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Jones Day

Vital Signs: Digital Health Law Update | Winter 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 HHS' recent final rule on the confidentiality of substance use disorder patient...more

Jones Day

Vital Signs: Digital Health Law Update | Fall 2023

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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, our lawyers describe the increasingly common regulation of...more

Foley & Lardner LLP

Decentralized Clinical Trials: Sponsor Responsibilities

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In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

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Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...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FDA Issues Draft Guidance for Decentralized Clinical Trials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On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices.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FDA issues milestone draft guidance on decentralized clinical trial design & implementation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The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices.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

Wilson Sonsini Goodrich & Rosati

FDA Issues Draft Guidance Related to Marketing Submissions for AI/ML-Enabled DSFs, and Final Guidance Describing the FDA's...

The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released draft guidance titled “Marketing Submission...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

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Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Morgan Lewis

Digital Health Trends to Watch in 2022

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In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

Sheppard Mullin Richter & Hampton LLP

Top 5 Legal Issues in Digital Health to Watch for in 2022

The use of digital health to deliver healthcare has seen unprecedented growth over the past few years, with significant acceleration due to the COVID-19 Public Health Emergency (PHE). As patients seek ways to empower...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2021

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The pace of impact through digital health in 2021 is off to a rapid start—be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated...more

Womble Bond Dickinson

The Future is Digital Healthcare

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The use of digital technologies has accelerated almost overnight due to the COVID-19 pandemic, with healthcare providers and patients finding new and innovative, socially-distanced ways to deliver and receive services. This...more

Jones Day

Vital Signs Digital Health Law Update | Winter 2021

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Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

Rivkin Radler LLP

FDA Announces Digital Health Center of Excellence

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On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2020

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Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...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

McDermott Will & Emery

On the Digital Health Frontier: Developments Driving Industry Change in 2018

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As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to...more

Manatt, Phelps & Phillips, LLP

Health Update - January 2018

The Eight Key Elements of Effective Compliance Programs - Editor’s Note: In a recent webinar for Bloomberg BNA, Manatt examined game-changing fraud and abuse trends and cases—and revealed strategies for avoiding False...more

McDermott Will & Emery

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

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Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

McDermott Will & Emery

21st Century Cures: A Closer Look

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On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Cooley LLP

Alert: Key Regulatory Considerations for Digital Health Companies

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Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more

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