TUV Rheinland OpenSky helps Insulet Corporation achieve cybersecurity certification by DTSec

TUV Rheinland OpenSky helps Insulet Corporation’s Omnipod® DASH™ Insulin Management System to be the first FDA-cleared insulin pump to achieve certification under the Diabetes Technology Society’s cybersecurity assurance standard and program, known as DTSec

TUV Rheinland OpenSky, DTSec Accredited Lab and the world’s premier cybersecurity testing services provider achieve another first in cybersecurity certification for internet-enabled medical devices

Cologne, Germany, and Littleton, U.S. – November 6, 2018:  Diabetes Technology Society announced that the first FDA cleared insulin pump has received certification under the Diabetes Technology Society’s “Standard for Wireless Diabetes Device Security” cybersecurity assurance standard and program, known as DTSec. This distinction goes to Insulet Corporation’s Omnipod DASH™ Insulin Management System.

As the DTSec Accredited Lab, TUV Rheinland OpenSky was engaged to evaluate and test Insulet Corporation’s Omnipod® DASH™ Insulin Management System against the Standard for Wireless Diabetes Device Security (DTSec) Version 2.0. The evaluation and testing provide users of connected diabetes devices with confidence that the products include the security protections claimed by their developers.

See Insulet Corporation’s Omnipod® DASH™ Insulin Management System – DTSec Certificate: https://www.diabetestechnology.org/dtsec/omnipod-dash-dtsec-certificate.pdf.

According to Anish Srivastava, CEO and President of TUV Rheinland OpenSky, “In the coming years we expect the proliferation of internet-enabled medical devices. This would drive the convergence of cybersecurity and data privacy with safety. We’re proud to be the DTSec Accredited Lab and a part of the process that helps life-saving devices get to market safely and quickly.”

According to Dr. David Klonoff, Clinical Professor of Medicine at UCSF and Chair of the DTSec steering committee, “Certification per the DTSec Standard demonstrates a commitment to cybersecurity by the manufacturer of this connected wireless insulin pump system. The Omnipod® DASH™ System is part of the Internet of Medical Things and is the first insulin pump system to be DTSec-certified. Diabetes Technology Society commends Insulet Corporation’s dedication to improved safety and security demonstrated by achieving this important milestone.”

According to Dr. Aiman Abdel-Malek, Executive Vice President and Chief Technology Officer at Insulet, “We are highly supportive of DTS’ efforts in pushing commercial best practice guidance for cybersecurity in the connected medical device systems space. We are committed to remaining at the forefront of best-in-class standards for security to ensure patient safety and privacy.”

About TUV Rheinland OpenSky

At TUV Rheinland OpenSky, we build secure and safe digital solutions. We offer consulting, systems integration, testing, certification and managed security services to protect today’s digital enterprise. Our holistic framework addresses Cyber Security, Privacy, Cloud Infrastructure, IoT, and Functional Safety requirements to build trusted connected platforms.

 TUV Rheinland OpenSky is a wholly owned subsidiary of TÜV Rheinland Group, a testing and certification leader who has created a safer world for over 140 years. We keep our clients at the global forefront of interoperability, performance and safety.


About TUV Rheinland

TÜV Rheinland is a global leader in independent inspection services, founded 145 years ago. The group maintains a worldwide presence of more than 20,000 people; annual turnover is nearly EUR 2 billion. The independent experts stand for quality and safety for people, technology and the environment in nearly all aspects of life. TÜV Rheinland inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies. Its experts train people in a wide range of careers and industries. To this end, TÜV Rheinland employs a global network of approved labs, testing and education centers. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption. For more information on TUV Rheinland please visit http://www.tuv.com


About the Diabetes Technology Society

The Diabetes Technology Society (DTS) is a nonprofit organization committed to promoting development and use of technology in the fight against diabetes. The DTS mission is to spearhead collaborative efforts by experts in academia, clinical practice, industry, and government to accelerate development of practical technology for treating, monitoring, diagnosing, and preventing diabetes mellitus and its complications. For more information visit https://www.diabetestechnology.org.

DTSec is the first consensus cybersecurity standard for connected diabetes devices with input from academia, industry, government, and clinical centers of excellence. Established by the Diabetes Technology Society in 2016, the goal of DTSec is to raise confidence in the security of connected medical devices through independent expert security evaluation. https://www.diabetestechnology.org/dtsec.shtml.


About Insulet Corporation

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to making the lives of people with diabetes and other conditions easier through the use of its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod, by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across multiple therapeutic areas. Founded in 2000, more than 140,000 users across the globe rely on Insulet’s Omnipod Insulin Management System to bring simplicity and freedom to their lives.

On July 1, Insulet assumed direct operations of its Omnipod Insulin Management System product line in Europe, including sales, marketing, training and customer support activities. This allows Insulet to be closer to the diabetes community and identify opportunities to support European customer needs over the long-term, as Insulet does in the United States and Canada.

For more information, please visit: www.insulet.com and www.myomnipod.com.


Contact Information:
Jen Picardo, Director of Communications, TUV Rheinland of North America, Inc.
978-266-9500
jpicardo@us.tuv.com