VA Technical Reference Model v 24.11

Biosim

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	The biosim-pro software is a technology that provides prosthetists and therapists with the ability to help their patients select the grip patterns and control settings for i-limb ultra-revolution, i-limb ultra, i-limb digits, i-limb access and virtu-limb devices. The biosim-pro software can be used to access usage information for Touch Bionics prostheses, which provides insight into how the patients are using the device, and can provide diagnostic information regarding the relative health of the prosthesis. The technology allows adjustments to be made to the electrode settings to optimize device performance. The technology connects to the device via a Bluetooth wireless connection. Note: This technology was sold to Össur by Touch Bionics Inc. in 2016. This technology is available in two editions, Biosim and My i-Limb. This entry covers all both editions. The application for clinicians is called biosim, and the application for users is called My i-Limb. This entry covers the Desktop Edition of this technology and not any mobile versions. Please note that the implementation of mobile technology applications that operate on Mobile Operating Systems must be reviewed and authorized by the Mobile Technology and Endpoint Security Engineering Team: http://vaww.eie.va.gov/SysDesign/CS/MT/default.aspx
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:	This technology has not been assessed by the Section 508 Office. The Implementer of this technology has the responsibility to ensure the version deployed is 508-compliant. Section 508 compliance may be reviewed by the Section 508 Office and appropriate remedial action required if necessary. For additional information or assistance regarding Section 508, please contact the Section 508 Office at Section508@va.gov.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v22.10
Decision Date:	10/25/2022 at 19:17:56 UTC
Aliases:	My i-Limb; Biosim-pro
Introduced By:	TRM Request
Vendor Name:	Touch Bionics Inc.

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Technology, obtained from the vendor (or from the release source).

You must be logged into the RSAA website prior to clicking the Attestation URLs or the URLs won't open.

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
2.5.0	08/28/2012
2.6.0	10/06/2012
2.7.0	01/15/2013
2.8.0	04/11/2013
2.8.1	06/17/2013
2.8.2	09/26/2013
2.8.3	05/30/2014
2.9	07/23/2015
2.11.x	01/01/2017

Current Decision Matrix (10/14/2022)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VAIT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported.

Legend:

White	Authorized: The technology/standard has been authorized for use.
Yellow	Authorized w/ Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Authorized w/ Constraints (POA&M): This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Authorized w/ Constraints (DIVEST): VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unauthorized may be found on the Decision tab for the specific entry.
Black	Unauthorized: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Authorized w/ Constraints (PLANNING/EVALUATION): The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology authorized with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology authorized with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

Any major.minor version that is not listed in the VA Decision Matrix is considered Authorized w/ Constraints (POA&M).

<Past

CY2024

CY2025

CY2026

Future>

Release

2.5.0

Unapproved