Product Requirement Specification (PRS) ######################################## .. note:: This section is a work in progress. This section gathers the product requirements for the ScanHub platform, derived from stakeholder and user needs. It forms the design input from which the :doc:`Software Requirements Specification ` and, ultimately, the :doc:`Software Architecture Design Description ` are derived. Stakeholders and User Roles ============================= The table below lists the stakeholder groups considered when deriving the product requirements. Each stakeholder ID is referenced from the requirement tables below to indicate who a given need originates from. .. list-table:: :header-rows: 1 :widths: 10 25 65 * - ID - Stakeholder - Description * - SH_010 - Medical Professional (MTRA, Radiologist) - Medical professionals who operate or interpret the MRI scans. Operators prepare patients, ensure optimal image quality, and provide feedback on the system's usability and functionality. Radiologists interpret the MRI scans to diagnose medical conditions. * - SH_020 - Scientist - Researchers who use MRI for advanced studies and require access to experimental features, customized sequences (upload), and retrieval of raw data at distinct stages. * - SH_030 - System Administrator - IT professionals responsible for the setup, maintenance, and security of the system. They ensure the reliability and data integrity of the system. * - SH_040 - (Field/Service) Engineer - Technical experts responsible for the installation, maintenance, and repair of the system. They ensure that the hardware and software components are functioning correctly. * - SH_050 - Patient - Individuals undergoing MRI scans. They are concerned with the comfort, safety, and privacy aspects of the MRI experience. * - SH_060 - Medical Device Manufacturer (Regulatory Affairs) - Company that produces and distributes the MRI system. It is concerned with the system's marketability, quality, and regulatory compliance. * - SH_070 - Healthcare Facility / Clinic / Hospital / Research Institution / Customer (Interoperability Manager) - Organizations that provide healthcare services and use the MRI system for patient diagnosis. They are concerned with the system's reliability, efficiency, and integration with other healthcare IT systems and workflows. User Needs ========== The following tables translate the stakeholder concerns above into concrete, prioritized product needs. Each need is assigned a unique ``PRS_xxxx`` ID that is referenced from the corresponding software requirement in the :doc:`SWRS `. General ------- Needs that apply broadly to everyday use of the platform, covering the core acquisition, planning, viewing, and administrative capabilities. .. list-table:: :header-rows: 1 :widths: 10 30 35 15 15 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0010 - Execution of an MRI acquisition/job/experiment (Medical Professional, Scientist) - Upload Pulseq sequence, execute MRI job with workflows - - - * - PRS_0020 - Planning of an MRI examination (Medical Professional, Scientist) - Protocol tree, workflows, processing modality worklist - - - * - PRS_0030 - DICOM viewer (Medical Professional, Scientist) - View DICOM image of a selected record, compare DICOM images, annotate DICOM image - - - * - PRS_0040 - User management (System Administrator) - Assign different user roles, support multi-tenancy cloud environment - - - * - PRS_0050 - Monitor device status (Medical Professional, Scientist) - Current execution progress, detectable device malfunctions, device connection - - - * - PRS_0060 - Monitor patient safety (Medical Professional) - Specific absorption rate (SAR), temperature, total scan time duration; optional video stream and patient communication system - - - * - PRS_0070 - Integration of processing workflows (Scientist) - Assembling of workflow steps to be executed on MRI raw data or images, including system calibration, image reconstruction, and analysis - - - * - PRS_0080 - System calibration (Medical Professional, Scientist, Site Engineer) - Adjust Larmor frequency, adjust gradients, adjust system flip angle, B0-field shimming - - - * - PRS_0090 - Clinical report (Medical Professional) - Structured form to create a clinical report allowing formulation of a diagnosis, viewer for clinical reports - - - * - PRS_0100 - Device management (System Administrator, Medical Professional, Medical Device Manufacturer) - Organization of different devices, device authentication, device selection, device access management (who is trained on which device?) - - - Operational Needs ------------------ Needs related to how reliably and flexibly the system runs once deployed, independent of a specific clinical workflow. .. list-table:: :header-rows: 1 :widths: 10 25 35 15 20 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0710 - Real-time monitoring (Medical Professional) - * Continuously monitor and display MRI scan data in real time. * Provide real-time feedback on scan quality and progress. * Instant notification for scan completion. - 99% uptime - Ensure real-time monitoring for accurate diagnosis. - Must Have * - PRS_0720 - Alerting (Medical Professional) - Real-time alerts for scan anomalies or issues. - < 5 minutes - Rapid response to scan anomalies or issues. - Should Have * - PRS_0730 - On-prem setup (System Administrator) - Support for on-prem setups. - 100% compatibility - Provide flexibility in deployment options to cater to different organizational needs. - Must Have * - PRS_0740 - Cloud setup (System Administrator) - Support for cloud setups in environments with no local compute workstations. - 100% compatibility - Enable versatile deployment options to accommodate varying infrastructure. - Must Have Regulatory Needs ------------------ Needs driven by applicable healthcare, data-protection, and medical-device regulations that the platform must comply with. .. list-table:: :header-rows: 1 :widths: 10 25 35 15 20 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0110 - Compliance (Regulatory Affairs) - * Compliance with HIPAA, GDPR, and FDA regulations. * Regular updates to adhere to evolving regulations. * Detailed logging and audit trails. - 100% compliance - Ensure compliance with industry regulations for patient safety. - Must Have * - PRS_0120 - Data security (System Administrator) - Strong data encryption and role-based access control. - 100% compliance - Secure patient data and adhere to compliance requirements. - Nice to Have * - PRS_0130 - Compliance with ISO 14971:2019 (Regulatory Affairs) - Implementation of Risk Mitigation Measures (RMM) in adherence to ISO 14971:2019. - 100% compliance - Minimize risks associated with system operation. - Must Have Reliability and Resilience Needs ----------------------------------- Needs concerning system uptime and the ability to keep operating dependably over time. .. list-table:: :header-rows: 1 :widths: 10 25 35 15 20 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0210 - Reliability (Field Engineer) - System stability with minimum downtime. - 99.99% uptime - Maintain a reliable and stable MRI acquisition system. - Must Have Usability Needs ------------------- Needs concerning ease of learning and day-to-day efficiency for platform users. .. list-table:: :header-rows: 1 :widths: 10 25 35 15 20 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0310 - User-friendly (Medical Professional) - * Intuitive UI for scan setup and patient management. * Comprehensive user manuals and guides. * Quick access to frequently used features. - < 30 minutes onboarding - Streamline user interaction for increased productivity. - Should Have * - PRS_0320 - Advanced features (Scientist) - Access to raw MRI data and experimental sequence options. - N/A - Facilitate sequence development and research. - Nice to Have Interoperability Needs -------------------------- Needs concerning the exchange of data with third-party systems and standard medical imaging formats. .. list-table:: :header-rows: 1 :widths: 10 25 35 15 20 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0410 - Interoperability (Medical Device Manufacturer) - Compatibility with various DICOM systems. - N/A - Seamless integration with existing healthcare systems. - Should Have * - PRS_0420 - Data storage (Medical Professional) - Support for XNAT storage. - N/A - Ensure compatibility with widely used medical imaging data storage formats. - Must Have * - PRS_0430 - File format (Medical Professional) - Support for NIfTI file format. - N/A - Facilitate diverse data representation and interoperability. - Must Have * - PRS_0440 - File format (Scientist) - Support for ISMRMRD file format. - N/A - Facilitate diverse data representation and interoperability. - Must Have * - PRS_0450 - File format (Scientist) - Support for raw MR file format. - N/A - Facilitate diverse data representation and interoperability. - Must Have Maintainability Needs ------------------------- Needs concerning the ability to evolve, scale, and update the platform over its lifetime without degrading performance. .. list-table:: :header-rows: 1 :widths: 10 25 35 15 20 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0510 - Scalability (System Administrator) - * Scalable architecture to accommodate increasing data and users. * Modular design for easy updates and enhancements. * Efficient data management and storage solutions. - < 10% degradation at 2x data - Ensure system performance as data and users grow. - Should Have System Interfaces to Third-Party Solution Needs ---------------------------------------------------- Needs concerning integration with external systems that are not part of ScanHub itself, such as patient monitoring equipment. .. list-table:: :header-rows: 1 :widths: 10 25 35 15 20 10 * - ID - Product Requirement (Stakeholder) - Design Input - Acceptance Criteria - Intended Claim - Priority * - PRS_0610 - Patient monitoring systems (Medical Device Manufacturer) - Seamless interaction with patient monitoring systems. - Real-time data exchange - Ensure real-time data exchange and patient safety. - Must Have