MoFo Life Sciences

December 23, 2021 - FDA, Medical Devices + Diagnostics, Litigation, Healthcare
3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session
FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021. The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022. The session included presentations from Ann Oxenham (CFSAN),
... ›
December 23, 2021 - FDA, COVID-19, Healthcare, Pharma
Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the Consumer Protection Branch in 2021, and highlighted areas of
... ›
December 22, 2021 - FDA, Healthcare
What New FDA Policy Means for COVID Tests and Beyond
Stacy Amin and Bethany Hills, co-chairs of our FDA Regulatory + Compliance practice, authored an article for Law360 discussing the U.S. Department of Health and Human Services (HHS) withdrawing a controversial Trump administration policy that prohibited the U.S. Food and Drug Administration (FDA) from requiring
... ›
November 30, 2021 - United States, FDA, Healthcare
Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As we reported in an earlier blog post , CMS first proposed
... ›
October 26, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop
On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology in
... ›
October 01, 2021 - United States, Healthcare, Privacy + Data Security
Health App and Device Providers Take Note: Health Breach Notification Rule Enforcement Is Coming
By: Melissa M. Crespo
As the mobile health and connected device market continues to grow at an exponential pace, the Federal Trade Commission (“FTC”) has issued a Policy Statement that emphasizes its commitment to ensuring the protection of sensitive information collected by these apps and devices. On September
... ›
September 22, 2021 - United States, FDA, Healthcare
CMS Proposes to Repeal MCIT Final Rule
Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed Rule”), which CMS published on January 14, 2021 in the waning
... ›
September 15, 2021 - United States, COVID-19, Healthcare, Pharma
Is the Future of Telehealth in OIG’s Hands?
Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of Inspector General (OIG) appear primed to audit telehealth services and ramp
... ›
July 26, 2021 - United States, FDA, Healthcare
Cures 2.0: Will It Be Better Than the Original?
It’s summer blockbuster season and that means sequels abound. Now it seems that the U.S. Congress wants in on the action. Just five years after Congress passed the 21st Century Cures Act, a bipartisan group of representatives is looking to enact follow-up legislation—“Cures 2.0.”
... ›
July 15, 2021 - United States, Healthcare, Antitrust
BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a comprehensive summary of the efforts to change both the substance and the approach
... ›

Topic Archives: Healthcare

3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

Key Takeaways from FDLI’s Enforcement, Litigation, and Compliance Conference Keynote Address

What New FDA Policy Means for COVID Tests and Beyond

Rescinding the MCIT/R&N Final Rule, CMS Seeks New Approaches for Innovative Technology Coverage

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop

Health App and Device Providers Take Note: Health Breach Notification Rule Enforcement Is Coming

By: Melissa M. Crespo

CMS Proposes to Repeal MCIT Final Rule

Is the Future of Telehealth in OIG’s Hands?

Cures 2.0: Will It Be Better Than the Original?

BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives