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Data Protection Life Sciences

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

McDermott Will & Schulte

What ICO guidance on anonymisation means for health and life sciences companies

What new guidance on anonymisation from the UK Information Commissioner’s Office (ICO) means for healthcare and life sciences companies....more

Gardner Law

New DOJ Rule Restricts Deidentified Data Transfer

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No Safe Harbor: New DOJ Data Export Rule Restricts Deidentified Data Transfer - This article outlines new requirements from the Department of Justice regarding “bulk sensitive data”, including de-identified, anonymized,...more

A&O Shearman

The future of the robotics metaverse in the healthcare sector

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On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

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

Goodwin

Life Sciences Companies Must Navigate the DOJ Data Rule

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Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...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

Cooley LLP

The DOJ’s Bulk Sensitive Personal Data Rule’s Imminent Relevance to Life Sciences Companies

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A new US Department of Justice (DOJ) rule on “Preventing Access to US Sensitive Personal Data and Government-Related Data by Countries of Concern (including China) or Covered Persons” (rule) prohibits and restricts certain...more

Goodwin

US Emerging as Top Global Medtech Destination

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For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Foley & Lardner LLP

Beyond the Polanyi Paradox: How Human-Aware AI Unlocks Creativity And Breakthrough Discoveries

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Artificial intelligence (AI) has transformed scientific research and innovation, yet as previously discussed, the Polanyi Paradox remains a significant obstacle to using AI to generate creative solutions or breakthrough...more

Orrick, Herrington & Sutcliffe LLP

U.S. Data Localization Law Coming Soon: What Life Science Companies Need to Know

The DOJ has finalized a set of prohibitions and restrictions on cross-border transfers of certain U.S. data to China and other “Countries of Concern” (for now, Cuba, Iran, North Korea, Russia, and Venezuela), as well as to...more

Ballard Spahr LLP

Key Takeaways From the 2025 J.P. Morgan Health Care Conference

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Cautious Optimism for Deal Making. The general consensus is that we will likely see an increase in M&A and capital market transactions in the life sciences sector in 2025....more

Morgan Lewis - As Prescribed

IP, Licensing, and M&A in the Life Sciences Industry: Trends to Watch in 2025

The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....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

Smart & Biggar

2024 highlights in Canadian life sciences IP and regulatory law

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In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....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

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Spilman Thomas & Battle, PLLC

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

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

American Conference Institute (ACI)

How Can Companies Tackle Europe’s AI and Data Protection Rules?

Life science companies will have to grapple with unique questions in complying with the European Artificial Intelligence Act, including the scope of the law’s research exemption and the use of AI in personalized medicine and...more

Morgan Lewis

EU High Court Allows GDPR Claims in Business Litigation, Expands Scope of ‘Health Data’ Impacting Life Sciences and Consumer...

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The Court of Justice of the European Union (CJEU), the EU’s highest court, recently announced its significant Lindenapotheke decision, permitting companies to use the General Data Protection Regulation in business-to-business...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 211: Cybersecurity and Privacy Risks for the Healthcare...

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For episode 211, Heather and Lauren are joined by their colleague Brandon Robinson, who heads up Maynard Nexsen’s Data Privacy and Cybersecurity team. Brandon shares his wealth of knowledge on cybersecurity best practices for...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Gardner Law

[Ongoing Program] SESSION 3: Privacy Policy Pop Quiz – Are You Ready? - August 8th, 1:00 pm - 1:45 pm CT

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Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more

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