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Epstein Becker & Green

HISAA: New Legislation Would Bring Cybersecurity Requirements for HIPAA Covered Entities and Business Associates

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In response to several high-profile cybersecurity incidents affecting hospitals and other health care providers, including the Change Healthcare breach, new federal legislation was recently introduced by Senators Ron Wyden...more

Nelson Mullins Riley & Scarborough LLP

CPPA Board Advances Formal Rulemaking for Automated Decision-Making and Other Key Regulations

The California Privacy Protection Agency (CPPA) Board has initiated a formal rulemaking process on a new regulatory package, moving forward with proposals for automated decision-making technology (ADMT) rules, cybersecurity...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – AI outlook for second Trump administration, OpenAI scores lawsuit victory over news outlets, Instagram using AI...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

NAVEX

DORA: Exploring Finance Compliance Requirements

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Numbers never lie. The second most targeted industry in terms of hacking and breaches is Finance, which was the victim somewhere in the realm of 2,306 to 2,792 cyberattacks in 2023 (depending on the source). With each data...more

Bradley Arant Boult Cummings LLP

Happy Workers and Robots? DOL Guidance on AI and Well-Being

The landscape of employment is undergoing a seismic shift as employers increasingly integrate technology, particularly artificial intelligence (AI), into workplace practices. AI workplace uses include a variety of...more

Barnea Jaffa Lande & Co.

EU’s New Guidance: Travel Rule to Combat Money Laundering in Crypto

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The EU is continuing to shape the regulatory landscape in the crypto market After the Markets in Crypto-Assets Regulation (MiCA) entered into force in June 2024, a significant step took place last July with the publication of...more

Bass, Berry & Sims PLC

DoD Announces Cybersecurity Maturity Model Certification 2.0 Final Rule (Finally!)

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After numerous fits and starts, on October 14, the Department of Defense (DoD) published a final rule implementing the Cybersecurity Maturity Model Certification (CMMC) program. Borne from documented deficiencies in the...more

Sheppard Mullin Richter & Hampton LLP

UK and US Issue Joint Statement on Children’s Privacy

The United Kingdom and the United States released a joint statement last month outlining plans focused on children’s online privacy. As indicated in the statement, they intend to engage national institutions and other...more

Bradley Arant Boult Cummings LLP

Pentagon's cybersecurity rules reflect the growing threat from state-sponsored hackers

On October 11, 2024, the United States Department of Defense (DOD) published a final rule implementing its Cybersecurity Maturity Model Certification (CMMC) program, which is designed to verify that defense contractors are...more

Eversheds Sutherland (US) LLP

Dual registrant regulatory roundup - November 2024

Welcome to the Regulatory Roundup. Each month, Eversheds Sutherland Investment Services attorneys review significant regulatory developments (including notable rulemakings and guidance from securities regulators) from the...more

McDermott Will & Emery

CMS Extends Remote Direct Supervision Flexibilities in CY 2025 Physician Fee Schedule Final Rule

McDermott Will & Emery on

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year 2025 final rule for services reimbursed under the Medicare physician fee schedule. Among other developments, the final rule...more

Bergeson & Campbell, P.C.

NASEM Announces New International Bioeconomy Forum to Launch in Early 2025

On October 28, 2024, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced that a new NASEM initiative, the International Bioeconomy Forum, will launch in early 2025. According to NASEM, its...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

McDermott+

Virtual Care Policy Update: What to Expect in Lame Duck

McDermott+ on

The Consolidated Appropriations Act (CAA), 2023 (Public Law 117-328), signed into law on December 29, 2022, extended certain key virtual care flexibilities instituted during the COVID-19 public health emergency (PHE) through...more

Latham & Watkins LLP

Final US Outbound Investment Rules to Be Effective January 2, 2025: Key Questions Answered

Latham & Watkins LLP on

The Final Rule prohibits or requires notification of certain US investments in Chinese and Chinese-controlled entities involved in semiconductors, quantum information technologies, and artificial intelligence....more

A&O Shearman

Election Results Are In—Here’s How IP Disputes Policy May Change.

A&O Shearman on

Intellectual property policy may not have driven many voters to the polls on November 7, but change was on the ballot. Below, we summarize changes in U.S. intellectual property law that you might see starting in January 2025....more

A&O Shearman

Zooming in on AI #11: EU AI Act – What are the obligations for the limited-risk AI systems

A&O Shearman on

The EU Artificial Intelligence Act (“AI Act”) exemplifies a highly advanced risk-based approach to European regulation. One of its distinguishing features is the detailed classification of various risk levels associated with...more

Hogan Lovells

Adapting to Change: Winnik panelists discuss regulatory changes in a shifting geopolitical landscape

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In September 2024, the Hogan Lovells Communication, Internet, and Media practice presented its annual Winnik International Tech and Telecoms Forum, highlighting common themes throughout the technology and telecommunications...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) - November 2024

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

BCLP

Proposed Planning Policy for Data Centres, Gigafactories and Biotech Labs

BCLP on

Consultation closed in late September on proposals to align national planning policy with the Government’s industrial strategy for key growth industries. Government’s response is awaited. In the meantime, what Planning...more

Morgan Lewis

How the US Election May Affect the FDA Regulation of Life Sciences Products – Key Areas to Watch

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The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift...more

EDRM - Electronic Discovery Reference Model

Designing Generative AI for Legal Professionals: Key Principles and Best Practices

Generative AI is transforming the landscape of legal technology, offering unprecedented opportunities to automate tasks and streamline complex workflows. Yet, designing AI tools that truly meet the needs of legal...more

Paul Hastings LLP

SEC Examination Priorities Signal Capital Markets Enforcement

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The Securities and Exchange Commission’s Division of Examinations recently released its 2025 priorities. These identify several new or emerging areas of focus that could be precursors to enforcement actions, such as the use...more

Constangy, Brooks, Smith & Prophete, LLP

Where should the buck stop? Risks to CISOs in today’s regulatory environment

Joseph Sullivan, Uber’s beleaguered former Chief Information Security Officer, was back in the news last month when he appealed his 2023 conviction for his role in concealing a 2016 breach of Uber’s network and customer data....more

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - November...

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Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

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