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Akin Intelligence - July 2024

Welcome to the July edition of Akin Intelligence. This month, United States agencies released several key pieces of artificial intelligence (AI) guidance, including patent eligibility guidance from the United States Patent...more

Akin Intelligence - June 2024

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

Hot Issues in 2024 for TMT Companies

2024 is shaping up to be a busy year in Washington for telecom, media and technology (TMT) companies. A number of notable topics will require public comment this year, including net neutrality, digital discrimination, data...more

Akin Intelligence - January 2024

Welcome to the January edition of Akin Intelligence. Artificial Intelligence (AI) remains a key area for state and federal legislators in the new year. State executives and legislators continue to propose AI-related...more

The 21st Century Cures Medical Software Provisions: Additional Clarity for Digital Health, but Also More Questions

Key Points - - Although the Cures medical software provisions largely align with FDA's current policies, certain of the Cures exemptions may be broader than those under current agency policy. - Many clinical...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

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