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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

Fenwick & West LLP

Your Digital Health Regulation Questions Answered

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regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...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FDA Issues Draft Guidance Related to Marketing Submissions for AI/ML-Enabled DSFs, and Final Guidance Describing the FDA's...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 On April 3, 2023, the FDA released draft guidance titled “Marketing Submission...more

King & Spalding

Pharma Investment Trend Report: What We’re Watching in 2023

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2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...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

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

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

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

Wilson Sonsini Goodrich & Rosati

Digital Health Report: Q1 2020

During this unprecedented time, digital health is disrupting our healthcare delivery system for the better. Digital health companies are working hard to provide innovative telehealth, digital screening, and testing services....more

McDermott Will & Emery

Special Report - 2019 Digital Health Year in Review - January 2020

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Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more

King & Spalding

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

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On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more

Wilson Sonsini Goodrich & Rosati

Digital Health: FDA Gives Nod to Multiple First-in-Class Devices

Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

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As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

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