Insight
Is AI the Solution to Regulatory Modernization?
1 minute read | July.27.2023
AI presents opportunities and challenges as it expands access to consumer credit and modernizes regulatory compliance.
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Insight
FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions
by Georgia C. Ravitz, Shari Esfahani, Stephen Thau, Thora Johnson, Jeremy D. Sherer and Amy M. Joseph
2 minute read | January.13.2025
The FDA issued draft guidance on assessing AI model credibility for drug safety, effectiveness, and quality in regulatory decisions.
Insight
The Download: A Private Sector Model for Responsible AI in Healthcare & Why Value-Based Care Is Good Business
4 minute read | January.23.2025
In this Life Sciences & Healthtech edition of The Download, we take on key trends with the Coalition for Health AI, Aledade and BofA Securities.
Insight
US Data Localization Law Coming Soon: DOJ Issues Final Rule on Certain Data Transfers to “Countries of Concern”
by Harry Clark, Benjamin Hutten, Thora Johnson, Jeanine P. McGuinness, Shannon Yavorsky, Elizabeth Zane, James Chou, Olivia Rauh and Cosmas Robless
10 minute read | January.17.2025
The DOJ has finalized prohibitions and restrictions on cross-border transfers of certain data to China and other “Countries of Concern.”
Insight
Proposed HIPAA Security Rule Update: What It Means for Cybersecurity in Health Care
by Thora Johnson, Alyssa Wolfington and Michaela Frai
6 minute read | January.27.2025
The Department of Health and Human Services’ OCR issued a notice of proposed rulemaking (NPRM) to update the HIPAA Security Rule.
Insight
New Export Controls on Advanced Computing Items and AI Model Weights
by Harry Clark, Elizabeth Zane, Gregory I. Hume and Maria Sergeyeva
5 minute read | January.27.2025
The Commerce Department issued a rule that increases export controls on AI-related items, among other unprecedented steps. We discuss 3 key takeaways.
Insight
Health Tech Regulatory Trends to Watch in 2025
by Thora Johnson, Georgia C. Ravitz and Amy M. Joseph
7 minute read | January.03.2025
Orrick's Life Sciences team explores how the healthcare industry is bracing for significant developments in regulation and litigation in a recent ...
Insight
Managing AI Risk: 3 Laws Companies Using Consumer Data for AI Development Need to Know
by Shannon Yavorsky
2 minute read | May.16.2023
An update on the FTC’s focus on three “laws important to developers and users of AI” which may impact your business.
Insight
How Employers and In-House Counsel Can Adapt to AI Workplace Use
by Alexandra Stathopoulos
1 minute read | May.04.2023
Alex Stathopoulos assesses the fast-moving AI sector and provides guidance for corporate counsel on how to review processes and workplace adoption.
Insight
The EEOC on AI in Employment Decisions: What Companies Should Know and Do
by Tierra D. Piens
2 minute read | May.23.2023
An update on the EEOC's reminder about potential discrimination when companies use “algorithmic decision-making tools” or software systems.
Insight
AI Model Diligence: 3 Steps for Financial Institutions to Manage Model Risk
by Amanda Lawrence and Caroline Stapleton
4 minute read | July.07.2023
The three steps financial institutions should follow to manage artificial intelligence (AI) model risk.
Insight
When the CFPB Investigates: Responding to a CFPB CID
by John Coleman, Amanda Lawrence, John (Jay) Williams, Brian Bartholomay and Ronald Williams
11 minute read | July.06.2023
Since 2011, the Consumer Financial Protection Bureau has enforced actions against companies, recovering billions. CIDs demand docs, testimony.