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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

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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Rivkin Radler LLP

NP Gets Jail Time for DME Fraud Scheme

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On April 10, Virginia-based nurse practitioner Daphne Jenkins was sentenced to prison for her participation in a $7.8 million telemedicine fraud scheme that involved medically unnecessary orders for durable medical equipment...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

Bass, Berry & Sims PLC

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

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We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...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

Foley & Lardner LLP

Top 5 Rules for Medicare 2024 Remote Patient Monitoring and Remote Therapeutic Monitoring: What Companies Need to Know

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On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare...more

Wilson Sonsini Goodrich & Rosati

Off-Label Communications Back in the Spotlight at the FDA

For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Wilson Sonsini Goodrich & Rosati

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care...

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Hosts Matthew Roberts, Darra Coleman, and Tina Emerson sit down together for a compelling conversation about health care hot topics currently impacting the industry. They discuss everything from behavioral health issues and...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | May 2022 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more

Knobbe Martens

Pfizer Australia Announces Deal to Acquire ResApp Health

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ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more

Morgan Lewis

Digital Health Trends to Watch in 2022

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In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

Faegre Drinker Biddle & Reath LLP

Smart Medical Devices Open New Treatment and Litigation Doors While Confirming Age-Old Balancing Acts

Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...more

Fenwick & West Life Sciences Group

The Most-Funded Year Ever for Digital Health Startups – New Trends, Opportunities Emerge in Q3

At the end of Q3, aggregate funding raised by digital health startups in 2021 surpassed $20 billion. Although 2021 continues to be a record-breaking year for digital health startups, investors gently tapped the breaks in Q3....more

ArentFox Schiff

Investigations Newsletter: DOJ Announces Charges Against 138 Defendants for Alleged Health Care Fraud Schemes Resulting in $1.4...

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DOJ Announces Charges Against 138 Defendants for Alleged Health Care Fraud Schemes Resulting in $1.4 Billion in Losses, with Focus on Telemedicine - On September 17, 2021, the Department of Justice (DOJ) announced criminal...more

McDermott Will & Emery

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

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Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

Hogan Lovells

The UAE's Health Data Law: an important and welcome update permitting certain transfers of health data

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The United Arab Emirates has issued guidance in relation to the cross-border transfer of health-related data, including telemedicine, which was previously prohibited under the UAE's Health Data Law. In this article, we...more

Reveal

There Are More Challenges in Managing Discovery in Healthcare Than You Probably Realize

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A few months ago on this blog, I wrote about using Artificial Intelligence (AI) to keep up with the “alphabet soup” of compliance. An important area to address from a compliance standpoint is health data and at least two of...more

Bass, Berry & Sims PLC

Medical Device Dealmaker Perspectives Takeaways

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Bass, Berry & Sims recently presented the latest in its Dealmaker Perspectives series on the medical device industry. Ryan Thomas, Member of Bass, Berry & Sims and Co-Chair, Healthcare Private Equity Team, and Frank...more

Pillsbury Winthrop Shaw Pittman LLP

Boom in the Medical Spa Industry Amid Regulatory Uncertainty Creates Perfect Storm

How should booming medical spa businesses proceed with little to no guidance from state medical boards? The American medspa industry, dominated by small, single-location, single-owned businesses, is booming in the wake of...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2021

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The pace of impact through digital health in 2021 is off to a rapid start—be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated...more

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