News & Analysis as of

Regulatory Requirements Data Privacy Healthcare

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

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The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

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We are in an era where smartphones track sleep patterns, fitness apps monitor heart rates, and online searches reveal sensitive medical inquiries. As a result, the notion of “health data” has expanded dramatically. This...more

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

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A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Foley & Lardner LLP

AI Contracts in Health Care: Avoiding the Data Dumpster Fire

Foley & Lardner LLP on

For AI companies in the health care space, data is everything. It fuels model performance, drives product differentiation, and can make or break scalability. Yet too often, data rights are vaguely defined or completely...more

Seyfarth Shaw LLP

Time to Revisit Your HIPAA Documents After Reproductive Health Privacy Rule Vacated

Seyfarth Shaw LLP on

In the wake of a recent federal District Court decision, the reproductive health care HIPAA Privacy rules finalized during the Biden Administration have been vacated and plan sponsors should re-evaluate the language included...more

McDermott+

Health Information Technology Policy Under the Trump Administration

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Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

White & Case LLP

AI Watch: Global regulatory tracker - Hong Kong

White & Case LLP on

Hong Kong lacks comprehensive AI legislative framework but is developing sector-specific guidelines and regulations, and investing in AI. Laws/Regulations directly regulating AI (the "AI Regulations") At present, Hong...more

Stikeman Elliott LLP

Ontario’s More Convenient Care Act, 2025: A New Strategy for the Healthcare Sector

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On May 5, 2025, the Ontario government introduced Bill 11, the proposed More Convenient Care Act, 2025 (“MCCA”), a legislative initiative aimed at supporting the province’s long-term healthcare goals for first reading. Bill...more

Sheppard Mullin Richter & Hampton LLP

Montana Amends Law to Cover Collection and Use of Neural Data

Montana recently revised its Genetic Information Privacy Act to address neural data. The law went into effect in 2023, and applies to both entities that offer genetic testing services as well as entities that use genetic...more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

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The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

Sheppard Mullin Richter & Hampton LLP

Guarding Against the Unknown: M&A Due Diligence of AI Companies in Data-Sensitive Sectors

M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more

A&O Shearman

The future of the robotics metaverse in the healthcare sector

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On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

Katten Muchin Rosenman LLP

Have You Done Your Part to Comply with Part 2 Changes?

Important changes are coming to 42 CFR Part 2 (Part 2), which deals with the confidentiality of patients’ substance use disorder (SUD) records. On April 16, 2024, the US Department of Health and Human Services (HHS) published...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Virginia Governor Signs Bill Restricting Minor’s Use of Social Media:...more

MoFo Life Sciences

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

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AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more

Bradley Arant Boult Cummings LLP

Colorado’s Artificial Intelligence Act (CAIA) Updates: A Summary of CAIA’s Consumer Protections When Interacting with Artificial...

During the 2024 legislative session, the Colorado General Assembly passed Senate Bill 24-205, which is known as the Colorado Artificial Intelligence Act (CAIA). This law will take effect on February 1, 2026, and requires...more

Gardner Law

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

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On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more

A&O Shearman

European Health Data Space Regulation sets requirements for electronic health record systems

A&O Shearman on

On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more

McDermott Will & Emery

European Health Data Space Regulation enters into force

McDermott Will & Emery on

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

MoFo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more

Sheppard Mullin Richter & Hampton LLP

New Ohio Transparency Pricing Rules for Hospitals Comes with Limits to Targeted Advertising

Starting April 3, Ohio hospitals will have to navigate new requirements under House Bill 173. This law mandates greater transparency in healthcare pricing. It also includes rules for selling or targeted advertising related to...more

Moore & Van Allen PLLC

New York Businesses Must Now Disclose Data Breaches of “Medical Information” Under New Law

Moore & Van Allen PLLC on

On February 14, 2025, New York’s Governor Hochul signed into law A.B. 920, which amended the state’s Information Security Breach and Notification Act to add personal health information to the types of data that constitute...more

Sheppard Mullin Richter & Hampton LLP

If You Are Uptight About AI, This May Relax You

While AI has many people uptight, Aescape has developed technology to help you relax – AI robotic massage. Aescape touts that it combines the timeless art of massage with robotics and artificial intelligence to deliver an...more

Pullman & Comley, LLC

2025 Ohio Maximum Fees for Copying Medical Records

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The Ohio Department of Health (the “Department”) published its 2025 Medical Records Price Index in accordance with the Ohio Revised Code which sets forth that the fees charged for the copying of medical records may be...more

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