MoFo Life Sciences

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
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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
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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
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July 26, 2021 - United States, FDA, Healthcare
Cures 2.0: Will It Be Better Than the Original?
By: Stacy Cline Amin
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.”
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July 15, 2021 - United States, Healthcare, Antitrust
BIDEN ADMINISTRATION Executive Order on Promoting Competition in the American Economy: Drug Pricing and Healthcare Industry Initiatives
By: Stacy Cline Amin
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
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June 29, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape
Christine Lentz , a Morrison & Foerster summer associate in our San Diego office , contributed to the writing of this article. The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in
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May 13, 2021 - United States, FDA, COVID-19, Healthcare
New Face Mask Performance Standard Has Consumers Covered
ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain filtration requirements enforced by government agencies like the U.S. Occupational Safety
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May 11, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
COVID-19 Vaccines: And Then There Were Three (Again)
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others (produced by Moderna and Johnson & Johnson) have also been
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April 22, 2021 - United States, Digital Health, Healthcare, Regulatory
Is 2021 the Value-Based and Shared Savings Revolution?
By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS regulations, OIG created new safe harbors
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March 31, 2021 - United States, FDA, COVID-19, Healthcare, Pharma
Vaccine Production and State Intervention in the U.S.
By: Brigid DeCoursey Bondoc
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector.[1] State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes
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Topic Archives: Healthcare

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?

By: Stacy Cline Amin

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

By: Stacy Cline Amin

EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape

New Face Mask Performance Standard Has Consumers Covered

COVID-19 Vaccines: And Then There Were Three (Again)

Is 2021 the Value-Based and Shared Savings Revolution?

Vaccine Production and State Intervention in the U.S.

By: Brigid DeCoursey Bondoc