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McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Health Care Compliance Association (HCCA)

OCR: Rule Halts Disclosures Under ‘Presumption of Lawfulness,’ Shares Model Attestation Form

Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more

ArentFox Schiff

Top 10 Legal Issues for 2024 For the Consumer Products Industry

ArentFox Schiff on

On August 16, 2022, US Congress enacted Reese’s Law, which aims to protect children from ingestion hazards associated with certain lithium batteries found in consumer electronics. The law stems from the death of 18-month-old...more

Davies Ward Phillips & Vineberg LLP

Doing Business in Québec

Our Doing Business in Québec guide provides an overview of the legal framework governing Canadian business operations in the province of Québec. This guide provides up-to-date information about the following topics: •...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - August 2023

In this month’s Privacy & Cybersecurity Update, we analyze the Biden administration’s proposed cybersecurity labeling program for smart devices, NIST’s extensive overhaul of its cybersecurity framework, and data privacy law...more

Pierce Atwood LLP

Supreme Court Agrees to Hear Appeal from First Circuit of Website Accessibility Tester Case

Pierce Atwood LLP on

On March 27, 2023, the Supreme Court granted a petition for a writ of certiorari by Acheson Hotels in Acheson Hotels, LLC v. Deborah Laufer, Case No. 21-1410. In its petition to appeal from an earlier First Circuit decision...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

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