FDA Law Blog
MAY 4, 2023
Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).
FDA Law Blog
MAY 8, 2023
Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).
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FDA Law Blog
NOVEMBER 29, 2023
Additionally, when models are periodically or continually trained after deployment, there are appropriate controls in place to manage risks of overfitting, unintended bias, or degradation of the model (for example, dataset drift) that may impact the safety and performance of the model as it is used by the Human-AI team.
LawSites
MARCH 17, 2022
.” Wolters Kluwer Passport , “legal spend, matter management, and insurance claims defense applications connect every part of your legal ecosystem.” ” Rowan Patents , “designed specifically to draft and prosecute patents.”
Everchron
MARCH 7, 2024
From drafting documents to legal research, AI can enhance efficiency and provide insights previously unattainable through traditional methods. This includes verifying that AI systems offer adequate security protections, do not share information with unauthorized parties, and comply with data retention protocols.
The Fashion Law
SEPTEMBER 3, 2021
At the time of writing, a draft of the Administrative Rules on Algorithmic Recommendation-based Internet Information Services has been released by the Cyberspace Administration of China for public consultation. The PIPL creates a new world for personal data management for all companies doing business in or with China.
Patently O
MARCH 17, 2022
I really want to commend Chief Judge Moore and the whole Federal Circuit, its clerks office, and the data management folks for making these key orders available. The draft of that paper, entitled Legal Research as a Collective Enterprise: An Examination of Data Availability in Empirical Legal Scholarship , is now available.
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