21st Century Cures Act

Rules for clinical research are undergoing major changes in both the United States and the European Union. In the United States, the 21st Century Cures Act, which was signed into law on December 13, 2016, creates a new paradigm for modern trial design and clinical evidence development, and the Department of Health and Human Services has proposed significant revisions to the Common Rule, which governs human subject research. In the European Union, imminent changes to the clinical trial regulation No. 536/2014 and general data protection regulation could substantially impact the administration of clinical trials in European countries. The changes will greatly affect the conduct of clinical trials by sponsors and clinical researchers all over the world.

To find out more about these changes and how to address them in your trials, join our two-part upcoming webinar, “Conducting Multi-Jurisdictional Trials: Understanding Changes in the US and EU.” The first part, on January 24 at 11 AM EST, will feature Bethany Hills, Dianne Bourque, and Benjamin Zegarelli from Mintz Levin’s FDA practice group, who will share insights on changes that will impact the design and conduct of clinical trials in the US. The second part, on February 7 at 11 AM EST, will feature Laura Liguori and Elisa Stefanini from Portolano Cavallo, who will cover the important changes to clinical trial administration in the EU and Italy.

Register now!

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you with a basic understanding of FDA’s evolving approach to mobile apps so that you can make informed decisions about the legal consequences of your app’s functionality. Continue Reading Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” Continue Reading FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

shutterstock_282978377Although telehealth has the potential to improve or maintain quality of care for Medicare beneficiaries, payment and coverage restrictions create barriers that prevent providers from fully utilizing telehealth technologies. That is the core finding of a report issued by the Government Accountability Office (GAO) this month on telehealth and remote patient monitoring use for Medicare beneficiaries.

The GAO report was issued as part of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which included a provision for the GAO to study telehealth and remote patient monitoring. In compiling the report, the GAO interviewed representatives of nine provider, patient, and payor associations who provided feedback on, among other things, barriers to providing telehealth services to Medicare beneficiaries. Continue Reading GAO Report: Medicare Reimbursement Policies Impede Telehealth Adoption