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J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

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Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Linda Liu & Partners

The Practice of Producing Evidence for the Prior Use Right Defense in Patent Infringement Disputes

Linda Liu & Partners on

As Chinese enterprises’ technological innovation level and their R&D capabilities has grown by leaps and bounds in recent years, it is not uncommon for them to defend based on prior use right in patent infringement disputes....more

Gardner Law

FDA Highlights the Promise of AI in Healthcare

Gardner Law on

On June 17, 2024, the U.S. Food and Drug Administration’s (FDA) Digital Health Center of Excellence (DHCE), published a blog article highlighting the promise of artificial intelligence (AI) in healthcare. In the article, the...more

Wiley Rein LLP

New Report from NTIA Calls for More AI Regulation

Wiley Rein LLP on

At the end of March, the National Telecommunications and Information Administration (NTIA) issued its long-awaited AI Accountability Policy Report (Report), which provides federal policy recommendations regarding...more

Holland & Knight LLP

Negotiating Cost Share in Technology Investment Agreements

Holland & Knight LLP on

Note: This is the second article in our series on capturing industrial base funding from the U.S. Department of Defense In our last post, we discussed the Defense Production Act (DPA) and Technology Investment Agreement...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McGlinchey Stafford

Is THCA Legal? The State Line is the Bottom Line

McGlinchey Stafford on

Tetrahydrocannabinolic acid (THCA) is one of the most misunderstood and controversial cannabinoids in the Cannabis sativa (cannabis) plant. While booming in popularity, THCA is also a high-risk cannabinoid from a legal...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Perkins Coie

FDA Releases Guidance on Clinical Research into Cannabis-Derived Drugs

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 19, Number 12. Groups Seek Substantive Revisions to HHS Misconduct Regs, Investigations:...

Two organizations representing research institutions and integrity officials have called for a virtual rewrite of the regulations that govern misconduct in Public Health Service-funded studies. The Association of Research...more

Vicente LLP

Understanding the Current Legal Status of Psychedelics in the United States

Vicente LLP on

In a previous article, we explored one potential current opportunity for entrepreneurs interested in psychedelics and mycelium—producing non-psychoactive mushroom supplements. But are there any current commercial...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Transformational Artificial Intelligence: Prioritizing AI in Healthcare While Maintaining Legal Compliance

In February 2019, President Trump signed an executive order titled “Maintaining American Leadership in Artificial Intelligence,” also known as the American AI Initiative, that aims to increase the use of artificial...more

Hogan Lovells

New scientific data rules in China: China claims "data sovereignty"

Hogan Lovells on

In March of this year, the State Council released the Scientific Data Administrative Measures, a set of rules with the seemingly innocuous aim of collecting and making public the results of government-funded scientific...more

Hogan Lovells

EMA provides essential considerations to be taken into account for successful qualification of novel methodologies

Hogan Lovells on

The European Medicines Agency (“EMA”) has published a checklist of the essential considerations to be addressed for successful qualification of novel methodologies....more

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