AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
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
As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs. In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more
In December 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of real-world evidence to support regulatory decision-making for medical devices. While the guidance is currently in draft form...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
An Illinois federal court recently rejected an online eyewear retailer’s request for attorneys’ fees as the prevailing party in a Biometric Information Privacy Act (BIPA or Privacy Act) class action over its virtual try-on...more
An estimated 350,000 out-of-hospital cardiac arrest deaths occur each year in the U.S. Approximately 10% of those who experience out-of-hospital cardiac events survive. Use of automated external defibrillators (AED), however,...more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more
A federal judge in Illinois recently ruled that online shoppers cannot sustain claims that a virtual try-on (VTO) tool that allegedly scans facial geometry to preview the look of sunglasses on their face violates the...more
Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more
The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more
CHIPS and Science Act Will Lower Costs, Create Jobs, Strengthen Supply Chains, and Counter China "Spurred by the passage of the CHIPS and Science Act of 2022, companies have announced nearly $50 billion in additional...more
Report on Medicare Compliance 31 no. 18 (May 16, 2022) - In a version of the future that hopefully never comes, malware is able to remove malignant-looking tumors from CT or MRI scans before they were reviewed by...more
In this month’s Privacy & Cybersecurity Update, we examine the FTC chair’s comments suggesting a potential shift in its approach to data privacy regulation, the European Data Protection Board’s request for comment on its...more
The Cryptocurrency Revolution and President Biden's Formal Recognition - Out of the ashes of the 2008 financial crisis, Bitcoin sprang up like an insurgency, targeting both the unbridled activity of large financial...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
In this month’s Privacy & Cybersecurity Update, we examine the U.S. Chamber of Commerce’s letter to Congress calling for federal cybersecurity legislation, the New York attorney general’s report on “credential stuffing”...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
In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more
Nature of Patents and Patent Rights - When a patent is issued under the seal of the United States Patent and Trademark Office, it is signed by the Director of the USPTO or an Office official. The patent contains a grant...more
The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more
Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more