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A transformational 2025 in US healthcare – and more to come in 2026
In many ways, 2025 found the healthcare sector at a crossroads, with compliance officers holding their heads.
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Bill to limit US biotech companies doing business with China advances
The new bill would have government agencies referring to the Department of Defense’s 1260H list of Chinese military companies operating in the US.
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FDA turns focus on biologics in spate of warning letters
The three letters point to an enforcement posture toward manufacturers marketing biologics derived from human placentas and umbilical cords.
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Wearable maker Whoop continues to push back against FDA warning
Dispute centers on whether wearable wellness kit should be classified as medical devices.
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HHS rolls out ‘whole of department’ AI strategy and compliance plans
The agency is hailing its strategy as the fulfillment of its commitment to enhance efficiency – but will it make personal health information any safer?
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Coalition of providers and insurers call on HHS to strike proposed cybersecurity demands
A letter from 100 industry orgs told HHS that healthcare providers would face an “extreme and unnecessary regulatory burden” under the proposals.
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Illinois men face charges for $300m healthcare fraud scheme
The brothers allegedly tried to defraud Medicare, Medicaid, and private insurers by filing claims for COVID-19 testing that was never given.
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Approval deadline for CMS $50 billion rural health fund fast approaching
The extent to which the federal grant program will support the nation’s 1,800 struggling rural hospitals remains unclear.