1. HIPAA Training for Pharmaceutical Industry Representatives University of Utah Hospitals & Clinics

2. Objectives Describe key features of HIPAA and how it impacts pharmaceutical representatives Identify when a business associates or shadow agreement is necessary Describe issues related to reporting ADRs.

3. HIPAA Health Insurance Portability and Accountability Act 1996 Continuity of health plan when moving from one plan to another Fraud enforcement Privacy and security rules

4. Privacy An ethical issue; now the law! Individual right to control access and disclosure of protected health information Paper, electronic, oral communication

5. Without the patient’s permission.... Providers directly involved in care may discuss patient’s status Disclose information to consulting physicians or for referral But not to those without clinical responsibilities.

6. Protected Health Information (PHI) Name Biometric identifiers Full face images Geographic subdivisions Dates SS Phone, FAX E-mail, IP, URL MR, health plan # Account #, Cert., licenses Vehicle identifiers Device identifiers Other

7. Security and Confidentiality Agreement All vendors Covers “incidental” exposure to PHI Handled as part of our workforce Exceeds requirements of HIPAA Important to protect the privacy of our patients

8. Business Associates Agreement Another person uses PHI to perform function or activity on behalf of the covered entity Provide services to the covered entity that involves PHI Used for ongoing relationship

9. Shadowing agreement Use for one time situations with exposure to PHI greater than just “incidental” Requires consent of patient Approval of service director

10. If you violate HIPAA... Loss of privileges Dismissal Civil or criminal penalties

11. TPHA When can you share patient info? Treatment Payment Healthcare operations Authorized by the patient

12. Keeping it private... Don’t communicate information that may be potentially patient related Includes Who you see What you see What you heard

13. Disclosing PHI without permission There are exceptions—most related to public health and legal requirements to report Example: Reporting ADRs to FDA UUHSC must keep a record of any disclosures Notify HIPAA office if you are informed of an ADR

14. Myths HIPAA doesn’t apply to me Not part of workforce Doesn’t apply to drug companies I don’t need to sign your agreement This is just for the Hospital, Right?

15. For more information UUHSC HIPAA office CDC summary: www.cdc.gov/mmwr/preview/mmwrhtm l/m2e411a1.htm www.cdc.gov/mmwr/preview/mmwrhtm l/m2e411a1.htm www.HIPAA.org www.cms.hhs.gov/hipaa

17. Resources Website http://uuhsc.utah.edu/pharmacy/msr Guidelines All forms Links to privacy office Database of all representatives in our system

18. Summary UUHSC sets a higher standard around privacy issues HIPAA and privacy issues apply any time you are at one of our facilities In addition to confidentiality and security agreements, reps must sign a business associates or shadowing agreements when applicable Report HIPAA issues Ask questions!

20. Questions Our Business Associates Frequently Ask Where can I go to get my questions answered quickly? privacy@hsc.utah.edu http://uuhsc.utah.edu/privacy How long will it take? Most questions are answered in 1 business day. Why so much paper work? To protect our patient’s privacy.

21. What Can You Do To Make The Process Go Faster? Understand our goal is: To give outstanding medical care to all of our patients. To protect the privacy of our patients at all times. Understand what your role is in meeting our goal What you see and hear in the hospitals and clinics stays there.

22. Making The Process Easier And Faster Complete and sign our business associate agreement (BAA). BAA’s are self renewing They can be modified They can be customized One per company They are found on our web page

26. Screen shots summary Main web page http://uuhsc.utah.edu/privacy Site for faculty, student, staff, volunteers (this page links to the next two) http://intranet.uuhsc.utah.edu/privacy/wo rkforce/en/index.html http://intranet.uuhsc.utah.edu/privacy/wo rkforce/en/index.html

27. QUESTIONS?