Research Issues – FAHC Data College of Medicine Home 的研究的问题–fahc数据医学院的家.pptVIP

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Research Issues – FAHC Data College of Medicine Home 的研究的问题–fahc数据医学院的家.ppt

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Research Issues – FAHC Data College of Medicine Home 的研究的问题–fahc数据医学院的家

Patient Health Information and HIPAA First Meeting for Researchers Frank Fontana December 17, 2002 Research Issues – FAHC Data As everyone knows, there is an extremely close relationship between UVM and FAHC The relationship is so close that it is easy to not recognize the separate identity of each legal entity The Privacy Rule forces us to acknowledge and respect the legal distinctions Research Issues – FAHC Data Why does it force us to do that? Because disclosures of health information from a covered entity (like FAHC) to any other entity (like UVM) must be justified by a specific provision in the Privacy Rule So now let’s consider the FAHC data and how it flows for research projects Research Issues – FAHC Data And remember – with some exceptions, there either has to be an authorization from a patient to release information for research, or the IRB has to waive or alter the authorization requirement So, when UVM desires access to FAHC patient information for research, because UVM is performing the research, UVM must produce for FAHC either an authorization or an IRB waiver Research Issues – FAHC Data When FAHC is performing the research, FAHC is responsible for obtaining the authorization or the IRB waiver Another issue with respect to the separation between UVM and FAHC – we have to remain very aware of disclosures between the two entities, and think about whether they are justified by the Privacy Rule Research Issues – FAHC Data In other words, if FAHC is the researcher for a certain study, the Privacy Rule may very well prohibit FAHC from freely sharing the research records with UVM Conversely, if UVM is the researcher, the Privacy Rule may prohibit UVM from freely sharing the research records with FAHC Research – Other Issues We have to think in terms of recruitment and the actual study – we need to focus on what obligations exist at each stage, because they may very well be different We should also focus on where research records are kept, as FAHC w