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Machine Learning Healthcare Regulatory Reform

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

Frost Brown Todd on

In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

DLA Piper

FDA in focus: 2024 in review and 2025 outlook

DLA Piper on

In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a global supply chain, rapid...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Skadden, Arps, Slate, Meagher & Flom LLP

AI Insights: Biden Administration Passes Sweeping Executive Order on Artificial Intelligence

On October 30, the U.S. government released its long-awaited, sweeping executive order (the AI EO or Order) on artificial intelligence (AI). The Order directs various U.S. government departments and agencies to evaluate AI...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

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