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					Privacy Issues In Research



        Stephania H. Putt, RHIA
      Department of Veterans Affairs
          VHA Privacy Officer
   Federal Info & Privacy Laws
Title 38, United States Code (USC), Section 5701
Freedom of Information Act, Title 5 USC 552
Privacy Act of 1974, Title 5 USC 552a
Title 38 USC Section 7332
Standards on Privacy of Individually Identifiable
Health Information, 45 CFR Part 164
Title 38, Code of Federal Regulations, Sections
1.460 - 1.582
        Title 38 USC 5701
Applies to VA only
Predates FOIA and Privacy Act
Affords special protections to veteran’s
names and addresses
Is still in effect even after veteran’s death
Freedom of Information Act (FOIA)
Federal records available to any person
upon request unless authorized withholding
under the law.
Pertains to all federal agency records:
– agency rules, policy memorandum, directives,
  manuals, opinions
– electronic mail messages
– telephone directory, employee salaries
– various records
         FOIA within VA
Requests must be in writing and signed, as well
as, contain a reasonable description of records
sought.
Timeframes for responding to requesters with
decision is 10 days.
Fees are to be charged for copying, search time,
and direct employee cost.
– Costs calculated according to 38 CFR §1.555).
– Requester notified when charges exceed $25.00
VA has no obligation to “create” information to
meet a request.
          Privacy Act (PA)
Pertains to any group of VA records
(patient or employee) contained in a
system of records.
Prohibits disclosure of any record
contained in a system of records unless
specifically authorized by the Act (5
U.S.C. §552a(b))
Provides rights to the individuals to whom
the records pertain
      Privacy Act Definitions
System of Records – a group of any records
under the control of any agency from which
information about an individual is retrieved by
the name of the individual or by some
identifying number, symbol, or other identifying
particular assigned to the individual.
Disclosure - whenever VA (employees)
communicates, by any means, to anyone in or
outside of VA who is not aware of the
information.
 PA Disclosure of Information
Disclosure prohibited without specific
written consent from the individual or
Privacy Act authority, 5 USC §552a:
– (b)(1) – employee of agency in order to
  perform duties
– (b)(3) – published routine use
– (b)(5) – statistical research
– (b)(8) – health or safety of an individual
– (b)(11) – court order
 7332-Protected Information
38 USC Section 7332-Protected
information is any information relating
to the condition of:
– HIV or
– Sickle Cell Anemia;
Or the condition and/or treatment of:
– Drug abuse or
– Alcoholism or alcohol abuse.
     7332-Protected Information
Protected information may only be disclosed to
a third party with the special written consent of
the patient except where expressly authorized
by 38 USC 7332.
VA can disclose this information to:
– VA employees on a need to know basis - more
  restrictive than Privacy Act need to know.
– Contractors who need the information in order to
  perform or fulfill the duties of the contract.
– Researchers who provide assurances that the
  information will not be identified in any report.
        HIPAA Privacy Rule
Notice of Privacy Practices
Authority to use and/or disclose information
for treatment, payment or health care ops
Other authority to disclose information for
purposes such as:
– Law Enforcement
– Public Health Reporting
– Research with IRB Waiver
Authorization for other uses and/or
disclosures of information not otherwise
allowed
         HIPAA Privacy Rule
Administrative Requirements
– Privacy official
– Privacy Policies
– Training
Accounting of Disclosures
Individuals’ Right to:
–   Access their information
–   Request an Amendment
–   Receive Confidential Communications
–   Request Restrictions on the use or disclosure
    of their information
   Relationship b/w Laws
All applicable privacy laws and regulations
must be applied when:
– Using or Disclosing information, and
– Process Requests from individuals exercising
  their privacy rights.
When conflicts arise between the laws:
– The more stringent law applies for disclosures,
– The one that affords the greatest rights to the
  individual applies for privacy rights.
See VHA Handbook 1605.1
       Use of Information
Employees must have authority to use
information other than just a “need to
know” to perform duties.
Authority to USE data for Research:
– PA (b)(1) Provision
– HIPAA Privacy Rule – Authorization as
  part of Informed Consent or IRB Approval
  of Waiver of Authorization
– 38 USC 7332 – Employee official duties
  Disclosure of Information
VHA must have authority in order to disclose
information outside VA under all applicable
laws.
Authority to disclose for Research:
– FOIA – Written request with no exemptions
– PA – Routine Use in system of records
– HIPAA Privacy Rule – Authorization as part of
  Informed Consent or IRB Approval of Waiver of
  Authorization
– 38 USC 7332 – Authorization as part of Informed
  Consent or assurance of no identified data in
  report
    Disclosure from VHA
Requests for patient specific information
must be in writing; and
– Contain the written authorization of the
  patient or legal guardian/representative; or
– Legal authority to disclose must be present.
VA can charge most third parties for
search fees, copying fees, and abstracts
Accounting of disclosures must be
maintained.
   Accounting of Disclosures

VHA is required to keep an accurate
accounting of disclosures for research.
The accounting must include:
– Date, nature, and purpose of the
  disclosure; and
– Name and address of the person or
  agency to whom the disclosure is made.
  Accounting of Disclosures
Retain accounting for 6 years or life of
the record, whichever is longer.
An accounting is NOT required for
use of information for research.
          Privacy Review
Review of Research Documentation to
ensure all privacy requirements are met.
– Verification of PI
– Research Protocol
– IRB Approval of Study
– IRB Approval of Waiver of Authorization
– Review of Informed Consent, if applicable
       For Additional Information

VHA Privacy Office web site at:
http://vaww.vhaco.va.gov/privacy
Contact:
 – Stephania H. Putt, VHA Privacy Officer,
 (727) 320-1839
 – Clay Johnson, VHA FOIA Officer,
 (202) 273-6266

				
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