Industry Healthcare and Life Sciences
Solution Type Certification for Medical Device
Needs Insulet needed to prepare a medical device system for review for DTSec certification. We conducted an end-to-end security assessment of the device and its drug platform management system.
With the proliferation of Internet-enabled medical devices, TUV Rheinland OpenSky sought the opportunity to pursue testing according to the Diabetes Technology Society’s “Standard for wireless Diabetes Device Security” cybersecurity assurance standard and program, known as DTSec. 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.
One of the prerequisites for being a DTSec Accredited Lab was to show proper laboratory accreditations, which TUV Rheinland OpenSky was able to achieve. As a DTSec Accredited Lab, TUV Rheinland OpenSky’s credentials and experience stood out from other security companies. Our company had a clear edge to evaluate and test Insulet Corporation’s Omnipod® DASH™ Insulin Management System against DTSec Version 2.0.
The evaluation and testing provides confidence to users of connected diabetes devices that the products include the security protections claimed by their developers.
With TUV Rheinland OpenSky, Insulet had a partner with credibility in the medical device space. Our team does not just check the boxes during the evaluations. Our team works closely with organizations to establish testing best practices and identify the types of threats that need to be addressed in the final design and implementation phases of product development.
The practices at the TUV Rheinland OpenSky lab align with the Healthcare Information and Management Systems Society (HIMSS), the Medical Device Innovation, Safety & Security Consortium (MDISS), and ISO 15408, to meet the expectations of the Diabetes Technology Society.
At the end of the day
- Protect their business medical device management system from cyber risks
- Mitigate potential compromise and exploitation
- Enhance device safety for end users
Insulet Corporation (NASDAQ: PODD) 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 other therapeutic areas. Founded in 2000, more than 150,000 users across the globe rely on Insulet’s Omnipod® Insulin Management System to bring simplicity and freedom to their lives.