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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.

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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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Another Update on Medical Abortion Litigation

Drug & Device Law

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

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Another Update on Medical Abortion Litigation

Drug & Device Law

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

FDA 52