' required?
Which of the following is NOT an acceptable reason for a covered entity to use or disclose PHI without authorization?
Which of the following is NOT an acceptable reason for a covered entity to use or disclose PHI without authorization?
Signup and view all the answers
What does HIPAA include in its definition of 'research'?
What does HIPAA include in its definition of 'research'?
Signup and view all the answers
Study Notes
Recruitment in Research
- Initial contact with potential research participants can be considered "preparatory to research."
- Data from this preparatory phase must remain within the covered entity and should not be shared externally.
Protected Health Information (PHI)
- HIPAA protects identifiable health information created or held by covered entities and their business associates.
- PHI must involve identifiable information related to individuals and is not limited by the individual's citizenship status.
Disclosure Accounting under HIPAA
- Disclosure accounting is mandatory for human subjects research using PHI when authorization from the data subject is absent.
- Exceptions include research utilizing limited data sets, simplifying the accounting requirements for such cases.
Use and Disclosure of PHI
- Covered entities can disclose PHI without authorization in several situations but not for limited data sets unless there's an approved data use agreement.
- Researchers must provide specific representations when using decedents' information or when research data does not cross state lines.
Definition of Research under HIPAA
- The term "research" under HIPAA encompasses activities aimed at generating generalizable knowledge.
- This definition is broad and includes various domains such as population health and quality assessment, not limited to federally-supported laboratories.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
Test your knowledge on health privacy issues and regulations relevant to researchers. This quiz covers important concepts such as patient recruitment and the necessary authorizations for contact. Enhance your understanding to ensure compliance in your research endeavors.