Generally, when state, Tribal, local, and territorial (STLT) public health agencies share data sets with other entities for public health surveillance or other public health programmatic activities, all parties sign a data use agreement (DUA), also known as a data sharing agreement. This resource answers some common questions about when a Data Use Agreement is need to disclose public health data.
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Must I Have a Data Use Agreement in Place to Share Public Health Data?
From a strictly legal perspective, it is often the case that the law does not explicitly require a DUA. For example, the Health Insurance Portability and Accountability Act (HIPAA) only requires an agreement to share protected health information (PHI) in some circumstances, such as disclosures of a limited data set.1,2 Most federal and state privacy or confidentiality laws do not require a legal agreement to disclose data. The question of whether a DUA is required by law is something that STLT public health agency staff should discuss with their attorneys. Regardless, there are many reasons why it may make sense to execute a DUA. This resource lays out considerations for determining when a DUA is needed to share public health data.
1 45 C.F.R. §§ 164.514(a)–(c), (e) (2025).
2 A limited dataset, as defined by HIPAA, is a dataset made up of protected health information that excludes specific direct identifiers such as names and addresses but includes certain information like zip codes and age in years. A limited dataset is still considered protected health information as it has not been completely deidentified.
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What Does a Data Use Agreement Do?
A DUA documents the terms of the data sharing as well as the process for monitoring the activity covered by the agreement and the accountability of the parties involved.3 Typically the process of developing and executing a DUA requires the involvement of program staff, STLTs leadership, and legal and privacy staff. This resource is not a substitute for the judgement of STLT leadership, legal, and compliance teams regarding the need for specific data sharing agreements.
3 An Introduction to Legal Agreements that Facilitate Public Health Data Sharing, Pub. Health Law Ctr., https://www.publichealthlawcenter.org/resources/introduction-legal-agreements-facilitate-public-health-data-sharing [https://perma.cc/3CT9-DE59] (last visited Feb. 6, 2025).
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What are the Terms and Conditions Typically Covered in a Data Use Agreement?
A DUA provides specific terms and conditions that govern the relationship between the parties sharing the data. Typically, a DUA includes terms and conditions on the topics listed below. This is not an exhaustive list.
- Purpose of data sharing
- Description of the data to be shared
- Permitted uses and disclosures of the data, as well as any secondary use or disclosure restrictions
- Method of data transmission
- Data security measures
- Data access controls
- Breach notification requirements
Other terms and conditions may be required, either to comply with law or to meet internal policies and procedures or other best practices. Consult your organization’s attorney to determine the terms and conditions that best apply to a particular data sharing agreement.
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What Considerations go into Determining Whether or Not a Data Use Agreement is Needed?
There are many considerations for a health department to assess when determining whether a DUA is needed to disclose public health data. This determination may need to be made in consultation with your STLT attorney, privacy officer and security officer. It is important to understand the circumstances and goals of the data sharing project. This will help your attorney or privacy officer to determine whether data sharing is consistent with applicable law and will help your organization be consistent with its policies, procedures, and priorities. Below are some of the key considerations:
- What is the purpose of sharing the data?
- What data will be shared?
- In what form will the data be shared? Is it identifiable, aggregate, de-identified, or a HIPAA limited data set?
- What are the public health goals of sharing the data?
- Will the data sharing relationship be one-time or on-going?
For more information, see The Network for Public Health Law’s checklist of information needed to address proposed data collection access and sharing.
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What are the Applicable Laws?
Public health data sharing efforts implicate many laws. This resource is intended to provide public health managers with general insights into the information their attorneys and privacy officers may be thinking about in response to a data sharing request. Federal, state, and local laws, as well as agency policy may apply to data sharing activities. State and local laws and agency policy vary by jurisdiction.
Relevant Federal Laws
The sections below summarize information about some of the federal laws that most commonly apply to public health data sharing.4
- The Health Insurance Portability and Accountability Act (HIPAA)
HIPAA is a federal law that created national standards for electronic health care transactions and incorporated privacy protections applicable to protected health information or PHI.5 HIPAA applies to “covered entities,” which it defines as a health plan, health care clearinghouse, or health care provider.6 HIPAA’s privacy and security rules dictate how a covered entity may use and disclose PHI. Most health departments are HIPAA covered entities or hybrid entities.7 Broadly speaking the application of HIPAA’s privacy and security rules follows these steps:
- Assuming your organization is covered by HIPAA, before entering into a DUA, your organization will need to assess whether HIPAA applies to the data to be disclosed. If the data is considered PHI, HIPAA will apply.
- If HIPAA applies, the next step is determining whether a HIPAA authorization is needed from the individuals whose PHI is to be shared or whether an applicable exception to the authorization rule applies (e.g., HIPAA’s public health exception).8
- Then, depending on the format of the data to be shared (identifiable9, limited data set10, deidentified11), HIPAA’s regulations may require a DUA with specific terms and conditions.
HIPAA permits covered entities to disclose limited data sets in specified circumstances for research, public health, and health care operations without first obtaining a patient authorization or waiver, as long as the parties executed a DUA that includes required provisions. HIPAA’s privacy rule requires a DUA when a limited data set is used or disclosed.12 HIPAA does not require a DUA to disclose PHI under HIPAA’s public health exception; however, a DUA is often considered a best practice.
4 Note that this is not an exhaustive list of federal privacy laws or regulations that may apply to public health data.
5 Health Insurance Portability and Accountability Act of 1996, Pub L. No. 104-191, 110 Stat. 1936; see also HIPAA for Professionals, U.S. Dep't of Health & Hum. Servs. (July 19, 2024), https://www.hhs.gov/hipaa/for-professionals/index.html [https://perma.cc/G9JC-VK73].
6 45 C.F.R. § 160.103 (2025). Note that HIPAA only applies to health care providers who transmit health information in electronic form in connection with a HIPAA covered transaction. For practical purposes, this covers most health care providers.
7 A hybrid entity is a single legal entity that is covered by HIPAA and whose business activities include both covered and non-covered functions under HIPAA. To become a hybrid entity, an organization must designate its covered and non-covered components, which then allows HIPAA to apply only to the HIPAA covered functions the organization performs. 45 C.F.R. §§ 164.103, 164.105 (2025).
8 See 45 C.F.R. §§ 164.508 (authorizations),164.512 (exceptions to authorization) (2025).
9 Identifiable health information or protected health information is data that can identify an individual and relates to their past, present, or future health or healthcare.
10 A limited data set is identifiable healthcare information with certain direct identifiers removed, used for research, public health, or healthcare operations under a data use agreement (DUA).
11 De-identified health information is health information from which all individual identifiers have been removed, making it impossible to identify an individual.
12 45 C.F.R. § 164.514(a)–(c), (e) (2025).
- 42 CFR Part 2
In addition to HIPAA, there are other federal privacy laws that may apply to certain types of health data.13 For example, 42 CFR Part 2 applies to and imposes restrictions on the use and disclosure of substance use disorder patient records maintained as part of a Part 2 program. Part 2 is more restrictive than HIPAA and its application needs to be evaluated carefully.
13 Note that this is not an exhaustive list of federal privacy laws or regulations that may apply to public health data.
- The Common Rule
Furthermore, federal protections for human research subjects, also known as the Common Rule,14 may apply to public health research activities. The Common Rule outlines the basic provisions for Institutional Review Boards (IRBs), informed consent, and assurances of compliance.15 While not a privacy rule, the Common Rule sets out ethical and other principles for human subjects research and may need to be complied with in addition to other privacy protections. For instance, it may be the case that a health department needs to comply with both the Common Rule and HIPAA’s privacy protections when sharing data as part of a research project.
14 45 C.F.R. pt. 46 (2025).
15 See Federal Policy for the Protection of Human Subjects, U.S. Dep't of Health & Hum. Servs. (Jan. 15, 2026), https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html [https://perma.cc/PN8H-PL4D] (providing overview of Common Rule). HIPAA’s privacy rule contains standards for the use and disclosure of PHI for research purposes. 45 C.F.R. § 164.512(i) (2025).
State Privacy Law
State laws may impose additional privacy protections on public health data.16 State law is often less detailed than HIPAA and may allow disclosure so long as no particular individual can be identified.
16 50-State Survey of Health Care Information Privacy Laws, Seyfarth Shaw LLP (2023), https://www.seyfarth.com/a/web/bhRXWBkMif111KfVwiQN6V/50-state-survey-of-health-care-information-privacy-laws-2023-2024-edition.pdf [https://perma.cc/SXQ7-MBET].
- Subsets of Data That Frequently Have Special Legal Protections in State Law
Although state law often mirrors or defers to federal law on data protection, certain subsets of data may be specially protected under state law. Common examples include special privacy protections for HIV, immunization, communicable disease, and other information that may carry an increased risk of stigma or discrimination.17
17 See, e.g. Mich. Comp. Laws § 333.5131 (2025); Tex. Health & Safety Code Ann. §§ 161.0073, 161.008 (2025); Mich. Admin. Code r. 325.181 (2025).
- Comprehensive Privacy Legislation
In addition to state privacy laws applicable to public health, many states have adopted privacy laws that are more generally applicable. As of April 2025, 19 states have adopted comprehensive privacy legislation, and 15 states have introduced bills that are at various stages of the legislative process.18 These consumer protection laws generally establish a set of rights and responsibilities for the collection, use, and sharing of personal data across all sectors of the economy by non-governmental organizations.19 These laws may encompass PHI but the data they protect are broader. While many of these comprehensive privacy laws exempt state and local governments and/or HIPAA covered entities, health departments need to be aware of how comprehensive privacy laws may impact their ability to collect and use data.
18 David Botero, US State Privacy Legislation Tracker, Int’l Ass’n of Priv. Pros. (Feb. 10, 2026), https://iapp.org/resources/article/us-state-privacy-legislation-tracker/ [https://perma.cc/Q9PG-U6Y7].
19 Jordan Francis, Anatomy of State Comprehensive Privacy Law, Future of Priv. Forum (Nov. 2024), https://fpf.org/wp-content/uploads/2024/11/REPORT-Anatomy-of-State-Comprehensive-Privacy-Law.pdf [https://perma.cc/DU3N-GM39].
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How do Health Agencies’ Relevant Policies and Procedures Fit into the Analysis?
It is also important to be familiar and consistent with your organization’s policies and procedures regarding privacy, security, and data sharing. Each organization handles this a little differently. For example, there may be HIPAA and non-HIPAA policies and procedures or there may be policies and procedures applicable to different program areas within the department. While the law will not always require a DUA, your organization might as a matter of policy. There may also be non-legal discussions to engage in with your attorney, privacy officer, and/or departmental leadership regarding organizational priorities and resources when evaluating a data sharing request. North Carolina’s Department of Health and Human Services Data Sharing Guidebook is a great example of a comprehensive approach to data sharing considerations.20
20 Data Sharing Guidebook, N.C. Dep’t of Health & Hum. Servs. (June 2025), https://www.ncdhhs.gov/ncdhhs-data-sharing-guidebook/open [https://perma.cc/Q94R-XYWQ].
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When is a Data Use Agreement Not Needed?
A DUA may not be needed in all circumstances. You may not need a DUA if:
- The data can be shared openly, either at an aggregate or individual level, based on state and federal law. For example, some state health departments have data portals where partners can review publicly available datasets and data dashboards.21
- The data are requested as part of a public records request, an audit, or as part of a legal proceeding. Many government agencies, including health departments, have departments that oversee public records requests to ensure they are balancing privacy and transparency considerations.22
- The party requesting the data is part of the same governmental agency. Some states have passed policies that aim to harmonize data sharing practices across government agencies with the goal of facilitating effective intra-agency data sharing to deliver responsive government services while protecting privacy.23
In summary, a DUA may not be necessary when the data are publicly available or properly deidentified so that the risk of reidentification is sufficiently low; or if the sharing is happening within a state government entity. This is a determination that needs to be made in consultation with your organization’s attorney, privacy officer, and security officer and consistent with internal policies and procedures.
21 Search Data Assets, Ariz. Dep’t of Health & Hum. Servs., https://data.azdhs.gov/data-assets/search-data [https://perma.cc/U8TN-J3P4] (last visited Sept. 10, 2025).
22 See, e.g., Public Health Records Center, Cal. Dep’t of Pub. Health, https://cdph.govqa.us/WEBAPP/_rs/(S(k4owj5izbsmllkjwxjb15ck0))/SupportHome.aspx [https://perma.cc/QFP3-NEB4] (last visited Sept. 10, 2025).
23 See, e.g., Colo. Rev. Stat. § 24-37.5-705 (2024).
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What is the Connection Between Data Use Agreements and Data Governance?
It’s not unusual for agency staff to start the process of assessing a data request by consulting with their legal or privacy officer. However, this is only one element of what should be a broader framework of data governance. “Data governance is the people, policies, and procedures that support how data are used and protected.”24 A data governance framework should be an iterative and on-going process that incorporates perspectives from a wide range of stakeholders across an agency. While data use agreements and the laws that govern data sharing are important pieces of the data governance puzzle, there is a lot more that goes into effectively managing data and protecting the privacy and security of data while making it available for appropriate public health purposes. The Public Health Informatics Institute has created an on-line resource about data governance for public health which is a guide to agency-wide data governance through the lens of data modernization.25
24 Amy Hawn Nelson et al., Finding a Way Forward: How to Create a Strong Legal Framework for Data Integration, Actionable Intelligence For Social Policy (June 2022), https://aisp.upenn.edu/wp-content/uploads/2022/06/AISP_Finding-A-Way-Forward_Final_6.16.2022.pdf [https://perma.cc/Y2KK-43JS].
25 Data Governance for Public Health, Pub. Health Informatics Inst., https://rise.articulate.com/share/YFnvtDOHKU8yOrXeVH59lJH7zZUfMkx5#/ [https://perma.cc/XCD5-YU7P] (last visited Sept. 22, 2025)
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Questions?
For legal technical assistance on public health data sharing agreements, reach out to our Public Health Infrastructure team here. This resource is part of a series of factsheets prepared by the Public Health Law Center.
The development of this resource was supported by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $750,000 with 100 percent funded by CDC/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement, by CDC/HHS, or the U.S. Government.