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
The eleventh edition of The Life Sciences Law Review covers a total of 24 jurisdictions, providing an overview of legal requirements of interest to pharmaceutical, biotechnology and medical device companies. The chapters are...more
RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more
A new French template agreement for clinical trials (Convention Unique) was published on April 9, 2022. This new version was much awaited since the initial version, dated back to 2016, was missing some key provisions...more
L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more
The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more
An ordinance (« arrêté ») was published in the French Official Gazette of 8 March 2022 that sets out a quality charter overseeing the professional practices of individuals responsible for the presentation of educational...more
France is generally known for its high quality and also highly regulated healthcare system. As an EU Member State, France has implemented the EU medicines and medical devices regimes. This chapter should therefore be read in...more
UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...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
On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products before access to reimbursement by the public health insurance...more
The two arrêtés [orders] setting thresholds for transfers of value from pharmaceutical and medical devices companies to healthcare professionals, institutions, and other actors of the healthcare sectors (Healthcare...more
Key Takeaways - - Foreign Direct Investment (FDI) controls are proliferating around the globe. Since the pandemic, “health” has become a particular focus. - Several countries have adapted their existing FDI rules, or...more
In France, Ordinance No 2017-49 of 19 January 2017 significantly modified the rules governing payments from life sciences companies to the healthcare sector. After more than three years, on June 15, 2020, Decree No 2020-730...more
The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more
Faced with the unprecedented sanitary crisis caused by the COVID-19 epidemic, Article 4 of emergency law n° 2020-290 of 23 March 2020 has created the new legal concept of a health state of emergency and has invoked this...more
Since 2017, the French financial regulation applicable to medical devices is gradually moving closer to the regulation governing pharmaceutical products. ...more
On June 27 the third edition of our new global series, Life Sciences and Health Care Horizons, took place in Paris with discussions focused on the pricing and financial regulation of health products after the latest reforms....more
18 April 2019 Almost one and a half years after the launch of the sector inquiry, the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector....more
The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
With Brexit under way, the European Medicines Agency is looking for a new home. France revealed itself as a serious contender when it considered offering not just one hosting place for the Agency, but five! Up until recently,...more
The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more
On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more
InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood...more
The number of eligible associations and the law’s broad scope could portend a significant number of health-related class actions. A new law, referred to as Loi Santé No. 2016-41 and enacted on 26 January 2016, contains...more