MoFo Life Sciences

August 08, 2023 - FDA, Pharma, United States, Healthcare
Medicare Drug Price Negotiation Program Final Guidance
By: Stacy Cline Amin and Wendy C. Chow
Elena Klonoski, a summer associate in our Boston office, and Lauren Limbach, a summer associate in our Washington, D.C. office, contributed to the drafting of this post. 1. Introduction On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated
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August 02, 2023 - FDA, Regulatory, AI + Robotics, Healthcare
5 Questions About Generative AI in Healthcare
By: Brigid DeCoursey Bondoc and Wendy C. Chow
Brigid Bondoc and Wendy Chow authored an article for HealthTech about what the recent growth of generative artificial intelligence (AI) tools means for providers and patients. “In the absence of a clear legal and ethical framework that promotes the complete scope of the benefits
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July 24, 2023 - FDA, Healthcare, Litigation, Pharma, United States
Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures
By: Stacy Cline Amin, Joseph R. Palmore, Wendy C. Chow and Will Baker
In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the Program’s first deadlines. Below we analyze the latest developments in the
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June 21, 2023 - Litigation, Healthcare, United States
Supreme Court: U.S. Government Has Broad Discretion to Dismiss False Claims Act Suits
By: J. Alex Ward, Demme Doufekias, Adam L. Braverman and Joseph R. Palmore
On June 16, 2023, the Supreme Court issued a decision in United States ex rel. Polansky v. Executive Health Resources, Inc. , giving the United States government broad power to dismiss qui tam FCA lawsuits even when it has initially declined to intervene. We have
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June 12, 2023 - Intellectual Property, Litigation, Digital Health, Healthcare, United States
United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim
By: Joseph R. Palmore, J. Alex Ward and Adam L. Braverman
On June 1, 2023, the Supreme Court issued a decision in United States ex rel. Schutte v. SuperValu, Inc. , clarifying when a defendant “knowingly” submits a false claim for payment under the False Claims Act (FCA). The Court held that a defendant that submits
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May 25, 2023 - Announcements, Healthcare, Regulatory, United States
New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways
By: Wendy C. Chow
On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions”
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May 03, 2023 - Announcements, Healthcare, Litigation, Regulatory, United States, FDA
FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims
By: Brigid DeCoursey Bondoc and Claudia M. Vetesi
On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties
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April 25, 2023 - European Union, Regulatory, Pharma, Healthcare, Privacy + Data Security
Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation
By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian
Clinical trials play a crucial role in the development of new medicines and medical devices, but conducting clinical trials involves ethical, legal, and regulatory challenges. As reported in our latest article, Prevent a Clinical Trial from Turning into a Criminal Trial , the United
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April 03, 2023 - Bioinformatics, Healthcare, Litigation, Privacy + Data Security, United States
Applying BIPA’s Health Care Exemption to Virtual Try-On Technologies in Light of Dior Dismissal
By: Melissa M. Crespo, Michael Burshteyn and Morgan O'Neill Mitruka
A recent putative class action case against luxury brand Christian Dior sheds light on the health care exemption in the Illinois Biometric Privacy Act (BIPA). In Delma Warmack-Stillwell v. Christian Dior Inc ., the plaintiff alleged Dior’s virtual try-on feature for sunglasses violated BIPA’s
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March 30, 2023 - COVID-19, FDA, Healthcare, Regulatory, Digital Health, Medical Devices + Diagnostics, United States
FDA Issues Final Transition Guidances for COVID-19 Devices
By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do
This week, the U.S. Food & Drug Administration (FDA) issued two much anticipated guidances, each outlining how COVID-19 devices will be treated after the expiration of the COVID-19 public health emergency (PHE) declaration or termination of the COVID-19 Emergency Use Authorization (EUA) declarations: 1)
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Topic Archives: Healthcare

Medicare Drug Price Negotiation Program Final Guidance

By: Stacy Cline Amin and Wendy C. Chow

5 Questions About Generative AI in Healthcare

By: Brigid DeCoursey Bondoc and Wendy C. Chow

Legal Battles Continue Over Inflation Reduction Act’s Drug Price Negotiation Measures

By: Stacy Cline Amin, Joseph R. Palmore, Wendy C. Chow and Will Baker

Supreme Court: U.S. Government Has Broad Discretion to Dismiss False Claims Act Suits

By: J. Alex Ward, Demme Doufekias, Adam L. Braverman and Joseph R. Palmore

United States Supreme Court: Look to Defendant's Subjective Beliefs to Decide Whether It "Knowingly" Submitted False Claim

By: Joseph R. Palmore, J. Alex Ward and Adam L. Braverman

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

By: Wendy C. Chow

FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

By: Brigid DeCoursey Bondoc and Claudia M. Vetesi

Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation

By: Robert Grohmann, Alex van der Wolk and Marta Hovanesian

Applying BIPA’s Health Care Exemption to Virtual Try-On Technologies in Light of Dior Dismissal

By: Melissa M. Crespo, Michael Burshteyn and Morgan O'Neill Mitruka

FDA Issues Final Transition Guidances for COVID-19 Devices

By: Stacy Cline Amin, Brigid DeCoursey Bondoc and Keunbong (KB) Do