Medical Technology Compliance: FDA, AKS, FCA and Other Regulatory Requirements

Mitigating Medical Device and Healthcare Technology Risks

A live 90-minute CLE webinar with interactive Q&A

Wednesday, September 6, 2017
1:00pm-2:30pm EDT, 10:00am-11:30am PDT

This CLE webinar will provide guidance to counsel in the medical technology industry on the regulatory compliance risks facing the industry and on implementing the optimal compliance program. The panel will discuss the pitfalls to avoid as well as healthcare fraud issues facing the industry.


The medical device industry is heavily regulated, and companies must follow strict guidelines. Due to confusion over implementing the regulations, healthcare companies often miss important compliance matters. The FDA can audit medical technology companies at any time, and counsel must prepare these companies.

Further, the government’s False Claims Act (FCA) enforcement continues to focus on key areas in pharmaceutical and medical device industries. In 2016, the healthcare industry paid $2.5 billion in settlements and judgments from FCA cases.

Similarly, the enforcement of the Anti-Kickback Statute (AKS) has been costly for companies. For example, medical device maker Olympus Corp. paid over $600 million to settle criminal and civil AKS and FCA charges in 2016.

Listen as our authoritative panel of healthcare attorneys examines the unique risks for medical technology companies and provides guidance on implementing appropriate and effective compliance programs. The panel will discuss AKS, FCA and other fraud issues as well as the key pitfalls to avoid.


  1. Unique risk profile for medical technology companies
    1. Evolving regulatory landscape
    2. Ever-increasing compliance requirements
    3. Safety, security and reliability
    4. Managing data
  2. Unique operational considerations for medical technology companies
  3. Tips on implementing a “right sized” compliance program
  4. “Toolkit” for fighting healthcare fraud
    1. Anti-Kickback Statute
    2. False Claims Act
    3. Open Payments/Sunshine Act
    4. “Whistleblower” suits
  5. Core components of effective compliance program
  6. Key questions to consider


The panel will review these and other key issues:

  • What are the unique risks facing medical technology and device companies?
  • What are the key pitfalls to avoid when implementing compliance programs?
  • What steps should counsel take to ensure compliance with FCA and AKS?


Jana Gerken, J.D., Co-Founder and Chief Legal Strategist
Kinetic Compliance Solutions, Brookfield, Wis.

Ms. Gerken develops and executes legal strategies that strike the right balance between risk and reward to help her clients gain a competitive edge while remaining compliant. She partners with clients in translating complex legal challenges into pragmatic business solutions. Prior to co-founding Kinetic Compliance Solutions, she was the General Counsel for GE Healthcare’s five-billion-dollar diagnostic imaging businesses (Detection & Guidance Solutions (DGS), Molecular Imaging & Computed Tomography (MICT), and Magnetic Resonance (MR)).

Ethan E. Rii, Shareholder
Vedder Price, Chicago

Mr. Rii focuses his practice on healthcare transactions and regulatory matters surrounding mergers and acquisitions, corporate restructurings and joint ventures for hospitals, health systems, multispecialty and large physician practices, specialty and ancillary care providers, managed care organizations, private equity firms and financial institutions investing in the healthcare space. He counsels clients on healthcare compliance issues, including fraud and abuse and related matters, such as physician referral and anti-kickback regulations.

Live Webinar

Live Webinar $297.00

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This webinar is eligible for at least 1.5 general CLE credits.

CLE credits are not available for PR.

*In KS, OH, PA, for more than 1 attendee on the connection you must contact Strafford CLE via email or call 1-800-926-7926 ext. 35 prior to the program for special instructions.


CLE On-Demand - Streaming Video

Includes recorded streaming video of full program plus PDF handouts.

On-demand is the only recorded format recognized for CLE credits in DE, IN, KS, LA, MS, NC, OH, OK, SC, TN, VA, WI.

AK, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN*, KS, KY, LA, ME, MN, MO, MT, NC, ND, NH**, NJ, NM, NV, NY, OH*, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)

*Only available for attorneys admitted for more than two years. For OH CLE credits, only programs recorded within the current calendar year are eligible - contact the CLE department for verification.

**NH attendees must self-determine if a program is eligible for credit and self-report their attendance.

CLE On-Demand Video $297.00
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AK, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KY, ME, MN, MO, MT, ND, NJ, NM, NY, OR, PA, TN, TX, UT, VT, WA, WV, WY (Note: Some states restrict CLE eligibility based on the age of a program. Refer to our state CLE Map for additional information.)

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Customer Reviews

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Skilled Care

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Sarah Cannon Research Institute

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Health Law Advisory Board

Lowell C. Brown


Arent Fox

Jennifer L. Evans



Ryan S. Johnson


Fredrikson & Byron

Gina M. Kastel


Faegre Baker Daniels

Karen S. Lovitch


Mintz, Levin, Cohn, Ferris, Glovsky and Popeo

David A. Manko


Proskauer Rose

John J. Miles

Senior Counsel

Baker Donelson

C. Elizabeth O'Keeffe


Wyatt, Tarrant & Combs

J. Peter Rich


McDermott Will & Emery

Donald H. Romano

Of Counsel

Foley & Lardner

Judith A. Waltz


Foley & Lardner

John R. Washlick


Buchanan Ingersoll & Rooney

Jesse A. Witten


Drinker Biddle & Reath

or call 1-800-926-7926

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