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BakerHostetler

[Podcast] 2024 DSIR Deeper Dive: Preserving Ephemeral Messaging – Capture Data Before Its Ghosts Haunt Your Compliance

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We’re back with a deeper dive into the 2024 Data Security Incident Response Report, which features insights and metrics from 1,150+ incidents in 2023. This episode dives deeper into information governance and...more

Bergeson & Campbell, P.C.

NNCO Releases NNI Supplement to President Biden’s 2025 Budget

On December 19, 2024, the National Nanotechnology Coordination Office (NNCO) released The National Nanotechnology Initiative Supplement to the President’s 2025 Budget, which also serves as the annual report for the National...more

Kelley Drye & Warren LLP

Commerce Department Publishes Artificial Intelligence “Diffusion” Rulemaking

On January 13, 2025, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) published an interim final rule (IFR) announcing (1) updated controls for advanced computing chips and associated license...more

Hogan Lovells

DOJ restricts data transfers to protect national security; research exemptions expanded in final rule

Hogan Lovells on

The U.S. Department of Justice (DOJ) has finalized its rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” which restricts data brokerage...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - December 2024

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Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more

Wilson Sonsini Goodrich & Rosati

CFPB Takes Aim at Crypto Wallets and Gaming Platforms with Proposed "Interpretive Guidance" to Expand EFTA's Scope

The Consumer Financial Protection Bureau (CFPB) has proposed an interpretive rule on how the Electronic Fund Transfer Act (EFTA) and its implementing regulation, Regulation E, would apply to new and emerging digital payments....more

Dorsey & Whitney LLP

Justice Issues Final Rule Restricting Transfer of Personal U.S. Data to Countries of Concern, Effective in April 2025

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The U.S. Department of Justice (“DOJ”) published its final rule (“Final Rule”) on January 8, 2025, that will prohibit or restrict transfer of certain data of U.S. persons to countries of concern, including to China. The Final...more

Vinson & Elkins LLP

Biden Issues Executive Order to Bolster AI Infrastructure in the U.S.

Vinson & Elkins LLP on

On January 14, 2025, President Joe Biden issued an executive order aimed at advancing U.S. leadership in AI infrastructure (the “Order”). This directive seeks to address the growing strategic importance of artificial...more

McDermott Will & Emery

ASTP Adopts New Protecting Care Access Exception

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On December 17, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

McDermott Will & Emery

ASTP Final Rule Codifies Requirements for TEFCA-Qualified Health Information Networks

McDermott Will & Emery on

On December 16, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

New York Amends Data Breach Notification Law to Enhance Notification Requirements, Expand Definition of ‘Private Information’

On December 24, 2024, New York Governor Kathy Hochul signed into law amendments to New York’s private-sector data breach notification law (General Business Law § 899-aa) and government agency data breach notification law (New...more

Fisher Phillips

Top 5 Surprising Takeaways as Fisher Phillips Launches Digital Wiretapping Litigation Tracker

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Some businesses might be surprised to learn that digital wiretapping litigation claims are one of today’s fastest-growing compliance risks, with over 1,560 lawsuits filed in 28 states since a groundbreaking 2022 decision...more

Baker Botts L.L.P.

President Biden Issues Executive Order on Advancing United States Leadership in Artificial Intelligence Infrastructure

Baker Botts L.L.P. on

On January 14, 2025, President Biden issued an Executive Order (EO) on Advancing United States Leadership in Artificial Intelligence Infrastructure. The EO, among other things, directs the Secretary of Defense and the...more

Goodwin

Fundraising Strategies for Early-Stage Medtech Startups

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Investor interest in the medtech sector is strong. According to DealForma and JPMorgan, medtech companies raised $16.1 billion from 544 funding rounds, including $3.3 billion from 244 seed and Series A rounds, through the...more

Fenwick & West LLP

What Startups and Big Pharma Need to Know About AI Drug Discovery

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Integrating AI tools into drug discovery introduces a mix of opportunities and challenges for startups and large pharmaceutical companies. These challenges often center on intellectual property (IP) risks, licensing...more

A&O Shearman

Business email compromise and invoice fraud – a duty of care on the innocent?

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The Western Australian District Court’s recent decision in Mobius Group Pty Ltd v Inoteq Pty Ltd1 highlights the potential consequence for the innocent party where fraudulent changes in bank details are sent from their...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Reverses PTAB’s holding of Non-Obviousness of Standard Adopted 3G Technology

The recent decision by the Federal Circuit in Honeywell International Inc. v. 3G Licensing, S.A., issued on January 2, 2025, overturned the Patent Trial and Appeal Board’s (“the Board”) factual and legal holdings in the final...more

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

Gardner Law on

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more

King & Spalding

EU & UK AI Roundup – January 2025

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The second half of 2024 saw a myriad of Artificial Intelligence (AI) related legal and regulatory developments for the EU and UK, critically with the EU AI Act coming into force on 1 August 2024. This has been followed by...more

A&O Shearman

UK Financial Conduct Authority publishes research note on bias in natural language processing

A&O Shearman on

The Financial Conduct Authority has published a research note on a pilot study into bias in natural language processing (NLP). The research note presents the results of a technical investigation into biases in word...more

A&O Shearman

Brussels enterprise court clarifies requirements for SPC manufacturing waiver

A&O Shearman on

In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of...more

Seyfarth Shaw LLP

FTC Workshop Targets Digital Marketplaces for Potential Predatory Pricing Claims

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During a recent virtual workshop hosted by the Federal Trade Commission (FTC), academics, trade association representatives, and two FTC commissioners advocated for change in the application of Section 2 of the Sherman Act to...more

Sheppard Mullin Richter & Hampton LLP

FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials

On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft...more

Adler Pollock & Sheehan P.C.

The U.S. Patent and Trademark Office (USPTO) Fee Changes – What You Need to Know

The USPTO has announced fee increases and new fees for patents and trademarks to take place on January 18, 2025, for trademarks, and January 19, 2025, for patents.  The increase in fees and the introduction of new fees by the...more

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