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FDA Announces Device Trial Participation Snapshots

FDA’s Center for Devices and Radiological Health (CDRH) recently announced a pilot program to provide consumers and health care professionals with key information about clinical trials that supported the FDA’s approval of new...more

FDA Announces New Director of the Center for Devices and Radiological Health

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent...more

In Effort to Avoid Supply Chain Disruptions, FDA Extends DSCSA Exemptions

On October 9, the FDA announced that the agency is providing exemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading...more

FDA Publishes Digital Health and Artificial Intelligence Glossary

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here. FDA intends the glossary to be...more

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

Akin Intelligence - April/May 2024

Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more

FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more

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

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

ONC Steps into AI Regulation by Imposing Requirements for ‘Predictive Decision Support Interventions’; Also Updates Information...

On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more

Congress and White House Press Ahead on AI in Health Care & Life Sciences

Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more

FDA Serves Up More Food for Thought: 2024 Will Be a Pivotal Year for the Agency’s Reorganization Efforts

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more

Akin Intelligence - November 2023

Welcome to the November edition of Akin Intelligence. Looking back, October 2023 may be remembered as the month when the U.S. government tried to assume the mantle of global leadership on responsible artificial intelligence...more

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Life Sciences Regulators Must Write Cloud-Specific Guidance

Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more

Akin Intelligence - October 2023

Welcome to the October edition of Akin Intelligence. We continue to see bipartisan and international interest in artificial intelligence (AI) regulation. In the executive branch, agencies are working towards developing...more

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

Akin Intelligence - August 2023

Welcome back to Akin Intelligence: Hot AI Summer Edition! This month’s newsletter reflects the ongoing and increasing global activity around artificial intelligence (AI), including more proposed AI legislation and court...more

Akin Intelligence - July 2023

Welcome to the July edition of Akin Intelligence. In this month’s AI news, the U.S. Senate receives member-only briefings on AI, U.S. states continue to debate and legislate on AI issues, the U.S. prepares new AI-related...more

Akin Intelligence - June 2023

Welcome back to Akin Intelligence! May featured major congressional hearings and state action in the United States, calls from industry and lawmakers for artificial intelligence (AI) regulation, and significant...more

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