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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

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 282
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Health Provider News

Hall Render

million for youth mental health care KENTUCKY Pike County nursing home officials release statement following loss of Medicare agreement Three Humana executives drop $11.2M

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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

Apparently, a fraudulent foreign-trained “doctor” treated the plaintiffs, none of whom claimed malpractice or any physical injury whatsoever. For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. 471 (11th Cir.

Doctors 52