MoFo Life Sciences

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: Matt Karlyn 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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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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December 11, 2019 - European Union, Privacy + Data Security
EU Adopts Whistleblowing Directive to Protect Whistleblowers
By: Alja Poler De Zwart
The whistleblowing rules in Europe are about to change dramatically. The new Directive on the protection of persons who report breaches of Union law , also referred to as the “Whistleblowing Directive,” will require Member States to create rules that mandate organizations with more
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July 16, 2019 - European Union, Regulatory, Privacy + Data Security
European Commission Q&A on the interplay between the Clinical Trials Regulation and GDPR
By: Alex van der Wolk
In response to the opinion of European Data Protection Board (EDPB), the European Commission has issued its Question and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) (Q&A). The non-binding Q&A offers some additional clarifications
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February 26, 2019 - European Union, Pharma, Regulatory, Privacy + Data Security
The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR
By: Miriam H. Wugmeister
There has been a lot of confusion in the past months on applying the General Data Protection Regulation (GDPR) to clinical trials. For example, the GDPR requires honoring specific individual rights such as notice, access and deletion. However, that seems to be at odds
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February 05, 2019 - United States, Biotech, Blockchain, Privacy + Data Security
Transforming the U.S. Healthcare Industry with Blockchain Technology
By: Spencer D. Klein, Julie O'Neill and Mary Race
Patients accumulate vast quantities of healthcare data over the course of their lives. Those data are generally housed in centralized servers operated by various unrelated industry participants, including government regulators and payors, insurance carriers, hospitals, doctors, pharmacies and pharmaceutical companies. Unfortunately, those repositories rely
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Topic Archives: Privacy + Data Security

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

By: Matt Karlyn and Michael Ward Ph.D.

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

EU Adopts Whistleblowing Directive to Protect Whistleblowers

By: Alja Poler De Zwart

European Commission Q&A on the interplay between the Clinical Trials Regulation and GDPR

By: Alex van der Wolk

The Trials That Lie Ahead: EDPB Opines on Interplay Between EU Clinical Trials Regulation and GDPR

By: Miriam H. Wugmeister

Transforming the U.S. Healthcare Industry with Blockchain Technology

By: Spencer D. Klein, Julie O'Neill and Mary Race