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Privacy Laws Clinical Trials

Health Care Compliance Association (HCCA)

Understanding the requirements for waiving or altering HIPAA authorization for research

The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...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

Foley & Lardner LLP

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

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On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...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

CCPA Amendment Further Harmonizes with HIPAA and Provides Additional Exemptions

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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

Jones Day

JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes

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Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more

McDermott Will & Emery

California Bill Proposes CCPA Exceptions for HIPAA De-identified Information, Other Health Data

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On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more

Verrill

More Proposed Changes to CCPA Geared to Health Care and Life Sciences Industries

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The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more

Bradley Arant Boult Cummings LLP

Lawmakers Propose CCPA Amendment to Further Except Healthcare and Research Information - Cybersecurity and Privacy Alert

A little more than a week after California’s groundbreaking California Consumer Protection and Privacy Act (CCPA) went into effect on January 1, the Senate Health Committee unanimously approved A.B. 713, introduced by...more

Dechert LLP

GDPR and the EU Clinical Trials Regulation

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On 23 January 2019, the European Data Protection Board (“EDPB”) issued an opinion on the interplay between the EU General Data Protection Regulation (“GDPR”) and the EU Clinical Trials Regulation (“CTR”). The CTR is not yet...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

Hogan Lovells

California Consumer Privacy Act: The Challenge Ahead — Introduction to Hogan Lovells’ Blog Series

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Groundbreaking. Watershed. Unprecedented. - We have heard the California Consumer Privacy Act of 2018 (CCPA) called all these things and more since its enactment on June 28, ?2018. Our experience to date has confirmed the...more

Patrick Malone & Associates P.C. | DC Injury...

Here’s why you’re getting those unsolicited mailings about clinical trials

When consumers around the country started getting letters from a company that they had never heard of, inviting them to participate in clinical trials for medical conditions that they hadn’t disclosed to many or didn’t even...more

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