Government Regulation and AI

2019 Imaging Informatics Summit

July 6 – 7, 2019 | 5:00pm – 8:00pm | Washington D.C.
Add to Calendar

As development of AI accelerates, it creates challenges for government regulation. You’ll hear a brief history of AI/ML regulation and learn the major pathways for software as a medical device to become commercially available. We’ll also cover proposed modifications to the regulatory framework for modifications to AI/ML and ACR® initiatives to support the use of AI in medical imaging.

The Total Product Lifecycle in AI for Radiological Imaging

By: Alex Cadotte, PhD

This video provides an overview of the regulation of radiological AI and Machine Learning (ML). After reviewing the Center for Devices and Radiological Health’s (CDRH) mission and vision, key regulatory concepts, and a brief history of AI/ML regulation, the video summarizes how policies could change for new technologies, including autonomous AI and AI-guided imaging.

Learning Objectives:
  • Learn about the regulation of radiological AI and ML.
  • Understand CDRH’s mission and vision.
  • Explore key regulatory concepts.
  • Grasp the difference between general and special controls for medical devices.
  • Learn the available pre-market submission pathways.
  • Get a glimpse of the future of regulation practices.

Overview of FDA Regulatory Framework

By: Howard Chen, MD, MBA

Many of the commercial imaging AI models have already gone through the complex FDA review process. This video highlights the differences between the FDA’s 510(k) premarket notification, a De Novo classification, and Pre-market Approval (PMA).

Because updating ML models is unlike updating typical software, it’s not always clear when a new FDA review submission is required. The video gives an overview of the proposed modifications to the regulatory framework for modifications to AI/ML.

Learning Objectives:
  • Learn FDA medical device classifications.
  • Discover major pathways for “software as medical devices” to become commercially available.
  • Understand the needs surrounding an amended process, and the FDA’s proposal.

Regulatory Issues Related to AI: ACR Initiatives

By: Bibb Allen Jr., MD, FACR

In response to regulatory issues related to AI in diagnostic imaging, the ACR has several ongoing initiatives to ensure the safety and effectiveness of AI for all patients. Along with leveraging existing resources including data registries, the Center for Research and Innovation, and Appropriateness Criteria, the ACR launched the ACR Data Science Institute® (DSI) in 2017.

The DSI continues to promote clinically relevant, safe, and effective use of AI in clinical practice. Some DSI resources reviewed in this video include structured use cases, AI-Central, AI-LAB, and ACR Connect.

Learning Objectives:
  • Discover ACR and DSI initiatives to support the use of AI in medical imaging.
  • Navigate current challenges in the FDA regulatory process for AI algorithms.
  • Learn how to ensure AI is safe and effective for patients.