Medical Device Legal News with Sam Bernstein: Episode 9
On May 9, 2024, the U.S. Department of Justice’s Antitrust Division (DOJ) announced it is “upping [its] game” on health care enforcement through the Task Force on Health Care Monopolies and Collusion (HCMC). The most recent...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by Southwest Conference (SXSW),...more
Hosted by American Conference Institute, the 2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities returns for another exciting year with curated programming that will highlight leveraging...more
DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...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
Of Counsel James Hastings will present a webinar titled "Managing Risks through IP Innovation Management Training" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
Partners Jenny Colgate and Jennifer Maisel will present a webinar titled "Artificial Intelligence Litigation Risks for the Medical Technology Industry" for Medmarc, the leading expert in the products liability risks facing...more
Can privacy law and trade secret law coexist, or is compliance with both impossible? We are experiencing the fourth industrial revolution, driven by the rise in data and connectivity, analytics and artificial intelligence....more
While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more
The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable...more
ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May, to provide practical insights on how to maximize your patent term and develop strategies to enhance global protections for your patent...more
The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions. On March 20,...more
Technology companies, providers, investors, and other stakeholders should prepare for potential policy changes. In the coming months, a number of significant developments are anticipated to influence the future of the...more
Medical Technology Company President Convicted for Participation in $77 Million COVID-19 and Allergy Testing Scheme - On September 1, 2022, the president of Arrayit Corporation, a medical technology company in Silicon...more
Today’s global healthcare marketplace is marked by unprecedented transformation. This presents both challenges and opportunity to today’s market participants. We know how important it is to structure cross-border investments...more
On March 24th, 2022, the Advanced Medical Technology Association’s (AdvaMed) Board of Directors approved updates to the AdvaMed Code of Ethics (Code), which provides guidance to the health care industry on interactions...more
On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021, acquiring Hillrom (a global medical equipment maker headquartered in Chicago) for a purchase...more
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act...more
A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily...more
Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more