MVP Scope – Hospital Oncology Longitudinal Record (v1)¶

Document Purpose¶

This document defines the Minimum Viable Product (MVP) for deploying the oncology longitudinal patient record at pilot hospitals. It is the authoritative reference for:

✅ What the system MUST do in MVP
❌ What is explicitly OUT of scope
🎯 Acceptance criteria for each MVP module
🔗 Integration requirements and data sources

MVP Goals¶

Primary Objectives¶

Prove Clinical Value
Oncologists save 5-10 minutes per consultation by having unified patient view
Validate Technical Integration
Successfully ingest data from 3+ different hospital systems (EMR, LIS, PACS)
Demonstrate Indian Language Support
Hindi OCR/ASR accuracy >80% on real medical documents
Establish Trust
Zero data loss, clear provenance, 99.5% uptime

Success Metrics¶

Metric	Target (6 months post-deployment)
Clinician Daily Active Use	>50% of oncologists
Data Completeness	>80% of available modalities
Time Saved per Consult	5-10 minutes
System Uptime	>99.5%
User Satisfaction (NPS)	>40

In-Scope Modules¶

1. Longitudinal Timeline View¶

Purpose: Unified chronological view of patient's cancer journey

Features: - Display all clinical events in single timeline - Events grouped by month/year for easy navigation - Filter by event type (labs, imaging, procedures, treatments) - Click to expand event for details

Event Types Included: - ✅ Diagnosis date - ✅ Hospital admissions/discharges - ✅ Surgical procedures - ✅ Chemotherapy/radiation cycles - ✅ Lab test dates (with ability to drill down) - ✅ Imaging studies - ✅ Pathology reports - ✅ Genomics/molecular tests - ✅ Clinical notes/consultations

UI Requirements: - Timeline loads in <3 seconds - Supports 500+ events without performance degradation - Mobile-responsive (tablet support)

Related Use Cases: UC-UI-003

2. Vitals & Performance Status¶

Purpose: Track functional status and key vitals over time

Data Captured: - Vitals: - Weight, Height, BMI - Blood Pressure (systolic/diastolic) - Heart Rate - Respiratory Rate - Temperature - SpO2 (oxygen saturation)

Performance Status:
ECOG score (0-5)
Karnofsky score (0-100)
Subjective assessment notes

Display Features: - Trend charts for weight, BP over time - Latest vitals snapshot on overview page - Alerts for rapid weight loss (>5% in 30 days)

Data Sources: - EMR vitals module - Manual entry by nurses/physicians

3. Labs (Hematology, Chemistry, Tumor Markers)¶

Purpose: Comprehensive lab results with trends and abnormal value highlighting

Lab Categories: - Hematology: CBC, differential, platelets - Chemistry: Metabolic panel, liver/renal function - Tumor Markers: CA-125, CA 15-3, CEA, PSA, AFP, etc. - Coagulation: PT/INR, aPTT - Urinalysis

Features: - ✅ Latest vs. previous value comparison (Δ value, % change) - ✅ Normal/abnormal/critical flags - ✅ Reference range display - ✅ Trend charts for key tests (e.g., hemoglobin over 6 months) - ✅ Tumor marker longitudinal tracking

Data Format:

{
  "testName": "Hemoglobin",
  "value": 12.5,
  "unit": "g/dL",
  "referenceRange": "12-16 g/dL",
  "status": "normal",
  "date": "2024-12-01",
  "source": "LIS-HOSPITALX",
  "change": { "delta": -0.3, "percent": -2.3, "direction": "down" }
}

Related Use Cases: UC-ING-001, UC-UI-004

4. Imaging (PACS Integration)¶

Purpose: Display imaging studies with key measurements

Supported Modalities: - CT, MRI, PET, X-Ray, Ultrasound, Mammography

Features: - ✅ Study list with modality, date, body part, findings - ✅ Radiologist impression/report text - ✅ Structured measurements (when available): - RECIST target lesion diameters - SUVmax for PET scans - ✅ Links to DICOM viewer (if hospital has one) - ✅ Asset availability status (complete/incomplete)

Data Sources: - PACS JSON feeds (preferred) - HL7 ORM (Order) / ORU (Result) messages - Manual PDF upload with OCR

Related Use Cases: UC-ING-002

5. Pathology Reports¶

Purpose: Display pathology findings and biomarkers

Report Types: - Biopsy reports - Surgical pathology - Cytology

Key Data Extracted: - ✅ Specimen type and site - ✅ Histology (e.g., "Invasive Ductal Carcinoma") - ✅ Grade (G1, G2, G3) - ✅ Biomarkers: - ER/PR/HER2 status (breast) - Ki67 proliferation index - p16/HPV (head & neck) - MSI/dMMR status - ✅ Margin status (if surgical specimen)

Display: - Tabular view with key findings - Full report text (OCR if PDF) - Link to original document

6. Genomics / Molecular Testing¶

Purpose: Track genetic mutations and actionable biomarkers

Data Captured: - Somatic Mutations: - Gene name - Variant (HGVS notation) - VAF (Variant Allele Frequency) - Clinical significance (pathogenic/VUS/benign)

Key Biomarkers:
TMB (Tumor Mutational Burden)
MSI (Microsatellite Instability)
PD-L1 expression
EGFR, ALK, ROS1, BRAF, KRAS, etc.

UI Features: - ✅ Actionable variants highlighted - ✅ Link to genomics report PDF - ⚠️ NOT included in MVP: Treatment recommendations, trial matching

Related Use Cases: UC-ING-003

7. Therapy & Treatment Lines¶

Purpose: Track cancer treatments and response

Treatment Types: - Chemotherapy - Targeted therapy - Immunotherapy - Radiation therapy - Surgery - Palliative care

Data per Treatment: - Regimen name (e.g., "FOLFOX", "Pembrolizumab") - Start and end dates - Line of therapy (1st line, 2nd line, etc.) - Status: Planned / Ongoing / Completed / Abandoned - Response assessment: CR, PR, SD, PD (or free text) - Cycle information (when available)

UI Display: - Treatment timeline showing start/end of each line - Current active treatments highlighted - Response summary per line

8. Medications & Allergies¶

Purpose: Current medication list and allergy tracking

Features: - ✅ Active medications (oncology and non-oncology) - ✅ Home medications - ✅ Drug allergies and intolerances - ✅ Reaction type and severity

Data Sources: - EMR medication module - Pharmacy feeds (if available) - Manual physician entry

⚠️ NOT in MVP: Drug-drug interaction checking

9. Notes with OCR/ASR (English + Hindi)¶

Purpose: Capture clinical notes in multiple formats and languages

Note Types: - EMR text notes - PDF documents (via OCR) - Audio recordings (via ASR)

Language Support: - ✅ English (OCR + ASR) - ✅ Hindi (OCR + ASR) - ⚠️ Other Indian languages: Post-MVP

Features: - ✅ Display note type, date, language tag - ✅ Full text search within notes - ✅ Filter by language - ✅ OCR/ASR confidence score visible - ✅ Link back to original document/audio

Quality Requirements: - English OCR: >90% accuracy - Hindi OCR: >80% accuracy - English ASR: <15% word error rate - Hindi ASR: <20% word error rate

Related Use Cases: UC-PROC-001 through UC-PROC-004, UC-UI-006

10. FHIR R4 Bundle Generation¶

Purpose: Enable interoperability and ABDM compliance

FHIR Resources Generated: - Patient - Condition (cancer diagnosis) - Observation (labs, vitals, biomarkers) - ImagingStudy - DiagnosticReport (labs, imaging, pathology, genomics) - MedicationStatement - Procedure - (Optional) AllergyIntolerance

Validation: - ✅ Structural validation via FHIR Validator - ✅ Zero critical errors - ✅ MUST-SUPPORT elements populated where data available - ✅ Provenance metadata included

API Endpoint:

GET /api/patients/:abhaId?format=fhir
Response: FHIR R4 Bundle (JSON)

Related Use Cases: UC-API-004

11. Basic Rule-Based Alerts¶

Purpose: Notify clinicians of critical conditions

Alert Types (MVP): 1. Critical Lab Values - Hemoglobin <7 g/dL - Platelets <20,000 - Creatinine >3.0 mg/dL - (Configurable thresholds)

Rapid Weight Loss
5% in 30 days
10% in 90 days
Overdue Labs/Imaging
Simple rules: "CBC due every 2 weeks during chemo"
Configurable per treatment protocol

Alert Display: - ✅ Alert badge on patient card and overview - ✅ Alert details with timestamp and trigger - ✅ Physician can dismiss or acknowledge

⚠️ NOT in MVP: - Complex clinical decision support - Guideline adherence checking - LLM-based predictions

Data Sources & Integrations¶

Supported Integration Methods¶

Method	Priority	Use Case
HL7 v2 (MLLP)	P0	Labs (ORU), Admissions (ADT)
FHIR R4 (REST)	P1	External lab systems, future PHR apps
File-based JSON	P0	PACS, Genomics, legacy systems
Document/Audio Upload	P1	OCR, ASR processing

Expected Data Sources at Pilot Hospital¶

EMR/HIMS
  ├─ HL7 ADT (Admissions/Transfers/Discharges)
  ├─ Demographics, allergies, medications
  └─ Clinical notes (text)

LIS (Lab System)
  └─ HL7 ORU (Lab results)

PACS (Imaging)
  └─ JSON feed with study metadata + DICOM links

Pathology
  └─ JSON feed OR PDF upload with OCR

Genomics Lab
  └─ JSON feed (custom schema)

Therapy Management
  └─ JSON feed OR manual entry

Related Use Cases: UC-ING-001, UC-ING-002, UC-ING-003, UC-INT-001, UC-INT-002

Non-Goals (Out of Scope)¶

To maintain MVP focus, the following are explicitly excluded:

1. Advanced Clinical Decision Support¶

❌ LLM-based treatment recommendations
❌ Trial matching algorithms
❌ Guideline adherence scoring
❌ Survival/outcome predictions

Rationale: Requires large longitudinal datasets, regulatory approval, and clinical validation we don't have yet.

Future: Post-MVP Phase 2

2. Full Financial/Billing Workflows¶

❌ Insurance pre-authorization automation
❌ Cost estimation tools
❌ Billing code suggestions (ICD-10, CPT)

Rationale: Out of core competency; specialized billing systems exist.

MVP Includes: Display insurance type, basic coverage info if available.

3. Rich Lesion Tracking UI¶

❌ Interactive RECIST measurement tool
❌ Lesion target selection workflow
❌ Automated tumor volume calculations

Rationale: Complex radiology workflow; most hospitals use dedicated PACS tools.

MVP Includes: Display RECIST measurements if provided by radiologist.

4. Global Multilingual Support¶

❌ Languages beyond English + Hindi
❌ Automated translation between languages

Rationale: Resource constraints; focus on India market.

Future: Add Tamil, Telugu, Kannada based on hospital demand in Phase 2.

5. Detailed Adherence Tracking¶

❌ Medication compliance monitoring
❌ Appointment reminder system
❌ Treatment schedule management

Rationale: Operational workflows best handled by existing hospital systems.

MVP Includes: Display medication list, appointment history if available.

6. Advanced Research/Cohort Tools¶

❌ De-identification pipelines
❌ Cohort query builder for researchers
❌ Export to research data warehouses

Rationale: Research workflows are post-clinical-adoption priority.

Future: Phase 3 after achieving scale (10,000+ patients).

Acceptance Criteria¶

Data Platform & Pipelines¶

Criterion	Target
HL7 ORU Processing	<500ms (p95)
File Ingestion Latency	<15 minutes from file drop
Bundle Validation Success	100% (zero critical schema errors)
FHIR Generation	100% of patients have valid bundles
English OCR Accuracy	>90%
Hindi OCR Accuracy	>80%
Data Loss	0 (all ingestion tracked, DLQ for failures)

API & Frontend¶

Criterion	Target
API Response Time (Patient GET)	<2s (p95)
Timeline Page Load	<3s
API Uptime	>99.5%
Browser Support	Chrome, Firefox, Safari (latest 2 versions)
Mobile/Tablet	Responsive layout, functional on iPad

Deployment & Operations¶

Criterion	Target
Deployment Time	<2 weeks per hospital
Monitoring Coverage	Metrics for all critical paths
Alert Response	DLQ depth >10 → Slack/email alert
Backup Frequency	Daily automated backups
Audit Logging	100% of patient data access logged

Technical Constraints¶

Must Adhere To¶

ABDM Compliance
ABHA ID as primary patient identifier
FHIR R4 standard for interoperability
Digital consent framework (prepare architecture)
Data Privacy (DPDP Act 2023)
Encryption at rest and in transit
Role-based access control (RBAC)
Audit logs for all access
Data retention policies defined
Hospital IT Policies
Deploy in hospital-approved environment (on-prem or VPC)
No internet-accessible PHI without VPN/tunnel
Coordinate with hospital IT for firewall rules, network access
Performance
Support 100+ concurrent clinicians
Handle 10,000+ patients per instance
Scalable architecture for future growth

Success Checklist (Before MVP Sign-Off)¶

[ ] All in-scope modules functional and tested
[ ] Integrated with 3+ hospital data sources
[ ] 100 patients loaded with >80% data completeness
[ ] 5-10 oncologists trained and using system
[ ] Zero critical bugs in production
[ ] FHIR bundles validate without errors
[ ] Hindi OCR tested on 50+ real documents (>80% accuracy)
[ ] Audit logs capturing all patient access
[ ] Backup and disaster recovery tested

Document Owner: Product Manager
Last Updated: 2024-12-03
Related: Vision & Strategy | High-Level Architecture