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!

Whistleblowers remain a steady source of False Claim Act (FCA) suits against health care and life science companies each year.  Join our upcoming webinar – “Qui Tam Relators: What You Need to Know” on July 12 at 1pm ET. Colleagues in our Health Care Enforcement Defense Practice Group will help companies better understand how to deal with FCA cases, which result in billions of dollars of recovery for the government each year.  Hope Foster, Larry Freedman, Karen Lovitch and Ellyn Sternfield will share insights to the relator process, help companies understand how to react if it is named in a whistleblower suit, and provide tips for how to prevent them.

Register now!

If you missed the Mintz Levin Privacy and Security Practice Webinar last week, you can still get it here!

The current Privacy Webinar Series is focusing on the EU General Data Protection Regulation (GDPR), which will impact how US businesses handle and process personal data from the EU, including possible changes to business processes.  The healthcare industry is no stranger to privacy and data protection, but any business that deals with personal data from the EU needs to understand the reach and scope of the GDPR, so they can prepare for this potentially game-changing privacy regulation.

In the webinar focusing on Accountability, Data Security, Data Impact Assessments and Breach Notification, our colleague Sue Foster covers the practical implication of the GDPR for your business.

And register now for the next webinar in the series on November 10, which will focus on the new restrictions around relying on user consent to data processing and data transfers.

Pill BottlesPlease join Mintz Levin for a webinar discussing health care fraud enforcement in the pharmacy and pharmaceutical industry on October 26, 2016 at 1 pm (ET). My colleagues Theresa Carnegie, Larry Freedman, and Ellyn Sternfield, members of Mintz Levin’s Health Law and Health Care Enforcement Defense practices, will discuss enforcement trends facing the industry.

The webinar will cover topics relevant to virtually all sectors of the health care and life sciences industries, especially pharmaceutical manufacturers, pharmacies, pharmacy benefit managers (PBMs), and health insurers as well as those who invest in the health care and life sciences industries.

During the webinar, my colleagues will discuss:

  • Litigation, investigations, and settlements involving pharmaceutical manufacturers, PBMs, specialty pharmacies, and health care providers;
  • Federal (including the Department of Justice and the Office of Inspector General) and state enforcement focus on the financial relationships among the companies and providers involved in the pharmaceutical supply chain; and
  • Emerging trends in government enforcement and what is fueling them.

The webinar is approved for CLE credit in California and New York.

You can register for the webinar here.

phone_175284335On June 28 at 1:00pm ET, please join me and my Mintz Levin colleagues, Joshua Briones and Russell Fox, for our webinar, “A Year Since the FCC’s Declaratory Ruling — Critical Issues and Latest Trends on TCPA.”

Back in 1991, Congress passed the Telephone Consumer Protection Act (TCPA) to stop the seemingly endless barrage of unwanted phone calls to consumers. Since then, telecommunications technology has improved, allowing companies to contact their customers in different ways. Yet, despite these technological advances, Congress has not amended the law and recent FCC activity and has led to considerable uncertainty and an astronomical increase in TCPA-related litigation. For example, according to the U.S. Chamber’s Institute for Legal Reform, in 2007 there were just 14 TCPA actions filed as compared to 3,710 filed in 2015. Continue Reading Upcoming Webinar to Address Critical Issues and Latest Trends on TCPA

Is your company trying to understand the Department of Labor’s (DOL) new white-collar overtime rule before the rule’s December 1st effective date?  My colleagues from Mintz Levin’s Employment, Labor, and Benefits group are hosting a one-hour webinar on June 21, 2016 at 2pm (ET) to discuss the DOL’s recently released overtime rule.

At its core, the new overtime rule will require all types of companies, including those in the health care and life sciences industries, to decide how to compensate their employees and how to schedule and track their hours, among other things.

The webinar will offer employers an overview of this new overtime rule, and it will also provide unique insights on the overtime rule’s potential impact in the workplace.  The webinar will help companies navigate the complex issues that may arise when making the required employee classification decisions, and it will suggest best practices for implementing the new overtime rule. Continue Reading Employers, Join Us for a Webinar: The New White-Collar Overtime Rule

As 2015 comes to a close and you look ahead to the New Year, we hope that you will consider joining us for an informative webinar on health care enforcement trends for 2016. On Wednesday, January 13, 2016, my colleagues Hope Foster, Laurence Freedman, and Bridget Rohde will host “Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead.” The webinar will highlight key enforcement activities from 2015 and the trends we expect to see in 2016. Continue Reading Upcoming Webinar and Report – Health Care Enforcement in 2016

On April 8th I will be presenting in a Health Care Compliance Association webinar entitled “Hot Topics in Laboratory Compliance.”  My co-presenter is Rob Rossi, Senior Vice President and Chief Compliance Officer, Calloway Laboratories.   Rob is a seasoned laboratory industry veteran who also has served as General Counsel of a pathology laboratory and who has spent time in state government.  Together we will offer legal guidance while taking into account the operational and business challenges laboratories face in today’s health care enforcement environment.  Laboratories seem to be in the spotlight lately, as evidenced by the HHS OIG’s issuance of last year’s Special Fraud Alert on payments by laboratories to referring physicians and Advisory Opinion 15-04 addressing a proposed business arrangement between a laboratory and its physician practice clients.  If you are interested in learning more about these issues, there is still plenty of time to register.

Earlier this month, Mintz Levin’s Hope Foster and Bridget Rohde hosted a webinar entitled “Health Care Enforcement in 2015: A Look Back on 2014 and Forecasting the Year Ahead.” A video recording of the webinar, along with an accompanying PDF, can be found below.

The webinar provides a detailed look back on the health care enforcement efforts of 2014, by focusing on three core areas:

  1. Criminal Prosecutions. The webinar addresses the high priority that DOJ officials are giving to their health care enforcement efforts, highlighted by U.S. Attorney Loretta E. Lynch underscoring the importance and effectiveness of DOJ’s Health Care Fraud Prevention and Enforcement Action Team (“HEAT”) and the Medicare Fraud Strike Force (“Strike Force”). Hope and Bridget identify and discuss four notable characteristics of the 2014 Strike Force prosecutions: the geographic breadth of the prosecutions, the variety of the providers and medical professionals targeted, the types of charged crimes (including both fraud and financial crimes), and the wide-ranging penalties that have included stiff sentences and hefty fines. For example, the presenters discuss the case of ArthroCare Corporation, a medical device manufacturer, in which the DOJ was able to obtain 20 year and 10 year prison sentences against the CEO and CFO, respectively.
  2. Joint Civil and Criminal Matters. Hope and Bridget discuss notable criminal and civil resolutions, including a massive civil and criminal action against Endo Health Solutions, Inc., and its subsidiary Endo Pharmaceuticals, Inc. (collectively, “Endo”).  In response to criminal and civil allegations related to Endo’s off-label promotion of its drug Lidoderm, Endo paid $193 million and entered into a corporate integrity agreement.
  3. Civil Enforcement. The webinar also focuses on the continued role of the False Claims Act as the government’s primary civil remedy, with recoveries totaling $2.3 billion in 2014. Also discussed is the extraordinary increase in the number of whistleblowers coming forward as qui tam relators.

After discussing the three areas above, the presenters provide insight into the likely trends of health care enforcement in 2015.

Webinar Video
Webinar Video
Webinar PDF
Webinar PDF

My colleagues Susan Berson, Karen Lovitch, and I hosted a webinar on December 16, 2014 entitled “Practical Tips for Health Care and Life Sciences Companies to Protect the Attorney-Client Privilege.”  A link to the recorded presentation can be found here.

In the webinar, we:

  • Provided an overview of attorney-client privilege considerations particular to the health care and life sciences industries;
  • Described recent case law addressing the contours of the attorney-client privilege;
  • Explained how the privilege applies to communications with in-house counsel, outside counsel, and compliance professionals;
  • Discussed common privilege issues, including those issues that may arise in internal investigations and corporate transactions; and
  • Gave some practical tips for protecting the privilege.