ビジネス

AI for Healthcare

定義

AI applications in clinical and administrative healthcare, including medical image analysis, clinical decision support, drug discovery, and patient flow optimisation. Healthcare AI faces dual regulation in the EU under the AI Act (high-risk) and the Medical Device Regulation (MDR), requiring CE marking.

例

Radiology AI for tumour detection
Sepsis early-warning systems
AI-powered patient triage

関連用語

High-Risk AI System

An AI system classified under the EU AI Act as posing significant risks to health, safety, or fundamental rights. High-risk systems must undergo conformity assessment, maintain technical documentation, enable human oversight, and be registered in an EU database before market deployment.

EU AI Act

The world's first comprehensive AI regulation, adopted by the European Union in 2024 and phasing in through 2027–2028 (prohibitions from February 2025, GPAI obligations from August 2025, stand-alone high-risk systems from 2 December 2027, and high-risk AI embedded in regulated products from 2 August 2028). It classifies AI systems by risk level—unacceptable, high, limited, and minimal—and imposes obligations proportionate to risk, from outright bans to conformity assessments and transparency requirements.

Explainability (XAI)

The ability to understand and explain how an AI model reaches its decisions. Explainable AI is a mandatory requirement for high-risk AI systems under the EU AI Act and is critical for building trust with regulators, auditors, and end users.

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