This page houses the data governance policies and procedures developed by the NACHC Clinical Affairs team in partnership with other NACHC teams and external partners. These policies and procedures can be applied to any activities where data is received, collected, or generated, referred to as 'data sharing work' hereinafter.involved but are primarily focused on data sharing that is defined as 1) NACHC receiving from an external organization, or 2) NACHC sharing data with an external organization.
What Does Data Governance Mean to NACHC?
Data governance is central to effective data sharing work. NACHC defines data governance as a framework to guide the usability, integrity and security of data and to instill trust in the use of data and data-related sources across systems. At NACHC, the data governance infrastructure encompasses includes a decision-making body, rules (policies and procedures), decision rights (how we “decide how to decide”), accountabilities, and enforcement methods for people and information systems as they perform information-related processes.
There are four domains of governance that are relevant to NACHC's informatics work: data governance, information governance, software governance, and partnership governance. While these policies and procedures are focused on data governance, some aspects of information governance, software governance, and partnership governance may be relevant. Within those domains, NACHC adheres to eight governance principles: accountability, transparency, integrity, protection, compliance, availability, retention, and disposition as identified by the American Health Information and Management Association (AHIMA). Definitions of each are available on a related site. Relevant topics within each governance domain are addressed below.
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NACHC's organization-wide data management, privacy, and security practices and infrastructure is directed and managed by the information technology (IT) department.
Within that context, NACHC's Clinical Affairs Division operates a Data Governance Council ('GC') to advise on data -sharing work which may be housed sharing including projects within the Clinical Affairs Division (CAD) or led by other divisions. The GC does not provide direct project oversight, but does make recommendations and decisions about project participation, implementation, and the technical architecture used to carry out data sharing work. A description of the NACHC technical architecture is available here.
The GC meets monthly and includes members who represent 1) NACHC leadership, regulatory, and analytic staff, and 2) external data partners and project partners who represent a range of perspectives and collective expertise in clinical care, informatics, data science, and population health. Details of the GC membership, scope, and operations are defined in a charter.
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Project Structure
NACHC conducts organizes and tracks data sharing work in partnership with data partners and project partners. A data partner is an organization owning and/or sharing data with NACHC which can include organizations providing direct health services such as within projects. Most projects use Confluence to manage information and safely share data through a Confluence website which defines the project team, provides links to relevant project documentation and agreements, location of project data, and tracks project progress. Projects have regular status meetings. Minutes and meeting materials from status meetings are made available on Confluence. At the start of each project, a project team is identified and includes members of the data contributor and NACHC staff and documented on the project Confluence page. Additionally, members of the project team who will have access to project data are identified at the project inception. As the project team evolves through the project lifecycle, the project team is updated on Confluence and in project-related documentation, as appropriate.
Project Roles and Terminology
NACHC conducts data sharing with data partners and project partners.
A data partner is the organization sharing data with NACHC which can include federally qualified health centers (FQHCs), primary care associations (PCAs), or health center controlled networks (HCCNs). FQHCs are data owners in that they own the data collected by their organization. PCAs and HCCNs do not collect clinical data but serve as a data steward for clinical data provided by their members and contribute data on behalf of their member organizations. Federal agencies such as the Health Resources and Services Administration may also be data partners, providing UDS data to NACHC on behalf of FQHCs (example: UDS data).
A project partner is an organization who participates in or supports projects with data sharing work by providing subject matter expertise, funding, vendor services, or other technical assistance. Vendor services may include analysis The CDC and HRSA are to common project partners. Project partners may perform project-related analyses or create project related data products (i.e., manuscripts, abstracts, or reports) which can require direct access to project data.
Project Structure
NACHC organizes and tracks data sharing work in projects Every project is different. Depending on the scope of the project, a project may have one or multiple datasets from one or more data partners that is housed by NACHC. Most projects use Confluence to manage information and safely share data through a Confluence website which defines the project team, provides links to relevant project documentation and agreements, location of project data, and tracks project progress. Projects have regular status meetings. Minutes and meeting materials from status meetings are made available on Confluence. At the start of each project, a project team is identified and includes members of the data contributor and NACHC staff and documented on the project Confluence page. Additionally, members of the project team who will have access to project data are identified at the project inception. As the project team evolves through the project lifecycle, the project team is updated on Confluence and in project-related documentation, as appropriate.
Services
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For each project, the project data is defined as the data that will be shared by data partners with NACHC. Based on the project data, the analytic results that will be derived from project data and data products are also defined. Generally, analytic results and data products are either generated by NACHC or project partners.
An example figure illustrating the flow of data in a project with two data partners is shown below.
Services
Projects involving data sharing can also include the following services: subject matter expertise, technical assistance, data management, and analysis services, which are defined in the table below. Most informatics projects involve multiple informatics services.
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NACHC uses data either shared with NACHC by another organization or collected by NACHC. When NACHC has received data from an outside organization, NACHC acts as a data steward. Data stewardship is the collection of practices that ensure an organization’s data is accessible, usable, safe, and trusted.
Data Shared with NACHC
There are many types of data that may be shared with NACHC including UDS data, clinical data, and financial data.
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For some projects, NACHC collects its own data, usually in the form of surveys that are completed by health centers or member information. These surveys will be anonymous and do not collect patient identifiers if received or held directly by NACHC. Need to expand this. Talk to Meg.
Requests for Data
NACHC receives requests for data that are either apart of a new or existing project.
NACHC uses a central request process where requests are received, reviewed by the GC, approved/denied, and then delegated to the appropriate project lead. Requests can be submitted here. Request submission requires a detailed description of what data is desired, how the data will be used, the type of use (e.g., research, surveillance, quality improvement or other) and how the request aligns with the NACHC vision. Incomplete requests cannot be evaluated and will be returned to the requester.
Requests for data are evaluated by the GC. Requesters will be notified of an approval or denial within one week of the GC meeting.
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The following topics apply specifically to NACHCs use of data for human subjects research.
Federal regulations require that research projects involving human subjects be reviewed by an Institutional Review Board (IRB). According to the FDA, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. The IRB must approve or determine the project to be exempt or approved prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded.
IRB review and approval is required for projects that:
- Meet the definition of research
- Involve human subjects and
- Include any interaction or intervention with human subjects or involve access to identifiable private information
The federal regulations define both "research" and "human subject." Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.Studies must be reviewed by an Institutional Review Board (IRB) only if both definitions apply. A project may involve data from human subjects, but not meet the definition of research and would, therefore, not require an IRB review. Research is defined by federal regulations at 45 CFR 46.102 (Protection of Human Subjects 2009), as "a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
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