MoFo Life Sciences shares timely legal and business insights and in-depth analyses on the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and agtech fields in the United States, Europe and Asia. Here’s a round-up of our recent posts:

  • Is 2021 the Value-Based and Shared Savings Revolution? By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS regulations, OIG created new safe harbors for: (i) value-based arrangements and (ii) arrangements related to the Centers for Medicare & Medicaid Services (CMS) sponsored model arrangements and modeled patient incentives.
  • Pay-for-Delay Has a Tough (Antitrust) Time at EU Top Court In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission and the European Courts. In two recent rulings – “Lundbeck” and “Paroxetine” – the European Court of Justice dealt with settlement agreements between originator companies and generic companies aimed at delaying the introduction of generic drugs to the market, so-called “pay-for-delay” or “reverse patent settlement” agreements.
  • Software as a Medical Device in Europe - New Regulatory Regime About to Enter Into Force - (Part 6 of 6) In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (MDR), which will govern medical devices software (MDSW) in the EU, we turn to the transition periods that certain MDSW companies can benefit from before being required to fully comply with the MDR.
  • Global Healthtech CEO Connect: Software as a Medical Device in the U.S. and EU Recap On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device (SaMD) in both the United States and Europe and specific use cases for digital therapeutics and other digital health products.
  • FDA Clinical Decision Support Software vs. EU's Medical Device Regulation In a follow-up to our colleagues recent post about the newly implemented Medical Device Regulation in the European Union, this post discusses some of the similarities between the FDA’s Clinical Decision Support (CDS) Software Draft Guidance and the MDR. While still in draft form, we note that the FDA has signaled its intent to finalize the CDS Draft Guidance in 2021.
  • Vaccine Production and State Intervention in the U.S. During the COVID-19 pandemic, governments around the globe have become increasingly involved in the private sector. State-owned enterprises have been common for a long time in Asia, but the pandemic has increased their prominence in Europe. In Italy and Norway, for instance, governments are taking equity stakes in the airline industry to help distressed companies. Now, with vaccine manufacturing ramping up, it makes sense that governments would intervene in the life sciences and pharmaceutical sectors as well.
  • Software as a Medical Device in Europe - New Regulatory Regime About to Enter Into Force - (Part 5 of 6) The preceding articles of this series laid out how the new EU Medical Device Regulation 2017/745 leads to a broader coverage of medical devices and an overall deeper level of regulation in areas that were already regulated. This episode puts the spotlight on a feature introduced to the European medical devices market for the first time: the Unique Device Identification system, also referred to as the bar-code system for medical devices.
  • Software as a Medical Device in Europe - New Regulatory Regime About to Enter Into Force - (Part 4 of 6) After having dealt with the issue of when software may be considered a medical device according to its intended purpose (in Part 2) and the implications of the new risk classification regime (in Part 3), in this Part 4 of our series on software as a medical device in Europe, we explore key changes to the quality assurance and documentation requirements for stand-alone medical device software under the new EU Medical Device Regulation 2017/745.
  • FDA's Plan for AI/ML-Based Software as Medical Devices: Progress and Concerns The U.S. Food and Drug Administration has acknowledged the prevalence of Artificial Intelligence/Machine Learning-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to stakeholder feedback. It is now one month later, and the FDA has yet to implement any steps outlined in its action plan, all the while approving more and more AI products.
  • COVID-19: State Intervention in Times of Vaccine Shortages The European Union and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain vaccine doses as the pharmaceutical industry slows down deliveries due to manufacturing issues. Yet, time is of the essence when it comes to vaccine rollouts, particularly amid a surge in cases due in part to the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.