An accomplished C-Level Vice President (VP), Chief Compliance & Ethics Officer, Risk & Regulatory Mitigation, Privacy-InfoSec, Data Governance and Protection Officer, Internal Audit and Legal executive leader, Mr. Flax builds first-rate compliance programs, reporting structures, ecosystems, internal control and risk management systems in the healthcare, pharmacy and insurance industries, designed to motivate, monitor, measure and protect the company's regulatory, legal, reputation and data assets while significantly mitigating the risk of noncompliance, regulatory investigations or enforcement actions. He has extensive experience leading the development and operationalization of four (4) large Corporate Compliance and Ethics Programs based on the FSG's seven (7) elements, FAR, DFARS, OECD's Good Practice Guidance, and UK's Bribery Act, managing the obligations of an OIG Corporate Integrity Agreement, providing legal guidance to senior management in product development, overseeing large-scale HIPAA Privacy ("PHI" and "PII") and data protection programs and providing legal and compliance guidance for multi-state Medicaid and Medicare (MA, MA-PD and PDP) Programs. Mr. Flax also has experience preparing, filing and interfacing with federal and state government agencies, including the FDA, CMS, HHS, OIG, DOL and OSHA. With 40+ published articles, Mr. Flax is a shrewd thought-leader known for demonstrated leadership abilities in a fast-paced environment. He is a trusted team player, managing a heavy workload and tenures marked by significant performance improvement and sound judgments that achieved business goals, improved services and increased shareholder value.Mr. Flax has a broad range of experience in using and interpreting regulations and how they shape and impact business prerogatives, strategies and priorities:🌟 Federal Acquisition Regulations (FAR)(FOCI, DFARS, DEAR, GSAM, HSAR and TAR), RoHS, REACH ;🌟 Medicare Advantage Plans & PDPs; Medicare Secondary Payer (MSP); 🌟 Medicaid Programs;🌟 HIPAA/HITECH; NIST & NIST Privacy; GDPR; CCPA; CPRA; ISO/IEC 27000; FISMA; SOC2; TCPA, CAN-SPAM & COPPA, Part 2, PCI-DSS; CLIA🌟 Foreign Corrupt Practices Act (FCPA); EU-US Privacy Shield🌟 Office of Foreign Assets Control (OFAC); DCCA; DCMA; EAR🌟 UK Bribery Act; 🌟 FWA, Stark & Anti-Kickback Laws;🌟 Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practices (GMPs) Guidance;🌟FFDCA (REMS);🌟 Sarbanes-Oxley Act (SOX); and🌟 PPACA; ERISA; COBRA; JCAHO; DQSA; WHCRA; MHPA; NMHPA; FMLA; USERRA; ADEA; ADA.
Listed skills include Leadership, Team Building, Cobra, Ethics, and 33 others.
