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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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Presentation Transcript
  • 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.
  • Health Insurance Portability and Accountability Act 1996
  • Continuity of health plan when moving from one plan to another
  • Fraud enforcement
  • Privacy and security rules
  • An ethical issue; now the law!
  • Individual right to control access and disclosure of protected health information
  • Paper, electronic, oral communication
without the patient s permission
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.
protected health information phi

Biometric identifiers

Full face images

Geographic subdivisions



Phone, FAX

E-mail, IP, URL

MR, health plan #

Account #, Cert., licenses

Vehicle identifiers

Device identifiers


Protected Health Information (PHI)
security and confidentiality agreement
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
business associates agreement
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
shadowing agreement
Shadowing agreement
  • Use for one time situations with exposure to PHI greater than just “incidental”
  • Requires consent of patient
  • Approval of service director
if you violate hipaa
If you violate HIPAA . . .
  • Loss of privileges
  • Dismissal
  • Civil or criminal penalties
  • When can you share patient info?
  • Treatment
  • Payment
  • Healthcare operations
  • Authorized by the patient
keeping it private
Keeping it private . . .
  • Don’t communicate information that may be potentially patient related
  • Includes
    • Who you see
    • What you see
    • What you heard
disclosing phi without permission
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
  • 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?
for more information
For more information
  • UUHSC HIPAA office
  • CDC summary: www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm
  • www.HIPAA.org
  • www.cms.hhs.gov/hipaa
  • Website
    • http://uuhsc.utah.edu/pharmacy/msr
    • Guidelines
    • All forms
    • Links to privacy office
  • Database of all representatives in our system
  • 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!
questions our business associates frequently ask
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.
what can you do to make the process go faster
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.
making the process easier and faster
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
screen shots summary
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