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.

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 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. 

Section 1: Governance Approach

Data Governance Decision-Making 

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 operates a Data Governance Council ('GC') to advise on data-sharing work which may be housed 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. 

Roles 

NACHC conducts 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 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 data to NACHC on behalf of FQHCs (example: UDS data). 

A project partner is an organization who participates in or supports data sharing work by providing subject matter expertise, funding, vendor services, or other technical assistance. Vendor services may include analysis which can require direct access to project data.

Project Structure

NACHC organizes and tracks data sharing work in projects. 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

NACHC's data sharing work includes 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. 

*Technical Assistance and Analysis can involve the support of contractors or other project partners. AT Still University is frequently used for advanced statistical methods. 

Section 2: Data 

Data is either collected by NACHC or owned by another organization and shared with NACHC, where NACHC acts as a data steward. 

Data Collected by NACHC

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.

Data Shared with NACHC

There are many types of data that may be shared with NACHC including UDS data, clinical data, and financial data.

UDS Data

NACHC receives UDS data from HRSA that includes health-center level information on a variety of topics including services, staff, capacity, and financial data so that NACHC can perform analyses on behalf of HRSA and FQHCs to describe the health center landscape and services. The UDS data that NACHC receives includes some data that is available publicly and some sensitive data that only NACHC holds. UDS data does not contain PHI but is sensitive and requires physical, technical, and administrative safeguards.

Sharing UDS data with NACHC occurs under a cooperative agreement with HRSA which is overseen by the Director of Knowledge Management and Learning (Currently Margaret Davis). The parameters of UDS data sharing and use are defined in two HRSA agreements (Authorization letter, NACHC DUA). Included in these documents are explicit directions about how findings from the UDS data should be communicated in a way that protects the identity of health centers and their patients. 

The UDS data is stored securely at NACHC (currently in Amazon cloud). Only NACHC staff who have signed a UDS specific DUA are permitted to access and use the UDS data. Once a DUA has been executed with an individual and access granted to the UDS datasets, all uses of UDS data must be approved by the UDS Program Director. 

Clinical Data

NACHC receives clinical data primarily extracted from EHRs at the patient level. These clinical data are bound by HIPAA and can fall into the below categories. 

De-identified data is data that has been “stripped of all HIPAA defined identifiers” which includes Personally Identifiable Information (PII) and Protected Health Information (PHI). PII is a subset of PHI and the list of 18 data elements that are considered PHI are documented in the HIPAA Safe Harbor definition. To be considered de-identified under HIPAA, all 18 identifiers must be removed. Some data partners participate in date-shifting to remove real encounter and birth dates Julia Skapik (Deactivated) remove this?  

A limited data set (LDS) includes data that has been stripped of all 18 HIPAA identifiers, except age, full dates, and five digit zip code, as identified by HIPAA Safe Harbor guidelines.  

Identified data sets which include PHI identified beyond that which would qualify as an LDS and are not accepted by NACHC at this time. 

Financial Data

Others?

Requests for Data 

NACHC receives many requests for data that has already been shared with them for an existing project or a request for data related to a new project. Additionally, NACHC receives requests for information partnership meaning a desire from one organization to partner and share data with a health center through support from NACHC.  

Requests for data or information partnerships are evaluated by the GC which meets monthly. Requests can be submitted here. Requests ​must include 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. Requesters will be notified ​of an approval or denial within one week of the GC meeting. ​

Section 3: Statutes, Contracts, and Regulatory

Contracts 

At NACHC, Contracts and DUAs are separate....

HIPAA 

According to HIPAA, NACHC is not a covered entity. However, NACHC receives limited and de-identified datasets from HIPAA covered entities. Though the amount of PHI received by NACHC is minimal, NACHC treats all of its data from covered entities as PHI and as such, complies with the relevant security and privacy expectations outlined by HIPAA. 

TEFCA 

Launched in January 2022, TEFCA provides a framework for networks to collaborate and share data interoperable. Network to network collaboration has many similarities to NACHC's informatics work. Thus, NACHC seeks to align with TEFCA when applicable and feasible.

Data Use Agreements (DUAs)

NACHC requires the execution of a data use agreement (DUA) whenever data is being shared with NACHC. For projects where a LDS is being shared, a DUA is required by HIPAA. For projects where deidentified data is being shared, a DUA is executed based on NACHC policy.

NACHC observes the HIPAA Privacy Rule standards for a DUA. The purposes of a DUA are to:

• establish the permitted uses and disclosures of the limited data set;
• identify who may use or receive the information;
• prohibit the recipient from using or further disclosing the information, except as permitted by the agreement or as permitted by law;
• require the recipient to use appropriate safeguards to prevent a use or disclosure that is not permitted by the agreement;
• require the recipient to report to the covered entity any unauthorized use or disclosure of which it becomes aware;
• require the recipient to ensure that any agents (including a subcontractor) to whom it provides the information will agree to the same restrictions as provided in the agreement; and
• prohibit the recipient from identifying the information or contacting the individuals.

Because DUA's require a high level of specificity, each DUA is project-specific. DUAs can be two party, meaning between NACHC and a data contributor, or multi-party, meaning between NACHC and multiple parties. The structure and contents of a DUA are customized based on project structure and needs. 

• When NACHC is the provider of data to an outside organization: NACHC has created a DUA template for use with to recipients.  This template may be accessed from the NACHC contracts office. When NACHC is providing a LDS, if any material change is to be made to the NACHC template, or if another party’s version of a DUA is to be used, the NACHC legal council must review and approve the terms of the agreement. 
• When NACHC is the recipient of the data: If NACHC is the recipient of a LDS of PHI from a non-NACHC source, the NACHC project lead with either use the NACHC DUA template or modify the other party’s Data Use Agreement.  When using another party's DUA, the NACHC project lead is responsible for reviewing the Data Use Agreement and determining if it complies in material terms with the NACHC DUA template.  If the other party’s DUA differs materially from the NACHC DUA template, or if there is any uncertainty, the NACHC legal council must be consulted.

NACHC has a DUA template that has been approved by NACHC legal council. Alternatively, data partners are welcome to request the use of their institutional DUA template that can be customized for the project by NACHC staff. A process to initiate a DUA is documented below.

1. NACHC project lead completes the NACHC DUA Checklist to determine if a DUA is needed. This should occur as part of the project's initiation.
2. The checklist is reviewed with data partner at an early project meeting to confirm the need for a DUA and level of identification of a dataset.
3. Once completed, the DUA checklist is stored in the project Confluence page. 
4. If the DUA checklist identified a need for a DUA, the checklist is shared with the NACHC contract officer to begin the creation of a project-specific DUA.
5. NACHC populate the DUA with project specific information and share with other parties for comment
6. NACHC receives and integrates comments and recirculates to other parties and NACHC legal until DUA is ready for signature
7. DUA is signed by other party(ies) and returned to NACHC for counter signature and execution
8. DUA is executed by NACHC legal and executed agreement is shared with all parties

Section 4: Work Products

Work Products and Attribution

Informatics work generates the following work products: data quality results, analytic results, value sets, measure definitions, and recommendations. Work products are owned by all members of the project team and can be disseminated in manuscripts, abstracts, reports, presentations, and guidance documents. How and to whom work products are attributed is discussed with all project partners at the outset and as the project evolves to ensure that attribution of work projects is accurate and equitable.  

DEI in Work Products

TBD. Need some guidance here. 

Identification of Health Centers in Work Products

TBD. Need some guidance here. 

Section 5: Data Security, Privacy, and Confidentiality 

Patient data has become increasingly valuable to potential attackers. The rapid and continuous evolution of both healthcare information technology and attacker tools makes data security a constantly moving target, with methods of protection struggling to stay in front of attack efforts. NACHC believes that the security, privacy, and confidentiality of patient and health center data is of paramount importance. As such, NACHC takes a number of steps to ensure data security, protect their environment from security threats, and address security incidents when they occur. A summary of NACHC's data security and privacy policies are available here. 

NACHC adheres to data security standards defined in the HIPAA security rule (45 CFR Part 160), the National Institute of Standards and Technology (NIST) Cybersecurity Framework, and the Common Agreement (Section 12), Not every part of these three resources apply directly to NACHC's informatics work, thus NACHC complies and aligns with them to the degree that they apply.  

Section 6: Other Governance Topics 

Institutional Review Board (IRB)

NACHC adheres to the Office for Human Research Protections regulations (45 CFR part 46) of human subjects research. NACHC informatics work is primarily quality improvement (QI) in nature which OHRP provides specific IRB guidelines. In general, OHRP states that QI is not human subjects research. Research is defined as systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  When QI projects do not align with this research definitions, HHS regulations for the protection of human subjects do not apply and there is no requirement under these regulations for such activities to undergo review by an IRB, or for these activities to be conducted with provider or patient informed consent.

However, NACHC does conduct research and some quality improvement projects with research elements, which requires IRB review. NACHC has a relationship multiple IRBs but recommends the use of the IRB at AT Still University with whom NACHC has an established relationship. A detailed manual is available to provide guidance for an IRB submission. NACHC also supports data partners or project partners use of an affiliated IRB. When IRB is needed, NACHC appoints an institutional primary investigator. Individuals who can be NACHC PI's maintain the appropriate CITI certifications and have an established PI number with AT Still's IRB.