Insulet Omnipod

# ICS Medical Advisory (ICSMA-20-079-01) ## Insulet Omnipod Original release date: March 19, 2020 [Print Document](javascript:window.print\(\);) [Tweet](https://twitter.com/share?url=https%3A%2F%2Fus- cert.cisa.gov%2Fics%2Fadvisories%2Ficsma-20-079-01) [Like Me](https://www.facebook.com/sharer.php?u=https%3A%2F%2Fus- cert.cisa.gov%2Fics%2Fadvisories%2Ficsma-20-079-01) [Share](http://www.addthis.com/bookmark.php?url=https%3A%2F%2Fus- cert.cisa.gov%2Fics%2Fadvisories%2Ficsma-20-079-01) ### Legal Notice All information products included in [https://us-cert.gov/ics](/ics) are provided "as is" for informational purposes only. The Department of Homeland Security (DHS) does not provide any warranties of any kind regarding any information contained within. DHS does not endorse any commercial product or service, referenced in this product or otherwise. Further dissemination of this product is governed by the Traffic Light Protocol (TLP) marking in the header. For more information about TLP, see [https://www.us- cert.gov/tlp/](/tlp/). * * * ## 1\. EXECUTIVE SUMMARY * **CVSS v3 7.3** * **ATTENTION:** Low skill level to exploit/public exploits are known for this vulnerability * **Vendor:** Insulet * **Equipment:** Omnipod Insulin Management System * **Vulnerability:** Improper Access Control ## 2\. RISK EVALUATION Successful exploitation of this vulnerability may allow an attacker to gain access to the affected products to intercept, modify, or interfere with the wireless RF (radio frequency) communications to or from the product. This may allow attackers to read sensitive data, change pump settings, or control insulin delivery. ## 3\. TECHNICAL DETAILS ### 3.1 AFFECTED PRODUCTS The following versions of the Omnipod Insulin Management System are affected: * Product ID/Reorder number: 19191 and 40160 * UDI/Model/NDC number: ZXP425 (10-Pack) and ZXR425 (10-Pack Canada) ### 3.2 VULNERABILITY OVERVIEW #### 3.2.1 [IMPROPER ACCESS CONTROL CWE-284](https://cwe.mitre.org/data/definitions/284.html) The affected insulin pump is designed to communicate using a wireless RF with an Insulet manufactured Personal Diabetes Manager device. This wireless RF communication protocol does not properly implement authentication or authorization. An attacker with access to one of the affected insulin pump models may be able to modify and/or intercept data. This vulnerability could also allow attackers to change pump settings and control insulin delivery. [CVE-2020-10597](http://web.nvd.nist.gov/view/vuln/detail?vulnId=CVE-2020-10597) has been assigned to this vulnerability. A CVSS v3 base score of 7.3 has been assigned; the CVSS vector string is ([AV:L/AC:L/PR:N/UI:N/S:U/C:L/I:H/A:L](https://www.first.org/cvss/calculator/3.0#CVSS:3.0/AV:L/AC:L/PR:N/UI:N/S:U/C:L/I:H/A:L)). ### 3.3 BACKGROUND * **CRITICAL INFRASTRUCTURE SECTORS:** Healthcare and Public Health * **COUNTRIES/AREAS DEPLOYED:** United States, Canada, Europe * **COMPANY HEADQUARTERS LOCATION:** United States ### 3.4 RESEARCHER Thirdwayv Inc. reported this vulnerability to Insulet; Insulet reported this vulnerability to CISA. ## 4\. MITIGATIONS Insulet recommends patients using the affected products talk to their healthcare provider about the risks of continued use, including the possibility of changing to the latest model with increased cybersecurity protection. Additionally, Insulet recommends all patients take the cybersecurity precautions indicated below. * Do not connect to or allow any third-party devices to be connected to or use any software not authorized by Insulet. * Maintain tight physical control of the pump and devices connected to the pump. * Be attentive to pump notifications, alarms, and alerts. * Immediately cancel any unintended boluses (a single dose of insulin administered all at once). * Monitor blood glucose levels closely and act as appropriate. * Get medical help immediately when experiencing symptoms of severe hypoglycemia or diabetic ketoacidosis or if you suspect insulin pump settings or insulin delivery has changed unexpectedly. Insulet has released additional [patient-focused information](https://www.myomnipod.com/security-bulletins). More information is available regarding [Insulet's product security and vulnerability management](https://www.myomnipod.com/product-security). CISA recommends users take defensive measures to minimize the risk of exploitation of this vulnerability. Specifically, users should: * Restrict system access and access to devices able to connect to the affected device to authorized personnel only and follow a least privilege approach. * Where additional information is needed, refer to existing [cybersecurity in medical device guidance](https://www.fda.gov/medical-devices/digital-health/cybersecurity) issued by the FDA. CISA reminds organizations to perform proper impact analysis and risk assessment prior to deploying defensive measures. CISA also provides a section for [control systems security recommended practices](https://www.us-cert.gov/ics/recommended-practices) on the ICS webpage on [us-cert.gov](https://www.us-cert.gov/ics). Several recommended practices are available for reading and download, including [Improving Industrial Control Systems Cybersecurity with Defense-in-Depth Strategies](https://www.us- cert.gov/sites/default/files/recommended_practices/NCCIC_ICS- CERT_Defense_in_Depth_2016_S508C.pdf). Additional mitigation guidance and recommended practices are publicly available on the [ICS webpage on us-cert.gov](https://www.us-cert.gov/ics) in the Technical Information Paper, [ICS-TIP-12-146-01B--Targeted Cyber Intrusion Detection and Mitigation Strategies](https://www.us-cert.gov/ics/tips/ICS- TIP-12-146-01B). Organizations observing any suspected malicious activity should follow their established internal procedures and report their findings to CISA for tracking and correlation against other incidents. This vulnerability is not exploitable remotely.