ORO Findings on Privacy, Confidentiality, and Information Security

Peter N. Poon, JD, MA, CIPP/GOffice of Research Oversight

2012 Update

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

60

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 Findings6 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 1605.1, 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.”

“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?:

• 0• 4• 7• 9

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 1200.05 §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 1200.05 §37.b(3)(a)2

6 Findings

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

Health Insurance Portability and Accountability Act

= HIPAA

HIPPA