Artificial intelligence (AI) and machine learning (ML) technologies are transforming healthcare delivery. Understanding the regulatory framework for study AI/ML utility, accuracy, efficacy, and reproducibility is key to the research process prior to its use in patient diagnosis and care. This is a cutting-edge topic upon which many new federal guidance documents have focused. It is often misunderstood by sponsors, sites, and investigators that if AI/ML is used for diagnosis, the technology it is FDA regulated. Operationally, the inclusion or exclusion of AI/ML findings into the electronic health record is poorly understood, although it is analogous to the 21 CFR 812 Investigational Device Exemption or 510 K pathway used for new laboratory testing procedures.

CEU: 1.00 ACRP

Speakers:

• Betty Donoval, Director, Research & Regulatory Affairs, Cook County Health

• Pamela Gonzalez, Manager Research Consultant, Huron LLC

Watch a Sneak Peek into the Session Content:

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.