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
Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more
The lazy, hazy days of summer are definitely not lazy or hazy when it comes to health planning in North Carolina. At this point in the year, the draft State Medical Facilities Plan (SMFP) has been published, and the summer...more
Below is Part II of our New Jersey Statutory update. As you can see from the below, several statutes were passed imposing requirements on health insurance payers, including new requirements for prior authorization request and...more
The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more
Manufacturers of all types of products have been using per- and polyfluoroalkyl substances (PFAS) for decades. From a manufacturing perspective, PFAS have several benefits, including resistance to grease, oil, water, heat and...more
This issue features articles on the firm’s Business Advisory Practice supporting Nervosave Therapeutics’ U.S. expansion; the USPTO’s forthcoming guidance on AI innovation protection; option pool sizes for life sciences...more
In response to the COVID-19 outbreak, and the need to quickly develop medical products and services to fight the virus, the United States Patent and Trademark Office (“USPTO”) is allowing the trademark examination process for...more
Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more
COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more
In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more
Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the...more
Along with the US Food and Drug Administration’s guidance addressing shortages of masks and respirators, FDA has released guidance aimed at increasing the supply of other personal protective equipment important in the fight...more
At the same time as the Federal Communications Commission (“FCC”) adopted final rules to establish a multi-year telehealth pilot program entitled the “Connected Care Pilot Program,” the commission released a Report and Order,...more
On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public...more
...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more
Recently, health care providers – in particular hospitals – have been requested by the federal government to share data related to the treatment of COVID-19 (coronavirus) patients and have been ordered by the Ohio Department...more
In April 2017, the EU has revised the regulatory framework for medical devices and in vitro medical devices in the EU. The package, which includes regulation (EU) 2017/745 on medical devices (Medical Device Regulation or MDR)...more
On November 2, 2015, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its Work Plan for Fiscal Year 2016 (“2016 Work Plan”).1 The 2016 Work Plan outlines the areas of...more
The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more
For 2014, the Joint Commission approved standards changes for hospitals, critical access hospitals, and others concerning medication management and provision of diagnostic imaging services. The Joint Commission also revised...more