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.
...
*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
...
Data is either collected by NACHC or owned by another organization and shared with NACHC, where NACHC acts as a data steward.
...
Data Shared with NACHC
There are two many types of data that may be shared with NACHC .
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.
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. 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.
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. 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
...
- 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 agreementsafeguards 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 recipientprovider 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 uncertaintyto 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 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.
- 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.
- 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.
- Once completed, the DUA checklist is stored in the project Confluence page.
- 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.
- NACHC populate the DUA with project specific information and share with other parties for comment
- NACHC receives and integrates comments and recirculates to other parties and NACHC legal until DUA is ready for signature
- DUA is signed by other party(ies) and returned to NACHC for counter signature and execution
- DUA is executed by NACHC legal and executed agreement is shared with all parties
Section 3: 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 4: Other Governance Topics
Requests
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.
...
- 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.
- 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.
- 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.
- Once completed, the DUA checklist is stored in the project Confluence page.
- 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.
- NACHC populate the DUA with project specific information and share with other parties for comment
- NACHC receives and integrates comments and recirculates to other parties and NACHC legal until DUA is ready for signature
- DUA is signed by other party(ies) and returned to NACHC for counter signature and execution
- 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)
...