Artificial Intelligence/Machine Learning -Based Software as a Medical Device

By Brittany Mierzwa – FDA Press Release January 12th 2021 – The FDA has published their Action Plan as they move forward with Artificial Intelligence/Machine Learning (AI/ML) -based software as a Medical Device. The FDA’s vision through AI/ML -based software ‘will deliver safe and effective software functionality that improves the quality of care that patients receive’. AI is being introduced through Radiological Imaging and Cardiac Ultrasound software, both received their first marketing authorizations in February of 2020.

The Action Plan addresses 5 specific concerns that stakeholders have such as apprehensions of cybersecurity, clear transparency as the software trains the algorithm, and regulatory review to ensure the algorithm does not present biases while learning the importance of racially and ethnically diverse patient populations. As the FDA moves forward with their January 2021 Action Plan, AI/ML has become a rapidly progressing field all while maintaining a patient centered approach.

Link: https://www.fda.gov/media/145022/download?utm_medium=email&utm_source=govdelivery

Remembering Fredric G. Levin

This week we lost our dear friend and colleague, Attorney Fredric G. Levin of Levin Papantonio Rafferty Law Firm, when he succumbed to the ravages of COVID-19 at age 83. He was an award-winning attorney who fought tirelessly against the tobacco industry and other Big Corporation malfeasance, while advocating for civil rights and helping the people of his own hometown of Pensacola with generous donations. He will forever be remembered with respect and admiration as one of the most pro-active attorneys of our era.
He will be greatly missed.

 

 

Twenty-four States Increase Minimum Wage

By Brittany Mierzwa – As we ring in the new year, twenty-four states have increased their minimum wage. With the largest increase being $1.50 in New Mexico to $10.50 per hour, other states are seeing an increase to $12 and even $14 per hour. Some states such as Minnesota and California have different requirements based on the size of the business and employer, Nevada takes a different look at minimum wage having different wages if health benefits are offered. US News breaks it down by state.

URL: https://www.usnews.com/news/articles/best-states/minimum-wage-by-state

Perdue Pharma Family Questioned by Congress

By Lacey Crawford – For nearly four hours Congress questioned two members of the billionaire Sackler family, David Sackler, 40, and his cousin, Dr. Kathe Sackler, 72, both having served on Purdue Pharma’s board for years. Purdue Pharma is the maker of OxyContin, the aggressively promoted painkiller that began America’s massive opioid epidemic that has killed more than 450,000 Americans.

From 2008 through 2017, the family skimmed approximately $10 billion from Purdue Pharma, placing the money in “offshore shell companies” as the two family members tried to lay blame on “management” and independent, nonfamily board members.

Eight members of the Sackler family have been named in several state cases.

URL: https://www.nytimes.com/2020/12/17/health/opoids-sacklers-purdue-testimony.html

Firm Administrator Awarded Prestigious Status of ALA Distinguished Member

 

By Cindy Nations – Congratulations to our firm administrator Joanna Meinecke who has just been awarded the prestigious status of ALA Distinguished Member in honor of her participation in the Association of Legal Administrators for 30 years! Joanna’s unwavering commitment to the legal profession has served as an example to newer generations of law firm administrators and has helped to shape the ALA organization over the years. Joanna has been the administrator of The Nations Law Firm for 35 years. It is a privilege to work under her guidance and management. Congratulations, Ms. Meinecke!

Noses On!

By Andrea Schmauss –

In the spirit of spreading laughter and awareness, several members of The Nations Law Firm staff donned their red noses in recognition of Walgreens “Red Nose Day.”  A tradition which began in the United Kingdom is being celebrated at Walgreens nationwide with the selling of red noses, pens and wrist bands which supports non-profit organizations that help lift children and young people out of poverty in the United States and overseas. 

“Happiness and health are at the heart of Walgreens’ mission and at the heart of what Red Nose Day is all about. Just the simple, silly act of putting on a red nose means that anyone can benefit children in poverty,” said Alex Gourlay, president of Walgreens. “We’re thrilled to join Red Nose Day as the exclusive red nose retailer in the U.S. and encourage our entire Walgreens family – our customers, employees, and vendor partners – to join us in having a good laugh for a good cause.”

The noses, pens and wrist bands are on sale at Walgreens’ stores through May 30.  Proceeds benefit the Red Nose Day Fund, which supports the following pre-selected charity partners: Boys & Girls Clubs of America; Charity: Water; Children’s Health Fund; Feeding America; Gavi, The Vaccine Alliance; the Global Fund; LIFT; National Council of La Raza; National Urban League; Oxfam America; Save the Children and United Way.

More information here: https://news.walgreens.com/press-releases/general-news/noses-on-walgreens-welcomes-red-nose-day-back-to-america-as-the-exclusive-retailer-of-the-new-sparkle-red-nose.htm