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 • Describe issues related to reporting ADRs.
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
Privacy • 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. . . . • 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.
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)
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 • 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 • 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 . . . • Loss of privileges • Dismissal • Civil or criminal penalties
TPHA • When can you share patient info? • Treatment • Payment • Healthcare operations • Authorized by the patient
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 • 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
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?
For more information • UUHSC HIPAA office • CDC summary: www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm • www.HIPAA.org • www.cms.hhs.gov/hipaa
Resources • Website • http://uuhsc.utah.edu/pharmacy/msr • Guidelines • All forms • Links to privacy office • Database of all representatives in our system
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!
Questions Our Business Associates Frequently Ask • Where can I go to get my questions answered quickly? • firstname.lastname@example.org • 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? • 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 • 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 • 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