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HIPAA Training for Pharmaceutical Industry Representatives. University of Utah Hospitals & Clinics. Objectives. Describe key features of HIPAA and how it impacts pharmaceutical representatives Identify when a business associates or shadow agreement is necessary

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Hipaa training for pharmaceutical industry representatives l.jpg

HIPAA Training for Pharmaceutical Industry Representatives

University of Utah Hospitals & Clinics


Objectives l.jpg
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.


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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


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Privacy

  • An ethical issue; now the law!

  • Individual right to control access and disclosure of protected health information

  • Paper, electronic, oral communication


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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.


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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

Protected Health Information (PHI)


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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


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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


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Shadowing agreement

  • Use for one time situations with exposure to PHI greater than just “incidental”

  • Requires consent of patient

  • Approval of service director


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If you violate HIPAA . . .

  • Loss of privileges

  • Dismissal

  • Civil or criminal penalties


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TPHA

  • When can you share patient info?

  • Treatment

  • Payment

  • Healthcare operations

  • Authorized by the patient


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Keeping it private . . .

  • Don’t communicate information that may be potentially patient related

  • Includes

    • Who you see

    • What you see

    • What you heard


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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


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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?


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For more information

  • UUHSC HIPAA office

  • CDC summary: www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm

  • www.HIPAA.org

  • www.cms.hhs.gov/hipaa


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Resources

  • Website

    • http://uuhsc.utah.edu/pharmacy/msr

    • Guidelines

    • All forms

    • Links to privacy office

  • Database of all representatives in our system


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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!


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Questions Our Business Associates Frequently Ask

  • Where can I go to get my questions answered quickly?

    • [email protected]

    • 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.


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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.


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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


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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/workforce/en/index.html



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