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.”