Healthcare AI Governance FAQs

Question 1

Can Healthcare AI Governance classify AI/ML software as a Medical Device?

Accepted Answer

Yes, the tool includes a dedicated `classify_samd` function that helps determine if your AI/ML software qualifies as a Software as a Medical Device (SaMD) according to FDA guidelines, based on its description, intended use, and patient risk.

Question 2

What is Healthcare AI Governance?

Accepted Answer

Healthcare AI Governance is a powerful software tool designed to help organizations ensure their artificial intelligence systems in healthcare comply with critical regulatory frameworks and ethical guidelines, including FDA, HIPAA, WHO, and the EU AI Act.

Question 3

Is there a free tier or trial available for Healthcare AI Governance?

Accepted Answer

Yes, a free tier is available, allowing users to make up to 15 API calls per day. For unlimited access and advanced features, users can upgrade their plan at meok.ai/pricing.

Question 4

How does it assist with HIPAA compliance for AI systems?

Accepted Answer

The `hipaa_ai_check` function within Healthcare AI Governance evaluates AI systems processing protected health information. It verifies compliance based on data types, processing purposes, and the presence of a Business Associate Agreement (BAA).

Question 5

Which specific compliance frameworks does the tool support?

Accepted Answer

It provides robust support for FDA (Software as a Medical Device (SaMD) classification and Clinical Decision Support (CDS) exemption), HIPAA for health data processing, WHO's 6 principles for health AI ethics, and dual compliance checks for FDA and EU AI Act for medical AI devices.

Healthcare AI Governance

Healthcare AI Governance

Características Principales

Casos de Uso

Características Principales

Casos de Uso