HIPAA compliance in data sharing agreements

Healthcare organizations can ensure HIPAA compliance in data sharing agreements by conducting risk assessments, enforcing business associate agreements (BAAs), adhering to the minimum necessary rule, and implementing strong security measures like encryption and access controls. 

Understanding data sharing agreements

Data sharing agreements are formal contracts that define when protected health information (PHI) is shared between healthcare entities. They outline how data will be used, protected, and managed, ensuring that all parties adhere to agreed-upon standards.

Common agreements include business associate agreements (BAAs) and data use agreements (DUAs). BAAs are used when a business associate performs duties that require Protected Health Information (PHI), while DUAs typically govern data shared for research purposes. According to the HHS, "The agreement delineates the confidentiality requirements of the relevant legal authority, security safeguards, and the OPDIV’s data use policies and procedures. The DUA serves as both a means of informing data users of these requirements and a means of obtaining their agreement to abide by these requirements.". 

Effective DUAs should include a clear scope of data usage, security measures, responsibilities of each party, and protocols for handling breaches or data misuse.

How HIPAA applies to data sharing agreements

The Privacy Rule sets standards for the use and disclosure of PHI. It mandates that PHI can only be shared when necessary and with appropriate safeguards. DUAs must align with these requirements, ensuring that PHI is not used or disclosed beyond what is permitted.

According to the HHS, the Security Rule “requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards for protecting e-PHI.". DUAs should specify technical, physical, and administrative safeguards to be implemented by both parties, such as data encryption and secure access controls.

BAAs are required under HIPAA when PHI is handled by third-party vendors. The agreement must detail the business associate’s responsibilities, including implementing appropriate security measures and reporting breaches. Regular audits and reviews of BAAs ensure ongoing compliance.

Ensuring HIPAA compliance in DUAs

Healthcare organizations should conduct risk assessments to identify vulnerabilities that could compromise PHI. Assessment may involve evaluating systems, processes, and personnel to pinpoint potential risk areas. Based on the findings, organizations can develop and implement safeguards such as encryption, access controls, and secure storage solutions. Regular updates and monitoring of these safeguards help address emerging threats.

Read more: How to perform a risk assessment

A well-crafted BAA should define the roles and responsibilities of the covered entity and the business associate, including specifications on how PHI will be used, stored, and protected.

BAAs must require business associates to implement robust security measures, including encryption and access controls. Ensure that these measures meet the Security Rule’s requirements. Incorporate provisions for periodic audits and reviews to assess the business associate’s compliance with HIPAA and the agreement.

Related: FAQs: Business associate agreements (BAAs)

The minimum necessary rule dictates that only the amount of PHI necessary for the intended purpose should be shared. DUAs should specify this limitation and include data minimization strategies. Regularly review data collection and retention practices to eliminate unnecessary PHI. Implement policies for purging outdated or excessive data to maintain compliance with the minimum necessary rule.

• Access controls: Implement role-based access controls (RBAC) to restrict PHI access based on job functions. Multi-factor authentication (MFA) should also be used to secure access.
• Data encryption: Encrypt PHI at rest and in transit to prevent unauthorized access. Use industry-standard encryption protocols and update them as needed.
• Employee training: Provide ongoing training on HIPAA compliance and security best practices. Conduct phishing simulations and other security awareness exercises.
• Incident response plan: Develop a comprehensive incident response plan to address data breaches. This plan should include steps for breach notification, mitigation, and reporting.

Ensure patient rights under the Privacy Rule are protected, including the rights to access, amend, and obtain an account of PHI disclosures. Provide patients with clear and understandable information about how their PHI will be used and disclosed. Ensure that the notice of privacy practices (NPP) is easily accessible.

Conduct regular audits to identify and address potential compliance gaps. Use automated tools to streamline and enhance the audit process. Continuously monitor data sharing activities and implement real-time monitoring tools to detect and respond to unauthorized access.

FAQs

What should be included in a data sharing agreement about data breach notifications? 

Data sharing agreements should specify the timeframe and process for notifying all parties in case of a data breach, including the obligation to report it to relevant authorities and affected individuals as required by HIPAA.

How can healthcare organizations verify that a third party is HIPAA compliant before sharing data?

Organizations can verify a third party's compliance by requesting documentation of their security practices, conducting on-site assessments, and reviewing their compliance history through audits or certifications.

Should data sharing agreements discuss data retention?

Data sharing agreements should establish clear data retention policies that align with HIPAA regulations, ensuring that PHI is retained only as long as necessary and securely disposed of when no longer needed.