A Software Requirements Specification (SRS) document serves as a formal description of a software system’s functional and non-functional requirements. It acts as a single source of truth for stakeholders, developers, testers, and project managers, ensuring that everyone has a common understanding of what the system is expected to deliver before development begins.
The Hospital Management System (HMS) is designed to streamline and automate the day-to-day operations of a hospital, including patient registration, appointments, clinical workflows, billing, inventory, and reporting. This SRS document presents a comprehensive overview of the functional and non-functional requirements of the HMS, serving as a blueprint for designing a scalable, secure, and efficient healthcare information system.
1. Introduction
1.1 Purpose
The purpose of this Software Requirements Specification (SRS) document is to provide a comprehensive and detailed description of the Hospital Management System (HMS). This document serves multiple critical purposes:
- To establish a clear understanding of system requirements among all stakeholders including hospital administrators, medical staff, IT personnel, and development team
- To serve as a contractual agreement between the development team and stakeholders regarding system functionality and capabilities
- To provide a foundation for system design, development, testing, and validation activities
- To facilitate project planning, cost estimation, and resource allocation
- To serve as a reference document for system maintenance and future enhancements
This document is intended for use by software developers, testers, project managers, system administrators, hospital management, medical staff, and quality assurance teams.
1.2 Document Conventions
This document follows IEEE Standard 830-1998 for Software Requirements Specifications.
1.3 Intended Audience and Reading Suggestions
This document is organized to accommodate different readers:
- Project Managers
- Developers
- Testers:
- Hospital Administrators
- Medical Staff
1.4 Project Scope
The Hospital Management System (HMS) is a comprehensive integrated information system designed to automate and streamline all major operational, clinical, and administrative functions of a healthcare facility. The system aims to:
- Replace paper-based processes with digital workflows to improve efficiency and reduce errors
- Provide centralized patient data management ensuring data consistency and accessibility
- Enable real-time information sharing across departments and authorized personnel
- Improve quality of patient care through better information availability and clinical decision support
- Enhance financial management through accurate billing, inventory control, and reporting
- Ensure compliance with healthcare regulations and data security standards
- Support data-driven decision making through comprehensive analytics and reporting
The system will NOT include:
- Advanced medical imaging systems (PACS) – integration interface will be provided
- Telemedicine capabilities (planned for future release)
- Integration with external insurance claim systems (planned for future release)
1.5 Definitions, Acronyms, and Abbreviations
| Term | Definition |
| HMS | Hospital Management System |
| UI | User Interface |
| DBMS | Database Management System |
| API | Application Programming Interface |
| OPD | Outpatient Department |
| IPD | Inpatient Department |
| ER/ED | Emergency Room / Emergency Department |
| EHR | Electronic Health Record |
| EMR | Electronic Medical Record |
| PACS | Picture Archiving and Communication System |
| HIPAA | Health Insurance Portability and Accountability Act (US) |
| GDPR | General Data Protection Regulation (EU) |
| HL7 | Health Level Seven – healthcare data exchange standard |
| PHI | Protected Health Information |
| RBAC | Role-Based Access Control |
| SSL/TLS | Secure Sockets Layer / Transport Layer Security |
| REST | Representational State Transfer |
| CRUD | Create, Read, Update, Delete operations |
1.6 References
- IEEE Std 830-1998, IEEE Recommended Practice for Software Requirements Specifications
- ISO/IEC 25010:2011, Systems and software Quality Requirements and Evaluation (SQuaRE)
- HIPAA Security and Privacy Rules (45 CFR Parts 160, 162, and 164)
- HL7 FHIR (Fast Healthcare Interoperability Resources) Standard
- OWASP Top 10 Web Application Security Risks
- W3C Web Content Accessibility Guidelines (WCAG) 2.1
2. Overall Description
2.1 Product Perspective
The Hospital Management System is a new, self-contained web-based application designed to operate as the central information system for healthcare facilities. The system architecture consists of:
- Presentation Layer: Responsive web interface accessible via standard web browsers
- Application Layer: Business logic and workflow management hosted on application servers
- Data Layer: Centralized relational database for persistent storage
- Integration Layer: REST APIs for external system integration (future medical devices, lab equipment, pharmacy systems)
The system will interface with:
- Payment gateways for online payment processing
- Email/SMS services for notifications and alerts
- Barcode scanners for patient identification and inventory management
- Thermal printers for receipt and label printing
2.2 Product Functions
The HMS provides the following major functional capabilities:
- Patient Management: Registration, demographic data, medical history, allergies, emergency contacts
- Appointment Management: Scheduling, rescheduling, cancellation, reminders, waitlist management
- Doctor & Staff Management: Profiles, schedules, specializations, availability, leave management
- OPD Management: Consultation tracking, prescription generation, diagnosis recording
- IPD Management: Admission, bed allocation, discharge, transfer, ward management
- Emergency Department: Triage, priority-based treatment, critical care tracking
- Laboratory Management: Test ordering, sample tracking, result entry, report generation
- Pharmacy Management: Inventory control, prescription dispensing, expiry tracking, reorder alerts
- Billing & Financial Management: Invoice generation, payment processing, insurance claims, financial reporting
- Inventory Management: Medical supplies, equipment tracking, vendor management, purchase orders
- Reporting & Analytics: Operational dashboards, clinical reports, financial statements, compliance reports
- System Administration: User management, role configuration, system settings, audit logs
2.3 User Classes and Characteristics
| User Role | Description | Technical Expertise | Access Level |
| System Administrator | Manages system configuration, users, and security | High | Full system access |
| Hospital Administrator | Oversees operations, views analytics and reports | Medium | Read-only across all modules |
| Receptionist | Handles patient registration and appointments | Low to Medium | Patient registration, appointments, billing |
| Doctor | Views patient records, prescribes treatments | Medium | Patient records, prescriptions, lab orders |
| Nurse | Updates patient vitals, administers medication | Medium | Patient care records, medication administration |
| Lab Technician | Manages lab tests and enters results | Medium | Lab module only |
| Pharmacist | Dispenses medications and manages inventory | Medium | Pharmacy module only |
| Radiologist | Reviews imaging orders and uploads reports | Medium | Radiology module only |
| Accountant | Manages billing, payments, and financial records | Medium | Billing and financial modules |
| Inventory Manager | Manages medical supplies and equipment | Medium | Inventory module only |
| Patient | Views own medical records and appointments (Phase 2) | Low | Personal health records only |
2.4 Operating Environment
- Server Platform: Windows Server 2016+ or Linux (Ubuntu 20.04+, CentOS 8+)
- Web Server: Apache 2.4+ or Nginx 1.18+
- Application Server: Node.js 16+ or Java 11+ runtime environment
- Database: MySQL 8.0+ or PostgreSQL 13+
- Client Browser: Chrome 90+, Firefox 88+, Safari 14+, Edge 90+
- Minimum Client Device: Desktop/Laptop with 4GB RAM, 1280×720 resolution; Tablets with 1024×768 resolution
- Network: Minimum 10 Mbps for optimal performance; HTTPS (TLS 1.2+) for all communications
2.5 Design and Implementation Constraints
- Regulatory Compliance: Must comply with HIPAA (US) or equivalent local healthcare data protection regulations
- Data Security: All PHI must be encrypted at rest (AES-256) and in transit (TLS 1.2+)
- Authentication: Multi-factor authentication required for privileged users
- Session Management: Automatic session timeout after 15 minutes of inactivity
- Audit Trail: All data access and modifications must be logged with timestamp and user identification
- Data Retention: Medical records must be retained for minimum 7 years (configurable by jurisdiction)
- Accessibility: Must conform to WCAG 2.1 Level AA standards
- Browser Compatibility: Must function without plugins; JavaScript required
- Development Standards: Code must follow established coding standards and include comprehensive documentation
2.6 Assumptions and Dependencies
Assumptions:
- Users have basic computer literacy and can navigate web applications
- Hospital has reliable internet connectivity (minimum 10 Mbps)
- Hospital will provide adequate training to staff before system deployment
- Existing patient data will be migrated during initial deployment
- Power backup systems are in place to prevent data loss
Dependencies:
- Third-party payment gateway API availability and reliability
- Email/SMS service provider for notification delivery
- Database server performance and scalability
- Availability of technical support for infrastructure components
3. Functional Requirements
This section contains all the detailed functional requirements of the Hospital Management System, organized by feature/module. Each requirement is uniquely identified for traceability
3.1 Patient Management
The patient management module enables comprehensive registration, tracking, and management of patient information throughout their interaction with the healthcare facility.
3.1.1 Patient Functional Requirements
- Patient Registration (OPD, IPD)
- Patient Search
- Medical History Recording
- Document Upload
- Insurance Information
- Emergency Contact Management
- Patient Deactivation
3.2 Appointment Management
Comprehensive appointment scheduling system supporting booking, rescheduling, cancellation, and waitlist management across multiple departments and doctors.
3.2.1 Appointment Management Functional Requirements
- Appointment Booking
- Doctor Availability Display
- Appointment Confirmation
- Rescheduling Appointment
- Appointment Cancellation
- Appointment Status Tracking
3.3 Doctor and Staff Management
Management of healthcare professionals including doctors, nurses, and support staff with scheduling, specialization tracking, and performance monitoring.
3.3.1 Functional Requirements
- Staff Registration
- Doctor Schedule Management
- Leave Management
- Duty Roster Generation
- Specialization and Certification
- Doctor Profile Display
- Consultation History
3.4 Laboratory Management
Complete laboratory information system for test ordering, sample collection and tracking, result entry, quality control, and report generation
3.4.1 Functional Requirements
- Test Catalog
- Test Ordering
- Sample Collection and Labeling
- Test Sample Tracking System
- Result Entry Interface
- Reference Range Management
- Critical Value Alerting
- Report Generation and Printing
- External Lab Integration
- Quality Control Management
3.5 Pharmacy Management
Comprehensive pharmacy and medication management including inventory control, prescription dispensing, drug interaction checking, expiry management, and controlled substance tracking.
3.5.1 Functional Requirements
- Drug Master Database
- Inventory Tracking
- Stock Alert System
- Prescription Receipt and Verification
- Drug Interaction Checking
- Medication Dispensing
- Purchase Order Management
- Return Management
- Expiry Management
- Controlled Substance Tracking
- Pricing and Discount Management
3.6 Billing and Financial Management
Comprehensive financial management, including service catalog, charge capture, billing, payment processing, discount management, insurance claims, and financial reporting.
4. External Interface Requirements
4.1 User Interfaces
The HMS shall provide intuitive, responsive, and accessible user interfaces adhering to modern UX principles.
4.1.1 General UI Requirements
- Responsive Design: UI shall adapt seamlessly to desktop (1920×1080 minimum), laptop (1366×768), and tablet (1024×768) resolutions. Mobile responsiveness planned for Phase 2
- Navigation Structure: Consistent left sidebar or top navigation menu, breadcrumb trail showing current location, quick access shortcuts for frequently used features, search functionality accessible from every screen
- Dashboard Design: Role-specific landing page after login, customizable widget layout, real-time data display with auto-refresh, notification panel for alerts and tasks, quick action buttons (Register Patient, Book Appointment, etc.)
- Form Design: Clear field labels positioned above or left of input, mandatory field indicators (red asterisk), inline validation with helpful error messages, logical field grouping and tab order, auto-save draft for long forms, progress indicator for multi-step forms
- Search Functionality: Auto-suggest/type-ahead for common searches, advanced filter options (collapsible panel), recent searches quick access, saved search preferences per user, fuzzy matching for partial/misspelled queries
- Accessibility (WCAG 2.1 Level AA): Full keyboard navigation support (Tab, Enter, Esc), screen reader compatibility (proper ARIA labels), sufficient color contrast (4.5:1 minimum for text), focus indicators on interactive elements, no color-only information conveyance, text resize capability up to 200%
- Help and Support: Context-sensitive help icons (?), searchable online user manual, video tutorial library, tooltips on complex fields, chatbot support
4.1.2 Specific Screen Requirements
| Screen/Module | UI Requirements |
| Login Screen | Hospital logo and name, username and password fields, “Remember me” checkbox, “Forgot Password” link, captcha for security (after 3 failed attempts), loading indicator during authentication, error messages (invalid credentials, account locked) |
| Patient Registration | Single-page form with sections (demographics, contact, emergency contact, insurance), photo upload option (drag-drop or click), duplicate check alert display, clear submit and reset buttons, confirmation modal with patient ID display |
| Appointment Booking | Calendar view showing availability, color-coded slots (available/booked/blocked), doctor filter by department/specialization, time slot selection with duration display, appointment type dropdown, confirmation screen with print option |
| Doctor Dashboard | Today’s appointment list with time and patient name, upcoming queue with wait time, pending tasks (prescriptions to sign, reports to verify), performance metrics (consultations today, this month), quick access to patient search |
| OPD Consultation | Patient summary card (demographics, allergies, vitals), tabbed interface (medical history, current consultation, prescriptions, orders), vitals entry with normal range indicators, prescription builder with drug search, lab order multi-select, e-signature capability |
| IPD Ward View | Ward layout with bed status visualization (occupied/available color-coded), patient name on hover over occupied beds, quick filter by ward/floor, bed allocation interface with drag-drop, patient details panel on bed click |
| Laboratory Module | Pending tests queue with priority flags, sample tracking with barcode scan, result entry form with reference ranges, critical value alert display, report preview before printing, batch result entry for panel tests |
| Pharmacy Module | Prescription queue (pending/in-progress), drug search with auto-complete, stock availability indicator (green/yellow/red), interaction alert modal, dispensing interface with batch selection, print label option |
| Billing Dashboard | Pending bills list, payment entry form with calculator, payment mode tabs, discount authorization dialog, receipt preview and print, outstanding summary with aging view |
| Reports Module | Report categories in sidebar, parameter selection area (date range picker, dropdown filters), preview button, export format selection, save report template option, scheduled reports configuration |
4.2 Hardware Interfaces
The HMS shall interface with various hardware devices used in hospital operations.
| Hardware Device | Interface Requirements |
| Barcode Scanner | USB HID (Human Interface Device) class scanner, keyboard wedge interface (scanner acts as keyboard), support for 1D barcodes (Code 39, Code 128) and 2D barcodes (QR, Data Matrix), scan trigger: automatic detection in active input field, beep confirmation on successful scan, error indication for invalid/unreadable barcodes |
| Card Payment Terminal | Integration via payment gateway API (not direct device integration), support for EMV chip cards, contactless/NFC payments, PIN verification, transaction status callback (success/failure/timeout), receipt printing trigger after successful transaction, PCI-DSS compliant communication |
| Thermal Receipt Printer | USB or Network (Ethernet/WiFi) connectivity, ESC/POS command set support, paper width: 80mm (standard thermal rolls), print speed: minimum 150mm/sec, auto-cutter support, print status detection (paper out, cover open errors), Windows printer driver compatibility for browser-based printing |
| Label Printer | USB or Network connectivity, support for label sizes: 50mm x 25mm (patient wristbands), 70mm x 30mm (lab sample labels), barcode printing (Code 128, QR codes), thermal transfer or direct thermal printing, automatic label peeling (if supported), DYMO/Zebra/TSC printer compatibility |
| Vital Signs Monitor | (Future – Phase 2) HL7 or proprietary protocol integration, automatic data capture: BP, pulse, temperature, SpO2, data validation before import, device identification (associate with bed/patient), real-time data streaming, alert on abnormal values |
| Lab Analyzers | (Future – Phase 2) Bidirectional HL7 interface, automatic test order download to device, automatic result upload after analysis, sample ID barcode linkage, QC result integration, instrument-specific data parsing |
4.3 Software Interfaces
The HMS shall integrate with external software systems and services.
| External System | Interface Specifications |
| Database Management System | Type: MySQL 8.0+ or PostgreSQL 13+, Connection: Native database drivers (MySQL Connector, psycopg2), Connection pooling: minimum 10 connections, maximum 100 connections, Connection timeout: 30 seconds, Query timeout: configurable per query type (default 30 seconds for reports), Transaction isolation: READ COMMITTED level, Character encoding: UTF-8, SSL/TLS encryption for connections |
| Payment Gateway (Razorpay/Stripe/PayPal) | Protocol: HTTPS RESTful API, Authentication: API key and secret (stored encrypted), Endpoints: Payment initiation, Payment verification, Refund processing, Webhook for payment notifications, Data format: JSON request/response, Timeout: 30 seconds for API calls, Error handling: retry logic for network failures, logging of all transactions, Webhook signature verification for security |
| SMS Service Provider (Twilio/AWS SNS) | Protocol: HTTPS REST API, Authentication: API key, Endpoints: Send SMS (single/bulk), Delivery status callback, Data format: JSON, SMS length: 160 characters (single SMS), automatic splitting for longer messages, Rate limiting: respect provider limits, Queue management for bulk SMS, Delivery report processing, Opt-out management (do not disturb list) |
| Email Service (SMTP/SendGrid/AWS SES) | Protocol: SMTP (port 587 with TLS) or API (HTTPS), Authentication: Username/password for SMTP, API key for cloud services, Email format: HTML and plain text alternative, Attachment support: up to 5MB per email, Rate limiting: batch sending with delays, Bounce and complaint handling, Unsubscribe link management, Email delivery status tracking |
| PACS (Picture Archiving System) | (Future – Phase 3) Protocol: HL7 or DICOM, Integration points: Order transmission to PACS, Image availability notification, Image viewer launch from HMS, Report upload from PACS to HMS, Data mapping: patient ID, accession number, study details, Authentication: Single Sign-On (SSO) or API key |
| Laboratory Equipment | (Future – Phase 3) Protocol: HL7 2.x or vendor-specific API, Bidirectional interface: Order download (ORM messages), Result upload (ORU messages), Data elements: patient demographics, test codes, sample IDs, results with units, QC data, Data validation: range checking before acceptance, Duplicate detection, Error handling and manual override |
4.4 Communications Interfaces
The HMS shall use the following network communication protocols and standards.
| Interface Type | Specifications |
| HTTP/HTTPS Protocol | Primary protocol: HTTPS (HTTP over TLS), Port: 443 for HTTPS, TLS version: 1.2 or higher (1.3 preferred), Cipher suites: strong ciphers only (AES-GCM), Certificate: valid SSL certificate from trusted CA, HTTP redirect: all HTTP (port 80) redirected to HTTPS, HSTS header: enforce HTTPS for 1 year |
| RESTful API | Architecture: REST (Representational State Transfer), Data format: JSON for request/response, Authentication: JWT (JSON Web Token) or OAuth 2.0, Token expiry: 1 hour (access token), 7 days (refresh token), HTTP methods: GET (read), POST (create), PUT (update), DELETE (delete), Status codes: standard HTTP codes (200, 201, 400, 401, 404, 500), Rate limiting: 100 requests per minute per user, API versioning: URL-based (/api/v1/) |
| WebSocket Protocol | Use case: Real-time notifications and updates, Port: 443 (secure WebSocket – wss://), Connection: persistent bi-directional, Heartbeat: ping-pong every 30 seconds to keep connection alive, Auto-reconnect: on disconnection with exponential backoff, Message format: JSON, Events: queue updates, critical alerts, appointment changes, new lab reports |
| Database Connection | Protocol: TCP/IP, MySQL port: 3306, PostgreSQL port: 5432, Connection encryption: SSL/TLS, Connection string: includes SSL parameters, Firewall: database server accessible only from application server IPs, Connection timeout: 30 seconds, Query timeout: configurable |
| File Transfer | Document uploads: multipart/form-data over HTTPS, Maximum upload size: 5MB per file, Allowed file types: PDF, JPG, PNG (validated by MIME type and file extension), Upload location: encrypted storage, CDN integration: for faster document delivery (future) |
| Email Protocol | Outbound: SMTP with STARTTLS (port 587) or SMTPS (port 465), Authentication: username and password, SPF and DKIM: configured for domain to prevent spoofing, Inbound: IMAP/POP3 (if email monitoring required – future) |
5. Non-Functional Requirements
5.1 Performance Requirements
5.1.1 Response Time Requirements
| Operation Type | Target Response Time | Acceptable Response Time |
| Page Load (Dashboard, Lists) | < 1 second | < 2 seconds |
| Form Submission (Registration, Booking) | < 1 second | < 2 seconds |
| Search Operations (Patient, Medicine) | < 2 seconds | < 3 seconds |
| Report Generation (Standard Reports) | < 3 seconds | < 5 seconds |
| Complex Reports (with large datasets) | < 10 seconds | < 30 seconds |
| Database Query (Simple SELECT) | < 200 ms | < 500 ms |
| Database Query (with JOINs) | < 1 second | < 2 seconds |
| API Response Time (90th percentile) | < 500 ms | < 1 second |
| File Upload (5MB) | < 5 seconds | < 10 seconds |
| WebSocket Message Delivery | < 500 ms | < 1 second |
5.1.2 Throughput Requirements
- Concurrent Users: System shall support minimum 100 concurrent active users without performance degradation. Target: scalable to 500 concurrent users with hardware upgrades
- Transaction Throughput: Minimum 50 transactions per second (TPS) for typical operations (patient registration, appointment booking, prescription entry, billing)
- Database Operations: Minimum 500 database queries per second (read), 100 writes per second
- Batch Processing: Daily batch jobs (backup, data archival, report generation) shall complete within 2 hours during off-peak hours (2 AM – 4 AM)
5.1.3 Capacity Requirements
- Patient Records: System shall efficiently handle minimum 1 million patient records with support for growth to 5 million
- Transactions: System shall handle minimum 10 million transactions (appointments, consultations, prescriptions, bills) with support for 50 million
- Appointments: System shall support scheduling 10,000+ appointments per day
- Document Storage: System shall support storage of 100,000+ documents (patient records, reports, prescriptions) with total storage up to 1 TB
5.2 Safety Requirements
- Data Integrity: All database transactions shall follow ACID properties (Atomicity, Consistency, Isolation, Durability) to prevent data corruption. Critical operations (billing, prescription, lab results) shall use database transactions with rollback capability
- Medication Safety Checks: System shall perform mandatory checks before prescription finalization: drug-drug interactions (major severity), patient allergies to medications, dosage appropriateness based on age/weight. System shall block prescription if critical interaction or allergy detected (override requires senior doctor authorization)
- Critical Value Alerts: Laboratory results exceeding critical thresholds shall trigger immediate alerts to ordering doctor via SMS/email/system notification. Critical values shall require pathologist verification before report release
- Patient Identification Verification: Before critical operations (medication administration, blood transfusion, surgery), system shall enforce patient identity verification using two identifiers (patient ID + name/DOB)
- Graceful Degradation: If non-critical modules (reporting, analytics) fail, core clinical modules (OPD, prescriptions, lab orders) shall continue functioning. System shall display clear error messages and alternative action paths
- Error Logging and Handling: All system errors shall be logged with: error code, timestamp, user ID, module, stack trace (for debugging). Error messages to users shall be user-friendly without exposing sensitive system information. Critical errors shall trigger alerts to system administrators
5.3 Security Requirements
5.3.1 Authentication Requirements
| Security Control | Specification |
| User Authentication | Mandatory username and password for all users. No anonymous or guest access permitted |
| Password Complexity | Minimum 8 characters, at least: 1 uppercase, 1 lowercase, 1 number, 1 special character. Common passwords (password123, hospital123) shall be blocked |
| Password Storage | Passwords shall be hashed using bcrypt or PBKDF2 with salt. Plain text password storage strictly prohibited |
| Account Lockout | Account locked after 5 consecutive failed login attempts. Lockout duration: 30 minutes or until admin unlocks. Failed attempts counter reset after successful login |
| Multi-Factor Authentication | MFA mandatory for: System Administrator, Finance/Accountant, Pharmacy Manager. MFA optional but recommended for doctors. MFA methods: SMS OTP (6 digits, 5-minute validity), Authenticator app TOTP |
| Session Token | JWT or secure session token issued after authentication. Token includes: user ID, role, issue time, expiry time. Token signed with secret key to prevent tampering |
| Password Reset | Self-service: email with reset link (valid for 1 hour). Admin-initiated: temporary password sent via email, user forced to change on first login. Password reset attempts logged in audit trail |
5.3.2 Authorization Requirements
| Security Control | Specification |
| Role-Based Access Control | All system access governed by RBAC. Users assigned to one or more roles (Admin, Doctor, Nurse, Receptionist, etc.). Roles have predefined permissions for modules and features |
| Principle of Least Privilege | Users granted minimum permissions necessary for their job function. No blanket “all access” except System Administrator. Temporary elevated access requires approval and time limit |
| Granular Permissions | Module-level: access to Patient Management, OPD, IPD, Lab, Pharmacy, Billing, Reports, Administration. Feature-level: View, Create, Edit, Delete for each entity. Field-level: sensitive fields (salary, confidential notes) restricted based on role |
| Data Segregation | Department-based access: users may access only their department data (configurable). Doctor access: own patient consultations, referred patients. Receptionist: limited to patient demographics and appointments |
| Mandatory Access Review | User access and permissions reviewed every 6 months by department heads. Terminated employee access revoked immediately. Inactive users (no login for 90 days) flagged for review |
5.3.3 Data Encryption Requirements
| Encryption Type | Specification |
| Data at Rest | All PHI (Protected Health Information) encrypted using AES-256. Database: Transparent Data Encryption (TDE) enabled. File storage: encrypted file system or application-level encryption. Encryption keys stored securely in key management system (separate from data) |
| Data in Transit | All communication encrypted using TLS 1.2 or higher. Client-server: HTTPS (TLS 1.2+). Server-database: SSL/TLS connection. API calls: HTTPS with certificate pinning. Email: TLS for SMTP. Unencrypted HTTP strictly prohibited |
| Backup Encryption | Database backups encrypted using AES-256 before storage. Backup encryption keys separate from regular encryption keys. Encrypted backups stored in secure location with access logging |
5.3.4 Session Management Requirements
- Session Timeout: Automatic logout after 15 minutes of user inactivity (configurable: 10-30 minutes). Warning displayed 2 minutes before timeout with option to extend
- Concurrent Sessions: Maximum 2 concurrent sessions per user account. New login from 3rd device terminates oldest session. Session details visible to user (login time, device, IP address)
- Session Termination: User can explicitly logout (logout button). System administrator can force terminate any user session. Session automatically terminated on: password change, role/permission change, account deactivation
- Session Token Security: Session tokens: random, unpredictable, high entropy. Token rotation: new token issued every hour. Tokens invalidated immediately on logout. Token transmitted only via secure channels (HTTPS, secure cookies)
5.3.5 Audit Trail Requirements
| Audit Category | Events to be Logged |
| Authentication | Successful login (user, time, IP, device), Failed login attempt (username, time, IP, reason), Logout (user, time, duration), Password change, Account lockout, MFA enrollment/use |
| Data Access | Patient record viewed (which record, by whom, when), Medical history accessed, Lab reports viewed, Financial data accessed, Sensitive field access (credit card, SSN) |
| Data Modification | Record created (entity type, ID, by whom, when), Record updated (entity, ID, field changed, old value, new value, by whom, when), Record deleted (soft delete with details), Bulk operations |
| Authorization Changes | User created/deactivated, Role assigned/removed, Permission granted/revoked, Role permission modified |
| System Configuration | Configuration setting changed (parameter, old value, new value), Master data modified (drug master, service catalog), Integration settings changed |
| Critical Operations | Prescription generated, Lab test ordered, Medication dispensed, Payment processed, Refund issued, Discount applied (above threshold), Report exported |
5.3.6 Input Validation and Security
- Server-Side Validation: All inputs validated on server (never trust client). Data type checking (string, number, date), Length validation (max/min), Format validation (email, phone, date formats), Range validation (numeric ranges)
- SQL Injection Prevention: Parameterized queries (prepared statements) for all database operations. ORM framework usage where applicable. Input sanitization for special characters. No dynamic SQL construction with user inputs
- Cross-Site Scripting (XSS) Prevention: Output encoding before displaying user inputs. Content Security Policy (CSP) headers. HTML sanitization for rich text inputs. No inline JavaScript in user-generated content
- Cross-Site Request Forgery (CSRF) Prevention: CSRF tokens for all state-changing operations (POST, PUT, DELETE). Token validation on server. SameSite cookie attribute set
- File Upload Security: File type validation (MIME type and extension). File size limits enforced. Virus scanning before accepting. Uploaded files stored outside web root. Randomized filenames to prevent guessing
5.3.7 Privacy and Compliance
- HIPAA Compliance: (If applicable for US) Full compliance with HIPAA Privacy Rule (patient data confidentiality) and Security Rule (administrative, physical, technical safeguards). Business Associate Agreements (BAA) with third-party services
- GDPR Compliance: (If applicable for EU patients) Right to access (patient can request their data). Right to rectification (correct inaccurate data). Right to erasure (right to be forgotten – with legal exceptions for medical records). Data portability (export data in machine-readable format). Consent management for optional data processing
- Data Minimization: Collect only necessary data for healthcare operations. Avoid collecting overly sensitive data unless medically required. Regular review of data collection practices
- De-identification: Patient data de-identified for research/analytics purposes. Remove identifiers: name, contact, SSN, patient ID. Aggregate data reporting where possible
5.3.8 Vulnerability Management
- Regular Security Patching: Operating system patches applied monthly. Application framework patches applied within 7 days of release for critical vulnerabilities. Third-party library updates: quarterly review and update
- Vulnerability Scanning: Quarterly automated vulnerability scans using tools (Nessus, OpenVAS). Penetration testing annually by third-party security firm. Web application vulnerability scanning (OWASP Top 10)
- Secure Coding Practices: Development team trained in OWASP Top 10 and secure coding. Code review for security issues before deployment. Static code analysis tools integrated in CI/CD pipeline
5.4 Software Quality Attributes
5.4.1 Reliability
| Reliability Metric | Requirement |
| System Availability | 99.5% uptime per month (maximum 3.65 hours downtime). Scheduled maintenance during off-peak hours (2 AM – 4 AM) with advance notification |
| Mean Time Between Failures (MTBF) | Minimum 720 hours (30 days) for critical modules (patient registration, billing, prescriptions) |
| Mean Time To Recovery (MTTR) | Maximum 2 hours for critical issues (system down, data corruption). Maximum 4 hours for high-priority issues. Maximum 8 hours for medium-priority issues |
| Fault Tolerance | Database replication (master-slave) for redundancy. Application server clustering for load balancing and failover. Automatic failover to backup systems without manual intervention |
| Data Backup and Recovery | Daily full backup with 30-day retention. Hourly incremental/transaction log backups. Backup verification (test restore) monthly. Recovery Point Objective (RPO): < 1 hour (maximum 1 hour of data loss). Recovery Time Objective (RTO): < 4 hours (system restored within 4 hours) |
| Error Handling | Graceful error messages (no stack traces to users). User-friendly error descriptions with suggested actions. Automatic error logging and notification to IT team. Retry mechanisms for transient errors (network issues, temporary unavailability) |
5.4.2 Maintainability
| Maintainability Aspect | Requirement |
| Code Quality | Modular architecture (separation of concerns). Clear, descriptive variable and function names. Code complexity: maximum cyclomatic complexity 10 per function. Code duplication: maximum 5% duplicated code. Code coverage: minimum 70% unit test coverage |
| Documentation | Comprehensive technical documentation: system architecture diagrams, database schema documentation (ERD), API documentation with examples, deployment guide, troubleshooting guide. Code-level documentation: inline comments for complex logic, function/method documentation (parameters, return values). User documentation: user manuals per role, video tutorials, FAQ section |
| Coding Standards | Adherence to language-specific standards (PEP-8 for Python, PSR for PHP, etc.). Automated linting in CI/CD pipeline. Code review mandatory before merge to main branch. Version control: Git with meaningful commit messages |
| Logging and Debugging | Comprehensive application logging: INFO level (general events), WARN level (potential issues), ERROR level (failures requiring attention), DEBUG level (detailed troubleshooting info – disabled in production). Log rotation to prevent disk space exhaustion. Centralized log aggregation for distributed systems |
| Configuration Management | Environment-specific configuration files (development, staging, production). Externalized configuration (no hard-coded values). Configuration change tracking. Secure storage of sensitive configuration (database credentials, API keys) |
5.4.3 Portability
| Portability Aspect | Requirement |
| Platform Independence | Web-based application accessible from any operating system: Windows, macOS, Linux, ChromeOS. No OS-specific dependencies in application code. Cross-platform compatible database (MySQL/PostgreSQL available on all platforms) |
| Browser Compatibility | Support for major browsers: Google Chrome 90+, Mozilla Firefox 88+, Microsoft Edge 90+, Safari 14+. Consistent UI rendering across browsers. Progressive enhancement (core functionality works without JavaScript, enhanced with JavaScript). Browser compatibility testing before each release |
| Device Compatibility | Responsive design for devices: Desktop (1920×1080 and above), Laptop (1366×768 minimum), Tablet (1024×768 minimum). Mobile responsiveness (Phase 2). Touch-friendly interface elements for tablets |
| Data Portability | Export data in standard formats: Patient data export (CSV, Excel, PDF), Reports export (PDF, Excel, CSV), Prescription export (PDF), Lab reports export (PDF). Import data from standard formats: Patient data import (CSV with template), Bulk inventory import (Excel). Interoperability: HL7 FHIR compatibility (future for health information exchange) |
5.4.4 Usability
| Usability Aspect | Requirement |
| Ease of Learning | New users productive within 4 hours of training. Intuitive interface requiring minimal training for basic tasks. Onboarding tutorial for first-time users. Context-sensitive help at critical points |
| Ease of Use | Common tasks completable in maximum 5 clicks from dashboard. Keyboard shortcuts for power users (common actions like search, save). Consistent UI patterns across modules (location of save/cancel buttons, navigation structure). Auto-complete and suggestions for search fields. Undo functionality where applicable (before final save) |
| Error Prevention and Recovery | Clear labeling of mandatory fields. Inline validation with immediate feedback. Confirmation dialogs for critical/irreversible actions (delete, discharge). Descriptive error messages with guidance (not just “Error occurred”). Draft saving for long forms (no data loss on accidental closure) |
| User Satisfaction | User satisfaction survey: target 80%+ satisfaction rating. User feedback mechanism in application. Regular UX review and improvement. Accessibility for users with disabilities (WCAG 2.1 Level AA) |
| Help and Documentation | Context-sensitive help (? icon) on complex screens. Searchable online help documentation. Video tutorial library (role-specific). Chatbot support for common queries (Phase 2). Support contact information prominently displayed |
5.4.5 Scalability
| Scalability Dimension | Requirement |
| User Scalability | Current capacity: 100 concurrent users. Target capacity: 500+ concurrent users with horizontal scaling (additional application servers). Load balancer to distribute traffic across multiple servers. Session management compatible with server clustering (shared session store) |
| Data Scalability | Current capacity: 1 million patient records, 10 million transactions. Target capacity: 5 million patients, 50 million transactions. Database performance optimization: proper indexing, query optimization, partitioning for large tables. Database sharding capability (future for very large deployments) |
| Transaction Scalability | Support for increasing transaction volume without linear resource increase. Database connection pooling to efficiently manage connections. Caching layer (Redis/Memcached) for frequently accessed data. Asynchronous processing for non-critical operations (notifications, reporting) |
| Geographic Scalability | Multi-facility support: single database instance supporting multiple hospital locations. Data segregation by facility with proper access control. CDN for static content delivery (faster load times globally). Future: multi-region deployment with data replication |