MoFo Life Sciences

February 19, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition
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February 12, 2021 - Medical Devices + Diagnostics, European Union, Regulatory
Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)
By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this trend is likely to continue. As with every health-related product
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February 04, 2021 - United States, Litigation, Regulatory
EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million
On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying impermissible kickbacks related to its electronic health records (EHR) product. At the
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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 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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November 09, 2020 - Licensing + Commercial, United States, Corporate + Venture Capital, FDA, United Kingdom, Litigation, Startup, Regulatory, Intellectual Property, Announcements
Legal Topics for Scientists, Entrepreneurs, and Start Ups
By: Michael Ward Ph.D., Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis
The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn
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October 15, 2020 - United States, FDA, Regulatory
Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers
Morrison & Foerster Research Analyst Christine Lentz contributed to the writing of this article. The House of Representatives recently passed a proposed bill that encourages treatments for rare pediatric diseases by prolonging the authority of Health and Human Services to issue priority review vouchers.
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September 30, 2020 - Agtech, Pharma, Regulatory, Asia
China Technology Export Update: Amendment of The Export Technology Catalog
On August 28, 2020, China’s Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly published a notice on the adjustment of China’s Catalog of Technologies the Export of Which is Prohibited or Restricted (the “Catalog”). This is the first time the
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September 23, 2020 - Regulatory, Intellectual Property, Asia
China Patent Linkage Update: Codification and Rulemaking
On July 3, 2020, China’s National People’s Congress published the second draft of the latest amendment to China’s Patent Law (the “Draft Amendment”) for public comments, which were allowed to be submitted by August 16, 2020. The Draft Amendment included proposed revisions to 19
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July 22, 2020 - Biotech, Pharma, Regulatory, Asia
China to Criminalize Human Genetic Resources Violations
On June 28, 2020, the draft 11 th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human
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Topic Archives: Regulatory

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)

By: Wolfgang Schönig, Stephan Kreß and Robert Grohmann

EHR Vendor Settles Kickback Allegations to the Tune of $18.25 Million

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

By: Alex van der Wolk

UK Plans for Robust Life Sciences Regulation Post-Brexit

By: Gareth Rees KC and Wolfgang Schönig

Legal Topics for Scientists, Entrepreneurs, and Start Ups

By: Michael Ward Ph.D., Anita Choi, Andrew Boyd, Alfredo B. D. Silva, Matthew Karlyn, Jim Krenn and Matthew A. Chivvis

Bill Proposes Continuation of FDA Rare Pediatric Disease Priority Review Vouchers

China Technology Export Update: Amendment of The Export Technology Catalog

China Patent Linkage Update: Codification and Rulemaking

China to Criminalize Human Genetic Resources Violations