RFI_DRAFT_Statement_of_Work.docx

Software Development Associated with Commercial-Off-The-Shelf (COTS) Body Sensors Statement of Work (SOW)

1.0 BACKGROUND: The mission of the U.S. Army Research Institute of Environmental Medicine (USARIEM) is to “optimize Warfighter health and performance through medical research.” The Military Performance Division conducts research to enhance the performance (physical, cognitive, behavioral and psychomotor) of military occupational tasks, or to prevent performance decrements due to physical overload, nutritional deprivation, environmental and operational stresses, and musculoskeletal injuries.

1.1 The Military Performance Division is tasked with conducting biomechanics research into common Soldiering tasks. Current research is mostly laboratory based, and there is a large need to expand data collection capabilities to the field to increase the ecological validity of the research data collected. However, characterization of Soldiering tasks/physical activities through analysis of human movement and loading patterns requires new equipment and software. This requirement is to acquire advanced expertise on characterizing human movement through non-invasive sensors and development of software to both collect and process data to characterize human movement patterns.

2.0 SCOPE OF WORK: Identification of activity types and biomechanics using non-invasive sensors and development of a software to distinguish between multiple physical activiteis, provide software updates and training.

3.0 OBJECTIVES: USARIEM is looking to award a contract to one company who can supply body sensor devices that meet the minimum essential characteristics (MECs) listed in section 4.1.1.1 with associated software, provide technical training and support, develop software based on collected data to distinguish between multiple physical activities, and provide software updates

4.0 TASKS. Deliver non-invasive sensors, and provided software and hardware support for them .These sensors shall be used in a research study conducted by USARIEM during physical activities. The contractor shall then develop software to identify the different activities performed from the sensor data.

4.1. Task 1 – Purchase Seventeen (17) Body Sensor Devices Contractor shall:

4.1.1 Deliver 17 sensor devices that meet the MECs in paragraph 4.1.1.1 and associated software to distinguish between multiple physical activities within 60 days of contract award to USARIEM.

4.1.1.1 Body Sensor Minimum Essential Characteristics (MECs):

4.1.1.1.1 Size: < 20 cm3 (without attachment mechanism to body (strap, tape, pouch, etc.))

4.1.1.1.2 Mass < 20 g

4.1.1.1.3 Collects and stores (on sensor) 3D acceleration, direction/position and orientation (9 axes total) simultaneously. This collection and storage of data will use sampling rates of up to 1000, 100 and 100 Hz, respectively for each data type (acceleration, direction/position and orientation). For example, 1000 Hz for vertical acceleration, 1000 Hz for anterior/posterior acceleration and 1000 Hz for medial/lateral acceleration plus 100 Hz apiece for each of the 3 direction/position axes and 3 orientation axes. Stored data is retrieved from the device via USB cable connection between device and computer. Data is stored on computer in .csv files.

4.1.1.1.4 Sampling rates must have user selected options that are compatible for time synchronization (i.e., 50, 100 and 1000 Hz are compatible) and not simply set to the maximum value.

4.1.1.1.5 Tri-axial accelerometer: range ± 16 g and resolution minimum 16-bit

4.1.1.1.6 Direction/Position sensor: range ± 5 Gauss and resolution minimum 12-bit

4.1.1.1.7 Orientation sensor: range ± 2000 degrees/second and resolution minimum 16-bit

4.1.1.1.8 Durable and water-resistant

4.1.1.1.9 Continuous data collection and storage time of 4 hours without recharging or new power supply/battery when sampling and storing data at the maximum sampling rates listed above. A device to recharge the power to the sensors or new power supplies will be provided with the sensor. For either power option, enough power must be provided with the original devices for them to maintain this data collection requirement through the end of the contract.

4.1.1.1.10 Device attachment to human cannot impede ability to perform physical activities including, but not limited to: walking, running, load carriage, sitting, standing, lying prone, sit-ups, push-ups, jumping jacks, etc. Mechanism to attach device to human must be provided.

4.1.1.1.11 Ability to synchronize devices during data collection or synchronization in post-processing, i.e., “master time”.

4.1.1.1.12 Data collection software compatible with USARIEM information management (IM) requirements, see below in sections 4.0-4.4 General Requirements.

4.1.1.1.13 Ability to wirelessly (via bluetooth) stream data, to a computer (both stream and computer meeting MRMC IM requirements listed below in sections 4.0-4.4 General Requirements), in real-time, one axis of data at 100 Hz from either the position or orientation sensors or a minimum of 500 Hz from the accelerometer when data is not being stored on the device.

4.1.1.1.14 Device re-calibration requires minimal user input and time

4.1.1.1.15 Drift in the time domain between sensors of less than 5 milliseconds per minute (would be 300 ms per hour, or 1200 ms per four hours)

4.1.1.1.16 Auto-correction for drift, in signal value, during data collection or post-processing. Either option must not interfere with performance of activities. For instance, device cannot require a zero position of “no activity” every minute. If the auto-correction occurs during data collection, then the contractor must provide information about how the drift correction is not inducing signal error.

4.1.1.1.17 Data collection and processing software to initialize data collection on devices and obtain data files (tab or comma delimited (.txt or .csv) files) from devices.

4.1.2 Provide training on using the sensors and the data collection software. Contractor shall have at least one company representative visit USARIEM for in person training of up to ten (10) USARIEM personnel on sensors and software for data collection. The contractor shall provide a user manual regarding sensor set-up, calibration, data collection from both hardware and software perspectives and how to obtain data stored on devices. The in-person training will include topics in the user manual, time for USARIEM personnel to test out the devices and software as well as anything else the contractor deems necessary for the personnel to use the devices independently. Training will be scheduled at a date convenient for USARIEM and it must occur within 30 days of receipt of the sensors unless a specific request by USARIEM is made to hold training beyond the 30 days.

4.1.3 Provide Technical Support for both Software and Hardware. The contractor shall provide hardware and software technical support to USARIEM personnel for the duration of the contract. The contractor shall assist USARIEM investigators via telephone and email support, in setting up devices for use during data collection and reading data from devices. The contractor shall provide at least one phone number and one email address for USARIEM to contact with support questions. Additionally, the contractor shall provide updated data collection software to USARIEM if the software is updated by the contractor. Any data sent between the contractor and USARIEM as part of a support request will utilize the methods approved by USARIEM.

4.1.3.1 Hardware support. All phone calls and emails will be responded to within 24 hours of receipt, with the exception of phone calls or emails on a Friday, which will be responded to by Monday morning before 1200 (noon). All dates and time are using the Eastern Time Zone (Boston, MA, USA). All hardware problems will be resolved within one week of notification. Any hardware update to remedy the problem will be provided to USARIEM. In the event a device completely ceases to function, a new sensor will be provided and received by USARIEM within thirty (30) calendar days from the date of initial problem report by USARIEM.

4.1.3.2 Software support. All phone calls and emails will be responded to within 24 hours of receipt, with the exception of phone calls or emails on a Friday, which will be responded to by Monday morning before 1200 (noon). All dates and time are using the Eastern Time Zone (Boston, MA, USA). All software problems will be resolved * within one week of notification. Any software update to remedy the issue will be provided to USARIEM. Additionally, after the software development task is completed, software support for MATLAB upgrades will be provided. The contractor will supply upgrades within sixty days that the software to characterize activities no longer works with newer MATLAB versions.

4.1.3.3 At no point in time will the contractor have access to US Government systems.

4.1.4 Software Development. Knowledge of human movement patterns and activity identification from non-invasive sensor data is required. Services require proficiency in MATLAB (Mathworks, Natick, MA, USA). The contractor shall develop software to identify when Soldiers are performing each of the physical activities described in section 4.1.4.1. Subjects shall wear seven (7) sensors - 2 arm, 1 waist/torso, 2 leg and 2 feet. USARIEM investigators shall collect the data and provide the data from ten research participants to the contractor. This data shall be referred to as the ‘training data set’ for the software. Each participant’s data may be sent separately to the contractor to expedite when the contractor has a data set to begin work on this task. The contractor will provide software that contains generalizable algorithms and is not limited to only apply to the data set provided by USARIEM. The contractor shall provide their preferred method of test and validation to the COR for approval. After approval has been received, the contractor shall perform the testing and validation within the data set provided and provide the results to USARIEM. The contractor must provide tables and figures that indicate when the software classified each activity as occurring for inspection by USARIEM personnel. These tables and figures will include information about when USARIEM records indicated the actual activity started compared to when the software algorithms detected the activity started. Additionally, the contractor will provide information and results from their preferred method of validation within the data set provided including false positives and false negatives for each activity.

Milestones for Software Development:

For milestone 4, Example 1: Activity X was performed for 100 minutes in a 200 minute time period selected (comprised of four 50 minute periods of data). The software must identify activity X for at least 80 minutes of when it was actually performed and no more than 20 minutes of time when it was not performed.

For milestone 4, Example 2: Activity Y was performed for 3 minutes in a 5 minute file of data. The software must identify activity X for at least 2 minutes of when it was actually performed and no more than 1 minute of time when it was not performed.

The contractor will be provided with feedback after the version for each milestone, such as recommended changes to make the software more user friendly that the contractor will make

4.1.4.1 Software Capabilities and Specifications

Activity Characterization Specifications:

4.1.4.1.1 The following activities will be characterized: walking, running, sitting, standing, lying prone, change in position from standing to lying prone, lift and carry, sit-ups, push-ups and jumping jacks. The objective is to utilize two devices (or one, if possible), and the threshold is using three devices.

4.1.4.1.2 Ability to choose a minimum of twenty different epochs in time (time windows) consisting of different start and stop points for characterizing activities.

4.1.4.1.3 The aforementioned activities will be output as percentage of total time in each activity and actual time in each activity plus a percentage and time of unknown/other activities for each of the specified segments for analysis.

4.1.4.1.4 If a specific epoch of time was chosen for analysis, then the raw data specific to that time period will be output as a tab or comma delimited text file (.txt or .csv) including data from all sensors and the master time for each data point. The software must be able to read this file back into the activity characterization program without any editing. Additionally, the software will output a single file of all of the combined time epochs (with a master time for each data point) for all of the sensors.

4.1.4.1.5 The software for this program will meet USARIEM IM requirements listed in section 5.0-Information Management and Technology Compliance.

4.1.4.1.6 The algorithms and sensor locations used in the software to characterize each activity will be disclosed to USARIEM.

4.1.4.1.7 The software will work correctly, as specified by section 4.1.4, to process data and identify activities for data up to the maximum duration of data collection specified in section 4.1.1.1 MECs.

4.1.4.2 Software Testing: USARIEM will test all versions of software provided to ensure that they meet the milestones stated (Figures 1-3).

Figure 1: Software testing flow chart for milestone 1

Figure 2: Software testing flow chart for milestones 2-4.

Figure 3: Software testing flow chart for milestones 5-6.

The algorithms and sensor locations used in the final version of the software must be provided to USARIEM.

4.3 Task 3 – Purchase Eleven Body Sensor Devices (Optional CLIN) Contractor will provide 11 sensor devices in accordance with the MECs in paragraph 4.1.1.1. Contractor will assist USARIEM investigators, via phone and email support, in setting up devices for use during data collection and performing data processing to read data from devices. The sensors will be provided by the contractor to USARIEM within 60 days electing to purchase them.

4.3.1 Minimum Essential Characteristics (MECs) – 11 Sensors

Sensor Specifications shal1, at a minimum, be the same as 4.1.1.1 Minimum Essential Characteristics (MECs) with the exception that the new 11 sensors will be waterproof instead of water resistant.

5.0 Information Management and Technology Compliance.

5.1 Hardware. All software must operate on Department of Defense computers in accordance with DoD approved security configuration guidelines and which have no access to the internet and currently run 64 bit Windows 7. The use of the software will not require administrative privileges to run or write data files. It will run under a regular user account (no power users).

5.2 Software. The software for data collection must be compatible with a Department of Defense (DoD) computer that is locked down (i.e., not connected to the internet) running 64 bit Windows 7. The software for data processing must be written in MATLAB and include MATLAB m-file(s). The source code for the software (m-files), must be included in all versions supplied to USARIEM. The use of the software will not require administrative privileges to run or write data files. It will run under a regular user account (no power users).

5.2.1 Information Assurance (IA). The contract shall implement a comprehensive multi-approach methodology with respect to DoD IA configuration standards such as the Security Technical Implementation Guides (STIGs), http://iase.disa.mil/stigs/Pages/index.aspx.

5.2.1.1 Software Assurance and Security Engineering Practices

5.2.1.1.1 The contractor shall design, develop and implement secure applications and configurations through applying applicable DoD STIGs, checklists, vendor security guidance, industry best practices, and applicable vendor product security patches. The contractor shall ensure applications are in compliance with DoD instruction 8500.01 Cyber Security (dated 14 March 2014, www.dtic.mil/whs/directives/corres/pdf/850001_2014.pdf) and DoDI 8551.01 Ports, Protocols, and Services Management/ PPSM (dated 28 May 2014, www.dtic.mil/whs/directives/corres/pdf/855101p.pdf). The contractor shall leverage, to the maximum extent possible, automated tools to identify and remediate vulnerabilities or weaknesses in the application design/ coding.

5.2.1.1.2 The Information System Security Engineer shall participate in Government and contractor formal and informal design reviews to identify potential security weaknesses, deficiencies, and/ or vulnerabilities in the design. The Information System Security Engineer shall also ensure appropriate security requirements are included as part of the requirements traceability matrix and are evaluated as part of the security assessment. As part of the contractor’s change control process, the contractor shall ensure participation by the Information System Security Engineer or a qualified cyber security SME to evaluate the impact of each change on security. The contractor shall document the results of this evaluation.

5.2.1.2 Non-Secure Software

5.2.1.2.1 If the Government determines, after a security audit (e.g. security assessment), that software delivered under this contract is non-secure, the Government will provide written notice to the contractor of each non-conformity. Software shall be “non-secure” under this task order if it contains a software error or a web application security flaw.

5.2.1.2.2 The contractor shall have thirty (30) days after receipt of such notice (Remedy Period) to remedy each non-conformity by modifying/ replacing and redelivering the software to the Government; or shall notify the Government within 15 days as to why the remedy cannot be implemented in 30 days, and propose a timeline for correction. If the Government determines, after a security audit following a remedy period, that the redelivered software is non-secure, and thus non-conforming, the Government may reject the delivery, provide notice of the non-conformance, and document the contractor’s performance record. Alternatively, the Government may accept non-conforming software, receive appropriate consideration (equitable price reduction on a fixed price contract, reimbursement for costs of security audit, reimbursement for costs to correct the non-compliances, etc.), and document the contractor’s performance record.

5.2.1.3 Malicious Code Warranty. The contractor represents and warrants that upon delivery to the government the software shall be free from all computer viruses, worms, time-outs, time bombs, back doors, disabling devices and other harmful or malicious code intended to or which may damage, disrupt, inconvenience or permit access to the software user’s or another’s software, hardware, networks, data or information.

5.2.1.4 Source Code Configuration Control (Versioning). The contractor shall utilize a strict version control process for software development.

5.3. Data Security. With respect to USARIEM furnishing de-identified research data (no personally identifiable information, PII) and/or information relating to them, the Parties agree as follows:

5.3.1 Recipient agrees that the Data and/or Information will be used for body sensor and software development purposes only. The data and/or information shall not be sold, offered for sale, used for commercial purposes, or be furnished to any other party without advance written approval from the Commander, USARIEM, and any use or furnishing of Data and/or Information shall be subject to the restrictions and obligations imposed by this Agreement. The parties mutually agree that USARIEM is the repository and gatekeeper of the Data and/or Information and that the Recipient does not obtain any right, title, or financial interest in any of the Data and/or Information to which USARIEM grants access.

5.3.2 No further collaboration regarding the provided data is planned beyond this PWS. Any intellectual property rights to the Data and/or Information in existence prior to this Agreement, or potential rights, such as issued patents, patent applications or invention disclosures are retained by the Provider. Any invention patentable under U.S. patent law which is conceived or first reduced to practice under the Agreement shall be owned by the party entitled to ownership under U.S. patent law.

5.3.3 The Parties shall maintain in confidence all Information relating to these Data and/or Information and shall not disclose Information to others without specific written permission from USARIEM, in advance, unless required to by law. The Recipient shall notify USARIEM immediately if the removal of identifiers from the data has not been successful.

5.3.4 When the Data and/or Information are no longer being used for the above purposes, in accordance with this Agreement, all Data and/or Information will be destroyed or unless otherwise directed, in writing, by USARIEM.

6.0 General Requirements

6.1 Place of Performance. All software development work shall be performed at the Contractor's facility. Training associated with the body sensor device shall be conducted on-site at USARIEM, Natick, MA.

7.0 DELIVERABLES. All deliverables must meet MECs, professional standards and meet the requirements set forth in contractual documentation and shall be delivered to USARIEM.

7.1 17 (Seventeen) Body Sensors

7.2 Activity Characterization Status Reports for review and revision (as required). The contractor shall submit the reports using the format outlined in CDRL, Exhibit (TBD), DID # DI-MGMT-80368A.

7.2.1 First report is due three months from award date.

7.2.2 Subsequent reports are due differently for project phases

7.2.2.1 Monthly until final version of software is accepted by USARIEM. No report is due if USARIEM was testing the software for the entire month.

7.2.2.2 If software must be updated to work with subsequent MATLAB version or other technical issues then a report is due after each month of software development if it requires more than one month of effort.

7.3 Software Development Plan for review and revision (as required). The contractor shall submit the reports using the format outlined in CDRL, Exhibit (TBD), DID # DI-IPSC-81427A.

7.3.1 First report is due four months following award date.

7.3.2 Subsequent reports are only required if either of the following conditions apply

7.3.2.1 The report substantially changes

7.3.2.2 In option years 2-4 if software must be updated to work with subsequent MATLAB version or other technical issues.

7.4 Software Test Plan for review and revision (as required). The contractor shall submit the reports using the format outlined in CDRL, Exhibit (TBD), DID # DI-IPSC-81438A.

7.4.1 First report is due four months following award date.

7.4.2 Subsequent reports are only required if either of the following conditions apply

7.4.2.1 The report substantially changes

7.4.2.2 If software must be updated to work with subsequent MATLAB version or other technical issues.

7.5 Final written technical summary reports for review and revision (as required). The contractor shall submit the final report using the format outlined in CDRL, Exhibit (TBD) DI-MISC-80508B.

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