News & Analysis as of

Digital Health Health Technology Food and Drug Administration (FDA)

DLA Piper

New Federal Initiatives Signal Digital Health Access as a Key Priority

DLA Piper on

Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more

Jones Day

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

Jones Day on

The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

McDermott Will & Schulte

FDA Clears First OTC Continuous Glucose Monitor

On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more

Faegre Drinker Biddle & Reath LLP

Life Sciences AI Summit: Industry Leaders Highlight Key Opportunities and Urge Caution as AI’s Prominence Grows

The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...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

Axinn, Veltrop & Harkrider LLP

FDA Tackles AI . . . and Other Digital Health Technologies

FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] MDC 2023 Reception & Dinner Women’s Networking Event & Program - June 15th, Menlo Park, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Hogan Lovells

The next era of digital therapeutics

Hogan Lovells on

Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more

Hogan Lovells

FDA to regulate more AI & software tools as devices, guidance indicates - FDA also seeks new digital health regulatory paradigm in...

Hogan Lovells on

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope of the FDA’s oversight...more

Goodwin

On Remote Control: FDA Issues Draft Guidance to Facilitate Use of Digital Health Technologies for Remote Data Acquisition in...

Goodwin on

During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that...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

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

MoFo Life Sciences

Recent Digital Health-Related FDA Announcements

MoFo Life Sciences on

The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software...more

Holland & Knight LLP

FDA Establishes a New Digital Health Center of Excellence

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

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

McDermott Will & Schulte

[Event] Munich Life Sciences Bootcamp For In-House Counsel - November 21st, Munich, Germany

McDermott Will & Schulte on

McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Summer 2019

Avoid Potential Pitfalls When Incorporating Third-Party Software into Wearable Products - The global market for wearable devices continues to expand rapidly. Digital health companies that manufacture and sell their own...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

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