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BCLP

Navigating the FemTech regulatory landscape: which rules apply and what are the enforcement priorities?

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Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching 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

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

Goodwin on

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

McDermott Will & Emery

[Event] 2023 J.P. Morgan Healthcare Conference - January 10th, San Francisco, CA

Come together with key decision-makers, innovators and investors from across the healthcare, life sciences and private equity (PE) industries during the year’s largest healthcare investment symposium....more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q3 2022

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The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays....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

Smart & Biggar

New CADTH Report on Health Technology Trends in 2021

Smart & Biggar on

The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...more

McDermott Will & Emery

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

McDermott Will & Emery 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

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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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