Applying for Access to Administrative Health Data in Nova Scotia

1. Applying for Access to Administrative Health Datain Nova Scotia Jennifer Payne, PhD Co-Chair, Data & Privacy Advisory Committee & Associate Professor, Department of Diagnostic Radiology, Dalhousie University Halifax, 30Nov2016

2. Outline • Data Access General Principles (review) • Personal Health Information Act (PHIA) • Data Access Committees: EHS, HDNS, JDAC/RCP, NSDHW • REB & Data Access • Tips

3. Applying for Data Access: General Principles(see MSSU Training Archive)

4. ‘Secondary Data’ Projects Projects that may involve: • use of data that are not collected primarily for research purposes • use of data held by ‘data custodian’ (e.g., public, private) • use of dataset consisting of hundreds or thousands of observations • historical data on subjects • data for subjects who may have since died or moved • a rationale for a consent waiver

5. Data Access – General Principles Earlier session - MSSU Training Archive: • Meet with the custodian (data, feasibility, approach) • Ask for the minimum (derived variables) • Think through data flow (diagram) • Affects data access/collection (more than just final dataset) • Keep identifiers and analytic data separate • Design of linkage (no sharing between custodians) • Timelines (data access & data extraction) • Cost • REB & Data Access (aka Chicken & Egg)

6. Landscape in NS

7. Landscape in NS • Tri-Council Policy Statement on the Conduct of Research Involving Humans (Canada) • Chapter 3: Consent • Chapter 5: Privacy and Confidentiality (Secondary use, linkage) (www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default) • Personal Health Information Act (PHIA) • Collection, Use, Disclosure and Retention of PHI • See Sections 53-60 on research (novascotia.ca/dhw/phia/PHIA-legislation.asp)

8. Ask for the Minimum(PHIA Sec 54) The use and disclosure of personal health information by a custodian is limited to the minimum amount of information necessary to accomplish the research purposes for which it is to be used or disclosed.

9. REB Submission(PHIA Sec 55) A custodian may use personal health information for research if, before commencing the research, the custodian (a) prepares a research plan that meets the requirements in Section 59; (b) submits the research plan to a research ethics board; (c) receives the approval of the research ethics board; and (d) meets any conditions imposed by the research ethics board.

10. Process(PHIA Sec 56) 56 A custodian may disclose personal health information about an individual to a researcher if the researcher (a) submits to the custodian (i) an application in writing, (ii) a research plan that meets the requirements of Section 59, and (iii) a copy of the submission to, and decision of, a research ethics board that approves the research plan; and (b) enters into the agreement required by Section 60.

11. Consent - I (Sec 57) A custodian may disclose PHI about an individual to a researcher without the consent of the subject individual if (a) the researcher has met the requirements in Section 55; (b) a research ethics board has determined that the consent of the subject individuals is not required; (c) the custodian is satisfied that:

12. Consent – II(PHIA Sec 57) (i) the research cannot be conducted without using PHI, (ii) the PHI is limited to that necessary to accomplish research, (iii) the PHI is in the most de-identified form, (iv) the PHI will be used in a manner that ensures its confidentiality, and (v) it is impracticable to obtain consent; and (d) the custodian informs the Review Officer.

13. Plan – I(PHIA Sec 59) (1) Before commencing research, a researcher seeking to conduct research utilizing personal health information shall submit a research plan to a research ethics board. (2) The research plan must be in writing. (3) In order to meet the requirements for a custodian under this Act, the research plan must include:

14. Plan – II(PHIA Sec 59) (a) a description of the research; (b) a statement regarding duration; (c) a description of the personal health information required and the potential sources; (d) how the personal information will be used; (e) how the linkage will be conducted; (f) where the researcher is conducting the research on behalf of or with the support of a person or organization, the name of the person or organization;

15. Plan – III(PHIA Sec 59) (g) objectives .. public or scientific benefit; (h) why seeking consent is impracticable; (i) why the research cannot reasonably be accomplished without PHI; (j) explanation of data matching is required; (k) a description of the reasonably foreseeable risks arising from the use of personal health information and how those risks are to be mitigated; (l) a statement that PHI in most de-identified form;

16. Plan – IV(PHIA Sec 59) (m) a description of all individuals who will have access to the information, and (i) why their access is necessary, (ii) their roles (iii) their qualifications; (n) a description of the safeguards to protect the confidentiality and security of PHI; (o) how/and when PHI will be destroyed; (p) the funding source of the research;

17. Plan – V(PHIA Sec 59) (q) approval of research ethics board, status (r) statement - researcher's interest in PHI or research would potentially result in an actual or perceived conflict of interest

18. Agreement(PHIA Sec 60) (1) Where a custodian discloses personal health information to a researcher, the researcher shall enter into an agreement with the custodian to adhere to the requirements in subsection (2). “Data Sharing Agreement (DSA)” Note: a trainee cannot sign a DSA.

19. Purpose of Data Access • Custodian has duty to safeguard data • Identify required data source(s) • Ensure feasibility of proposed work • Data (available/appropriate) • Resource planning (extraction/linkage) • Review of data collection processes • Review nature of results (release)

20. NS Data Access Committees

21. 1. Emergency Health Services • Overview: • EHS data is accessed via the NS EMS Research Steering Committee • Submit protocol and REB application to committee BEFORE sending to REB • Review of privacy, operational impact, feasibility

22. EHS – Data Sources • Provincial data • ePCR: all paramedic charting – mostly queriable fields • CAD: dispatch data including times • MFR: work in progress • Data extraction (e.g., .csv) • Chart reviews must be done on site

23. EHS – Data Access Committee Membership • Medical Director, Provincial Air Medical Program • Medical Director Provincial Trauma Program • Provincial Medical Director EHS • Medical Director of Research EHS • Director, Division of EMS • Research Director, Department of Emergency Medicine Dalhousie University • Research Manager, Department of Emergency Medicine Dalhousie University • EHS Paramedic Research Coordinator • Manager of Performance, EMC • Paramedic KT Coordinator, Division of EMS • DHW Privacy

24. EHS - Process • https://medicine.dal.ca/departments/department-sites/emergency/divisions/ems/research/EMS_Research_SOP.html • ems@dal.ca

25. 2. Health Data Nova Scotia (HDNS) • Established in 1993 by Dalhousie University's Dept of Community Health and Epidemiology • Facilitates research and innovation by providing access to linkable administrative health data and analysis for research in a secure, controlled environment, while respecting the privacy and confidentiality of Nova Scotians

26. HDNS – Data Sources • MSI Physician Billings • CIHI Discharge Abstract Database (DAD) • CIHI National Ambulatory Care Reporting System (NACRS) • Insured Patient Registry • Licensed Provider Registry • Pharmacare Prescriptions • Patient Geography / Vital Stats (Death) • Linkages with external data sets • Note: External data sets must be ‘brought in’

27. HDNS - Process • Contact HDNS for consultation (hdns@dal.ca) • Submit a Data Access Feasibility and Cost Estimate Request • Obtain project funding • Submit a Data Access Request to the HDNS Data Access Committee (DAC) • Apply to REB (Application to an REB can occur prior to, at the same time or after applying to the HDNS DAC). • Once the HDNS DAC and REB approvals have been received, Data Sharing and Confidentiality Agreements will be administered. • HDNS will work with you to create a project charter to identify the details around the project dataset creation, analysis, packaging, and delivery of your data. For more information please go to http://medicine.dal.ca/hdns

28. HDNS - Process • Data Platform: • record-level data remains on HDNS data platform • location: on-site workstation, or remote access • Tools: SAS, Stata, R, MATLAB, ArcGIS • Only aggregate results can be exported from the platform (cell size >5)

29. HDNSCommittee Membership • Data management professional • Secondary data analysis professional • Privacy, confidentiality, security professional • DHW representative • HDNS representative • Head, Dalhousie CH&E (ex-officio) • Other members as appropriate (Health services researcher, Provincial Programs)

30. 3. NS Dept of Health and Wellness Data Access Committee • Overview: • The purpose of the DHW Data Access Committee (DHW DAC) is to review and recommend for approval the disclosure of person-identifiable information under the custody or control of the Minister of Health and Wellness for the purpose of research, planning, management, evaluation and monitoring according to the provisions of the Personal Health Information Act (PHIA).

31. NS DHW Data Sources • Cancer Care Nova Scotia • Renal Program • Cardiovascular Program • Blood Coordinating Program • Diabetes Care Program • Legacy of Life • Breast Screening • Continuing Care (Seascape) • Drug Information System • Discharge Abstract Database (DAD/NACRS) • Public Health • Nova Scotia Trauma Registry

32. NS DHWCommittee Membership • TOR under Review • 3 Health Privacy Officers • 1 Business Intelligence • 2 Epidemiology/Analytics

33. NS DHW DAC - Process • Request visits DHW (or program website) and is directed to contact the specific program of whom they’re seeking data • Requestor discuss project with program and completes DAC forms – Iterative! • Program issues “Feasibility Review Letter” to requestor to provide to DAC & REB • Requestor submits request form and supporting documents (e.g., REB submission) • DHW DAC Reviews as per TOR • Data Sharing Agreement signed (if required) • DHW DAC grants approval • Reporting Requirements • Amendment Process

34. 4. Joint Data Access Committee/Reproductive Care Program of NS Data Access Committee • Overview: • Review requests for data from the Nova Scotia Atlee Perinatal Database (managed by RCP) • Requests usually for research but possibly for other purposes, e.g. planning and management • Determine that the data requested is appropriate and pertinent to the project • Ensure to the extent that is possible that the data released to an analysis file protects the privacy and confidentiality of individuals (patients), care-providers, institutions and vulnerable sub-populations

35. JDAC/RCP DAC - Data Sources • Nova Scotia Atlee Perinatal Database (NSAPD)

36. Mandates JDAC • Research requests that involve: • Linkage of NSAPD to other databases (including linkage to a chart review file) • Sensitive populations • Out-of-province PIs or requests for a non-standard approach to data access • Other unusual features • Will review requests for non-research purposes (e.g., planning and management) RCP DAC • Research requests using data from NSAPD only • Funding rare, minimum when exists • Bulk of requests from three groups: • Members of PERU • Trainees (e.g., Residents, Fellows, RIM students) • Frequent flyers (typically IWK Obstetrician or Neonatologist

37. JDACCommittee Membership • Nine members • Representatives from: RCP, HDNS, DHW,legal profession, research community (PERU), IWK as well as privacy expert and clinicians • Members have clinical, health information, research ethics, privacy/privacy law, statistical/methodological & database knowledge • Chaired by an experienced clinician and researcher

38. RCP DAC Committee Membership • Five members, all RCP staff • Members have clinical, health information, statistical/methodological & database expertise • Co-chaired by RCP’s Clinical Data Coordinator & Research Analyst • ~ 80 years experience with RCP; 10¼ university degrees

39. JDAC/RCP DAC Review Process • Scientific Merit • Cursory statistical review • Fit between project objectives and database capabilities • Identifiability • REB/Consent • Safeguards: • Technical, Physical, Legal, Procedural

40. Tips – Talk to Custodian(s) • Talk to Custodian early on in development (!!!) • Research question – feasibility • Letter from custodian (REB/Data Access): • Feasibility • Data extraction costs • Timelines • Design of data collection • Flow of data (multiple custodians-linkage)

41. Tips – Planning/Timelines • Time upfront pays off in long run when applying for data access, and eventually getting the data (faster!!) • Timelines: • REB approval • Data Access (joint DAC review): • application, review, approval, agreement • Data Extraction • Custodian planning for extraction

42. REB & Data Access(Chicken & Egg) • Committees may differ in their process • Conceptually, REB and Data Access are parallel processes: • Content required for both quite similar • Order of submissions varies by committee

43. REB Best Practice Document • www.spor-maritime-srap.ca • research support (tab at top) • resources • privacy & ethics • (under MSSU subheading) • * Data flow diagrams • * Consent waiver criteria

44. Questions?