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Healthcare › Medical Devices › Software Developers

Fenwick & West LLP

NY Tech Week 2025: The Future of Femtech

Fenwick & West LLP on

Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

Mintz - Health Care Viewpoints on

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Gardner Law

What Does FDA Think of AI?

Gardner Law on

Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...more

McDermott Will & Schulte

FDA Issues Good Machine Learning Practice Guiding Principles

McDermott Will & Schulte on

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

Foley & Lardner LLP

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

Foley & Lardner LLP on

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Morgan Lewis

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

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