News & Analysis as of

Life Sciences Personal Data

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

Foley Hoag LLP - Security, Privacy and the...

DOJ’s “Bulk Sensitive Data Rule” is in Effect, and May Require Significant Compliance Obligations as Enforcement is Set to Begin

Pursuant to a newly effective U.S. Department of Justice (DOJ) regulation, the transfer and storage of certain sensitive U.S. government and personal data may be prohibited or restricted, depending on the intended recipient,...more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

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The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

Goodwin

Life Sciences Companies Must Navigate the DOJ Data Rule

Goodwin on

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

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

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

Robinson+Cole Data Privacy + Security Insider

Neural Data Included in CCPA Amendments

As we outlined in our previous blog article, California recently became the second state to enact a law safeguarding consumer brain data, following a similar law passed by Colorado in April. Both state laws prevent the sale...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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....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

Spilman Thomas & Battle, PLLC

Decoded Technology Law Insights, V 5, Issue 4, May 2024

MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

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Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 10, December 2023

Revisiting…Are Automakers Making Sufficient Efforts to Protect Customer Data? As a follow-up to our previous article and webinar, “Are Automakers Making Sufficient Efforts to Protect Customer Data?", we are addressing the...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 9, September 2023

Are Automakers Making Sufficient Efforts to Protect Customer Data? With the ever-expanding Internet of Things, data privacy is a growing concern in today’s digital age. The automotive industry is no exception. The National...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 4, Issue 8, August 2023

AI-Created Art isn’t Copyrightable, Judge Says in Ruling that Could Give Hollywood Studios Pause - “A federal judge upheld a finding from the U.S. Copyright Office that a piece of art created by AI is not open to...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Ten: Operational Realities and Next Steps

Quarles & Brady LLP on

This is Part Ten in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act : Part Nine: Enforcement and Private Right of Action

Quarles & Brady LLP on

This is Part Nine in a series of legal updates on the Washington My Health My Data (“WMHMDA”) where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Seven: Biometric Data

Quarles & Brady LLP on

This is Part Seven in a series of legal updates on the Washington My Health My Data (“WMHMDA”), where Quarles continues its deep dive into the various factors and intricacies of WMHMDA that are creating waves in the privacy...more

Quarles & Brady LLP

Diving into the Washington My Health My Data Act - Part Two: Consumers Covered by WMHMDA

Quarles & Brady LLP on

This is Part Two in a series of legal updates on the Washington My Health My Data Act (“WMHMDA”) where Quarles is doing a deep dive into the various factors and intricacies of the Act that are shaping up to create a sea of...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 3, March 2023

Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more

Nelson Mullins Riley & Scarborough LLP

Clinical Research and Patient Data Protection are at a Complicated Intersection

The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more

Hogan Lovells

The UK's new health data strategy

Hogan Lovells on

On 13 June 2022, the Department of Health and Social Care released its new Strategy for the use of health and social care data in the UK (Data saves lives: reshaping health and social care with data), which should be read in...more

Butler Snow LLP

International Privacy Laws and Clinical Trials

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Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more

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