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Life Sciences Regulatory Oversight Artificial Intelligence

Fenwick & West LLP

Key Takeaways from the UN Report: ‘Governing AI for Humanity’

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The United Nations’ “Governing AI for Humanity” report published in September underscores existing guidance addressing the rapid advancements in artificial intelligence but also adds a focus on the need for a global...more

Arnall Golden Gregory LLP

Welcome to the Machine: FDA Issues White Paper on AI and Medical Products

For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 9, September 2023

Are Automakers Making Sufficient Efforts to Protect Customer Data? With the ever-expanding Internet of Things, data privacy is a growing concern in today’s digital age. The automotive industry is no exception. The National...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Butler Snow LLP

Looking Beyond the Pandemic – AI and Digital Health Kick into Warp Speed

Butler Snow LLP on

What This Means for the FDA and the Industry - The COVID-19 pandemic has spurred the development of digital health products utilizing artificial intelligence (AI) and machine learning (ML). When the pandemic passes, there...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Action Plan for Artificial Intelligence/Machine Learning-Enabled Software as a Medical Device

Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more

Hogan Lovells

Five highlights from FDA’s new AI device regulation Action Plan

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On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more

Robins Kaplan LLP

Financial Daily Dose 12.02.2019 | Top Story: US Restores Metal Tariffs on Argentina and Brazil

Robins Kaplan LLP on

The White House will again slap tariffs on steel and aluminum imports from Argentina and Brazil in an apparent reaction to “massive devaluation” of  currencies in both South American nations....more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

Hogan Lovells

An intelligent approach for regulating medical device AI

Hogan Lovells on

From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data such as electrocardiograms (ECG), these technologies have...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Hogan Lovells

Artificial Intelligence and your business: A guide for navigating the legal, policy, commercial, and strategic challenges ahead

Hogan Lovells on

Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning. Everything from healthtech to self-driving vehicles, to education and smart homes, drones and space, social...more

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