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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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 R. Ward
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 R. Ward
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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April 03, 2020 - United States, COVID-19, Healthcare, Privacy + Data Security
HHS Suspends Penalties to Encourage Sharing of COVID-19 Data by Business Associates
On April 2, 2020, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that, effective immediately, it will be halting enforcement of certain HIPAA provisions in order to enable state and federal public health authorities and emergency operations
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March 12, 2020 - United States, COVID-19, Healthcare, Privacy + Data Security
OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)
By: Melissa M. Crespo
In response to the recent outbreak of the novel coronavirus (2019-nCoV or COVID-19) and associated preparation and response, the Department of Health and Human Services Office for Civil Rights (OCR) recently released a bulletin (the “Bulletin”) outlining how entities subject to HIPAA may share
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February 27, 2020 - United States, FDA, Agtech, Litigation, Privacy + Data Security
January FDA Updates
As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and product development issues every month. Our January recap is below. 1. FDA, USDA and EPA announce joint platform to streamline information
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Topic Archives: Privacy + Data Security

FTC Brings First Enforcement Action of the Health Breach Notification Rule

By: Melissa M. Crespo and Libby Strichartz

Latest Genetic Data Privacy Law Goes into Effect

By: Melissa M. Crespo

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

By: Melissa M. Crespo

Health Data Made in France- Is France Moving Towards a Sovereign Cloud Requirement for Health Data?

By: Alex van der Wolk

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 R. Ward

Podcast: Unpacking the Science and Legal Considerations of COVID-19 Testing

By: Matthew Karlyn, Kristen J. Mathews and Michael R. Ward

FTC Seeks Comments on Health Breach Notification Rule

By: Melissa M. Crespo

HHS Suspends Penalties to Encourage Sharing of COVID-19 Data by Business Associates

OCR Bulletin on HIPAA Privacy and Coronavirus (COVID-19)

By: Melissa M. Crespo

January FDA Updates