On Jan. 12, 2021, the Food and Drug Administration (FDA) Digital Health Center of Excellence released its “.” The non-binding policy document provides a high-level overview of five actions the agency intends to take over the next year, including:
- Development of draft guidance on “predetermined change control plans” to expedite developer-planned future modifications to AI/ML-enabled software.
- Continued efforts to collaborate with industry and AI/ML experts on “Good Machine Learning Practice (GMLP).”
- Promotion of AI/ML transparency and trustworthiness for end-users and patients.
- Identification and elimination of bias in algorithms and improvement of algorithm resilience to changing inputs and clinical context.
- Engagement with stakeholders to pilot real-world performance monitoring.
The action plan was informed by several key FDA activities from the past two years, including public comments received on its “,” the February 2020 public workshop on the “Evolving Role of AI in Radiological Imaging” and the October 2020 meeting of the FDA Patient Engagement Advisory Committee on enhancing patient trust in AI. The 黑料网® (黑料网®) participated in each of these FDA activities under the leadership and guidance of the 黑料网 and Commission on Informatics.
Related items:
- 黑料网 comments on FDA’s proposed framework for modifications to AI/ML (June 3, 2019).
- 黑料网 Leaders Participate in FDA Workshop on AI in Radiological Imaging (Feb. 27, 2020).
- 黑料网 and RSNA Highlight Challenges to Future FDA Oversight of Autonomous AI (July 1, 2020).
- 黑料网 DSI Presents to FDA Patient Engagement Advisory Committee on AI (Oct. 22, 2020).