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Healthcare Digital Health Medical Devices

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

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

Jones Day

Vital Signs: Digital Health Law Update | Winter 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 HHS' recent final rule on the confidentiality of substance use disorder patient...more

Foley & Lardner LLP

2024 Predictions: Unveiling the future of healthcare mergers and acquisitions

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Today, a tale of two markets are seen in healthcare mergers and acquisition (M&A): the present (as reflected in the data about declining dealmaking) and the future (reflected in the increasingly positive outlook by...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

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

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The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

McDermott Will & Emery

Top Takeaways | 2023 Digital Health Forum | Innovative Partnerships in Action: Fireside Chat with Best Buy and Atrium Health, a...

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In this lively and practical conversation, panelists elaborated on the recently announced partnership between Atrium Health, a part of Advocate Health (Atrium), and Best Buy Health. The partnership is designed to leverage...more

Foley & Lardner LLP

Wondering if Your Digital Health Product or Service is Subject to FDA Regulations?

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The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more

Sheppard Mullin Richter & Hampton LLP

FDA Delays Enforcement of UDI Reporting Requirements for Consumer Health Products

With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data for low-risk consumer...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

DIGAS und DIPAS gemäß dem Entwurf des digitale-Versorgung-und Pflege-Modernisierungs-Gesetzes

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Das Bundeskabinett hat am 20. Januar 2021 den Entwurf zum Gesetz zur digitalen Modernisierung von Versorgung und Pflege verabschiedet (Digitale-Versorgung-und Pflegemodernisierungsgesetz (DVPMG)), dem ein Referentenentwurf...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2020

USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies - On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more

McDermott Will & Emery

International News: Private Equity - December 2019

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A recent McDermott round table on European health private equity generated key insights into the future of medtech, digital health, and data analytics, and identified opportunities for companies and investors. Digital...more

McDermott Will & Emery

Disrupting Healthcare – Constructively: Considerations for Executing Innovation

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The healthcare industry is facing significant disruption from new market entrants and technology innovations that have the potential to improve how care is delivered, to lower healthcare costs, and to improve healthcare...more

Jones Day

Patenting Digital Health Innovations Incorporating AI in View of USPTO's Recent Subject Matter Eligibility Guidance

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Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more

Mintz - Health Care Viewpoints

Regulatory Challenges for the New Frontier of Medical Imaging: Terahertz Spectrum

Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the Federal Communications Commission (FCC). While the Food and Drug...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

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

McDermott Will & Emery

Digital Health Solutions are Key to Success under Health Care Payment Innovations

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Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held...more

Fenwick & West Life Sciences Group

More Digital Health Device Makers Expected to Seek FDA Clearance

Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation. Until recently, some investors shied away from companies targeting the...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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

Mintz

FDA Issues Draft Guidance Easing Compliance for Medical Device Data and Image Systems

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In what has been an active couple of months of released guidance documents, the FDA issued another draft guidance on June 20, 2014 entitled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image...more

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