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

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

4.  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 How does the proposal address the problem statement? 4

5.  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 How will this be different in practice? 5

6.  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 How will members implement this proposal? 6

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

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

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

10.  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. General Statement 10

11. Requests for Person Identified Data 11 If the requestor is…Then the OPTN Contractor may release the following person-identified data: An individualData pertaining to that individual Anyone granted authorization to receive information about an individual Data pertaining to that individual A member  Data previously submitted by that member to the OPTN Contractor  Data that are necessary for that member to prepare a report required by the OPTN Contractor  Data that enable the OPTN Contractor to fulfill its obligations under the OPTN contract An OPO Recipient characteristics and outcomes data for each transplanted organ that was recovered by that OPO A transplant hospital  Recipient characteristics and outcomes for each organ offer received by that transplant program  Whether the transplant program’s candidate is registered on the waiting list at more than one transplant program, according to Policy 3.4.G: Multiple Transplant Program Registrations. A transplant hospital or its affiliated histocompatibility laboratory Prior donor’s HLA information for any recipients under that transplant program’s care A histocompatibility laboratory HLA information of deceased donors and recipients typed by that laboratory when discrepant HLA information is reported to the OPTN Contractor Anyone authorized to receive data, according to federal laws and regulations Data approved by the U.S. Department of Health and Human Services (HHS), according to federal laws and regulations

12.  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. Requests for Person-Level De-Identified Data (e.g., STAR files) 12

13.  The OPTN Contractor will release confidential information if the following requirements are met: Requests for Confidential Information 13 The requestor is at least one of the following: And both of the following are true: Bound by a fiduciary responsibility to the OPTN Contractor Contractually obligated to the OPTN Contractor to maintain the confidentiality of the released information Acting on behalf of the OPTN Board of Directors Acting on behalf of an OPTN Committee 1.The request is necessary to perform an OPTN function on behalf of the OPTN Board of Directors or an OPTN Committee 2.The OPTN Contractor approves the request

14.  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 Requests for Personnel Information at Member Institutions 14