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Data Protection Life Sciences Clinical Trials

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

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

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

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...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

Hogan Lovells

A closer look: Remote monitoring terms in Clinical Trial Agreements require careful review

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Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more

Morgan Lewis

Impact of Recent China Data Protection Laws on Asian Life Sciences Industry

Morgan Lewis on

Multinational pharmaceutical companies, by nature of their business, handle a great deal of data, often transferred across borders, whether based on research, clinical trial data, and employee personal data....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

Troutman Pepper Locke

CCPA Amendment Further Harmonizes with HIPAA and Provides Additional Exemptions

Troutman Pepper Locke on

On September 28, California Governor Gavin Newsom signed AB-713 into law, which relaxes some of the California Consumer Privacy Act (CCPA) compliance challenges faced by the health care and life science industries — more...more

Hogan Lovells

New Data Protection-Friendly eCommercial Model Clinical Trial Agreements Now Available

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Updated versions of the UK model Clinical Trial Agreement (mCTA) and the Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) have been published. ...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2020

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NOTE FROM THE EDITORS - Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital...more

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Hogan Lovells

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

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With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

WilmerHale

Data Protection Rules Could Seriously Impede Clinical Trials in Europe

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The European Data protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, recently adopted an Advisory Opinion (“Opinion”) on...more

Hogan Lovells

California Consumer Privacy Act: The Challenge Ahead – Four Key Considerations For Health And Life Sciences Companies

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This is the sixth installment in Hogan Lovells’ series on the California Consumer Privacy Act. The California Consumer Privacy Act of 2018 (CCPA) adds another set of privacy requirements for health and life sciences...more

Morgan Lewis

European Life Sciences Review: Issue 3

Morgan Lewis on

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

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