1. Rationale, Policies and Procedures OSP Seminar May 27, 2014

2. Background HPHC is NOT a research organization  Most PHI openly accessible to most HPHC employees  Different privacy protection concerns Misconception of Institute/HPHC relationship  Different organization  Different mission

3. Background (con’t) The Institute is NOT a covered entity under Harvard Pilgrim Health Care  Treated as an external organization requesting access to HPHC data  Exception: data requests through RSDC

4. Background (con’t) Must abide by rules and procedures that govern HPHC  Work with staff to devise protocol  Determine resource needs (personnel costs, software costs, etc)  Complete internal application/requests forms  Submit to review boards  Execute data agreements, if needed Similar relationship as a subcontracting collaborator

5. HPHC/HPHCI Data Release Team Medical Informatics: Sharon Pigeon Corporate Information Management: Maureen Hernberg Compliance: Dee Chouinard OSP: Charlotte Johnson; Sheila Fireman DPM: Charlene Gay

6. Definitions Business Request Liaison (BRL) -The HPHC research review coordinator (Sharon Pigeon) Business Unit Champion (BUC) - The HPHC department collaborator Business Unit Data Requests (BUDR) – mechanism through which HPHC department provides data directly to the Investigator Virtual Extract Team (VET) – Committee which reviews non-routine disclosure requests for PHI, PI and BPI

7. Data Retrieval Mechanisms Provided Directly from an HPHC Business Unit Self-Service via the Informatics Tool Set  Optum Impact Pro  Optum Impact Intelligence

8. Activities Preparatory to Research Data Requests Pre-award Research Data Requests Post Award Research Data Requests Amendment Requests

9. Preparatory to Research Data Requests – BUDR Process NO PHI will be used in prep-to-research activities Connect with Business Champion(s) to discuss proposal Contact Business Request Liaison  Brief meeting BRL confirms Business Champion(s) involvement  Requirements  Within 1 business day of discussion with PI

10. Preparatory to Research Data Requests – BUDR Process (con’t) PI completes HPHC Business Unit Preliminary Data Reqeust Form  Submits to BRL and Business Champion Business Champion completes data request  Transmits data to PI  Notifies BRL  Turnaround?

11. Preparatory to Research Data Requests – Informatics Tools Complete Informatics Tool Access Request  Optum Impact only approved tool  Procedures pending completion of Institute role integration Submit request to Charlene Gay, Institute Manager of Administration  Request reviewed and documented  AIM request generated Email notification of access approval Active Users: Informatics Tool Access Request required for ALL projects

12. Pre-award Research Data Requests – BUDR Process Approval only, no data released Connect with Business Champion(s) to discuss proposal Contact Business Request Liaison  Submit proposal and SPA Sections I, II and VC o Copy Business Champions o SPA Section VC is for BRL signature  Brief meeting

13. Pre-award Research Data Requests – BUDR Process (con’t) BRL confirms Business Champion(s) involvement  Business Champion Checklist  Within 2 business days of discussion with PI BRL enters project in HPHC Business Unit Request system (ITG)  Within 1 business day of confirming with Business Champion BRL coordinates with VET to complete initial review  Within 1 business day of entering in ITG  VET review within 2 days Signed SPA Section VC and VET approval email to PI  Same day receives VET approval

14. Pre-award Research Data Requests – Informatics Tools Approval only, no data released Indicate Informatics Tool that will be utilized in research proposal and SPA documents

15. Post Award Research Data Requests – BUDR Process VET approval required; IRB approval required Update SPA, as needed Complete Work Plan for all Studies Requiring HPHC Business Unit Support  Exact data elements Email BRL and Business Champion(s):  Notice of Grant Award  SPA Sections I and II (note if updated from pre-award review)  Work Plan for all Studies Requiring HPHC Business Unit Support

16. Post Award Research Data Requests – BUDR Process (con’t) BRL will activate Business Unit Request in system (ITG)  Separate BU requests for each department involved  Important – indicate if iterative data releases required (different system)  Within 1 business day of receiving documents VET review:  Privacy and security requirements  IRB review can occur concurrently VET approval email  Submit to IRB to complete approval process

17. Post Award Research Data Requests – BUDR Process (con’t) Limited Data Sets  Master HPHC/HPHCI Data Use Agreement on file  Addendum required

18. Post Award Research Data Requests – Informatics Tools Update SPA, as needed, and submit for IRB approval Once approved complete Informatics Tool Access request Submit request to Charlene Gay, Institute Manager of Administration  Request reviewed and documented  AIM request generated Email notification of access approval Active Users: Informatics Tool Access Request required for ALL projects

19. Amendment Requests – BUDR Process VET approval required; IRB approval required Connect with Business Champion(s) to discuss proposed changes to protocol Contact Business Request Liaison to discuss changes BRL confirms Business Champion(s) involvement BRL enters project in HPHC Business Unit Request system (ITG)

20. Amendment Requests – BUDR Process (con’t) BRL coordinates with VET to complete review of proposed amendments PI updates DUA addendum, if needed VET approval email  Submit to IRB to complete approval process

21. Amendment Requests – Informatics Tools Submit IRB amendment Once approved, complete Informatics Tool Access request indicating changes to previously approved access Submit request to Charlene Gay, Institute Manager of Administration Manager of Administration emails approval to PI Request reviewed and documented

22. Questions? Charlene Gay Manager of Administration charlene_gay@harvardpilgrim.org x39945