ORO Findings on Privacy, Confidentiality, and Information Security Peter N. Poon, JD, MA, CIPP/G Office of Research Oversight Initially presented June 2011 at ORD Local Accountability Meeting

Background of Findings Findings from the last 12 ORO Research Information Protection Program (RIPP) Reports Site visits from July 2010 to March 2011 Research programs of varying sizes and complexity These are sample findings April 2011 to April 2012

Of the following situations, which did the ORO RIPP team make the most noncompliance findings regarding? Use of non-VA, non-encrypted thumb drives Posting passwords on or near computer Failure to log-off or enable password protected screen saver when leaving work area VASI not stored in locked file or cabinet when not in use

4. VASI was not stored in locked file or cabinet when not in use: Herding Cats 10 Findings Non-VA, non-encrypted thumb drives: 2 Posting passwords: 0 No log-off or screen saver: 6 7 Findings 6 0 2

Complete the following sentence with the best answer: Storage media such as CDs and DVDs… Must be locked in secure storage if they contain VASI Must never contain VASI Must be encrypted if they contain VASI Must never leave the VA if they contain VASI

3. Must be encrypted if they contain VASI:5 Findings Where Are My Keys?? 3 Findings

VASI residing on non-VA owned equipment (OE) requires the approval of a supervisor AND: Approval by the facility ISO Waiver by the VISN ISO Waiver by the VA CIO (Assistant Secretary IT) or designee (ADAS OCS) Approval by ORD

Elephant in the Room 3. Waiver by VA CIO (Assistant Secretary IT) or designee (ADAS OCS) : 5 Findings Exceptions: MOU/ISA for system interconnections Contract with a vendor, with security controls 6 Findings

800 Pound Gorilla Folders on the [VA facility] server that contained study specific information, including PHI, were not configured to permit only the appropriate staff access to the folder contents. 7 Findings

Non-VA IT equipment (e.g., owned by the Academic Affiliate or Nonprofit Corporation) at a VA location: Must never be used for VA research Must be donated to VA if used for VA research Must meet all VA standards if used for VA research Must be accounted for in a VA property accountability system if used for VA research

4. Must be accounted for in a VA property accountability system : 8 Findings No Gatecrashers 9 Findings

HIPAA Authorizations must state that treatment, payment, enrollment, or eligibility for benefits cannot be conditioned on the individual: Signing the authorization Participating in the research Not withdrawing from the research Not revoking the authorization

1. Cannot be conditioned on individual signing (“completing”) the authorization: 8 Findings Starting at Square One 6 Findings

Using identifiable information to recruit subjects for VA research requires the IRB to approve both a waiver of HIPAA authorization and a waiver of informed consent True False

TRUE House Rules 5 Findings 6 Findings

Which of the following is a HIPAA identifier?: Subject X’s date of birth Subject Y’s date of medical treatment Subject Z’s date of research intervention All of the above

4. All of the above:6 Findings VHA Handbook , Appendix B §2.b(3): All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death. A Rose is a Rose is a Rose 5 Findings

What’s wrong with the following Privacy Policy statement?: “The facility may use or disclose PHI for research without written authorization from the individual for reviews preparatory to research, provided that the information is being sought solely for purposes preparatory to research or research itself.” You need an authorization to use/disclose PHI for preparatory to research You need an authorization to use/disclose PHI for research itself You need a waiver of authorization for preparatory to research Nothing is wrong

2. You need an authorization to use/disclose PHI for research itself: 9 Findings Hiding in Plain Sight “The facility may use or disclose PHI for research without written authorization from the individual for reviews preparatory to research, provided that the information is being sought solely for purposes preparatory to research or research itself.” 12 Findings

How many times did the ORO RIPP team find that the ISO or PO did not conduct a thorough review of the protocols?:

4. 9 Findings Drill, Baby, Drill 2 Findings

The PO and ISO did not provide summary reports on each study to the IRB prior to, or at, the convened IRB meeting at which the study is to be reviewed. Cart Before the Horse 5 Findings

At the current time, local research records may be destroyed…. Never 5 years after the study Whenever the data is not needed anymore According to FDA or sponsor guidelines, whichever is longer

1. Never:7 Findings The Venus Flytrap For waivers of HIPAA authorizations, the IRB must document that the use/disclosure of PHI involves no more than minimal risk to the individual’s privacy based on … “an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise mandated by applicable VA or other Federal requirements.” VHA Handbook §37.b(3)(a)2 For waivers of HIPAA authorizations, the IRB must document that the use/disclosure of PHI involves no more than minimal risk to the individual’s privacy based on … “an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise mandated by applicable VA or other Federal requirements.” VHA Handbook §37.b(3)(a)2 6 Findings

Fantasy Finding If I had a dollar for every time HIPAA is misspelled….

Health Insurance Portability and Accountability Act = HIPAA