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New Kickback Safe Harbor for Federally Qualified Health Centers

Client Alert | less than 1 min read | 07.01.05

The HHS Office of Inspector General has issued a proposed new anti-kickback law safe harbor protecting transfers of goods, items, services, donations and loans to federally qualified health centers if specific conditions are met. The proposed regulation implements a provision of the Medicare Modernization Act calling for the new safe harbor where an arrangement contributes meaningfully to the health center's provision of services to a medically underserved population.  The comment period on the proposed regulation runs until August 1, 2005. Click here to view the proposed rules published in the Federal Register.

Insights

Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...