MoFo Life Sciences

February 24, 2021 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
Life Sciences Regulatory Framework Becomes Law Post-Brexit
By: Gareth Rees KC and Jenny Galloway
Nearly one year after its introduction to the House of Commons, the Medicines and Medical Devices Bill 2019‑2021 (the Bill) was granted Royal Assent on 11 February 2021, becoming law as the Medicines and Medical Devices Act 2021 (the Act). The purpose of the Act is
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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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November 17, 2020 - United States, FDA, Healthcare
Recent Digital Health-Related FDA Announcements
By: Jean Nguyen
The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software Precertification Program. Manufacturers developing mobile medical devices, software as
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November 13, 2020 - Medical Devices + Diagnostics, United Kingdom, Healthcare, Pharma, Regulatory
UK Plans for Robust Life Sciences Regulation Post-Brexit
By: Gareth Rees KC and Wolfgang Schönig
As Brexit is finally completed in the UK, from 1 January 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) will be the UK’s standalone medicines and medical devices regulator. Transition from the EU allows the UK to offer fully independent regulatory decisions for
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September 18, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare
First Decisions Limit PREP Act Immunity in Coronavirus Context
By: Erin M. Bosman and Julie Y. Park
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act
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September 09, 2020 - United States, FDA, Biotech, Healthcare, Pharma, Intellectual Property
Pediatric Exclusivity for Biologics
The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At
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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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May 26, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps
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May 22, 2020 - COVID-19, CFIUS, Healthcare, Asia
Japan Moves to Tighten Restrictions on Foreign Investment in Healthcare Industries
By: Gary Mitchel Smith
Amid concerns about predatory acquisitions of weakened companies and strategic assets during the COVID‑19 crisis, more and more countries are restricting foreign direct investment (FDI) in their domestic companies, especially in the medical and healthcare industries. These restrictions tend to target Chinese investment in
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April 28, 2020 - United States, FDA, Medical Devices + Diagnostics, COVID-19, Healthcare
Mental Health during COVID-19: FDA Waivers for Digital Health Devices
By: Jean Nguyen
As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern. Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating
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Topic Archives: Healthcare

Life Sciences Regulatory Framework Becomes Law Post-Brexit

By: Gareth Rees KC and Jenny Galloway

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

By: Alex van der Wolk

Recent Digital Health-Related FDA Announcements

By: Jean Nguyen

UK Plans for Robust Life Sciences Regulation Post-Brexit

By: Gareth Rees KC and Wolfgang Schönig

First Decisions Limit PREP Act Immunity in Coronavirus Context

By: Erin M. Bosman and Julie Y. Park

Pediatric Exclusivity for Biologics

FTC Seeks Comments on Health Breach Notification Rule

By: Melissa M. Crespo

FDA Signals Flexibility with COVID-19 Tests

By: Erin M. Bosman and Julie Y. Park

Japan Moves to Tighten Restrictions on Foreign Investment in Healthcare Industries

By: Gary Mitchel Smith

Mental Health during COVID-19: FDA Waivers for Digital Health Devices

By: Jean Nguyen