K-Soft
Description: K-Soft is a software driver used to adjust Ottobock`s Kenevo microprocessor-controlled prosthetic knees. Communication between the software and the prosthesis takes place via Bluetooth data transfer.
Note: This software is included with the purchase of the hardware. There is no dedicated website for K-Soft that is maintained by the vendor.
K-Soft stores data locally in a Microsoft Structured Query Language (SQL) Server database (standalone file) and the Ottobock Data Station, which stores patient information (first name, last name, and gender only), as well as `jobs` for the patient. A job contains the programming settings for a patient`s prosthetic device. All users can open the Data Station without a password. However, users are required to enter a username, 6 character unlock-Personal Identification Number (PIN), and a subsequent password to open a job. A PIN can only be obtained by certified clinicians who have passed the vendor`s online product training.
Aliases: Ottobock
Vendor Name: Ottobock
1.2 Divest
Unapproved Unapproved Unapproved Unapproved Unapproved Unapproved Unapproved Unapproved Unapproved Unapproved Unapproved
1.4 Unapproved Unapproved Approved w/Constraints
[5, 6, 7, 8, 9, 10] Approved w/Constraints
[5, 6, 7, 8, 9, 10]
[4] This product includes a Bluetooth capability. If that capability is leveraged, the implementer must conform to the Bluetooth Standard. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.
[5] Users must ensure that Microsoft .NET Framework, Microsoft Outlook, Microsoft Structured Query Language (SQL) Server and Microsoft Internet Explorer are implemented with VA-approved baselines. (refer to the 'Category' tab under 'Runtime Dependencies')
[6] In cases where the technology is used for external connections, a full Enterprise Security Change Control Board (ESCCB) review is required in accordance VA Directive 6004 , VA Directive 6517, and VA Directive 6513. The local ISO can advise on the ESCCB review process.
[7] If this technology is an FDA certified medical device or is categorized by the Department as a networked medical device then it must be isolated and protected in accordance with The Medical Device Isolation Architecture (MDIA) 2015 Guidance. This guideline stipulates that if the device meets ANY of the following criteria, then it must be isolated:
If the device cannot have the VA standard desktop security suite loaded on it. This includes but is not limited to Anti-Virus, HIPS, USB Access controls, software/hardware inventory, automated software updates/patches and Group Policy Objects (GPOs)
If the device is a Windows device and cannot be part of the domain
If the device is not part of the regular IT patched management process
Non Windows devices (UNIX, Linux, MAC/Apple, etc.)
The criteria should be applied to both FDA certified and non-FDA certified devices which must maintain medical/clinical functionality. An example would be a PC that is not running the current supported operating system in order to manage medication-dispensing devices. While these may not be considered strictly medical devices, they are still vulnerable to attack and need to be protected. For guidance and assistance in security networked medical devices, please contact the Medical Device Isolation Architecture (MDIA) Working Group.
Note: At the time of writing, the current version of this technology is 1.4.
C-Soft
ElbowSoft
Plie Microprocessor Controlled (MPC) Knee Software
X-Soft
This is a mature technology.
At the time of writing, no National Institute of Standards and Technology (NIST) vulnerabilities had been reported and no VA Network Security Operations Center (NSOC) bulletins had been issued for the latest versions of this technology.
This technology may improve productivity for specific staff whose responsibilities include adjusting Ottobock`s Kenevo microprocessor-controlled prosthetic knees.
The potential of vendor lock exists when utilizing proprietary vendor technology.
Encryption in Bluetooth with Low Energy uses AES-CCM cryptography. Like BR/EDR/HR, the LE Controller will perform the encryption function. This function generates 128-bit encrypted data from a 128-bit key and 128-bit plaintext data using the AES-128-bit block cypher as defined in Federal
Information Processing Standards (FIPS) 1971, which is said to be FIPS 140-2 compliant. Adding this application to mobile devices that do not hold a FIPS 140-2 certification does not make the device FIPS 140-2 compliant. Security Mode 1 devices never initiate security and therefore should never be used.
In April 2017, security researchers at Armis discovered multiple exploits in the Bluetooth software in various platforms, including Microsoft Windows, Linux, Apple iOS, and Google Android. These vulnerabilities are collectively called "BlueBorne." The exploits allow an attacker to connect to devices or systems without authentication and can give them "virtually full control over the device." Armis contacted Google, Microsoft, Apple, Samsung and Linux developers so that they could patch their software before providing a coordinated announcement of vulnerabilities on September 12, 2017.
Bluetooth BR/EDR/HS specifications define four security modes. Each Bluetooth device must operate in one of these modes (1 through 4). These modes dictate when a Bluetooth device initiates security, not whether it supports security features. Per NIST, Security Mode 1 devices are considered non-secure. Security functionality (authentication and encryption) is never initiated, leaving the device and connections susceptible to attackers.
Bluetooth low energy security specifications are similar to GR/EDR/HS (i.e. Security Modes 2 and 4) in that each service can have its own security requirements. However, Bluetooth low energy also specifies that each service request can have its own security requirements also. Low energy Security Mode 1 Level 1 specifies no security (no authentication or encryption).
This technology is not portable as it runs only on Windows Client platforms.