Third-party risk management

Third-party risk management in Healthcare & Life Sciences is under direct regulatory pressure from multiple directions: the U.S. Department of Health and Human Services Office for Civil Rights has made vendor oversight a core enforcement priority under HIPAA's Security Rule, and the U.S. Food and Drug Administration's updated guidance on software as a medical device extends scrutiny to supplier chains embedded in product development. The European Medicines Agency has separately pushed member-state inspectorates to probe outsourced GxP activities with greater rigor, leaving multinational life sciences firms reconciling divergent vendor audit standards across jurisdictions.