Attachment 1_Encounter-Based Endoscopy Video Imaging System Tasks_1DEC2025.docx

Attachment 1: Defense Health Agency (DHA) Encounter-Based Endoscopy Video Imaging System Enterprise Capability Background:

Medical video imaging has revolutionized the field of healthcare by providing clinicians with invaluable visual information for diagnosis, treatment planning, and research. Endoscopy, a specialized form of medical video imaging, involves the use of a camera-equipped instrument to examine the interior of organs and tissues. By capturing high quality video sequences, endoscopy enables healthcare providers to identify abnormalities, assess disease progression, and guide minimally invasive procedures.

Challenges:

The Defense Health Agency’s (DHA) current medical video imaging capabilities are hindered by a multitude of challenges.

Standardization is lacking, as various specialties throughout the enterprise utilize disparate systems and protocols for image capture, storage, and retrieval. This inconsistency leads to difficulties in sharing and interpreting images.

Accessibility is limited, as endoscopic images and videos are often confined to local storage, preventing timely access for consultation, education, or research purposes.

Varying, and sometimes inefficient, workflows further exacerbate the problem, as manual processes for image management and sharing lead to delays in diagnosis and treatment.

Limited interoperability between the video imaging systems and the Electronic Health Record (EHR) can hinder the integration of imaging data into the patient's electronic medical record, hindering comprehensive care.

These challenges collectively contribute to suboptimal patient care and operational inefficiencies within the organization.

Objectives The high-level objectives of the requirements will aid the capability to:

1. Standardize the capture, storage, retrieval, and distribution of endoscopic images across all Department of War (DoW)/ Veterans Affairs (VA) healthcare facilities utilizing a centralized enterprise system or multiple regionalized systems using a hub and spoke methodology.

2. Ensure secure and reliable access to endoscopic images from anywhere in the world.

3. Integrate seamlessly with existing DoW EHR to optimize workflow and data sharing.

4. Provide a user-friendly interface for clinicians to view, annotate, and share endoscopic images.

5. Support a variety of endoscopic procedures and imaging modalities.

6. Comply with relevant regulatory requirements, including Health Insurance Portability and Accountability Act (HIPAA) regulations.

7. Enable efficient collaboration among healthcare providers for consultation and education purposes.

8. Optimize image quality and resolution to support accurate diagnosis and treatment.

9. Maintain data integrity and security to protect patient privacy and confidentiality.

10.Provide a scalable and flexible solution that can accommodate future growth and technological advancements.

Specific Tasks

1.0 Business Requirements 1.1 The capability SHALL be able to capture, manipulate, annotate, view, store and convert medical images in all standard and emerging imaging formats to ensure compatibility with various medical devices and systems.

1.2 The capability SHALL support bi-directional integrated data flow between Encounter Based Endoscopy Video Imaging System (EEVIS), Picture Archiving and Communication System (PACS) capability and the EHR.

1.3 The capability SHOULD incorporate, and support establish clinical practice guidelines (CPG) and National Protocol (NP) to ACHIEVE the Standard of Care (SOC).

1.4 The capability SHALL archive data and Digital Imaging and Communications in Medicine (DICOM) (images, video, audio files) to the enterprise archiving system to provide authorized users/clinicians with ease of access to view patient images and data from anywhere within the enterprise.

1.5 The Artificial Intelligence (AI) capability SHALL be compliant with the Risk Management Framework (RMF) standards established by the National Institute of Standards and Technology (NIST).

1.6 The capability SHALL ensure interoperability between disparate healthcare systems and applications, enabling the effective synchronous and asynchronous sharing and utilization of patient data across the facility.

1.7 The capability SHOULD enable secure and efficient sharing of patient medical information among healthcare providers across different specialties and departments within the facility.

1.8 The capability SHALL undergo a required security assessment and certification process to verify compliance with specific certification standards to meet the stringent requirements of specific regulations, [e.g., HIPAA] and applicable regulatory mandates.

1.9 The capability SHALL meet the enterprise equipment requirements to provide standardization and interoperability.

1.10 The capability SHALL adhere to the National Archives and Records Administration (NARA) DHA approved disposition schedules to ensure the responsible legal management of records.

1.11The capability SHALL be able to extract, process, and analyze image data to produce specific report types, e.g., trend reports, anomaly reports, for business use case, e.g., predictive maintenance, customer segmentation.

1.12 The capability SHALL provide the ability for quality assurance activities (peer review, peer assessment, equipment audit functions, etc.).

2.0 Functional Requirements (parent/child)

2.1 The capability SHALL capture, record, manipulate, and allow viewing of high-definition video (live or recorded) and still images. Video and images shall come from stand-alone endoscopic equipment of various brands and specialties, readily available in the healthcare facilities. (Scopes, cameras, light sources, and microscopes are examples of such stand-alone equipment, and therefore excluded from this procurement.)

2.2 The capture device SHOULD be able to record and play video in high definition.

2.3 The capture device SHALL be able to take and display pictures in high definition.

2.4 The capture device SHALL be Food & Drug Administration (FDA) approved and must comply with NFPA99 and Joint Commission rules for electronic/electrical medical devices.

2.5 The capability SHALL be able to integrate products from multiple vendors if they can be certified for operating within the required networks. In this case, the lead vendor would assume responsibility for the operation of the entire system, training, warranty, compliance, and information systems security.

2.6 The capability SHALL allow clinical providers to manipulate video and images, create or modify patient reports, and store reports with attached images/video from both, the point of care (patient treatment area) and government computers.

2.7 The capability SHALL provide enough local storage space for five year's worth of examinations and reports for the facility’s clinics

2.8 The capability SHALL contain image capture and management devices for use at the point of care which receive input directly from existing camera and scope systems from multiple manufacturers.

2.9 The capability SHALL be able to receive live and recorded video feed from the facilities’ existing endoscopy equipment.

2.10 The capability SHOULD provide tools for viewing, zooming, panning, and measuring medical images.

2.11 The capability SHOULD enable comparison of multiple images/videos side-by-side.

2.12 The capability SHOULD provide tools for measuring distances, angles, areas, and volumes within medical images.

2.13 The capability SHOULD allow for automated or manual segmentation of anatomical structures or regions of interest.

2.14 The capability SHOULD allow for the alignment of multiple images for comparison and analysis (current and archival).

2.15 The capability SHOULD enable the combination of images from different modalities into a single view.

2.16 The capability SHOULD provide tools for extracting quantitative data from images (e.g., density, texture, shape).

2.17 The capability SHOULD support basic statistical analysis of image data (e.g., mean, standard deviation, correlation).

2.18 The capability SHOULD enable the discovery of patterns and relationships within large image datasets.

2.19 The Capability SHALL provide peripherals (i.e. keyboard, handsfree activation devices (i.e., foot-pedal, additional activation capturing device (buttons)), and all connections necessary for operations of the device with attached images/video from both, the point of care (patient treatment area) and government computers with attached images/video from both, the point of care (patient treatment area) and government computers.

3.0 Reading and Storing Patient Reports

3.1 The capability SHALL have the ability to read and store all patient reports and be able to find and retrieve all patient reports using system query functionality.

3.2 The capability SHALL provide reports which can be generated at the time of the exam or later.

3.3 The capability SHALL allow for scheduled report generation and distribution (i.e. audits).

3.4 The capability SHOULD generate reports in various formats (PDF, CSV, Excel) based on defined templates or ad-hoc queries.

3.5 The capability SHOULD provide options for report distribution, including email, secure messaging, printing, and secure file transfer.

3.6 The capability SHOULD provide tools for data visualization within reports, such as charts, graphs, and tables.

3.7 The capability SHALL allow users to export report data for further analysis or integration with external systems.

3.8 The capability SHALL allow users to define custom report templates based on specific criteria (e.g., patient demographics, image type, exam date, department, ordering provider, specialty, etc.).

3.9 The capability SHALL provide reports which can be generated from the originating workstation or remotely.

3.10 The capability SHALL be capable of saving generated reports.

3.11 The capability SHALL be capable of printing stills of a video.

3.12 The capability SHALL allow for the creation, editing, and searching of metadata associated with medical images and videos.

4.0 Software for Managing, Viewing, and Endoscopic Images

4.1 The capability SHALL include software for managing, viewing, and editing endoscopic images and accompanying reports.

4.2 The capability software SHALL be approved for use in government networks operated by the DoW.

4.3 The capability SHALL be able to print images to multiple formats (printer models).

4.4 The capability SHOULD be able to transfer images/videos to various universal digital formats.

4.5 The capability SHALL allow providers to annotate images with markers, text, and drawing tools.

5.0 Encompass Specific Needs for Data Retention

5.1 The capability SHALL encompass specific needs for data retention, formatting, access, performance, and disaster recovery, ensuring that data is stored, accessed, and protected in a manner that aligns with organizational policies and operational requirements.

5.2 The capability SHALL provide secure storage for medical images/videos, patient data, and associated metadata.

5.3 The capability SHALL be able to integrate and archive to the enterprise vendor neutral archive.

5.4 The capability SHALL maintain a detailed audit trail of all user activities, including image access, sharing, and modifications.

6.0 Secure Web-based System

6.1 The capability SHALL provide a secure web-based system for use by authorized personnel capable of securely transmitting and storing endoscopic video and still images electronically.

6.2 The capability SHALL allow authorized users to share images with other providers/activities/departments within the Enterprise.

6.3 The capability SHALL support real-time collaboration features, such as chat, video conferencing, and screen sharing.

6.4 The capability SHALL provide a platform for virtual case conferences, including image sharing, discussion, and decision making.

7.0 Incorporate AI Algorithms

7.1 The capability SHOULD incorporate AI algorithms capable of analyzing medical images across various formats to extract relevant clinical information.

7.2 The capability SHOULD have the capacity to continuously learn and improve its AI algorithms.

7.3 The capability SHOULD provide an interface for integrating AI powered image analysis algorithms.

7.4 The capability SHOULD contain algorithms that would create and display a 3D model/view.

7.5 The capability SHOULD contain algorithms which assist the provider with the control of robotic arms that assist you in endoscopy procedures.

7.6 The capability SHOULD contain image fusion algorithm to comprehensively combine anatomical imagery for medical diagnosis and treatment.

7.7 The capability SHOULD be able to capture and analyze large sets of data and utilize the data to assist in endoscopy procedures and diagnoses.

7.8 The capability SHOULD provide navigation and guidance algorithms for the specialty endoscopies in accordance with the FDA.

8.0 Provide AI-driven Decision Support Tools

8.1 The capability SHOULD provide AI-driven decision support tools to assist providers with the diagnosis process (ex. blood flow visualization in ophthalmology).

8.2 The capability SHOULD assist the provider/operator in the detections of object abnormalities utilizing AI analysis.

8.3 The capability SHOULD assist the provider/operator in the classification of object abnormalities utilizing AI analysis.

9.0 Meet Specified DoW Information Assurance (IA) and Network Security Requirements

9.1 The capability SHALL meet specified DoW IA and Network Security Requirements (i.e., secure platform, completed security documentation & testing, etc.).

9.2 The capability SHALL maintain HIPAA regulation compliance.

9.3 The capability SHALL identify and classify all data elements containing Protected Health Information (PHI) as defined by HIPAA regulations.

9.4 The capability SHALL implement appropriate administrative safeguards to protect PHI, including policies, procedures, and training for personnel regarding HIPAA compliance.

9.5 The capability SHALL undergo regular internal and external compliance assessments/audits to identify and address potential HIPAA compliance gaps.

10.0 Ability to Conduct Quality Assurance Testing

10.1 The capability SHALL include the ability to conduct quality assurance testing using a combination of unit, integration, system, and acceptance testing to ensure its reliability, functionality, and performance.

10.2 The capability SHALL provide smooth and efficient playback of video and images, even for large files.

10.3 The capability SHALL allow users to zoom in and out on video and images to examine details.

10.4 The capability SHALL provide intuitive playback controls, such as play, pause, rewind, and fast forward.

10.5 The capability SHALL be compatible with a variety of display devices, including monitors, projectors, and mobile devices.

10.6 The capability SHALL provide local access to studies within a medical facility for clinical review.

10.7 The capability SHALL monitor and provide quality indicators which highlight the effectiveness and efficiency of the endoscopy activities (image capture, measurements, etc.).

10.8 The capability SHALL have the ability to allow for regular reporting and analysis of endoscopic data to identify trends, improve outcomes, and address quality issues.