Advanced 340B Operations for Maintaining Compliance during the Evolution of Technology

Published in 340B Report
December 11, 2025

The advancement of available technology solutions has 340B stakeholders turning to automation and artificial intelligence to support pharmacy operations such as inventory management, 340B claims qualification, and even auditing documentation. As technology continues to change, 340B Program leaders may want to leverage these new resources to assist with 340B Program management. However, they should ensure that the use of these technologies maintains compliance with 340B Program regulations and aligns with their organization’s data governance and information sharing policies.

Creating a Governance Structure

340B stakeholders interested in using new technology solutions to manage their 340B programs should have a formal approval process to vet these solutions through their organization’s leadership structure.

• Use of AI for 340B program management should align with the organization’s guiding principles for AI use. These guiding principles are commonly identified and adopted through the creation of an AI governance committee. The AI governance committee should be led by personnel from information technology (IT), but it should also include representatives from all areas of the organization, including pharmacy/340B, compliance, legal, finance or revenue cycle, and clinical staff where appropriate.
• The cross-functional representation for developing the guiding principles for AI use at an organization ensures standardization of use throughout all departments.
• In addition to representation on the AI governance committee, 340B program leaders should consider creating a standing agenda item surrounding AI use for their 340B oversight committee. Updates regarding how the organization is using advanced technology, along with staffing resources to accurately maintain oversight of 340B Program compliance, should be regularly reviewed.

Use of Third-Party Platforms

Almost all technology systems used to manage 340B programs rely on extensive data elements. When deciding to partner with a third-party platform, 340B leaders should take the necessary precautions to ensure data integrity and security, as follows:

Terms and Conditions

• Before creating an account and entering any organizational information, make sure the information requested is appropriate to share.
• Many organizations have parameters around how data and financial information are shared, so it is important to understand your organization’s position before moving forward with a third-party system.
• Have your legal team review the third-party platform’s terms and conditions to ensure that it is a reputable platform in the marketplace, and that it upholds your organization’s policies regarding data management.
• If reviewing a vendor’s terms and conditions reveals any concerns or gaps with your organization’s policies, your legal department should work with the vendor to amend the agreement, when possible.
• Identify the organization’s representative(s) with the appropriate legal authority to accept applicable terms and conditions.

Information Sharing with Third-Party Platforms

• Prior to submitting data to any third-party platform, check with your organization to ensure that policies surrounding data integrity and security, including the sharing of protected health information (PHI), are being upheld.
• This may include vetting of the third-party platform by your IT or data security team or implementation of formal agreements, such as a business associate agreement, to protect your institution in case of a data security breach.
• To ensure the proper handling of PHI, ensure that all applicable annual training requirements are completed.

Stay Up to Date

Advanced technology can assist with 340B Program management, but the key to running a compliant 340B program is staying up to date with the ever-changing 340B landscape. As an industry-recognized certificate program, the Apexus Advanced 340B Operations Certificate Program delivers quarterly content designed to keep 340B stakeholders informed on emerging operational topics affecting the 340B Program.

Advanced 340B Operations Certificate Program enrollees can learn more about the intersection of 340B with technology within the Advanced 340B Operations Certificate Program webinar “Reimagining 340B: How AI is Shaping the Future of Program Compliance and Operations” and the “Operational Considerations for Data Submission” section of the “2024 Wrapped: A Review of Legislative Updates and Insights” webinar. Advanced 340B Operations Certificate Program enrollees and 340B Apexus Certified Experts (ACEs) can access both webinars via the Exclusive Tools course in the Apexus Education Portal.

To continue strengthening your 340B Program operations, consider attending the quarterly Apexus compliance and operational webinars to stay current on the latest 340B news, policies, and procedures. Sign up to be notified when enrollment is open for our next Apexus Advanced 340B Operations Certificate webinar.

For questions, please email 340BCertificate@apexus.com.