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Digital Health Life Sciences

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Troutman Pepper

AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast

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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 Mason is joined by Partner Eric Rumanek and...more

McDermott Will & Emery

Trending in Telehealth: July 30 – August 12, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott Will & Emery

Trending in Telehealth: July 16 – 22, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

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

Sheppard Mullin Richter & Hampton LLP

FDA Revisits and Updates Guidance on Addressing Misinformation – Ten Years Later

On July 8, the U.S. Food and Drug Administration (“FDA”) announced its updated guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” which provides recommendations and...more

McDermott Will & Emery

Trending in Telehealth: July 2 – 8, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Faegre Drinker Biddle & Reath LLP

Digital Health ‘From the Inside Out’ Leadership Series: The Power of Public Policy with Amazon Health

We hosted an engaging discussion with Sarah-Lloyd Stevenson and Matt Rubin, two former Faegre Drinker colleagues who now serve on Amazon’s Public Policy team. With more than a decade of experience advocating for health care...more

Troutman Pepper

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

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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

Faegre Drinker Biddle & Reath LLP

Digital Health “From the Inside Out” Leadership Series: Empowering Women’s Health With Midi Health

In celebration of Women's Health Month in May, we hosted Joanna Strober, founder and CEO of Midi Health. Founded in 2021, Midi's mission is to revolutionize health care for women in midlife. As the fastest-growing virtual...more

McDermott Will & Emery

Trending in Telehealth: May 14 – May 20, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Orrick, Herrington & Sutcliffe LLP

The EU AI Act: Key Takeaways for Life Sciences and Digital Health Companies

This update is part of our EU AI Act Essentials Series. The European AI Act is a landmark piece of legislation that establishes the first major comprehensive framework for regulating the use of artificial intelligence,...more

Troutman Pepper

Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast

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Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this introductory episode, Brett is joined by Morgan Hague from...more

McDermott Will & Emery

Trending in Telehealth: May 7 – May 13, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

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

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 & Emery

Trending in Telehealth: April 30 – May 6, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...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

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

McGuireWoods LLP

[Event] 20th Annual Healthcare Private Equity and Finance Conference - May 8th - 9th, Chicago, IL

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Mark your calendar for the 2024 McGuireWoods Healthcare Private Equity and Finance Conference, and help us celebrate 20 years of bringing healthcare industry leaders together. This premier two-day healthcare...more

McDermott Will & Emery

FDA Clears First OTC Continuous Glucose Monitor

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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

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

American Conference Institute (ACI)

[Event] 22nd Advanced Summit on Life Sciences - May 29th - 30th, New York, NY

Hosted by American Conference Institute, the 22nd Advanced Summit on Life Sciences Patents returns for another exciting year with curated programming that will provide practical insights on how to maximize your patent term...more

Knobbe Martens

DarioHealth Acquires Digital Health Company Twill for $22.4 Million

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(February 22, 2024) Dario health announced on February 21, 2024 that it has acquired digital health company Twill. DarioHealth Corp. is a leading digital health company, shaping how people with chronic conditions manage their...more

Morgan Lewis

Key Contract Considerations and Trends: Buying, Selling, and Integrating With Digital Health Solutions

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These are exciting times for the advancement of healthcare, whether you’re a hospital, health system, or healthcare technology company or a consumer that benefits from the proliferation of products and services provided. In...more

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