Revised OPTN Data Release Policy Proposal

1. Proposal to Revise OPTN/UNOS Data Release Policies Data Advisory Committee Fall 2015

2. What problem will the proposal solve? • UNOS must operate the OPTN in accordance with the Final Rule • Final Rule requires the OPTN to release OPO- and hospital-identified data • data needed for bona fide research or analysis purposes • data needed to assess performance of the OPTN or SRTR • data needed to assess individual transplant programs and OPOs • Current OPTN/UNOS policy prevents release of OPO- and hospital-identified data • Therefore, current policy is not consistent with Final Rule

3. What is the goal of the proposal? • Revise OPTN/UNOS policy to be in accordance with the Final Rule

4. How does the proposal address the problem statement? • After discussion with HRSA, DAC replaced specific data release criteria in Policy 19 with the following: • “The OPTN Contractor will release OPTN data according to the Final Rule and other applicable federal and state laws and regulations. The OPTN Contractor will release all OPTN data requested by the Secretary of the Department of Health and Human Services.” • Created a Standard Operating Procedure for Review of OPTN Data Requests that will be made publicly available

5. How will this be different in practice? • Staying the same: • Detailed center-specific data available through PSRs • OPO reports available through SRTR • OPTN will review requests for reasonableness • HRSA must approve all patient-identified data requests • HIPAA and the Privacy Act bind the OPTN’s release of patient-identified data • All requestors must submit and abide by a data use agreement • Changed: • New policy allows release of de-identified data with institution identifiers • Potential impact: will allow analysis of institution-level data

6. How will members implement this proposal? • Members do not need to do anything to comply with this policy • Members should review the Standard Operating Procedures for Review of OPTN Data Requests

7. How does this proposal support the OPTN Strategic Plan? • Strategic Goal: Promote the efficient management of the OPTN • This proposal makes OPTN policy consistent with the requirements of the Final Rule.

8. Questions? Charlie Alexander, RN, MSN, MBA Committee Chair calexander@thellf.org Liz Robbins Callahan, Esq. Committee Liaison Liz.robbins@unos.org

9. Extra Slides: Standard Operating Procedures for Review of OPTN Data Requests

10. General Statement • The OPTN Contractor reviews all requests for OPTN data according to the Final Rule and other applicable federal and state laws and regulations and, as allowed in the Final Rule, can impose reasonable charges for the separable costs of responding to data requests.

11. Requests for Person Identified Data

12. Requests for Person-Level De-Identified Data (e.g., STAR files) • Before receiving person-level de-identified data from the OPTN Contractor, requestors must submit a signed data use agreement (DUA) to the OPTN Contractor. The DUA must contain both of the following agreements: • The requestor agrees to neither attempt, nor permit others to attempt, to learn the identity of any person whose information is contained in the data. • The requestor agrees to include the disclaimer in the signed DUA in any publication using the released data.

13. Requests for Confidential Information • The OPTN Contractor will release confidential information if the following requirements are met:

14. Requests for Personnel Information at Member Institutions • The OPTN Contractor will release contact information for personnel at member institutions only if both of the following requirements are met: • The requestor submits a signed data use agreement (DUA) to the OPTN Contractor • The OPTN Contractor approves the request