Topic
machine learning
213 published works
ComplexDiscovery
From Taxonomies to Threats? Securing Machine Learning Algorithms
By Rob Robinson
Editor’s Note: The European Union Agency for Cybersecurity, ENISA, is the Union’s agency dedicated to achieving a high common level of cybersecurity across Europe. In December of 2021, ENISA published…
Life Sciences Perspectives
3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices
By Steven Tjoe
Today, developers of innovative medical devices are increasingly utilizing artificial intelligence (AI) and machine learning (ML) technologies to derive important insights with the promise of transforming the delivery of healthcare.…
Eye On Privacy
FDA Joins Other Regulators in Focus on AI and Machine Learning
The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a…
Global Regulation Tomorrow
EBA discussion paper on machine learning for IRB models
On 11 November 2021, the European Banking Authority (EBA) published a discussion paper on machine learning for internal ratings-based (IRB) models. The discussion paper is a first step to engage…
BioSlice Blog
Ten International Guiding Principles on Good Machine Learning in Medical Devices
By Eleri Abreo, Arnold & Porter
The UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the US Food and Drug Administration (FDA) and Health Canada have recently published a joint statement identifying ten guiding principles to…
Life Sciences Perspectives
FDA Issues Guiding Principles for Good Machine Learning Practice for Medical Device Development
By Stephanie Philbin|Steven Tjoe|Emily Tribulski*
On October 27, 2021, the U.S. Food and Drug Administration (FDA), Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a set of ten guiding…
Global Policy Watch
U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices
By Sarah Cowlishaw, Olivia Dworkin
On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10…
Covington Digital Health
U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices
By Sarah Cowlishaw, Olivia Dworkin
On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10…
Health Law
FDA Publishes Principles for AI and ML in Medical Devices
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…
Health Law Prof Blog
Direct-to-Consumer Medical Machine Learning and Artificial Intelligence Applications
Boris Babic, Sara Gerke (Pennsylvania State University), Theodoros Evgeniou, I. Glenn Cohen (Harvard Law School), Direct-to-Consumer Medical Machine Learning and Artificial Intelligence Applications, 3 Nat Mach Intell, 283-287 (2021):Direct-to-consumer medical…