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Unpacking Averages: Is It Too Soon to Study the Postmarket Experience of AI-Driven Medical Devices?

I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...more

Unpacking Averages: Growth of AI/ML in Medicine as Evidenced by Clinical Trials

Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA. ...more

HHS Extends the Antidiscrimination Provisions of the Affordable Care Act to Patient Care Decision Support Tools, Including...

Turns out, ignorance really is bliss, at least according to the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), in publishing its final rule on algorithmic discrimination by payers...more

White House Executive Order on Artificial Intelligence: Implications for the Health Care and Life Sciences Industries

On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also...more

FDA Oversight of AI Software Developed by Health Care Providers

Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more

[Virtual Briefing] Achieving Legal Compliance in AI: Minimizing Bias in Algorithms - June 29th, 1:00 pm - 3:30 pm ET

We’ve all heard troubling stories involving emerging tools powered by artificial intelligence (AI), in which algorithms yield unintended, biased, or erroneous results. Here are a few examples: - A monitoring tool for...more

Unpacking Averages: Understanding the Potential for Bias in a Sepsis Prediction Algorithm, a Case Study

Would it surprise you if I told you that a popular and well-respected machine learning algorithm developed to predict the onset of sepsis has shown some evidence of racial bias? How can that be, you might ask, for an...more

[Webinar] Explainable Artificial Intelligence and Transparency: Legal Risks and Remedies for the “Black Box” Problem - June 9th,...

Artificial intelligence (AI) and machine-learning algorithms are powerful tools that can automate or inform decision-making. At the same time, those algorithms can be quite complex and appear to be a “black box”—inscrutable...more

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

[Virtual Roundtable] NIST’s Proposal on Bias in Artificial Intelligence Roundtable - July 27th, 12:00 pm - 1:00 pm ET

The effects of algorithmic and data biases continue to make headlines and erode public trust in artificial intelligence (“AI”). Recruiting software unfairly discriminates against women and minorities, facial recognition tools...more

AI-Based Compensation Management and Bias: Can AI Close the Pay Gap?

A critical component of a successful employer-employee relationship is the employer’s fair and equitable treatment of employees, often embodied in the employer’s employee engagement, retention, and compensation practices. ...more

Exploring Intentional Bias in the Marketing of Consumer Products

Advances in artificial intelligence (“AI”) continue to present exciting opportunities to transform decision-making and targeted marketing within the world of consumer products. While AI has been touted for its capabilities in...more

Bias in Healthcare Algorithms

The application of artificial intelligence technologies to health care delivery, coding and population management may profoundly alter the manner in which clinicians and others interact with patients, and seek reimbursement....more

7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 2020

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more

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