Research and HIPAA Privacy Protections (ID 14). /Research and HIPAA Privacy Protections. Questions, Answers and Explanations.

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Research and HIPAA Privacy Protections (ID 14) HIPAA's protections for health information used for research purposes... HIPAA protects a category of information known as protected health informati... on (PHI). PHI includes: When required, the information provided to the data subject in a HIPAA disclosure accounting ... HIPAA includes in its definition of "research," activities related to ... Under HIPAA, a "disclosure accounting" is required: A HIPAA authorization has which of the following characteristics: Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT: If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: EXPLANATION: An organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. HIPAA's protections for health information used for research purposes... Under HIPAA, a "disclosure accounting" is required: EXPLANATION: HIPAA's relatively new data-focused protections, which took effect starting in 2003, supplement Common Rule and FDA protections; they are not a replacement. Institutional Review Board (IRB) protocol reviews using Common Rule and FDA criteria remain as before, including aspects related to data protection. IRBs may have the responsibility for addressing HIPAA's additional requirements in their reviews when those apply; or some responsibilities may be given to another kind of body that HIPAA permits (a Privacy Board) or to an institutional official that HIPAA requires (a privacy officer). These federal standards complement states' and accreditation bodies' requirements. A HIPAA authorization has which of the following characteristics: EXPLANATION: Authorizations are required unless the proposed use meets one of the exceptions listed in the HIPAA regulation. It is never at the researcher's discretion. When they are required, authorizations must be: In "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision. ... HIPAA includes in its definition of "research," activities related to: Development of generalizable knowledge. The HIPAA "minimum necessary" standard applies... To all human subjects research that uses PHI without an authorization from the data subject. Recruiting into research ... Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity. When required, the information provided to the data subject in a HIPAA disclosure accounting ... HIPAA protects a category of information known as protected health information (PHI). PHI includes: When required, the information provided to the data subject in a HIPAA disclosure accounting ... HIPAA includes in its definition of "research," activities related to ... Under HIPAA, a "disclosure accounting" is required: A HIPAA authorization has which of the following characteristics: Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ... [Show More]

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