Members – Regulatory Compliance – AI Healthcare Community

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AI ETHICS AND GOVERNANCE Regulatory Compliance

Regulatory Compliance

Public Education

Active 8 weeks ago

Purpose: To provide a platform for discussing the regulatory landscape governing the use of AI... View more

Public Education

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Group Description

Purpose: To provide a platform for discussing the regulatory landscape governing the use of AI in healthcare across different jurisdictions.

Description: This subgroup focuses on navigating the complex regulatory frameworks that apply to healthcare AI, including certifications, approvals, and legal requirements.

Intended Use:
– Sharing insights into global regulations affecting healthcare AI (e.g., FDA, EMA)
– Discussing certification processes for medical devices powered by AI
– Exploring strategies to meet compliance requirements during development and deployment

Limitations:
– Not for discussing general legal issues unrelated to healthcare or AI
– Not for providing legal advice on specific cases

Key Activities:
– Analyzing updates from regulatory bodies (e.g., FDA’s Software as a Medical Device guidelines)
– Discussing challenges faced by startups in obtaining regulatory approvals
– Sharing experiences with audits or compliance reviews of healthcare AI systems

Potential Users:
– Policymakers
– Healthcare Administrators
– Vendors (developing regulated medical devices)
– Researchers (working on clinical-grade AI tools)

Possible Discussions:
– “Navigating FDA approval for an AI-powered diagnostic tool”
– “Differences between US and EU regulations on medical device software”

– “How startups can prepare for regulatory audits of their healthcare products”

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