1. HIPPA and Clinical Research HIPPA and Clinical Research By Kimberly Van Randall

3. The Health Insurance Portability and Accountability Act (HIPPA)

4. HIPPA was enacted by the U.S Congress in 1996 to provide confidentiality of health related information and the security of identifiable patient material.

6. Covered entities conduct clinical research involving protected health information (PHI), physician-investigators need to understand the Privacy Rule's restrictions on the use and disclosure of PHI for research purposes.

7. The Privacy Rules establishes the right of an individual, such as a research subject, to authorize a covered entity to use and disclose his/her PHI for research purposes.

9. De-identification of PHI means that the personal information (i.e. name, social number, phone number,etc.) have been removed and there is no actual knowledge that the subject could be identified.

10. Informed consent forms for research studies now required to include extensive detail on how the participant's protected health information will be kept private.

11. Elimination of the expiration on the Authorization and now allows either the inclusion of an expiration date or a statement that there is no expiration date.

13. For reviews preparatory to research with representations obtained from the researcher that satisfy section 164.512 (i)(1)(ii) of the Privacy Rule

14. Fore researcher solely on decedents' information with certain representations and, if requested, documentation obtained from the researcher that satisfies section 164.512 (i)(1)(iii) of the Privacy Rule

15. If the covered entity receives appropriate documentation of and IRB or a Privacy Board has granted a waiver of the Authorization requirement that satisfies section 164.512(i)

17. If the PHI has been de-identified in accordance with the standards set by the Privacy Rule at section 164.514(a)-(c) (in which case, the health information is no longer PHI

18. If the information is released in the form of a limited data set, with certain identifiers removed and with a data use agreement between the researcher and the covered entity, as specified under section 164.514(e)

19. Under a “grandfathered” informed consent of the individual to participate in the research, an IRB waiver of such informed consent, or Authorization or other express legal permission to use or disclose the information for research as specified under the transition provisions of the Privacy Rules at section 164.532 (c)

21. Obtaining PHI under false pretenses include fines up to $100,000 and up to 5 years in prison

22. Sponsors whom fail to comply with HIPPA regulations are subject to $250,000 and up to 10 years in prison

23. Civil penalties can reach as much as $100 per violation, not to exceed $25,000 per year with civil monetary damages to patients who win state tort claims, such as breach of privacy.

25. Autonomy

26. Allows human subjects and researchers to work together with an agreement that whatever is discussed or treated between the researcher and the subject will be held with the upmost discretion.

27. Non-malfeasance

28. Failing to respect one's privacy or to honor the confidentiality agreement could cause harm to the individual.

30. Justice

31. Allows subjects access treatment options where there are none, regardless of their background or economic stature.

33. Implementation of the HIPPA Privacy rule resulted in a drop from 96% to 34% in the proportion of follow-up surveys completed by study patients being followed after a heart attack.

34. HIPPA is not regulated by the FDA

35. Researchers overwhelmingly believe that he HIPPA Privacy Rule has had a negative impact on the scope, pace, and cost of research

37. The HIPPA Privacy Rule protects the privacy of individually identifiable health information

38. Changed the way clinical research is conducted in the United States and unintentionally created obstacles and restriction on clinical science.