Program 4 of 58-Hour IntensiveVP, SVP & Sr. Director, IT & Engineering

Governed AI for Life Sciences & Healthcare Leadership Track

Could You Name Every AI Tool in Your Org That Needs FDA Clearance?

An executive intensive for leaders across life sciences and healthcare focused on AI governance, regulatory readiness, and board-ready ROI.

AI LiteracyGovernanceFDA SaMD & EU AI ActExecutive Track

AI LITERACY: NON-NEGOTIABLE FOR EXECUTIVES

Executives are the last line of defense against AI-driven regulatory failure

30%

Health system leaders could correctly identify which AI tools in their organization required FDA clearance.

Source: JAMA 2024

2.4x

More likely to report that AI investments met or exceeded projected ROI. Correlated with overpayment and underperformance.

Source: McKinsey's 2024 State of AI Report

$$$

Margin expansion, growth and valuation impact. Tempus AI IPO achieved a $6.1B staggering valuation.

Market Impact

CURRICULUM OVERVIEW

PRE-WORK (OPTIONAL) · 8 HOURS · 2 WEEKS PRIOR
Client-Specific Use Case Research
Familiarize with AI regulations, identify enterprise AI tools & understanding of enterprise data & AI target operating model.
MORNING SESSION
AI Impact on Regulatory Landscape & Building ROI Model
Build/Buy/Partner Framework. Deep dive into EU AI Act, FDA SaMD, HIPAA; personal liability exposure; compliance obligations.
AFTERNOON SESSION
AI Governance Strategy
Playbook of building a governed AI ecosystem impacting EBITDA.

FDA SaMDEU AI ActHIPAA / GDPRROI ModelingTarget Operating ModelExecutive Playbook

LEARNING OUTCOMES

By end of day, executives will be able to:

Program 4 of 5ExecutivesLife Sciences & Healthcare