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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

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

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

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For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more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

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

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

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

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

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

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

Buchalter

Health Care and Life Sciences Practice Newsletter

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Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

Fenwick & West Life Sciences Group

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

Foley & Lardner LLP

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

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There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

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As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

Manatt, Phelps & Phillips, LLP

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

Mintz - ML Strategies

Telehealth and Health IT Policy: Considerations for Stakeholders

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In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

Pillsbury - Internet & Social Media Law Blog

FDA Draft Guidance Would Ease Regulatory Burdens for Certain mHealth Applications

On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more

Foley & Lardner LLP

AMA Adopts Telemedicine Policy for Coverage and Payment of Telemedicine Services

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During its Annual Meeting on June 11, 2014, the American Medical Association (AMA) voted to approve a list of guiding principles for coverage of and payment for telemedicine services, designed to “foster innovation in the use...more

Sheppard Mullin Richter & Hampton LLP

The FDA Releases Long-Awaited Final Guidance on Mobile Medical Applications

On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on...more

Morrison & Foerster LLP

FDA Letter to Mobile App Developer Signals Regulatory Scheme

Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more

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