Data use agreements versus business associate agreements

Both data use agreements and business associates agreements are used in healthcare for managing data responsibly, they serve distinct functions related to the type of data shared. A paper in the University of Maryland Baltimore notes, “BAAs are meant for specific circumstances and if those circumstances are not met, a Data Use Agreement (DUA) should be used.” The two have clear regulatory and functionality differences that should be noted when either is entered into.

What is a data use agreement? 

A data use agreement (DUA) is a legal instrument used to protect the interest of both the data provider and data recipient by outlining the terms under which data can be accessed, used, and protected. The agreement is set in place to uphold privacy rights in a way that clarifies the expectations and responsibilities of both parties. In healthcare, it defines the roles of ethical data sharing through the promotion of legal and clear practices between covered entities and business associates. 

The specific terms include: 

• A comprehensive description of the data being shared, including any restrictions on its use and who is authorized to access it.
• Clearly outlines the intended use of the data, ensuring it is used solely for the specified purpose.
• Clauses that prevent unauthorized disclosure of the data, detailing restrictions on copying, sharing, or transferring the data to third parties.
• Requirements for safeguarding the data, including technical and physical security measures such as encryption and access controls.
• Clarification of who owns the data and what rights the recipient has regarding its use or disclosure.
• Specifies the duration of the agreement and conditions under which it can be terminated, including breach scenarios.
• Provisions addressing liability in case of unauthorized use or disclosure, ensuring accountability for breaches.
• A commitment from both parties to adhere to relevant laws and regulations regarding data privacy and protection.
• Procedures for resolving conflicts between the parties may include mediation or arbitration options.
• Obligations related to reporting any incidents of data misuse or breaches.
• Guidelines on how records can be used, duplicated, or shared further.
• Identification of who will be responsible for managing and overseeing the data during its use.
• Designation of contacts for both parties to facilitate communication regarding the agreement.
• Details about any funding associated with the project that involves the shared data.
• Specific consequences are outlined for breaches of confidentiality or improper use of the data. 

What is a business associate agreement?

A business associate agreement (BAA) is a contract that outlines the responsibilities and obligations of a business associate who accesses protected health information (PHI). The agreement is established under the HIPAA Privacy and Security Rules and is further reinforced by the Omnibus Rule which reinforces the accountability of business associates. It established the contractual relationship between a covered entity and a business associate. 

The terms include: 

• Clear definitions of key terms, including "business associate," "covered entity,".
• Detailed descriptions of how the business associate may use or disclose PHI, including any limitations on such uses.
• Requirements for the business associate to implement appropriate administrative, physical, and technical safeguards to protect PHI from unauthorized access or disclosure.
• Provisions requiring the business associate to report any unauthorized uses or disclosures of PHI, including breaches, to the covered entity promptly.
• Obligations for the business associate to ensure that any subcontractors who have access to PHI also comply with HIPAA regulations and are bound by similar agreements.
• The business associate is responsible for supporting patients' rights under HIPAA, including access to their PHI, amendments, and disclosure accounting.
• Clauses that allow the covered entity to conduct audits or inspections of the business associate's records related to PHI usage and disclosure.
• Requirements for the business associate to return or destroy all PHI upon termination of the agreement, ensuring that no data is retained improperly.
• Provisions outlining liability in case of breaches or violations of the agreement, including indemnification clauses protecting the covered entity from losses due to the business associate's negligence.

The main differences 

The purpose

DUAs are mainly used for data sharing, especially related to limited data sets, for specific purposes like research or healthcare operations. They focus on the terms under which nonpublic data can be used. 

BAAs related to the relationship between a covered entity and business associate, ensuring that the business associate complies with HIPAA when handling PHI.

Types of data

DUAs usually involve sharing nonidentifiable data that do not contain direct identifiers of individuals. It allows for certain disclosures without needing patient consent. 

BAAs govern the use and disclosures of PHI which includes information like health conditions, healthcare services, and healthcare payments.

Regulatory requirements

DUAs are not required by HIPAA but are often used to comply with institutional policies or specific research regulations. They provide guidance for the ethical use of data but do not carry the same legal weight as BAAs. 

Scope of responsibilities 

In the DUA, the responsibilities mainly focus on how the data can be used and the obligation to protect it during research or operational activities. In a BAA, there is a broader scope that includes detailed provisions on protecting PHI and reporting breaches.

Related: HIPAA Compliant Email: The Definitive Guide

FAQs

What are the responsibilities of a business associate?

Business associates must implement appropriate safeguards to protect PHI, report any unauthorized uses or disclosures, and comply with the HIPAA Privacy, Security, and Breach Notification Rules.

Are business associates directly liable for HIPAA violations?

Yes, business associates can be held directly liable for HIPAA violations. Recent changes in regulations have established that they face penalties independently of covered entities for noncompliance.

What happens if a BAA is not in place?

If there is no BAA in place when required, covered entities may face significant fines for noncompliance with HIPAA.