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Regulating general-purpose AI in healthcare : how the AI Act and the Medical Device Regulation impact healthcare innovation

Year: 2024

Type: article

Abstract: General-purpose AI holds great potential to enhance healthcare delivery, but the AI Act, alongside the Medical Device Regulation, introduces complex risk classifications and stringent safety requirements that may slow market entry and increase regulatory burdens. This post explores the challenges that general-purpose AI-driven medical devices (GPAI-MD) face in navigating these regulations, highlighting their potential in healthcare and the difficulties in ensuring compliance under the evolving legal framework. It identifies the risk of delays and reduced availability of innovative medical technologies in the EU market and calls for guidance and support for industry stakeholders.

Source: Ghent University Academic Bibliography (Ghent University)

Author: Palmieri, Sofia

Language: English

Topic: Digitalization, Law, and Regulation

Subfield: Law

Field: Social Sciences

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W6986836240

FWCI:

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Related to: 10