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Health Care Providers Telemedicine Medical Devices

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

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

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For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

Bass, Berry & Sims PLC on

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

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

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

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

Womble Bond Dickinson

The Future is Digital Healthcare

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The use of digital technologies has accelerated almost overnight due to the COVID-19 pandemic, with healthcare providers and patients finding new and innovative, socially-distanced ways to deliver and receive services. This...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2020

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Bradley Arant Boult Cummings LLP

Lessons Learned in the Early Days of Telemedicine Prosecutions: Practical Tips for Defendants Facing Indictments

Last week, Acting Assistant Attorney General Brian C. Rabbitt delivered remarks to lawyers at an annual conference in Washington, D.C. While the remarks included the Justice Department’s annual boasting of significant...more

Jones Day

JONES DAY PRESENTS® Digital Health: Current Trends and Legal Issues

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The adoption of digital health technologies introduces a new range of efficiencies for health care delivery and marks a significant breakthrough in research and development capabilities for the life sciences industry. Jones...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year-in-Review and 2020 Outlook: Criminal Case Developments

As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, with opioid-related enforcement continuing to be the clear top priority for the...more

Epstein Becker & Green

7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 2020

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more

McDermott Will & Emery

Vetting Relationships for Telemedicine Collaborations

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As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration,...more

Mintz - Health Care Viewpoints

Telemedicine Platform Recalled Over Failure to Obtain Pre-Market Clearance or Approval from FDA

On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more

Foley & Lardner LLP

OIG Greenlights Digital Health Program Offering Free Smartphones to Patients

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Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more

McDermott Will & Emery

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

Ruder Ware

OIG Opinion on Donation of Telehealth Equipment

Ruder Ware on

A recent Advisory Opinion (Advisory Opinion 18-03) from the Office of Inspector General (OIG) of the Department of Health and Human Services addresses potential kickback issues involved in the donation of telehealth...more

Wilson Sonsini Goodrich & Rosati

Digital Health: FDA Gives Nod to Multiple First-in-Class Devices

Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more

Foley & Lardner LLP

Digital Health Care Investors Summit Highlights Digital Health Expansion

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In early December, leading experts in digital health and telemedicine came together at the Digital Health Care Investors Summit hosted by Foley & Lardner LLP and Deloitte. The Summit explored innovations in digital health...more

Foley & Lardner LLP

20 FAQs for Telemedicine Providers in Ohio

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The Ohio Medical Board just published new FAQs and guidance on practicing via telemedicine, addressed to Ohio physicians and physician assistants. The FAQs follow the Ohio rules for telemedicine prescribing of drugs and...more

Hogan Lovells

A Chinese healthcare boom

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Presenting a tremendous potential for growth fueled by domestic demographic and economic forces, China's healthcare industry has attracted notable PE investments in recent years. And with some commentators projecting that...more

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