News & Analysis as of

Food and Drug Administration (FDA) Today's Popular Updates Digital Health

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

Blank Rome LLP on

Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Jones Day

FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices

Jones Day on

While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on

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

Troutman Pepper Locke

The FDA's Response to AI Medical Innovation — The Good Bot Podcast

Troutman Pepper Locke on

Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

Jones Day on

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

Alston & Bird

Health Care Week in Review: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Jones Day

Vital Signs: Digital Health Law Update | Fall 2023

Jones Day on

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

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

Jones Day on

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

Cooley LLP

FDA’s Latest Twist on Digital Health Oversight Brings Big Shift

Cooley LLP on

Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness...more

Foley & Lardner LLP

Wondering if Your Digital Health Product or Service is Subject to FDA Regulations?

Foley & Lardner LLP on

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

Jones Day on

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

Morgan Lewis on

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

King & Spalding

New Standard Maps Medical Device Software Development Standard to Health Software and Health IT Cybersecurity

King & Spalding on

The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more

Bass, Berry & Sims PLC

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

Bass, Berry & Sims PLC on

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

Sheppard Mullin Richter & Hampton LLP

FDA Joins Other Regulators in Focus on AI and Machine Learning

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more

Epstein Becker & Green

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

Epstein Becker & Green on

Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Womble Bond Dickinson

The Future is Digital Healthcare

Womble Bond Dickinson on

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

Morgan Lewis

Three Considerations for AI Healthcare Application Developers and Users

Morgan Lewis on

The applications of artificial intelligence (AI) are seemingly innumerable with benefits reportedly as prolific as the technology behind them, including in the healthcare space. To keep pace, the US Food and Drug...more

Jones Day

Vital Signs Digital Health Law Update | Winter 2021

Jones Day on

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

Jones Day on

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

40 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide