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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

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

White & Case LLP

Digital healthcare in Southeast Asia offers healthy returns

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Rapid digitalization in the health industry is set to drive M&A across the region - Digitalization is reshaping the global healthcare industry as demand for personalized, more accessible care fuels innovative market...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

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

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

Manatt, Phelps & Phillips, LLP

[Webinar] Future of Health: The Emerging Landscape of Augmented Intelligence in Health Care - May 1st, 12:00 pm - 1:00 pm ET

The use of augmented intelligence (AI) in medicine has been increasingly used to develop cancer prognoses, respond to patient messages, predict adverse clinical events and recommend optimal staffing volumes in radiology,...more

Mintz - Health Care Viewpoints

2023: Another Year Chock Full of Challenges for FDA

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more

Jones Day

Vital Signs: Digital Health Law Update | Fall 2023

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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

BakerHostetler

FDA Forms Digital Health Advisory Committee to Navigate Emerging Technologies

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The FDA has announced the formation of the Digital Health Advisory Committee, a group dedicated to navigating the complexities of emerging DHTs like AI/ML, augmented reality and more. This development evidences the FDA’s...more

Holland & Knight LLP

Podcast - Artificial Intelligence in Healthcare and How to Comply with HIPAA & State Privacy Laws

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In this episode of "Counsel That Cares," HIPAA and healthcare privacy attorneys Beth Pitman and Shannon Hartsfield dissect the highly publicized Dinerstein v. Google case. They address the implications and concerns of sharing...more

Jones Day

Vital Signs Digital Health Law Update | Summer 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, we take an in-depth look at generative artificial intelligence...more

Fenwick & West Life Sciences Group

Generative AI And Digital Health–What Does the Future Hold?

Artificial intelligence and healthcare are hardly strangers, as machine learning programs have been aiding in the diagnosis of disease, drug discovery, the streamlining of clinical workflows and the analysis of medical data...more

McDermott Will & Emery

[Webinar] AI Risk Management 101 - June 29th, 12:00 pm - 1:00 pm ET

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Healthcare is rapidly changing, with artificial intelligence (AI) and algorithmic models leading the transformation. In recent years, big data and machine learning algorithms have revolutionized our ability to predict...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

MoFo Life Sciences

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

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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

Akin Gump Strauss Hauer & Feld LLP

ONC Proposes Sweeping Health IT Certification Program Requirements for “Predictive Decision Support Interventions”—Featuring...

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more

Hogan Lovells

HHS ONC proposes new AI / ML requirements for certified Health IT

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On April 11, the U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, and Interoperability: Certification Program Updates,...more

McDermott Will & Emery

FDA Issues Draft Predetermined Change Control Plan for Machine-Learning-Enabled Device Software Functions

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

Akin Gump Strauss Hauer & Feld LLP

Software and Digital Health Policies Issued by FDA

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more

Hogan Lovells

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

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The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more

King & Spalding

Pharma Investment Trend Report: What We’re Watching in 2023

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2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more

Mintz - Health Care Viewpoints

FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more

Smart & Biggar

Health Canada paving the way for more AI/ML medical devices

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Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more

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