AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Introduction to The Good Bot: Decoding AI and Its Integration Into Health Care — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Health + Tech - Leveraging AI to Drive Growth
Podcast - Artificial Intelligence in Healthcare and How to Comply with HIPAA & State Privacy Laws
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 157: Sarah Glover, Maynard Nexsen Cybersecurity Attorney
Podcast - Insights on the FTC's Approach to Digital Health Companies
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Podcast - SEC's Oversight on Cybersecurity Requirements
Podcast - Digital Health Market Assessment
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Video: Leaders Moving Business Forward Featuring Clear Eye Test
Guidepost in Motion: Vori Health Launching a Virtual Healthcare Start-Up from a Compliance Perspective
Leaders Moving Business Forward with Naveen Kathuria of eFamilyCare
Health+Tech - Episode 3: Leveraging Technology to Improve Physician Contracting
Health+Tech - Episode 2: Edge of Digital Health Transformation
Healthcare Headlines Episode 1 - Telehealth: Future Trends & Industry Impact
Healthcare Tech: How Are Licensing Agreements Bridging the Industry Divide?
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
Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more
On October 11, 2023, the U.S. Food and Drug Administration (FDA) announced that it will create and accept nominations for a new Digital Health Advisory Committee (DHA Committee) that will counsel the FDA on various issues...more
Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more
FDA recently issued draft guidance with updated recommendations for implementing the International Council for Harmonisation’s (ICH’s) guidelines on good clinical practice (GCP). The goal of the draft guidance is to modernize...more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more
On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more
On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more
The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more
On March 23, the U.S. Food and Drug Administration (FDA) published a framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. DHTs include a wide array of...more
The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more
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
The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more
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
Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more
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
Recent advancements in sensor technology and data transmission methods stand to benefit clinical trials by facilitating data collection through digital health technologies (DHTs). The U.S. Food and Drug Administration (FDA)...more
The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. DHT can take the form of hardware and...more
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
During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that...more
On December 23, 2021, the United States Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, investigators, and other stakeholders entitled “Digital Health Technologies for Remote...more
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
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