DTSec Diabetes Technology Society Mobile Platform Controlling a Diabetes Device Security and Safety Standard

BackgroundPeopleDTMoSt GuidanceDTSec StandardProtection ProfileExtended Package: Enhanced BasicExtended Package: Moderate

Diabetes Technology Society (DTS) is pleased to announce that the steering committee members of the Diabetes Technology Society Mobile Platform Controlling a Diabetes Device Security and Safety Standard (DTMoSt) project have developed the DTMoSt Guidance for Use of Mobile Devices in Diabetes Control Contexts.

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New Standard Provides Security Guidance for Consumer Mobile Phones Controlling Diabetes Devices

May 22, 2018 – Burlingame, CA – Diabetes Technology Society (DTS) today announced the first official public release of DTMoSt, a consensus cybersecurity standard whose goal is to provide assurance that consumer mobile phones can safely control diabetes devices.

Today, dozens of companies have developed mobile apps to help people monitor their diabetes. Soon, smartphones will also enable patients and healthcare professionals to directly manage care, including the use of apps as remote controls for insulin delivery. DTMoSt aims to ensure that sufficient security measures are taken to protect the integrity of these control solutions and the safety of patients with diabetes.

The DTMoSt Guidance builds upon the DTS Cybersecurity Standard for Connected Diabetes Devices (DTSec), which is the first consensus cybersecurity standard for connected diabetes devices with US government input. DTMoSt will be the first standard with both performance requirements and assurance requirements for manufacturers of connected medical devices controlled by a mobile platform. DTMoSt identifies threats, such as malicious remote and app-based attacks and resource starvation, to the safe operation of mobile device-enabled solutions and offers guidance to developers, regulators, and other stakeholders to help manage these risks.

Today, the public lacks visibility into and assurance for the security properties of connected devices,” said David Kleidermacher, Vice President - head of security for Android, Chrome OS, and Play at Google, and the standard’s Steering Committee technical chair. “DTMoST enables the application of a kind of security nutrition label, based on independent expert security evaluation, that is keenly needed to fill this gap, especially in critical solutions such as mobile-controlled medical care.”

“CyberSafety by-Design is integral to our Omnipod connected digital diabetes innovations at Insulet,” said Dr. Aiman Malek, Executive Vice President and Chief Technology Officer at Insulet. “The DTMoSt Guidance provides the cybersecurity blueprint to help address the diabetes community’s request to build mobile applications that provide safe control of their pumps.”

Anura Fernando, Principal Engineer – Medical Systems at UL, said “UL is glad to be a part of this effort focused on bringing more attention to the security issues that are driven by specific clinical use cases in diabetes management.”

The standard was open to public comment for 45 days, from February 7, 2018 through March 24, 2018.

AVAILABILITY

DTMoSt, The Diabetes Technology Society Guidance for Mobile Platforms Controlling a Diabetes Device Security and Safety Standard is available at https://www.diabetestechnology.org/dtmost.shtml

DTSec, The Diabetes Technology Society Cybersecurity Standard for Connected Diabetes Devices and the Diabetes Technology Society Protection Profile for Connected Diabetes Devices are available at https://www.diabetestechnology.org/dtsec.shtml

DTSecCertified Devices

Device Certification
CONTOUR©NEXT ONE
(Manufacturer: Ascensia Diabetes Care)
CONTOUR©PLUS ONE
(Manufacturer: Ascensia Diabetes Care)

DTSecApproved Testing Labs

Booz Allen Hamilton
Cyber Assurance Testing Lab (CATL)
Primary Contact: Eric Winterton
Email: catl@bah.com
BrightSight
Primary Contact: Ernst Bovelander
Email: bovelander@brightsight.com
TUV Rheinland TÜV Rheinland — North America
Primary Contact: Uwe Meyer
Email: umeyer@us.tuv.com
Underwriters Laboratories Logo Underwriters Laboratories (UL)
Primary Contact Name: Anura S. Fernando
E-mail: Anura.S.Fernando@ul.com
For inquiries regarding how to become an approved DTSec lab, please contact info@diabetestechnology.org.

Public Comment about DTMoSt is solicited

Diabetes Technology Society (DTS) is developing its second cybersecurity standard, called the Diabetes Technology Society Mobile Platform Controlling a Diabetes Device Security and Safety Standard (DTMoSt). This document is a guidance that expands upon the principles of the DTS Cybersecurity Standard for Connected Diabetes Devices (DTSec), DTS’ first cybersecurity standard.  DTMoSt applies these principles to the use of mobile phones to control actions by wearable or implantable diabetes devices. DTMoSt aims to provide assurance that off-the-shelf consumer mobile phones can safely control diabetes devices. This guidance is for industry, clinicians, patients, payers, and regulators.

The DTMoSt Steering Committee includes representatives from: 1) the US government, including FDA, DHS, FBI, NIH, NASA, and DoD; 2) the Australian government; 3) professional organizations, including ADA, The Endocrine Society, and AADE; 4) Standards Development Organizations, including IEEE and UL; 5) industry, including mobile phone manufacturers, hardware and software manufacturers, medical device manufacturers, and medical device testing labs 6) academicians from medicine, diabetes education, information technology, engineering, mathematics, and law; and 7) patients.

We are soliciting public comment about the Guidance document (which relates to the DTSec Standard and DTSec Protection Profile) and the two new extended packages called Advanced Basic and Extended Moderate, which together replace what was preciously a single assurance package within DTSec.  The public comment period will be 45 days from February 7, 2018 through March 24, 2018.  We will answer all comments.  Please fill in the boxes on this DTMoSt website to submit comments.

Thank you,

David Klonoff, Chair, DTMoSt Steering Committee
David Kerr, Chair, DTMoSt Steering Committee
Dave Kleidermacher, Technical Chair, DTMoSt Steering Committee
Barry Ginsberg, Assistant Chair, DTMoSt Steering Committee