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Cybersecurity › Life Sciences

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
Fisher Phillips

Protecting Trade Secrets in the Life Sciences Industry: 8 Steps to Prevent Corporate Espionage and Theft

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Protecting trade secrets in any business is critical, but the stakes are higher in life sciences. Given the high focus on innovation in the industry, corporate espionage can result in devastating financial and reputational...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 120

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Husch Blackwell LLP

Raising Capital in a Highly Regulated Market

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For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more

White & Case LLP

From personalization to supply chain optimization: How AI is shaping deals outside the tech arena

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Investors are ramping up AI-related M&A to secure cutting-edge capabilities and market-beating returns, but high valuations and open-source disruption are forcing a rethink on deal strategy - Global M&A saw a year-on-year...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 223: Cybersecurity and Privacy Risks with Healthcare...

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This week, Heather and Lauren welcome back their colleague Brandon Robinson, head of Maynard Nexsen’s Data Privacy and Cybersecurity team. Following up on our discussion of data privacy risks for health care providers on...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Mass layoffs of federal workers impact NIST and AI Safety Institute, Google unveils AI “co-scientist” system,...

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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

Gardner Law

Changes Proposed to HIPAA Security Rules

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On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more

Skadden, Arps, Slate, Meagher & Flom LLP

Executive Briefing: Latest Updates on Trump Executive Actions

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As Trump administration directives emerge, it’s crucial for businesses and other stakeholders to stay informed and adapt their strategies accordingly. We will provide ongoing coverage of these developments and their potential...more

Hogan Lovells

PRODUCT | Products Law Year in Review: Key Developments from 2024 and Future Impacts for 2025

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2024 was a transformative year for the products law landscape, marked by sweeping regulatory shifts, emerging trends, and heightened compliance challenges. These developments are reshaping industries worldwide and will...more

Morrison & Foerster LLP

2024 Healthcare Fraud Enforcement Year in Review

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In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

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Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

BakerHostetler

Healthcare Industry Team 2024 Year in Review

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As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Hogan Lovells

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

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Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

Ropes & Gray LLP

New Year, New Data Breach Notification Requirements in New York: Impactful Changes for Life Sciences and Consumer Health Care...

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In December 2024, New York Governor Kathy Hochul signed into law two bills (A8872A and S2376B; collectively, the “Bills”) that amend New York’s Data Breach Notification Law. The Bills introduce a maximum thirty-day timeframe...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

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On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Ropes & Gray LLP

DOJ Issues Final Rule Restricting Flow of Bulk Sensitive Personal Data to China and Other Countries of Concern

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On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...more

Goodwin

Changes Expected as Trump Administration Continues to Take Shape

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As Washington prepares for new leadership in January 2025, significant policy changes appear on the horizon. The incoming administration’s agenda suggests a substantial shift in US economic and regulatory priorities, with...more

Quarles & Brady LLP

Fresh From the Oven: OCR-HHS Issues a Notice of Proposed Rulemaking for the HIPAA Security Rule

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‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2024

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Key Points - - During its 2024 term, the U.S. Supreme Court is poised to provide important guidance on the Private Securities Litigation Reform Act’s (PSLRA’s) particularity requirement in NVIDIA Corp. v. E. Ohman J:or...more

Akin Gump Strauss Hauer & Feld LLP

Three Questions with Sedgwick’s Jeremy Schutz

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In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 9, November 2024

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Welcome to our ninth 2024 issue of Decoded - our technology law insights e-newsletter. How are States Using Generative Artificial Intelligence? and Employee AI Adoption Cools Globally - Why this is important: As...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

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On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

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