ashmatics-datamodels 0.3.2__tar.gz

ashmatics_datamodels-0.3.2/.github/workflows/publish.yml

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+name: Publish
+
+on:
+  push:
+    tags: ["v*"]
+  workflow_dispatch:
+    inputs:
+      target:
+        description: Publishing target
+        type: choice
+        options: [pypi, testpypi]
+        default: testpypi
+
+permissions:
+  contents: read
+
+jobs:
+  build:
+    name: Build sdist + wheel
+    runs-on: ubuntu-latest
+    steps:
+      - uses: actions/checkout@v4
+
+      - uses: actions/setup-python@v5
+        with:
+          python-version: "3.11"
+
+      - name: Install build tooling
+        run: python -m pip install --upgrade build
+
+      - name: Build distribution
+        run: python -m build
+
+      - name: Upload distribution artifact
+        uses: actions/upload-artifact@v4
+        with:
+          name: dist
+          path: dist/
+
+  publish:
+    name: Publish to ${{ inputs.target || 'pypi' }}
+    needs: build
+    runs-on: ubuntu-latest
+    environment:
+      name: ${{ inputs.target || 'pypi' }}
+    permissions:
+      id-token: write
+    steps:
+      - name: Download distribution artifact
+        uses: actions/download-artifact@v4
+        with:
+          name: dist
+          path: dist/
+
+      - name: Publish to PyPI
+        if: (inputs.target || 'pypi') == 'pypi'
+        uses: pypa/gh-action-pypi-publish@release/v1
+
+      - name: Publish to TestPyPI
+        if: inputs.target == 'testpypi'
+        uses: pypa/gh-action-pypi-publish@release/v1
+        with:
+          repository-url: https://test.pypi.org/legacy/

ashmatics_datamodels-0.3.2/.gitignore

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+# Byte-compiled / optimized / DLL files
+__pycache__/
+*.py[cod]
+*$py.class
+
+# Distribution / packaging
+dist/
+build/
+*.egg-info/
+*.egg
+
+# Virtual environments
+.venv/
+venv/
+ENV/
+
+# uv
+uv.lock
+
+# Testing
+.pytest_cache/
+.coverage
+htmlcov/
+.tox/
+
+# IDE
+.idea/
+.vscode/
+*.swp
+*.swo
+*~
+
+# mypy
+.mypy_cache/
+
+# ruff
+.ruff_cache/
+
+# OS
+.DS_Store
+Thumbs.db
+
+# Documentation
+site/

ashmatics_datamodels-0.3.2/CLAUDE.md

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+# CLAUDE.md
+
+This file provides guidance to Claude Code (claude.ai/code) when working with code in this repository.
+
+## Project Overview
+
+This is **ashmatics-core-datamodels**, a canonical Pydantic data models library for the AshMatics healthcare ecosystem. It serves as the single source of truth for data contracts across:
+- Ashmatics Knowledge Base (KB)
+- ashmatics-tools SDK
+- ashmatics-knowledgebase-tools (ingestion pipelines)
+- AI Watch applications
+
+Version: 0.2.0 (Phase 1 complete, Phase 2 in progress)
+
+## Development Commands
+
+### Environment Setup
+```bash
+# Python 3.11+ required
+python -m venv .venv
+source .venv/bin/activate  # or `.venv\Scripts\activate` on Windows
+pip install -e ".[dev]"
+```
+
+### Testing
+```bash
+# Run all tests
+pytest
+
+# Run with coverage
+pytest --cov=src/ashmatics_datamodels --cov-report=term-missing
+
+# Run specific test file
+pytest tests/fda/test_clearances.py
+
+# Run specific test
+pytest tests/fda/test_clearances.py::TestFDA510kClearance::test_k_number_validation
+```
+
+### Linting and Type Checking
+```bash
+# Lint with ruff
+ruff check src/
+
+# Format code
+ruff format src/ tests/
+
+# Type check with mypy
+mypy src/
+```
+
+### Building the Package
+```bash
+# Build wheel
+pip install build
+python -m build
+
+# Install locally in editable mode
+pip install -e .
+```
+
+### Documentation
+```bash
+# Install documentation dependencies
+uv pip install -e ".[docs]"
+
+# Serve docs locally (auto-reload on changes)
+uv run mkdocs serve
+# Open http://127.0.0.1:8000
+
+# Build static documentation site
+uv run mkdocs build
+# Output in site/
+```
+
+## Architecture
+
+### Module Organization
+
+The library follows a domain-driven structure:
+
+- **common/** - Cross-jurisdictional base models, validators, enums
+  - `base.py`: `AshMaticsBaseModel`, `TimestampedModel`, `AuditedModel`
+  - `validators.py`: Shared validators (ISO dates, country codes, FDA identifiers)
+  - `enums.py`: Global enums (`AuthorizationStatus`, `RegulatoryStatus`, `RiskCategory`)
+  - `regulators.py`: Multi-jurisdiction regulator schemas
+  - `frameworks.py`: Regulatory framework schemas (FDA, EMA, etc.)
+
+- **fda/** - FDA-specific schemas aligned with OpenFDA API
+  - `manufacturers.py`: FDA manufacturer schemas
+  - `clearances.py`: 510(k), PMA, De Novo clearance schemas
+  - `classifications.py`: Product codes, device classifications
+  - `products.py`: Product and regulatory status schemas
+  - `recalls.py`: FDA recall schemas
+  - `adverse_events.py`: MAUDE adverse event schemas
+
+- **use_cases/** - Clinical AI use case taxonomy
+  - `categories.py`: Use case category hierarchy
+  - `use_cases.py`: Use case schemas with evidence links
+
+- **documents/** - MongoDB three-tier document structure
+  - `base.py`: Base classes for all `kb_*` collections
+  - `evidence.py`: Evidence/publication documents
+  - `regulatory.py`: Regulatory document schemas (510k summaries)
+  - `models.py`: AI model card documents
+  - `products.py`: Product profile cards
+  - `manufacturers.py`: Manufacturer profile cards
+  - `use_cases.py`: Clinical use case documents
+
+- **utils/** - Parsing and normalization utilities (future)
+
+### Three-Tier MongoDB Document Pattern
+
+All `kb_*` collection documents follow this standardized structure:
+
+**Tier 1: metadata_object** - Artifact/file metadata (provenance, versioning, storage)
+**Tier 2: metadata_content** - Content classification metadata (search, filtering)
+**Tier 3: content** - Actual document body (sections, figures, tables, references)
+
+Example:
+```python
+from ashmatics_datamodels.documents import EvidenceDocument, EvidenceMetadataContent
+
+doc = EvidenceDocument(
+    _id="evidence-123",
+    metadata_object=MetadataObjectBase(  # Tier 1
+        storage_location="s3://kb/papers/file.pdf",
+        processing_pipeline="grobid_v0.7.2"
+    ),
+    metadata_content=EvidenceMetadataContent(  # Tier 2
+        document_type=DocumentType.EVIDENCE_DOC,
+        title="AI in Radiology",
+        clinical_domain="radiology"
+    ),
+    content=ContentBase(  # Tier 3
+        sections={"1_intro": SectionBase(title="Introduction", order=1)}
+    )
+)
+```
+
+See `src/ashmatics_datamodels/documents/base.py` for full implementation.
+
+### Validation Philosophy
+
+- **Strict validation**: Validators raise `ValueError` on invalid input (prefer fail-fast)
+- **Normalization**: Auto-uppercase codes (K numbers, product codes, country codes)
+- **Format checking**: Regex validation for FDA identifiers (K######, P######, product codes)
+- **Type safety**: Full Pydantic v2 type hints for IDE support
+
+Example validators:
+- `validate_k_number_format()`: Validates K######/BK######/DEN###### format
+- `validate_product_code()`: Validates 3-letter FDA product codes
+- `validate_iso_date()`: Parses YYYY-MM-DD or MM/DD/YYYY dates
+
+### OpenFDA Alignment
+
+FDA schemas mirror OpenFDA API response structures for easy data ingestion:
+- Field names match OpenFDA JSON keys
+- Enums align with OpenFDA terminology
+- Date formats support both ISO 8601 and US formats
+
+## Key Design Patterns
+
+### Base Model Inheritance
+All models inherit from `AshMaticsBaseModel` which provides:
+- `model_config = ConfigDict(use_enum_values=True, validate_assignment=True)`
+- Common serialization/deserialization behavior
+- Consistent JSON export with `model_dump(by_alias=True)`
+
+### Timestamped Models
+Use `TimestampedModel` for models requiring automatic timestamp tracking:
+```python
+class MyModel(TimestampedModel):
+    name: str
+    # created_at and updated_at auto-generated
+```
+
+### Document Summaries
+Each document type has a corresponding summary schema for list views:
+```python
+summary = EvidenceSummary.from_document(full_document)
+# Flattens three-tier structure for efficient API responses
+```
+
+## Migration Status (Phase Tracking)
+
+**Phase 1 (v0.1.0)** ✅ COMPLETE:
+- FDA core schemas (manufacturers, clearances, classifications, products)
+- Use case base schemas
+- Common validators and enums
+- Regulators and frameworks
+
+**Phase 2 (v0.2.0)** 🚧 IN PROGRESS:
+- MongoDB document schemas (three-tier structure)
+- Evidence and regulatory documents
+- Model cards, product cards, manufacturer cards
+
+**Future Phases**:
+- Phase 3: Ontology consolidation (terms, valuesets from ashmatics-tools)
+- Phase 4: Evidence quality metrics
+- Phase 5: Multi-jurisdiction (EMA, PMDA)
+
+See `docs/Plans/ENGR-DesignPlan-CompleteDataModels-2025-11-21.md` for full migration plan.
+
+## Important Constraints
+
+1. **No ORM coupling**: These are pure Pydantic models, no SQLAlchemy/Beanie dependencies
+2. **No business logic**: Models define structure and validation only
+3. **Database agnostic**: Work with any backend (MongoDB, PostgreSQL, etc.)
+4. **No auto-generated IDs**: Applications manage ID generation
+5. **Apache 2.0 licensing**: All files must include license header
+
+## Testing Standards
+
+- Test files mirror source structure: `tests/fda/test_clearances.py` → `src/ashmatics_datamodels/fda/clearances.py`
+- Use pytest fixtures for common test data
+- Test validation edge cases (invalid K numbers, out-of-range dates)
+- Test JSON serialization roundtrips
+- Test summary generation from full documents
+
+## Consumer Applications
+
+When making changes, consider impact on:
+- **KB FastAPI**: Uses these schemas for request/response validation
+- **ashmatics-knowledgebase-tools**: DocLing pipelines validate against these before API calls
+- **ashmatics-tools**: Will consolidate ontology schemas here
+
+## Version Bumping
+
+Follow semantic versioning:
+- Patch (0.X.Y): Bug fixes, clarifications
+- Minor (0.X.0): New schemas, backward-compatible additions
+- Major (X.0.0): Breaking changes to existing schemas
+
+Update both `pyproject.toml` version and `src/ashmatics_datamodels/__init__.py` `__version__`.

ashmatics_datamodels-0.3.2/LICENSE

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+      whether in tort (including negligence), contract, or otherwise,
+      unless required by applicable law (such as deliberate and grossly
+      negligent acts) or agreed to in writing, shall any Contributor be
+      liable to You for damages, including any direct, indirect, special,
+      incidental, or consequential damages of any character arising as a
+      result of this License or out of the use or inability to use the
+      Work (including but not limited to damages for loss of goodwill,
+      work stoppage, computer failure or malfunction, or any and all
+      other commercial damages or losses), even if such Contributor
+      has been advised of the possibility of such damages.
+
+   9. Accepting Warranty or Additional Liability. While redistributing
+      the Work or Derivative Works thereof, You may choose to offer,
+      and charge a fee for, acceptance of support, warranty, indemnity,
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+      on Your own behalf and on Your sole responsibility, not on behalf
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ashmatics_datamodels-0.3.2/PKG-INFO

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+Metadata-Version: 2.4
+Name: ashmatics-datamodels
+Version: 0.3.2
+Summary: Canonical Pydantic data models for AshMatics healthcare applications - FDA vocabulary, regulatory schemas, and clinical AI use cases
+Project-URL: Homepage, https://github.com/AshMatics/ashmatics-datamodels
+Project-URL: Documentation, https://github.com/AshMatics/ashmatics-datamodels#readme
+Project-URL: Repository, https://github.com/AshMatics/ashmatics-datamodels
+Project-URL: Bug Tracker, https://github.com/AshMatics/ashmatics-datamodels/issues
+Author-email: Asher Informatics PBC <info@asherinformatics.com>
+License: Apache-2.0
+License-File: LICENSE
+Keywords: 510k,clinical-ai,fda,healthcare,medical-devices,openfda,pydantic,regulatory
+Classifier: Development Status :: 3 - Alpha
+Classifier: Intended Audience :: Healthcare Industry
+Classifier: License :: OSI Approved :: Apache Software License
+Classifier: Programming Language :: Python :: 3.11
+Classifier: Programming Language :: Python :: 3.12
+Classifier: Programming Language :: Python :: 3.13
+Classifier: Topic :: Scientific/Engineering :: Medical Science Apps.
+Classifier: Typing :: Typed
+Requires-Python: >=3.11
+Requires-Dist: pydantic<3.0.0,>=2.0.0
+Provides-Extra: dev
+Requires-Dist: mypy>=1.7.0; extra == 'dev'
+Requires-Dist: pytest-cov>=4.1.0; extra == 'dev'
+Requires-Dist: pytest>=7.4.0; extra == 'dev'
+Requires-Dist: ruff>=0.1.0; extra == 'dev'
+Provides-Extra: docs
+Requires-Dist: mkdocs-material>=9.4.0; extra == 'docs'
+Requires-Dist: mkdocs>=1.5.0; extra == 'docs'
+Requires-Dist: mkdocstrings[python]>=0.24.0; extra == 'docs'
+Requires-Dist: pymdown-extensions>=10.0.0; extra == 'docs'
+Description-Content-Type: text/markdown
+
+# AshMatics Core DataModels
+
+**Version: 0.3.1**
+
+Canonical Pydantic data models for AshMatics healthcare applications.
+
+## Changelog
+
+### v0.3.1 (2026-01-25) — ASHKBAPP-66
+- Added `PROCESS_DOCUMENTATION` to `GovernanceCategory` enum
+- This is a core CAI framework category required for MCP service compatibility
+
+## Overview
+
+This library provides the **single source of truth** for data contracts across the AshMatics ecosystem:
+- Knowledge Base (KB)
+- CoreApp
+- ashmatics-tools SDK
+- AI Watch applications
+
+## Features
+
+- **FDA Vocabulary**: OpenFDA-aligned schemas for manufacturers, clearances, classifications, recalls, adverse events
+- **MongoDB Document Schemas**: Three-tier structure for all `kb_*` collections (evidence, regulatory, model cards, products, manufacturers, use cases)
+- **Governance Document Models**: Clinical AI Governance Framework artifacts (policies, SOPs, work products, process documentation)
+- **Use Case Taxonomy**: Clinical AI use case categorization
+- **Rich Validation**: Built-in validators for regulatory identifiers (K numbers, product codes)
+- **Database Agnostic**: Pure Pydantic models, no ORM coupling
+- **Type Safe**: Full type hints with mypy support
+
+## Installation
+
+```bash
+# From git (recommended for now)
+pip install git+https://github.com/AsherInformatics/ashmatics-core-datamodels.git
+
+# Or add to pyproject.toml
+# dependencies = [
+#     "ashmatics-datamodels @ git+https://github.com/AsherInformatics/ashmatics-core-datamodels.git",
+# ]
+```
+
+## Quick Start
+
+```python
+from ashmatics_datamodels.fda import (
+    FDA_ManufacturerBase,
+    FDA_510kClearance,
+    FDA_DeviceClass,
+    ClearanceType,
+)
+
+# Create a manufacturer
+manufacturer = FDA_ManufacturerBase(
+    manufacturer_name="Medical AI Corp",
+    applicant="Medical AI Corp",
+)
+
+# Create a 510(k) clearance with validation
+clearance = FDA_510kClearance(
+    k_number="K240001",  # Validated format
+    clearance_date="2024-08-15",
+    device_name="AI-Chest Scanner",
+    device_class=FDA_DeviceClass.CLASS_2,
+)
+```
+
+## Package Structure
+
+```
+ashmatics_datamodels/
+├── common/          # Base models, validators, regulators, frameworks
+├── fda/             # FDA vocabulary (manufacturers, clearances, classifications, recalls, adverse events)
+├── documents/       # MongoDB document schemas (three-tier structure)
+├── use_cases/       # Clinical AI use case taxonomy
+└── utils/           # Parsing and normalization utilities
+```
+
+## Documentation
+
+📚 **[Full Documentation](https://asherinformatics.github.io/ashmatics-core-datamodels/)** (when published)
+
+Or build locally:
+```bash
+uv pip install -e ".[docs]"
+uv run mkdocs serve
+```
+
+### Design Documents
+- [Phase 1: FDA & Common Schemas](docs/IMPL-CommonDataModel_Phase1-2025-11-21.md)
+- [Phase 2: MongoDB Document Schemas](docs/IMPL-MongoDocumentSchemas-Phase2-2025-11-21.md)
+- [Complete Migration Plan](docs/Plans/ENGR-DesignPlan-CompleteDataModels-2025-11-21.md)
+
+## License
+
+Apache 2.0 - See [LICENSE](LICENSE) for details.
+
+## Contributing
+
+This is an internal Asher Informatics library. For questions, contact info@asherinformatics.com.