On October 27, 2021, the U.S. Food and Drug Administration (FDA) in collaboration with Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), published Guiding Principles for the use of artificial intelligence and machine learning (AI/ML) in medical devices. The principles are designed to support good machine learning practices (GMLP) and to help promote safe, effective, and high-quality medical devices that use AI/ML. The FDA is accepting public comment on these principles on an ongoing basis.
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CMS offers $1.65 million in AI Health Outcomes Challenge
By Jodi G. Daniel & Amber Mulcare on
On March 27, 2019, the Centers for Medicare & Medicaid Services (CMS) announced a $1.65 million competition to accelerate development of AI solutions in health care. The Artificial Intelligence (AI) Health Outcomes challenge seeks innovative, AI-driven solutions that can predict unplanned hospital and skilled nursing facility (SNF) admissions and adverse events.
The challenge is a…
FDA Advances Flexibility-Based Framework for Digital Health and AI
By Jodi G. Daniel, Ashley N. Southerland & Maya Uppaluru on
The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.
During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives:…
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