BackgroundPeopleDTMoSt GuidanceDTSec StandardProtection ProfileExtended Package: Enhanced BasicExtended Package: ModerateDTSec Website
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.
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.
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
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, defining IT security requirements, called Enhanced Basic and Moderate, which together replace what was previously a single assurance package within DTSec. The red boxes above link to the new documents that are being published for review. The blue boxes link to previously published and finalized DTSec documents.
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.
David Klonoff (Chair)
Medical Director, Diabetes Research Institute
Mills-Peninsula Medical Center
San Mateo, California
David Kerr (Chair)
Director of Research and Innovation
Sansum Diabetes Research Institute
Santa Barbara, California
Dave Kleidermacher (Technical Chair)
VP, Head of Security - Android, Google Play and Chrome OS
Google
Mountain View, California
Barry Ginsberg (Assistant Chair)
Consultant
Diabetes Technology Consultants
Arlington, Virginia
Aiman Abdel-Malek
Senior Vice President, Advanced Technology & Engineering
Insulet Corporation
Billerica, Massachusetts
David Armstrong
Professor of Clinical Surgery
USC
Los Angeles, California
Guillermo Arreaza-Rubin
Director Clinical Immunology and Diabetes Technology Program
NIDDK / NIH
Bethesda, Maryland
Joshua Balsam
Mechanical Engineer
FDA
Silver Spring, Maryland
Steve Barnaby
Device Connectivity Engineer III
Novo Nordisk
Seattle, Washington
Stayce Beck
Branch Chief, Diabetes Diagnostic Devices
FDA
Silver Spring, Maryland
Don Boyer
President
BOYER@RegulatorySolns
Ottawa, Canada
Carole C. Carey
EMBS Standards Committee Chair
IEEE
Piscataway, New Jersey
Elvis Chan
Supervisory Special Agent
FBI
San Francisco, California
Joe Chapman
Principal, Digital-Micro Hardware Engineer
The MITRE Corporation
Bedford, Massachusetts
Penny Chase
Senior Principal Scientist
The MITRE Corporation
Bedford, Massachusetts
Kong Chen
Dir, Human Energy & Body Weight Regulation Core
NIDDK / NIH
Bethesda, Maryland
Sammy Choi
Chief, Department of Research
Womack Army Medical Center
Fort Bragg, North Carolina
Mark Coderre
National Security Practice Director / CISO
OpenSky Corporation
Tolland, Connecticut
Barry Conrad
Lead Diabetes Educator
Stanford Children’s Health
Palo Alto, California
Keesha Crosby
Founder/CEO
Tri-Guard Risk Solutions
Fairfax, Virginia
Eyal Dassau
Senior Research Fellow in Biomedical Engineering
Harvard University
Cambridge, Massachusetts
Sheldon Durrant
Sr. Infosec Engineer/Scientist
The MITRE Corporation
Bedford, MA
Anura Fernando
Principal Engineer – Medical Systems Interoperability & Security
UL
Northbrook, Illinois
Joseph Fernando
Principal Architect
ARM
Bellevue, Washington
Justin Fisher
Lead Associate
Booz Allen Hamilton
Annapolis Junction, Maryland
Brian Fitzgerald
General Engineer
FDA
Silver Spring, Maryland
Mike Golden
Senior Director, Business Development
Samsung IoT | Healthcare
San Jose, California
Christian Howell
Cyber Investigator
Department of Homeland Security
Washington, DC
Christopher Keegan
Senior Managing Director
Beecher Carlson
New York, New York
Lisa Kerr
Director Biomaterials and Engineering Section
Laboratories Branch, Therapeutic Goods Administration
Woden, Australia
Mandeep Khera
Security Executive
Independent consultant
Fremont, California
Michael Kirwan
Co-Chair, IEEE 11073 PHD Working Group
Vice President, Continua
Arlington, Virginia
Boris Kovatchev
Professor, Psychiatry and Neurobehavioral Sciences
University of Virginia
Charlottesville, Virginia
Jeffrey LaBelle
Assistant Professor of Biological & Health Systems Engineering
Arizona State University
Tempe, Arizona
Benjamin Lee
Senior Director, Head of Data & Analytics
Flex
San Jose, California
Bryan Mazlish
Chief Technology Officer
Bigfoot Biomedical
Milpitas, California
Luis Malave
President
EOFlow
San Jose, California
Laurel Messer
Manager, Pediatric Artificial Pancreas Research
University of Colorado/ Barbara Davis Center
Aurora, Colorado
Uwe Meyer
Director – Medical Testing, Business Field Manager – Products
TÜV Rheinland
Cologne, Germany
Thomas Miller
Vice President
Novo Nordisk
Seattle, Washington
Irina Nayberg
Research Coordinator, Diabetes Research Institute
Mill-Peninsula Medical Center
San Mateo, California
John Oberlin
Pediatric Endocrinologist
USAF
San Antonio, Texas
Dale Nordenberg
Executive Director
MDISS
New York, New York
Anil Patel
Global Strategy Director
UL
San Jose, California
Yarmela Pavlovic
Partner
Hogan Lovells
San Francisco, California
yarmela.
Matt Petersen
Managing Director, Medical Information
American Diabetes Association
Arlington, Virginia
Patrick Phelan
Chief Information Security Officer
UCSF
San Francisco, California
Gil Porat
R&D Software Manager
Abbott Diabetes Care
Alameda, California
Azhar Rafiq
Director, Medical Informatics
NASA
Richmond, Virginia
Kelly Rawlings
Vice President, Healthy Living Content
American Diabetes Association
Arlington, Virginia
Jeffery Reynolds
Technical Program Director, Product Engineering
Ascensia Diabetes Care
Tarrytown, New York
J.P. Ribeiro
Senior Director, Advanced Technology
Insulet Corporation
La Jolla, California
Linda Ricci
Health Scientist
FDA
Silver Spring, Maryland
Naomi Schwartz
Electrical engineer
FDA
Silver Spring, Maryland
Shahid Shah
Citus Health
Chairman of the Board
Washington, DC
Jennifer Sherr
Associate Professor, Pediatrics (Endocrinology)
Yale University
New Haven, Connecticut
Christine Sublett
President & Principal Consultant
Sublett Consulting, LLC
San Mateo, California
Michael Taborn
Platform Architect
Intel Corporation
Phoenix, Arizona
Eugene Vasserman
Associate Professor and Keystone Research Scholar, Department of Computer Science
Kansas State University
Manhattan, Kansas
Alicia Warnock
Endocrinologist
Walter Reed NNMC,
Bethesda, Maryland
Tim West
Chief Risk Officer
Atredis Partners
St. Louis, Missouri
Eric Winterton
Principal
Booz Allen Hamilton
Annapolis Junction, Maryland
Michael Wiseman
Assistant Secretary
Laboratories Branch, Therapeutic Goods Administration
Symonston, Australia
Jonathan Woo
Chief Strategy Officer
EOFlow
San Jose, California
Margie Zuk
Senior Principal Cybersecurity Engineer
The MITRE Corporation
Bedford, Massachusetts