News & Analysis as of

Life Sciences Government Accountability Office Artificial Intelligence

Spilman Thomas & Battle, PLLC

Decoded Technology Law Insights, V 5, Issue 4, May 2024

MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more

Manatt, Phelps & Phillips, LLP

The FDA and the Future of AI Oversight

In January 2024, the U.S. Government Accountability Office (GAO) issued a report highlighting current obstacles to the U.S. Food and Drug Administration’s (FDA) timely and effective regulation of artificial intelligence (AI)...more

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

BakerHostetler on

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

Womble Bond Dickinson

Artificial Intelligence - The Promise of Early Disease Diagnosis and Improved Treatment and the Potential of Liability

Womble Bond Dickinson on

If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more

Akin Gump Strauss Hauer & Feld LLP

FDA Changes Direction in Final CDS Guidance

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

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