FDA, Malpractice and Regulatory Compliance - Health Care Compliance Brief

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FDA

Malpractice

Regulatory Compliance

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

FDA

FDA Regulatory Compliance Malpractice Health Insurance

Dentists As Product Manufacturers? Bet On It In Nevada

Drug & Device Law

APRIL 21, 2023

The patient sadly passed away after having 23 teeth removed and replaced (for those keeping score, that is more than two-thirds of a normal human complement of teeth), and his family sued for medical malpractice and product liability. But point-of-care devices appear to still be a matter of regulatory discussion.

Informed Consent

Informed Consent Malpractice FDA Regulatory Compliance

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Dentists As Product Manufacturers? Bet On It In Nevada

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