Roles & Responsibilities

Project Team

The Project Team is a cross-functional team that is responsible for designing and implementing an algorithmic solution.

Project Teams generally include an Executive Sponsor, Clinical or Business Owner, Model Owner, and additional team members, as needed. The Business Owner and Model Owner are responsible for ensuring the Project Team satisfies the requirements of the oversight process and for maintaining communication of the project status to the Executive Sponsor, individual Project Team members, and the ABCDS Oversight Committee.

Executive Sponsor

The Executive Sponsor is the department chair, service line director/head, C-suite executive, or other leadership champion that is supportive of the Project Team’s algorithmic or AI-enabled solution.

The Executive Sponsor is responsible for prioritization and funding of the algorithmic solution throughout its development and deployment.

Clinical or Business Owner

The Clinical or Business Owner is responsible for representing the end user and use case and serves as a point of contact once the algorithmic solution is deployed. This may include, but is not limited to, providing feedback on solution design, conducting testing, and/or evaluating safety events or solution-related risks before or after deployment.

When an algorithmic solution is procured from a third-party vendor, the Clinical Owner is responsible for obtaining transparency information and specifications from the vendor, sharing guidance on its use, performing local validation of the solution, and testing updated versions of the solution.

The Clinical Owner is a permanent (i.e., not temporary) faculty or clinical staff member (e.g., healthcare professional, administrator), and is responsible for communicating relevant information regarding the function, use, and risks of the algorithmic or AI-enabled solution with the end users and for driving adoption.

Model Owner

When an algorithmic solution is developed internally, the Model Owner (or Technology Owner) is responsible for providing and maintaining information and documentation regarding the technical design, development, and maintenance of the solution, including the model and end-user interface of the solution, to ensures it operates as expected and is designed according to applicable requirements of this procedure.

The Model Owner may work alone or with additional technical resources (e.g., data scientist(s), statistician(s), information technology experts, etc.).

ABCDS Oversight Committee

The ABCDS Oversight Committee defines and provides Duke Health-wide oversight and management of the ABCDS Oversight process

The ABCDS Oversight Committee is responsible for:

  • Establishing and implementing the ABCDS Oversight process and procedural requirements
  • Evaluating algorithmic and AI-enabled solutions
  • Maintaining an inventory of algorithm-enabled solutions intended to be used for patient care
  • Determining which procedural requirements apply to algorithm-enabled solutions that are in scope.

The ABCDS Oversight Committee has three subcommittees. Each subcommittee is co-chaired by ABCDS Oversight Committee members selected by the ABCDS Oversight Leadership. 

  • ABCDS Oversight Evaluation Subcommittee
  • ABCDS Oversight Implementation & Monitoring Subcommittee
  • ABCDS Oversight Regulatory Advisory Subcommittee