MoFo Life Sciences

February 08, 2023 - Privacy + Data Security, Pharma, Healthcare, United States, Digital Health
FTC Brings First Enforcement Action of the Health Breach Notification Rule
By: Melissa M. Crespo and Libby Strichartz
The Federal Trade Commission (FTC) has enforced its Health Breach Notification Rule (the “HBNR”) for the first time since it was enacted in 2009. On February 1, the FTC announced a first-of-its-kind proposed order (the “Order”) with digital health platform GoodRx Holdings Inc. (“GoodRx”),
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November 29, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma, United States
CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies
By: Wendy C. Chow
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) published the final 2023 Medicare Physician Fee Schedule (“2023 Fee Schedule”). Although the 2023 Fee Schedule most notably sets the rates for Medicare services for the coming year, the rulemaking also traditionally includes
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November 17, 2022 - FDA, Healthcare, Digital Health, Regulatory, Pharma
FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance
By: Stacy Cline Amin and Brigid DeCoursey Bondoc
On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass
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November 15, 2022 - FDA, Healthcare, Digital Health, Regulatory
Prevent a Clinical Trial from Turning Into a Criminal Trial
By: Stacy Cline Amin, Kate Driscoll, Brian K. Kidd and Brian R. Michael
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the
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October 28, 2022 - United States, Healthcare, Regulatory, Digital Health, Biotech
U.S. Government Launches Billion-Dollar Biomedical Agency
By: Tina D. Reynolds
As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new
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October 18, 2022 - FDA, Digital Health, Healthcare
Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices
By: Kate Driscoll
Morrison Foerster's Kate Driscoll joined the American Bar Association Health Law Section "Voices in Health Law" podcast to discuss the latest telehealth enforcement trends. The rise of telehealth services during the COVID-19 pandemic resulted in new and adapted forms of fraud, and Kate offers
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February 17, 2022 - FDA, Digital Health, Healthcare
FDA Releases Draft Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
Special thanks to Morrison & Foerster Regulatory Analyst Brandy Guarda for contributing to this article. In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run
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February 03, 2022 - FDA, Medical Devices + Diagnostics, Digital Health, Healthcare, Pharma
MoForum Recap: Transformation Across the Industry
Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets. Digital Transformation in the Life Sciences
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January 31, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY
Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy. We welcomed 100+ participants over the three-day virtual program to hear from leaders from across the
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January 25, 2022 - United States, Digital Health, Biotech, Healthcare, Pharma
2022 Life Sciences MOFORUM Starts This Week
By: Matthew Karlyn
Morrison & Foerster kicked off its virtual 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy on January 25, 2022. With three days of programming planned, the series started with a discussion on the “Digital Transformation in Life Sciences,” featuring digital health advisor Melinda
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Topic Archives: Digital Health

FTC Brings First Enforcement Action of the Health Breach Notification Rule

By: Melissa M. Crespo and Libby Strichartz

CMS Publishes Final 2023 Medicare Physician Fee Schedule—Key Takeaways for Telehealth Companies

By: Wendy C. Chow

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

By: Stacy Cline Amin and Brigid DeCoursey Bondoc

Prevent a Clinical Trial from Turning Into a Criminal Trial

By: Stacy Cline Amin, Kate Driscoll, Brian K. Kidd and Brian R. Michael

U.S. Government Launches Billion-Dollar Biomedical Agency

By: Tina D. Reynolds

Telehealth Fraud Enforcement: Trends, Predictions, and Best Practices

By: Kate Driscoll

FDA Releases Draft Guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

MoForum Recap: Transformation Across the Industry

RECORDINGS NOW AVAILABLE: 2022 LIFE SCIENCES MOFORUM – GROWTH, INNOVATION, AND STRATEGY

2022 Life Sciences MOFORUM Starts This Week

By: Matthew Karlyn