AI Health Knowledge Hub

Curated database updated every Friday. Last updated: 07 Mar 2025. v1.0

Build in public. Next features: Summary of documents (Q1 2025), AI Health Central GPT (Q1 2025)

Title	Categories	Tags	Author	Link	hf:doc_categories	hf:doc_tags	hf:doc_author
Questionnaire “Cybersecurity for Medical Devices – Audit“	Document, EU	Questionnaire	IG-NB	DOWNLOAD	document eu	questionnaire	ig-nb
Questionnaire “Cybersecurity for Medical Devices – Technical Documentation”	Document, EU	Questionnaire	IG-NB	DOWNLOAD	document eu	questionnaire	ig-nb
Questionnaire: Artificial Intelligence (AI) in medical devices	Document, EU	Position Paper	Team NB	DOWNLOAD	document eu	position-paper	team-nb
Guideline for AI-based medical devices and IVD	Document, Global	Guidance	Johner Institute	DOWNLOAD	document global	guidance	johner-institute
Guideline for AI for medical products	Document, Global	Guidance	Johner Institute	DOWNLOAD	document global	guidance	johner-institute
EU AI Act Compliance Checker	Document, EU	Web page	Future of Life Institute	DOWNLOAD	document eu	web-page	future-of-life-institute
Software and artificial intelligence (AI) as a medical device	Document, UK	Guidance	MHRA	DOWNLOAD	document uk	guidance	mhra
European AI Office	Document, EU	Web page	EU Commission	DOWNLOAD	document eu	web-page	eu-commission
How to trust AI enabled Medical Devices. An overview covering technical and clinical aspects.	Document, EU	Webinar (on-demand)	TÜV SÜD	DOWNLOAD	document eu	webinar-on-demand	tuv-sud
Artificial intelligence and Machine Learning in Medical Devices	Document, EU	Webinar (on-demand)	TÜV SÜD	DOWNLOAD	document eu	webinar-on-demand	tuv-sud
Global Approach to Software as a Medical Device	Document, US	Web page	FDA	DOWNLOAD	document us	web-page	fda
What are examples of Software as a Medical Device?	Document, US	Web page	FDA	DOWNLOAD	document us	web-page	fda
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations	Document, US	Guidance	FDA	DOWNLOAD	document us	guidance	fda
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles	Document, US	Guiding Principles	FDA	DOWNLOAD	document us	guiding-principles	fda
Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles	Document, US	Guiding Principles	FDA	DOWNLOAD	document us	guiding-principles	fda
EU AI Act	Document, EU	Regulation	European Parliament and the Council	DOWNLOAD	document eu	regulation	european-parliament-and-the-council
AI Airlock: The Regulatory Sandbox for AIaMD	Document, UK	Collection	MHRA	DOWNLOAD	document uk	collection	mhra
Characterization Considerations for Medical Device Software and Software-Specific Risk	Document, Global	Guidance	IMDRF	DOWNLOAD	document global	guidance	imdrf
Good machine learning practice for medical device development: Guiding principles	Document, Global	Guiding Principles	IMDRF	DOWNLOAD	document global	guiding-principles	imdrf
South Africa’s Artificial Intelligence Planning	Document, South Africa	Discussion Document	Department of Communications and Digital Technologies	DOWNLOAD	document south-africa	discussion-document	department-of-communications-and-digital-technologies
Artificial Intelligence in Africa: Challenges and Opportunities	Africa, Document	Policy		DOWNLOAD	africa document	policy
Use Case Brief: Artificial Intelligence in Health – A Focus on Africa	Africa, Document	Use Case Brief	CIPIT	DOWNLOAD	africa document	use-case-brief	cipit
Artificial Intelligence in Healthcare: Proposals for Policy Development in South Africa	Document, South Africa	Author manuscript	Naidoo et al.	DOWNLOAD	document south-africa	author-manuscript	naidoo-et-al
Regulatory Considerations on Artificial Intelligence for Health	Document, Global	Guidance	World Health Organization	DOWNLOAD	document global	guidance	world-health-organization
Mapping the Regulatory Landscape of AI in Healthcare in Africa	Africa, Document	Research Article	Townsend et al.	DOWNLOAD	africa document	research-article	townsend-et-al
State of AI in Healthcare in Sub-Saharan Africa	Document, Sub-Saharan Africa	Report	Ceimia	DOWNLOAD	document sub-saharan-africa	report	ceimia
Seizing the Opportunity: The Future of AI in Latin America	Document, Latin America	Economic Report	The Economist Impact	DOWNLOAD	document latin-america	economic-report	the-economist-impact
Center of Artificial Intelligence and Health for Latin America and the Caribbean: Document	Caribbean, Document, Latin America	Policy	AI4Caribbean	DOWNLOAD	caribbean document latin-america	policy	ai4caribbean
Advances in the Use of Artificial Intelligence in Latin American Medical Education	Document, Latin America	Review Paper	Domínguez et al.	DOWNLOAD	document latin-america	review-paper	dominguez-et-al
Policy and Regulatory Recommendations for Digital Health in Latin America and the Caribbean	Caribbean, Document, Latin America	Policy	Americas Business Dialogue	DOWNLOAD	caribbean document latin-america	policy	americas-business-dialogue
Regulatory Ecosystem for Artificial Intelligence in the Health Sector	Document, Latin America	Technical Document	Regulatory Ecosystem Document	DOWNLOAD	document latin-america	technical-document	regulatory-ecosystem-document
Regulatory Mapping on Artificial Intelligence in Latin America	Document, Latin America	Report	Access Now	DOWNLOAD	document latin-america	report	access-now
The Artificial Intelligence and Data Act (AIDA) – Companion document	Canada, Document	Companion Document	Health Canada	DOWNLOAD	canada document	companion-document	health-canada
Transparency for machine learning-enabled medical devices: Guiding principles	Canada, Document	Guiding Principles	Health Canada	DOWNLOAD	canada document	guiding-principles	health-canada
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles	Canada, Document	Guiding Principles	Health Canada	DOWNLOAD	canada document	guiding-principles	health-canada
Good Machine Learning Practice for Medical Device Development: Guiding Principles	Canada, Document	Guiding Principles	Health Canada	DOWNLOAD	canada document	guiding-principles	health-canada
Pre-market guidance for machine learning-enabled medical devices	Canada, Document	Guidance	Health Canada	DOWNLOAD	canada document	guidance	health-canada
FDA Digital Health and Artificial Intelligence Glossary – Educational Resource	Document, US	Educational Resource	FDA	DOWNLOAD	document us	educational-resource	fda
Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products (March 2023)	Document, US	Discussion Paper	FDA	DOWNLOAD	document us	discussion-paper	fda
Good Machine Learning Practice for Medical Device Development: Guiding Principles	Document, US	Guiding Principles	FDA	DOWNLOAD	document us	guiding-principles	fda
Artificial Intelligence and Machine Learning Software as a Medical Device Action Plan	Document, US	Action Plan	FDA	DOWNLOAD	document us	action-plan	fda
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback	Document, US	Discussion Paper	FDA	DOWNLOAD	document us	discussion-paper	fda
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions	Document, US	Guidance	FDA	DOWNLOAD	document us	guidance	fda
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations	Document, US	Guidance	FDA	DOWNLOAD	document us	guidance	fda
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products	Document, US	Guidance	FDA	DOWNLOAD	document us	guidance	fda