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CMS and OIG release most expansive changes to the fraud and abuse laws in over a decade: Organizations seeking to resolve criminal charges brought by the DOJ now have a clearly defined framework for an ability-to-pay argument.

Amendment to Florida Patient Brokering Act may impact previously protected arrangements: The bill's application extends well beyond the substance abuse space to essentially all Florida healthcare providers.

Healthcare market proves strong with investors finding returns generally outweigh the risk: Understanding industry trends and managing risk assessment.

Fifth Circuit Court of Appeals affirms CMS demand for return of $8 million from failed care management demonstration project: In a demonstration project, the provider's rights and remedies must be expressed in the grant agreement.

The cybersecurity of digital medical devices: Higher technological capabilities, higher likelihood of liability – prudent medical device manufacturers are assessing their compliance with HIPAA and FDA Draft Guidance, then completing a Risk Management Plan.

Explainability: where AI and liability meet: Makers and users of AI face a new and interesting problem – what is the acceptable tradeoff between explanation and accuracy?

Plaintiff attorney advertising in pharmaceutical and medical device litigation: Regulatory bodies are recognizing that such advertising has the potential to cause harm and that some guardrails are necessary.

The learned intermediary doctrine in the WebMD era: The US medical system continues to put the physician between the treatment and the patient for a reason.

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