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Digital Health Clinical Trials Life Sciences

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

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The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...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

McGuireWoods LLP

FDA Establishes and Solicits Nominations for Digital Health Advisory Committee

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On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more

Hogan Lovells

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

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Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more

Morgan Lewis - As Prescribed

High-Tech Revamp: FDA Announces New Measures for Clinical Trials, Invites Feedback on GCP Guidelines

FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize...more

McDermott Will & Schulte

FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices

Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more

Goodwin

The ABCs of DCTs: New FDA Guidance Provides Recommendations for the Conduct of Decentralized Clinical Trials

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On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more

BakerHostetler

FDA Issues Draft Guidance for Decentralized Clinical Trials

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On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more

Hogan Lovells

FDA issues milestone draft guidance on decentralized clinical trial design & implementation

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The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

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Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

Latham & Watkins LLP

European Healthcare & Life Sciences Market Update - H1 2022

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Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more

McGuireWoods LLP

FDA Issues Draft Guidance on Digital Health Technologies in Clinical Trials

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Recent advancements in sensor technology and data transmission methods stand to benefit clinical trials by facilitating data collection through digital health technologies (DHTs). The U.S. Food and Drug Administration (FDA)...more

Bass, Berry & Sims PLC

New FDA Draft Guidance on Use of Digital Health Technologies in Clinical Trials

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On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more

Fenwick & West Life Sciences Group

The Most-Funded Year Ever for Digital Health Startups – New Trends, Opportunities Emerge in Q3

At the end of Q3, aggregate funding raised by digital health startups in 2021 surpassed $20 billion. Although 2021 continues to be a record-breaking year for digital health startups, investors gently tapped the breaks in Q3....more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2021

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NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

Hogan Lovells

Life Sciences and Health Care Horizons - 2021

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Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

Womble Bond Dickinson

Every Step We Take, Every Nightmare We Don’t Have: FDA Approval of Nightware

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Today’s wearable devices — the ones that monitor the number of steps we take, our heart rate, and our sleep habits (to mention only a few) — walk the line between personal accessories and true medical devices. To clarify the...more

McDermott Will & Schulte

What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott...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

Mayer Brown Free Writings + Perspectives

Update on Healthcare Financings in 2019

In a recent briefing, CB Insights reported increased funding in the healthcare sector for the first half of 2019 with $26.9 billion invested in healthcare companies across 2,258 deals globally. While promising, funding for...more

Hogan Lovells

View from the Horizon: Digital Health and Cell, Tissue, and Gene Therapies in Boston

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On April 30 our new global series, Life Sciences and Health Care Horizons, kicked off in Boston with two panel discussions that focused on the challenges and opportunities that our lawyers and clients are facing in two...more

Fenwick & West Life Sciences Group

Takeaways from Fenwick’s 2018 Digital Health Investor Summit

The Seventh Annual Fenwick & West Digital Health Investor Summit profiled a sector that continues to attract record levels in investment, further matures and consolidates, and that is leveraging the newest technologies in...more

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