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Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced between January 1 and March 31st, 2024.

New Guidance on Use of Artificial Intelligence-Based Tools in Practice Before USPTO

The United States Patent and Trademark Office (USPTO) published guidance on the use of artificial intelligence-based tools in patent practice to inform practitioners of important issues when using Artificial Intelligence (AI) in matters before the Patent Office.

NIST Releases New Draft Guidance to Improve Safety, Security and Trustworthiness of AI Systems

The flurry of AI-related activity has certainly begun. Earlier this week, the Department of Commerce’s National Institute of Standards and Technology (NIST) released new draft guidance to improve the safety, security and trustworthiness of...

Manatt Launches Health AI Policy Tracker

Manatt’s new Health AI Policy Tracker identifies key federal and state AI policy activity most relevant to the health care industry.

HIPAA Enforcer Updates Guidelines on Online Tracking Amid Calls for Clarity: Key Takeaways

On March 18, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) updated its December 2022 guidance for HIPAA-regulated entities regarding the use of online tracking technologies on websites and apps.

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) and machine learning (ML) in medical devices and other emerging health care technologies (GAO...

Advancing Women’s Reproductive Health Access: Medicaid Should Be a Part of Your Growth Strategy

Medicaid is a critical source of health care coverage for women in their childbearing years, covering 1 in 5, or 13 million, women of reproductive age.

FTC and HHS Send Letter Warning of Risks From Online Tracking Technologies

On July 20, 2023, the OCR at the HHS and the FTC sent a joint letter to approximately 130 hospital systems and telehealth providers to alert them to the “serious privacy and security risks” stemming from the use of online tracking technologies integrated into their websites and mobile apps.

Regulation of AI Systems is Already Here – Look to Data Protection Laws

As the scramble continues to reckon with the rapid advancement of generative artificial intelligence models like ChatGPT, Bard, DALL-E, and Midjourney, and the promise of other AI and machine learning systems (for simplicity, “AI systems”) to come, legal and business professionals across industries are asking whether these systems will be regulated, and if so, how.

Kraken Crypto Staking Program for U.S. Investors Shut Down in Aggressive Expansion of the Howey Test

Payward Ventures, Inc., d/b/a Kraken, the cryptocurrency exchange, has entered into a $30 million settlement agreement with the U.S. Securities and Exchange Commission (SEC) over allegations the company failed to register its cryptocurrency staking program, in violation of U.S. securities laws.