White Paper: Navigating Regulations for AI-Driven Clinical Decision Support Software
Understand the regulatory landscape. Build with confidence.
As AI transforms clinical decision support (CDS) software, navigating FDA oversight, HIPAA compliance, and international regulatory frameworks has become essential — and complex. This white paper offers healthcare founders, operators, and developers a clear, actionable breakdown of how to bring AI-powered CDS tools to market with transparency, compliance, and trust.
Inside you’ll learn:
Which AI-driven CDS tools fall under FDA’s Software as a Medical Device (SaMD) framework
How the 21st Century Cures Act impacts your regulatory path
Requirements for pre-market approval (510(k), De Novo, and PMA)
How to avoid bias and ensure equity in AI models
HIPAA, GDPR, and state-specific data privacy laws (including California’s genetic data protections)
Global frameworks: What to know about MHRA (UK) and WHO recommendations
Who it’s for:
Healthcare AI startups, regulatory leads, legal teams, investors evaluating digital health, and product teams building CDS tools.
Written by:
Dr. Adam Brown, MD, MBA
Dr. Steven A. Farmer, MD, PhD
Edited by Kerrie Rushton
Understand the regulatory landscape. Build with confidence.
As AI transforms clinical decision support (CDS) software, navigating FDA oversight, HIPAA compliance, and international regulatory frameworks has become essential — and complex. This white paper offers healthcare founders, operators, and developers a clear, actionable breakdown of how to bring AI-powered CDS tools to market with transparency, compliance, and trust.
Inside you’ll learn:
Which AI-driven CDS tools fall under FDA’s Software as a Medical Device (SaMD) framework
How the 21st Century Cures Act impacts your regulatory path
Requirements for pre-market approval (510(k), De Novo, and PMA)
How to avoid bias and ensure equity in AI models
HIPAA, GDPR, and state-specific data privacy laws (including California’s genetic data protections)
Global frameworks: What to know about MHRA (UK) and WHO recommendations
Who it’s for:
Healthcare AI startups, regulatory leads, legal teams, investors evaluating digital health, and product teams building CDS tools.
Written by:
Dr. Adam Brown, MD, MBA
Dr. Steven A. Farmer, MD, PhD
Edited by Kerrie Rushton
Understand the regulatory landscape. Build with confidence.
As AI transforms clinical decision support (CDS) software, navigating FDA oversight, HIPAA compliance, and international regulatory frameworks has become essential — and complex. This white paper offers healthcare founders, operators, and developers a clear, actionable breakdown of how to bring AI-powered CDS tools to market with transparency, compliance, and trust.
Inside you’ll learn:
Which AI-driven CDS tools fall under FDA’s Software as a Medical Device (SaMD) framework
How the 21st Century Cures Act impacts your regulatory path
Requirements for pre-market approval (510(k), De Novo, and PMA)
How to avoid bias and ensure equity in AI models
HIPAA, GDPR, and state-specific data privacy laws (including California’s genetic data protections)
Global frameworks: What to know about MHRA (UK) and WHO recommendations
Who it’s for:
Healthcare AI startups, regulatory leads, legal teams, investors evaluating digital health, and product teams building CDS tools.
Written by:
Dr. Adam Brown, MD, MBA
Dr. Steven A. Farmer, MD, PhD
Edited by Kerrie Rushton