The HIPAA Privacy Rule provides individuals with certain rights about how their health information is used and
Question:
The HIPAA Privacy Rule provides individuals with certain rights about how their health information is used and disclosed as well as how they can gain access to health records and information about when their PHI was released without their permission. At the same time, the privacy rule describes how covered entities can implement these rights while maintaining the integrity of the research project.
What do you consider are some ethical dilemmas that may arise as a result of the privacy rule's protection of human subjects in research studies?
For example, do you think the de-identification of data sufficiently protects participants/patients' privacy rights? Is choosing one de-identification method over another more restrictive or protective of patients' rights? Does the privacy rule limit or restrict investigators' clinical studies? To what extent does the role of the Institutional Review Board (IRB) help facilitate the balance between protecting participants' privacy and maintaining the integrity of research projects?
PART 2: You are an investigator for a human-subjects research project at Covered Entity A. You have in your possession a data set containing PHI of 500 internally recruited study participants/patients of Covered Entity A.
Discuss and analyze:
- How you would obtain consents, authorizations, IRB approval, and/or waivers for the use of PHI.
- How you wouldas an alternative to using PHI for your studyde-identify the data set.
- Any other HIPAA-related considerations you may take into account while conducting your study.
Income Tax Fundamentals 2013
ISBN: 9781285586618
31st Edition
Authors: Gerald E. Whittenburg, Martha Altus Buller, Steven L Gill