AI Regulatory Readiness Assessment | DREAM Method
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AI Regulatory Readiness Assessment
Evaluate your healthcare organization's readiness for AI implementation in Canada
Health Canada Compliance
SaMD & GMLP Requirements
Provincial Privacy Laws
PHIPA, PIPA, HIPA Compliance
Professional Standards
College Requirements
Assessment Progress
0% Complete
Complete all sections to receive your personalized compliance report
Organization Information
Organization Type
Select your organization type
Hospital/Health Authority
Private Clinic
Pharmacy
Allied Health Practice
Long-term Care
Mental Health Services
Other Healthcare Organization
Province/Territory
Select your province
Ontario
British Columbia
Alberta
Saskatchewan
Manitoba
Quebec
New Brunswick
Nova Scotia
Prince Edward Island
Newfoundland and Labrador
Yukon
Northwest Territories
Nunavut
Organization Size
Select organization size
Small (1-50 employees)
Medium (51-250 employees)
Large (251-1000 employees)
Enterprise (1000+ employees)
AI Implementation Stage
Select current stage
Planning/Researching
Pilot Implementation
Partial Deployment
Full Implementation
Advanced/Multiple Systems
Health Canada Regulatory Compliance
Assess your understanding and compliance with Health Canada's Software as Medical Device (SaMD) and Good Machine Learning Practice (GMLP) requirements.
1. Does your organization understand when AI tools qualify as Software as Medical Device (SaMD)?
Yes, we have clear policies and can classify AI tools appropriately
Mostly, but some uncertainty exists
Basic understanding, but need more guidance
Limited understanding of SaMD classification
No understanding of SaMD requirements
2. Are you familiar with Health Canada's Good Machine Learning Practice (GMLP) principles?
Very familiar and actively applying all 10 principles
Familiar with most principles and applying many
Some familiarity but inconsistent application
Limited familiarity with GMLP principles
Not familiar with GMLP principles
3. Does your organization have processes for evaluating AI vendor regulatory compliance?
Yes, comprehensive vendor assessment protocols in place
Basic vendor assessment process exists
Informal vendor evaluation practices
Limited vendor evaluation capabilities
No vendor assessment process
4. Does your organization understand post-market surveillance requirements for AI medical devices?
Yes, we have monitoring protocols for AI performance
Some monitoring in place but could be improved
Basic understanding but limited monitoring
Minimal understanding of post-market requirements
No understanding of post-market surveillance
5. Does your organization have multi-disciplinary expertise for AI evaluation as recommended by GMLP?
Yes, including clinical, technical, ethical, and legal expertise
Most expertise areas covered
Some expertise areas but gaps exist
Limited multi-disciplinary expertise
No structured multi-disciplinary approach
Provincial Privacy Legislation Compliance
Evaluate your compliance with provincial privacy laws including PHIPA (Ontario), PIPA (Alberta), HIPA (Saskatchewan), and other provincial requirements.
6. Does your organization understand the privacy legislation that governs your jurisdiction?
Yes, thoroughly understand applicable privacy laws
Good understanding with some areas for improvement
Basic understanding but need more guidance
Limited understanding of privacy requirements
Minimal understanding of privacy legislation
7. Do you have processes for obtaining appropriate consent for AI use with patient information?
Yes, comprehensive consent processes for AI applications
Good consent processes with minor gaps
Basic consent processes but AI-specific needs unclear
Limited consent processes for AI use
No specific consent processes for AI
8. Does your organization implement the "need-to-know" principle for AI access to patient information?
Yes, strict access controls limit AI to minimum necessary information
Good access controls with some room for improvement
Basic access controls but not AI-specific
Limited access control implementation
No specific access controls for AI systems
9. Do you have appropriate safeguards to protect personal health information used by AI systems?
Yes, comprehensive technical, administrative, and physical safeguards
Good safeguards with minor gaps
Basic safeguards but AI-specific needs unclear
Limited safeguards for AI systems
Minimal safeguards in place
10. Does your organization have procedures for managing patient access rights regarding AI use of their information?
Yes, clear procedures for patient access and correction rights
Good procedures with some areas for improvement
Basic procedures but AI-specific processes unclear
Limited procedures for patient access rights
No specific procedures for AI-related access rights
Professional Standards and Ethics
Assess your alignment with professional regulatory college requirements and ethical standards for AI use in healthcare practice.
11. Are you familiar with your professional regulatory college's guidance on AI use?
Yes, thoroughly familiar and compliant with college guidance
Familiar with most guidance and generally compliant
Some familiarity but need more understanding
Limited familiarity with professional AI guidance
Not familiar with professional college AI guidance
12. Does your organization ensure human oversight remains in clinical decision-making when using AI?
Yes, clear protocols ensure human oversight for all AI-assisted decisions
Generally good human oversight with minor gaps
Some human oversight but protocols could be clearer
Limited human oversight protocols
No specific human oversight requirements
13. Do you have processes to address bias and ensure equitable AI outcomes?
Yes, comprehensive bias detection and mitigation processes
Good bias awareness with some mitigation efforts
Basic understanding but limited bias mitigation
Minimal bias detection processes
No bias detection or mitigation processes
14. Does your organization provide AI literacy training for healthcare professionals?
Yes, comprehensive ongoing AI literacy training programs
Good training programs with regular updates
Basic training but could be more comprehensive
Limited AI literacy training
No AI literacy training provided
15. Do you have clear accountability frameworks for AI-assisted care decisions?
Yes, clear accountability and liability frameworks for AI use
Good accountability frameworks with minor gaps
Basic accountability but AI-specific needs unclear
Limited accountability frameworks
No specific accountability frameworks for AI
Organizational Readiness
Evaluate your organization's technical, financial, and cultural readiness for AI implementation.
16. Does your organization have adequate IT infrastructure to support AI implementation?
Yes, robust IT infrastructure with AI capabilities
Good infrastructure with some upgrades needed
Basic infrastructure but significant upgrades required
Limited IT infrastructure
Inadequate IT infrastructure for AI
17. Does your organization have dedicated resources (budget, personnel) for AI initiatives?
Yes, dedicated AI budget and personnel
Some dedicated resources with plans for expansion
Limited dedicated resources
Minimal resources allocated to AI
No dedicated AI resources
18. Does your organization have strong leadership support for AI implementation?
Yes, strong leadership commitment and vision for AI
Good leadership support with some hesitation
Moderate leadership support
Limited leadership support
Minimal or no leadership support
19. Is your organization's culture open to technological innovation and change?
Yes, highly innovative culture embraces new technology
Generally open to innovation with some resistance
Moderate openness to change
Resistant to change and new technology
Highly resistant to technological change
20. Does your organization have experience implementing new healthcare technologies?
Yes, extensive successful technology implementation experience
Good implementation experience with some challenges
Limited implementation experience
Minimal technology implementation experience
No significant technology implementation experience
Calculate Your Readiness Score
Your AI Regulatory Readiness Report
0%
Overall Readiness Score
Detailed Section Scores
Health Canada Compliance
0%
Privacy Compliance
0%
Professional Standards
0%
Organizational Readiness
0%
Personalized Recommendations
Priority Action Plan
Additional Resources
Federal Resources
Health Canada - Software as Medical Device Guidance
Health Canada - Good Machine Learning Practice
Privacy Commissioner - AI Decision-Making Guidance
Pan-Canadian AI for Health Principles
Provincial Resources
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const section2 = calculateSectionScore(['q6', 'q7', 'q8', 'q9', 'q10']);
const section3 = calculateSectionScore(['q11', 'q12', 'q13', 'q14', 'q15']);
const section4 = calculateSectionScore(['q16', 'q17', 'q18', 'q19', 'q20']);
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// Create chart
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// Generate recommendations
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// Generate action plan
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// Update provincial resources
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function getOverallInterpretation(score) {
if (score >= 80) return "Excellent readiness for AI implementation";
if (score >= 60) return "Good readiness with some areas for improvement";
if (score >= 40) return "Moderate readiness requiring focused preparation";
if (score >= 20) return "Limited readiness requiring significant preparation";
return "Foundational work needed before AI implementation";
}
function getSectionInterpretation(score) {
if (score >= 80) return "Strong performance";
if (score >= 60) return "Good foundation";
if (score >= 40) return "Needs improvement";
if (score >= 20) return "Requires attention";
return "Critical gaps";
}
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function generateRecommendations(section1, section2, section3, section4, overall) {
const recommendations = [];
if (section1 < 60) {
recommendations.push({
title: "Health Canada Regulatory Compliance",
level: "high",
content: "Immediate action needed to understand Software as Medical Device (SaMD) requirements and Good Machine Learning Practice (GMLP) principles. Consider engaging regulatory consultants and establishing multi-disciplinary evaluation teams."
});
}
if (section2 < 60) {
recommendations.push({
title: "Provincial Privacy Legislation",
level: "high",
content: "Strengthen understanding of provincial privacy requirements and implement robust consent processes for AI use. Establish clear data governance policies and access controls."
});
}
if (section3 < 60) {
recommendations.push({
title: "Professional Standards and Ethics",
level: "medium",
content: "Develop comprehensive AI literacy training programs and establish clear accountability frameworks. Implement bias detection and mitigation processes."
});
}
if (section4 < 60) {
recommendations.push({
title: "Organizational Readiness",
level: "medium",
content: "Invest in IT infrastructure upgrades and secure dedicated resources for AI initiatives. Build leadership support and foster a culture of innovation."
});
}
if (overall >= 80) {
recommendations.push({
title: "Advanced Implementation",
level: "low",
content: "Your organization shows excellent readiness. Focus on pilot implementations and continuous monitoring. Consider becoming a center of excellence for other organizations."
});
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`).join('');
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function generateActionPlan(section1, section2, section3, section4) {
const actions = [];
// Prioritize based on lowest scores
const sections = [
{ name: "Health Canada Compliance", score: section1, actions: ["Review SaMD classification requirements", "Establish GMLP compliance processes", "Create vendor assessment protocols"] },
{ name: "Privacy Compliance", score: section2, actions: ["Update consent processes for AI", "Implement need-to-know access controls", "Establish data governance framework"] },
{ name: "Professional Standards", score: section3, actions: ["Develop AI literacy training", "Create human oversight protocols", "Implement bias detection processes"] },
{ name: "Organizational Readiness", score: section4, actions: ["Assess IT infrastructure needs", "Secure dedicated AI resources", "Build leadership support"] }
];
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sections.sort((a, b) => a.score - b.score);
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`).join('');
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}
function updateProvincialResources() {
const province = assessmentData.orgInfo.province;
const resources = {
'ON': [
'Ontario - Personal Health Information Protection Act (PHIPA)',
'Information and Privacy Commissioner of Ontario',
'Ontario Health Data Centre',
'Digital Health Ontario Resources'
],
'BC': [
'British Columbia - Personal Information Protection Act',
'Office of the Information and Privacy Commissioner (BC)',
'BC Ministry of Health AI Guidelines',
'Provincial Health Services Authority'
],
'AB': [
'Alberta - Personal Information Protection Act (PIPA)',
'Office of the Information and Privacy Commissioner (AB)',
'Alberta Health AI Implementation Guide',
'Alberta Medical Association Resources'
],
'SK': [
'Saskatchewan - Health Information Protection Act (HIPA)',
'Saskatchewan Information and Privacy Commissioner',
'Saskatchewan Health Authority Guidelines',
'College of Physicians and Surgeons of Saskatchewan'
]
};
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${rec.title}
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Priority ${index + 1}: ${section.name} (${Math.round(section.score)}%)
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