Sanctions screening
Sanctions screening in Healthcare and Life Sciences sits at the intersection of two unforgiving enforcement regimes: the U.S. Department of the Treasury's Office of Foreign Assets Control, which maintains strict liability standards that leave no room for good-faith errors, and the U.S. Department of Health and Human Services Office of Inspector General, whose exclusion list obligations apply to vendors, contractors, and individual practitioners alike. Compliance teams in this sector are not just screening patients and payers. They are working through distribution partners, clinical trial sponsors, and overseas manufacturing relationships against OFAC's Specially Designated Nationals list and the OIG exclusion database on overlapping cycles.
Watch
- OFAC 50 Percent Rule: does your beneficial ownership screening reach foreign API suppliers?
- OIG exclusion list: monthly update cadence versus your current vendor re-screening frequency
- Russia/Belarus secondary sanctions exposure in medical device and diagnostics supply chains
- HHS OIG Self-Disclosure Protocol filings tied to sanctions-adjacent exclusion violations
- European Union Regulation 833/2014 amendments affecting EU-based clinical site payments
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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