News & Analysis as of

Digital Health

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

McDermott Will & Emery

Trending in Telehealth: August 13 – 26, 2024

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

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

Barnea Jaffa Lande & Co.

Femtech in Israel: The Challenges, Opportunities, and Legal Considerations Every Company Needs to Know

The field of women’s health technology (FemTech) is rapidly evolving, and Israel is considered one of the global leaders, ranking fourth worldwide in the number of FemTech companies. Additionally, Israel ranks second in...more

Alston & Bird

FTC’s Updated Health Breach Notification Rule Now in Effect

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The revamped Health Breach Notification Rule by the Federal Trade Commission (FTC) took effect on July 29, 2024, expanding consumer privacy protections to the users of online health platforms and health and wellness apps. Our...more

Foley & Lardner LLP

Technology Trends in Manufacturing and Associated Legal Risk Management: Driving Technological Advancement with an Ecosystem View 

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The importance of building technology-driven manufacturing businesses with an ecosystem focus—i.e., a comprehensive view of the complex network of suppliers, partners, and customers in a market—emerged as a critical theme for...more

McDermott Will & Emery

Trending in Telehealth: July 23 – 29, 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

Manatt, Phelps & Phillips, LLP

Proposed Medicare Physician Fee Schedule Would Extend Telehealth Flexibilities and Add New Coverage

The Centers for Medicare & Medicaid Services (CMS) released its annual proposed rule updating the Medicare Physician Fee Schedule (MPFS) for calendar year (CY) 2025....more

Clark Hill PLC

[Webinar] Telehealth Awareness Week - September 18th, 1:00 pm - 2:00 pm ET

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Join us for an insightful webinar as we delve into the ever-evolving landscape of telehealth in 2024. In this session, Carrie Foote and Paul Schmeltzer will explore the latest trends shaping telehealth, including advancements...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2024 #3

News Briefs - Joint Employer Rule Withdrawn by National Labor Relations Board - The National Labor Relations Board withdrew its appeal of a district court ruling that enjoined its "joint employer" final rule....more

Foley & Lardner LLP

A Look at the Current State of Funding for Digital Health

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As we look back at the data from Q2, digital health is a mixed bag. CB Insights has released its State of Digital Health Report for the second quarter of this year, and while it’s not all good news, there are a few bright...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

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q2 2024

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Deal volume across the healthcare industry generally appears to have steadied despite headwinds. The general sentiment is that buyers have adapted to the current interest rates and are gritting their teeth and pressing...more

McDermott Will & Emery

Trending in Telehealth: July 9 – 15, 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

A&O Shearman

Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

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Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more

Bass, Berry & Sims PLC

CMS Proposes to Extend Virtual Direct Supervision

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On July 10, the Centers for Medicare & Medicaid Services (CMS) proposed to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person...more

Sheppard Mullin Richter & Hampton LLP

Assessing Data Assets in Healthcare: A Discussion with Arti Bedi Pullins

Gradually, data is being recognized as an asset in an increasingly data-hungry healthcare industry. In the tenth episode of Sheppard Mullin’s Health-e Law Podcast, Arti Bedi Pullins, President and Chief Healthcare Officer at...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

McDermott Will & Emery

Trending in Telehealth: June 18 – 24, 2024

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

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

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Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

Quarles & Brady LLP

FTC Publishes Final Rule amending Health Breach Notification Rule

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The Federal Trade Commission (“FTC”) recently published its Final Rule amending the Health Breach Notification Rule (“HBNR”). The updated HBNR, which regulates entities that handle certain personal health information, other...more

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