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Food and Drug Administration (FDA) Health Technology Healthcare

Benesch

Dialysis & Nephrology Digest - June 2025

Benesch on

Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

Polsinelli on

With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

Nelson Mullins Riley & Scarborough LLP

Bipartisan House Task Force Report Outlines Key Areas of AI Focus for Health Care

As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more

Sheppard Mullin Richter & Hampton LLP

Healthy AI: 2024 Year in Review

On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - December 2024 #2

News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more

Akin Gump Strauss Hauer & Feld LLP

AdvaMed, Releases AI White Paper

AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more

Ankura

The Impact of the Proposed 2025 Physician Fee Schedule on Parity and Delivery

Ankura on

Healthcare in the United States is undergoing significant changes, particularly in the areas of reimbursement and coverage of telehealth, substance use disorders (SUDs), and mental health services. The proposed 2025 Physician...more

Jones Day

Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

Jones Day on

The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2024 #3

News Briefs - FTC Finalizes Providers' Reporting Rules Prior to M&A - The Federal Trade Commission finalized changes to a rule that will require healthcare companies, including hospitals and providers, to provide more...more

McDermott Will & Schulte

Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

McDermott Will & Schulte on

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more

McDermott Will & Schulte

[Event] Munich Life Sciences Bootcamp For In-House Counsel - November 21st, Munich, Germany

McDermott Will & Schulte on

McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - October 2019

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

McDermott Will & Schulte

Vetting Relationships for Telemedicine Collaborations

As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration,...more

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