RAPS10/14 20:06 UTC
MHRA announces strategy to streamline regulation in the AI era
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial intelligence (AI) and personalized medicine. The plan outlines commitments and steps the agency should take through 2030 to keep pace with rapid technological and scientific developments and bring safe and effective treatments to patients more quickly.
Read the original →Streetwise Reports10/14 23:24 UTC
The FDA Clarified Its Rules for Medical AI. This Stock Could Be on the Right Side of Them
Rocket Doctor AI Inc. (AIDR:CSE; AIRDF:OTCQB; 939:FSE) continues to develop its physician-led healthcare platform. Revised FDA guidance, new state healthcare AI laws and rising U.S. patient volumes are reshaping the regulatory and commercial environment.
Read the original →PharmTech.com10/13 12:07 UTC
How AI Can Assist With Postmarketing Changes
Postmarketing governance must be evidenced across the full life cycle, covering design, validation and live monitoring. It should not be documented once and assumed to hold.
Read the original →Bioengineer.org10/14 13:58 UTC
When AI Outruns the Doctor: A New Framework Measures the Human Oversight Gap in Cardiology
A new Journal of Medical Systems commentary proposes a task-level oversight-margin framework. It aims to quantify when human supervision of cardiovascular artificial intelligence falls behind the pace of the technology.
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