pf-consent-docs: Healthcare Consent Document Generator (v1.1)

Generate professional, state-aware informed consent documents for healthcare practices — procedure consents, telehealth consents, research consents, and complete new-patient consent bundles. All templates include mandatory attorney review disclaimer.

Important: All documents generated by this plugin are drafts intended as starting points. Clinical and healthcare documents must be reviewed by a qualified healthcare professional before use. This plugin does not provide medical advice and is not a substitute for professional clinical judgment. Ensure all output complies with your organization's HIPAA policies and applicable regulations.

Installation

1. Download the pf-consent-docs.plugin file
2. Open Claude Desktop and navigate to Settings > Plugins
3. Click Install Plugin and select the downloaded .plugin file
4. The plugin will be installed and available immediately

Note: All data stays local on your machine. No external API calls or cloud storage required.

Why This Exists

Healthcare practices spend significant time and money creating compliant consent documents:

• IntakeQ: $599-$959/year
• Formstack HIPAA: $1,188+/year
• Jotform HIPAA: $1,188+/year

This plugin generates professional consent documents for included with your subscription — documents stay Local processing, are fully customizable, and require no subscription or online service.

Quick Start (5 Steps)

1. Setup your practice profile (one-time)

   /consent-docs:consent-docs-setup
   

   Provide: practice name, state, specialty, provider name, credentials

2. Generate a consent document

   /consent-docs:consent-docs-generate
   

   Choose: Procedure consent, telehealth consent, research consent, or bundle

3. Edit the document (optional)

   • Download DOCX file
   • Edit in Word, Google Docs, or LibreOffice
   • Customize procedure-specific details
   • Save your modified version

4. Review with attorney (required)

   • Have qualified healthcare attorney review
   • Verify state law compliance
   • Approve before patient use

5. Deploy to patients

   • Print and use for in-person signatures
   • Upload to DocuSign/Adobe Sign for e-signatures
   • Store in patient records

Commands

Command	Purpose	Output
/consent-docs:consent-docs-setup	Initialize workspace, configure practice	.consent-docs/config.json
/consent-docs:consent-docs-generate	Generate procedure-specific consent	outbound/consent-{procedure}-{date}.docx
/consent-docs:consent-docs-telehealth	Generate telehealth consent (with state/specialty variants)	outbound/consent-telehealth-{date}.docx
/consent-docs:consent-docs-research	Generate IRB-aligned research consent	outbound/consent-research-{study}-{date}.docx
/consent-docs:consent-docs-bundle	Generate complete new-patient consent package (up to 6 forms)	outbound/consent-bundle-{date}.docx
/consent-docs:consent-docs-status	Check practice config, document count, dependencies	Console output

How It Works

1. Setup Phase — Run setup once to configure your practice profile (name, state, specialty, provider credentials). Saved to .consent-docs/config.json.

2. Generation Phase — Run any consent command (generate, telehealth, research, bundle). Provide procedure/study details via conversation.

3. Programmatic DOCX Creation — Plugin uses python-docx to build professional Word documents with:

   • Proper formatting (12pt body, 14pt headings, 1-inch margins)
   • State-specific legal language based on configured state
   • Practice information from setup
   • Professional structure with 11-14 sections depending on document type

4. Output — Documents saved as .docx files in outbound/ folder. Download, customize, review with attorney, and deploy.

What It's an Alternative To

Feature	pf-consent-docs	IntakeQ	Formstack	Jotform
Procedure consent forms	✅	✅	✅	✅
Telehealth consent forms	✅	✅	⚠	⚠
Research consent (IRB)	✅	❌	⚠	❌
New-patient consent bundles	✅	⚠	❌	❌
State-specific language	✅	⚠	❌	❌
E-signatures	❌	✅	✅	✅
Patient portal	❌	✅	✅	✅
EHR integration	❌	✅	⚠	❌
Data stays local	✅	❌	❌	❌
Customizable DOCX	✅	⚠	✅	✅
No subscription cost	✅	❌	❌	❌
Offline operation	✅	❌	❌	❌

pf-consent-docs cost: included with your subscription (included with Claude Desktop/Cowork subscription) Competitors: $1,188+/year + setup fees

Key Differentiators

• Included with your subscription — No subscription, included with Claude Desktop or Cowork
• Data Local — All documents processed within the Cowork environment; nothing uploaded to cloud
• Fully Customizable — Edit generated DOCX in Word, Google Docs, LibreOffice
• No Bloat — Focused tool; no patient portals, e-signature platform, or EHR integration to slow you down
• State-Aware — Generates state-specific consent language for all 50 states + DC
• AI-Powered — Claude synthesizes procedure risks, benefits, and state-specific legal language
• Offline-Ready — Generate documents without internet (after setup)
• Professional Output — 11-14 section DOCX documents with proper formatting

Feature Comparison

Aspect	pf-consent-docs	Competitors
Setup time	5 minutes	15-30 minutes (account creation, payment info, etc.)
Cost	Included with your subscription	$1,188-$2,876/year
Learning curve	Low (conversational)	Medium (form builders)
Customization	Full DOCX editing	Limited form templates
Integration	File-based	API/portal integrations
Data privacy	Local processing	Cloud-based (HIPAA BAA required)
Offline use	Yes	No
Regulatory citations	Source-level (CFR sections, case law, TJC standards)	Generic or none
State consent standard	Auto-classified (patient-centered vs physician-centered)	Manual
Knowledge base	Centralized, updatable	Embedded in templates
Validation checklists	Per-category (procedure, telehealth, research, HIPAA)	None

AI-Powered Features

• State-Aware Drafting: Automatically classifies each state's consent standard (patient-centered per Canterbury v. Spence or physician-centered) and generates jurisdiction-specific legal language
• Procedure Risk Synthesis: Synthesizes procedure-specific risks and benefits from clinical context provided by provider
• Consent Form Customization: Creates tailored consent documents with practice-specific information and provider credentials
• Telehealth Language: Generates specialty-specific telehealth consent forms with Ryan Haight Act (21 USC §829) compliance and two-party recording state detection
• Research Protocol Integration: Creates IRB-aligned research consent per 45 CFR §46.116 (8 required elements) and 21 CFR §50.25 with vulnerable population protections
• Compliance Framework: Validates against TJC RI.01.03.01 informed consent standards, CMS CoP 42 CFR §482.24/§482.51, and AMA Ethics Opinion 2.1.1
• Centralized Knowledge Base: All regulatory knowledge centralized in consent-docs-kb with source-level citations (specific CFR sections, case law, accreditation standards)
• HIPAA NPP Compliance: Bundle HIPAA acknowledgment cites specific patient rights per 45 CFR §164.520-§164.528 and HITECH §13402
• Interstate Licensing Detection: Identifies IMLC member states for telehealth interstate practice compliance
• Per-Category Validation Checklists: Procedure consent, telehealth, research, and HIPAA NPP checklists ensure no required element is missed

Estimated Cost per Use

Disclaimer: Token estimates are approximate and based on typical usage patterns measured from skill prompt sizes. Actual costs vary with input data size, conversation length, and complexity. Estimates use Claude Sonnet 4.6 pricing ($3/1M input, $15/1M output). Cowork and Claude Desktop subscription users (Pro/Max/Team) are not charged per-token — these estimates apply only to direct Anthropic API usage. Running stages individually in fresh sessions uses fewer input tokens than running the full pipeline sequentially, because pipeline mode accumulates conversation history across stages.

Per skill (run individually in a fresh session):

Stage	Skill Prompt	User Input	Total Input	Output	Est. Cost
intake-questionnaire	~3.3K	~800	~6.8K	~3.3K	~$0.07
consent-docs-generate	~4.8K	~800	~8.7K	~6.0K	~$0.12
intake-insurance	~2.7K	~800	~6.1K	~3.0K	~$0.06
consent-docs-kb	~5.2K	~800	~8.8K	~5.2K	~$0.10
consent-docs-bundle	~6.2K	~800	~10.8K	~6.0K	~$0.12
intake-history	~2.5K	~800	~6.0K	~3.0K	~$0.06
consent-docs-research	~5.7K	~800	~10.2K	~5.7K	~$0.12
consent-docs-telehealth	~6.3K	~800	~10.5K	~6.0K	~$0.12
Standalone total			~67.9K	~38.3K	~$0.78

Full pipeline (all stages in one session — context accumulates):

Stage	Base Input	+ History	Total Input	Output	Est. Cost
intake-questionnaire	~7.1K	0	~7.1K	~3.3K	~$0.07
consent-docs-generate	~8.6K	~4.1K	~12.8K	~6.0K	~$0.13
intake-insurance	~6.5K	~10.9K	~17.4K	~3.0K	~$0.10
consent-docs-kb	~9.0K	~14.7K	~23.8K	~5.2K	~$0.15
consent-docs-bundle	~10.0K	~20.8K	~30.8K	~6.0K	~$0.18
intake-history	~6.3K	~27.6K	~33.9K	~3.0K	~$0.15
consent-docs-research	~9.5K	~31.4K	~40.9K	~5.7K	~$0.21
consent-docs-telehealth	~10.1K	~37.9K	~47.9K	~6.0K	~$0.23
Pipeline total			~214.5K	~38.3K	~$1.22

Running the full pipeline once typically costs $0.85–$1.58 in API tokens (Claude Sonnet 4.6).

Known Limitations & Workarounds

Limitation	Impact	Workaround
No e-signatures natively	Forms require manual signing or DocuSign upload	Export DOCX to DocuSign, Adobe Sign, or other e-signature platform
No persistent database	No tracking of who signed what	Use your EHR or practice management system for signature tracking
Session-based operation	No automated signature reminders	Send reminders manually via email or patient portal
Knowledge cutoff (Feb 2025)	State laws may have changed	Always have attorney review before use; attorney review is mandatory anyway
No real-time API integrations	Cannot pull data from EHR	User provides procedure/study details via conversation
Legal disclaimer required	Every document must include AI disclaimer	Disclaimer is automatically included; cannot be removed

Context & Performance Guide

• DAG Architecture: Each consent command runs independently; no dependencies between commands
• Bundle Limit: Hard limit of 6 forms per bundle (for context safety and file size)
• Recommended Max: Generate up to 5 documents per session; start new session if hitting context limits
• Python Requirement: Python 3.9+ required; python-docx auto-installed during setup
• File Output: All documents saved with timestamps to avoid overwrites

Requirements

• Python: 3.9 or higher
• Python Library: python-docx (auto-installed via setup)
• Word Processor: Microsoft Word, Google Docs, or LibreOffice (for editing)
• Optional: DocuSign/Adobe Sign account (for e-signatures)

Important Disclaimers

• AI-Generated Content: This plugin uses AI (LLM) technology which can produce inaccurate or incomplete outputs. All content should be treated as a starting point and reviewed for accuracy before use.
• Not Professional Advice: Outputs do not constitute legal, financial, tax, medical, or other professional advice. Consult qualified professionals before making decisions based on generated content.
• No Compliance Guarantee: References to industry standards, regulations, or guidelines are for informational purposes only. This plugin does not guarantee compliance with any law or regulation. Users are responsible for verifying all outputs meet their specific regulatory requirements.
• No Endorsement or Affiliation: Mention of third-party products, standards, or organizations does not imply endorsement, partnership, or certification by those entities.
• Not Medical or Health Advice: Health and medical-related outputs are not a substitute for professional medical advice, diagnosis, or treatment. Always consult a licensed healthcare provider for health-related decisions.