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CORE
THEMES
Allegations of
antitrust, false claims,
and public nuisance
violations
Government audits
and investigations
Litigation, including
class actions,
intellectual property
disputes, and opioid
lawsuits
Key Risk Drivers:
• Ongoing and emerging government scrutiny
(FDA, DEA, HHS, DOJ)
• Complex and changing regulatory frameworks
(HIPAA, FCPA, state laws)
• Allegations of healthcare fraud, false claims, or
negligence
• Rising litigation in opioid distribution and public
nuisance claims
• Unpredictable legal outcomes that can escalate
exposure
Strategic Implications:
• Loss of licenses or access to key federal
programs (e.g., Medicare/Medicaid)
• Substantial legal and compliance costs that
strain margins
• Long-term reputational damage, eroding
customer and stakeholder trust
• Increased need for rigorous compliance and
risk management frameworks
Data privacy,
cybersecurity, and
HIPAA compliance
Healthcare fraud
and abuse
3. Compliance, Regulatory Scrutiny, and
Litigation Exposure
The evolving and complex regulatory environment in the healthcare and pharmaceutical industries
exposes companies to heightened legal, compliance, and litigation risks. Enforcement agencies and
shifting legal frameworks increase the potential for investigations, audits, and litigation. This scrutiny can
lead to significant financial burdens, reputational damage, and operational disruptions.