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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

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: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

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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

BCLP

Lessons From the Growth of Femtech and Women’s Health

BCLP on

BCLP’s Healthcare & Life Sciences Practice Group recently partnered with EMIG Digital Health Group to co-host an in-person breakfast seminar and networking event focused on FemTech. Specialists from across the FemTech and...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (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

Foley & Lardner LLP

2024 Predictions: Unveiling the future of healthcare mergers and acquisitions

Foley & Lardner LLP on

Today, a tale of two markets are seen in healthcare mergers and acquisition (M&A): the present (as reflected in the data about declining dealmaking) and the future (reflected in the increasingly positive outlook by...more

MoFo Life Sciences

Digitalization Of German Healthcare System To Receive Legislative Boost In 2024

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It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At...more

McGuireWoods LLP

FDA Establishes and Solicits Nominations for Digital Health Advisory Committee

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On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

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The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...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

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

Hogan Lovells

Takeaways from our Digital Deep Dive Webinar on AI & Digital Health

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In this article, we share our key takeaways from our recent webinar titled "AI, Digital Health & European Health Data Space", which was part of our "AI, Big Data and Law, Digital Deep Dive" webinar series. The webinar delved...more

Knobbe Martens

Venture Capitalist Funding in Medtech Increasing

Knobbe Martens on

Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter...more

McDermott Will & Emery

[Event] HPE Europe 2023 - September 21st, London, United Kingdom

McDermott Will & Emery on

HPE Europe is back! Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more

McGuireWoods LLP

Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare

McGuireWoods LLP on

Bradd Busick, senior vice president and chief information officer for MultiCare, joins hosts Holly Buckley and Kristen McDermott Woodrum on this episode of Health+Tech to provide insights into MultiCare’s recent successes in...more

Knobbe Martens

FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder

Knobbe Martens on

The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD).  According to the FDA’s press release,...more

Morgan Lewis

Key Tips and Considerations for Digital Health Transactions

Morgan Lewis on

The digital health space is seeing strong growth, with deal activity booming and new players eager to get involved. However, since these transactions may involve typically fast-moving tech companies joining forces with life...more

Foley & Lardner LLP

Regulation of Digital Health Products by FDA

Foley & Lardner LLP on

Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more

McDermott Will & Emery

Top Takeaways | 2023 Digital Health Forum | Innovative Partnerships in Action: Fireside Chat with Best Buy and Atrium Health, a...

McDermott Will & Emery on

In this lively and practical conversation, panelists elaborated on the recently announced partnership between Atrium Health, a part of Advocate Health (Atrium), and Best Buy Health. The partnership is designed to leverage...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

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

MoFo Life Sciences

FDA On Use Of AI/ML In Drug Development: Five Key Takeaways

MoFo Life Sciences on

On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more

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Updated: Dec 28, 2021:

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Links to Other Websites

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Information for EU and Swiss Residents

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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California Privacy Rights

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Privacy Officer
JD Supra, LLC
150 Harbor Drive, #2760
Sausalito, CA 94965

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Changes in Our Privacy Policy

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Contacting JD Supra

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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