MoFo Life Sciences

June 15, 2023 - AI + Robotics, Digital Health, FDA, Intellectual Property, Medical Devices + Diagnostics, Privacy + Data Security, Regulatory
The Legal and Regulatory Landscape Evolving with AI in Life Sciences
By: Brigid DeCoursey Bondoc, Wendy C. Chow and Anna Yuan
Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion.
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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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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
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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January 21, 2022 - United States, Medical Devices + Diagnostics, Healthcare, Privacy + Data Security
Latest Genetic Data Privacy Law Goes into Effect
By: Melissa M. Crespo
California is ringing in the New Year with new privacy and security protections for genetic data. On January 1, 2022, California’s new Genetic Information Privacy Act (GIPA) became the latest state genetic data privacy law to go into effect, adding to a growing number
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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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November 18, 2020 - European Union, Healthcare, Regulatory, Privacy + Data Security
Health Data Made in France- Is France Moving Towards a Sovereign Cloud Requirement for Health Data?
By: Alex van der Wolk
Since the decision of the European Court of Justice (“ECJ”) in the Schrems II case, transfers of personal data from the EU to the United States have been under scrutiny. The ECJ reviewed the situation where personal data are sent from an EU affiliate to its
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October 22, 2020 - AI + Robotics, Licensing + Commercial, FDA, COVID-19, Intellectual Property, Privacy + Data Security
Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations
By: Jean Nguyen, Kristen J. Mathews, Matthew Karlyn and Michael Ward Ph.D.
In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and
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October 13, 2020 - Licensing + Commercial, FDA, COVID-19, Intellectual Property, Privacy + Data Security
Podcast: Unpacking the Science and Legal Considerations of COVID-19 Testing
By: Matthew Karlyn, Kristen J. Mathews and Michael Ward Ph.D.
In this first of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and
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June 02, 2020 - United States, Healthcare, Privacy + Data Security
FTC Seeks Comments on Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) recently announced a review and open comment period for the Health Breach Notification Rule, 16 C.F.R. Part 318 (the “Rule”), which requires vendors of personal health records (PHR) and related entities that aren’t covered by HIPAA to provide notice
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