News & Analysis as of

Digital Health Clinical Trials Coronavirus/COVID-19

Alston & Bird

Health Care Week in Review: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

Goodwin on

Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

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In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

King & Spalding

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

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With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more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

Jones Day

Vital Signs: Digital Health Law Update | Summer 2021

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NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

Hogan Lovells

Life Sciences and Health Care Horizons - 2021

Hogan Lovells on

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 17, Number 12. In This Month's E-News: December 2020

Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more

McDermott Will & Emery

What is the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe?

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In the fourth installment of McDermott’s HPE Europe Summer Webinar Series 2020: What’s the Impact of Recent Regulation and Government Measures on Investments in Healthcare and Life Sciences in Europe? moderator and McDermott...more

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