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Posts related to ‘regulation’

September 28, 2021
Matt Walker
FDA regulations for AI/ML-based medical devices expected soon on heels of EU MDR

Following the lead of the European Union and Great Britain, the U.S. FDA has begun rolling out its action plan for regulating artificial intelligence/machine learning (AI/ML)-based software as a medical device. The United Kingdom’s Medicines and He…

September 28, 2021 by Matt Walker
September 16, 2021
Eur Ing Mark Hawksworth
Global technology specialist practice group leader and executive MCL adjuster
Claim farming for damages in light of data protection laws

As new data protection laws are introduced, so are new challenges. Claim farming occurs when parties submit claims for financial gain against targets unaware of data misuse and is on the rise in the UK. After navigating hardship related to COVID-19 a…

September 16, 2021 by Eur Ing Mark Hawksworth, Global technology specialist practice group leader and executive MCL adjuster
July 19, 2021
Chris Harvey
VP, crisis solution
CBD and cannabis: With opportunity comes risk

An exclusive life sciences webinar hosted recently by Sedgwick’s brand protection experts offered insight into the latest product safety challenges facing medical device, pharmaceutical and life sciences companies, including an insightful discussion …

July 19, 2021 by Chris Harvey, VP, crisis solution
July 13, 2021
Mark Buckingham
Recall advisor
Beware of all that glitters – it could be cadmium

Thanks to the ubiquity of ecommerce, consumers can now buy low-cost jewellery from anywhere in the world, but this is raising serious questions about the integrity and safety of the products, particularly the presence of potentially dangerous heavy m…

July 13, 2021 by Mark Buckingham, Recall advisor
June 18, 2021
Luke Evans
Green light for self-drive in UK raises risk concerns in motor supply chain

The UK is the first country in the world to announce regulated guidelines for self-driving cars on motorways. This means you could see cars with Automated Lane Keeping Systems (ALKS) on British roads by the end of 2021. Many cars already incorporate…

June 18, 2021 by Luke Evans
June 04, 2021
Mark Buckingham
The hidden danger in common crops

You can’t see, taste or smell them but aflatoxins can be present in everyday dried staples. And with COVID-19 and global warming impacting crop production and storage, they are on the rise. During the month of April 2021, there were 22 RASFF (Rapid…

June 04, 2021 by Mark Buckingham
June 02, 2021
Matt Walker
recall advisor
DOJ increasing enforcement on off-label promotion: Here’s what to expect

We’ve been warned. Recent settlements between the U.S. Department of Justice (DOJ) and several FDA-regulated drug and medical device manufacturers serve as a prelude to future DOJ enforcement activity involving off-label promotion. The DOJ and the U…

June 02, 2021 by Matt Walker, recall advisor
April 20, 2021
Amanda Combs
Embracing epidemiology in post-market surveillance

Women’s health products are facing increased regulatory scrutiny and epidemiology is the driving force behind pre-market and post-market surveillance. This evolution is driven by the premise that people of different biological sexes have unique respo…

April 20, 2021 by Amanda Combs
February 19, 2021
Max Koonce
Chief claims officer
COVID-19 vaccinations and workers’ compensation

Today’s COVID-19 environment continues to present unique questions within the workers’ compensation industry. Initially, questions focused on compensability of what some qualify as an “ordinary disease of life.” Many states enacted presumption laws o…

February 19, 2021 by Max Koonce, Chief claims officer
September 10, 2020
Andrew Robinson
Head of Product Liability and Recall
​Product recall, Brexit and COVID-19 – The triple threat to consumer safety

(Insurance POST) Product quality is essential to business survival, and yet these days it seems recalls are rarely out of the news. Mistakes happen and processes fail often resulting in disastrous consequences to the business and the brand. Given the…

September 10, 2020 by Andrew Robinson, Head of Product Liability and Recall
April 29, 2020
Kathy Tazic, Managing Director Client Services and Brad Krauss, VP Business Development
3 key questions: Getting back to business after COVID-19

While we will miss seeing you at the Annual RIMS Conference & Exhibition in Denver, there has never been a more important time for us to connect or a more valuable message to share. The global coronavirus (COVID-19) pandemic has affected us all deepl…

April 29, 2020 by Kathy Tazic, Managing Director Client Services and Brad Krauss, VP Business Development
November 27, 2019
Mike Merlino
SVP Medicare Compliance
WCMSA reference guide: Things to consider

Staying in the know about what’s happening with Medicare is critical, as the changes to regulations can have an impact on workers’ compensation for payers. Recently, the Centers for Medicare & Medicaid Services (CMS) released Version 3.0 of the WCMSA…

November 27, 2019 by Mike Merlino, SVP Medicare Compliance
January 10, 2017
Jim Ryan
President, Casualty
Insights for 2017

2017 is here and poised to challenge and change our industry in many areas. I think we can all agree the technological advances are moving at an unprecedented pace. The terms artificial intelligence, drones and wearables are changing our lives. Sti…

January 10, 2017 by Jim Ryan, President, Casualty
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