definiens: means ( a ) any and all federal, state and local laws, statutes, codes, acts, ordinances, orders, judgments, decrees, injunctions, rules, regulations, permits, licenses, authorizations, directions or requirements of any Governmental Authority relating to health careor insurance fraud and abuse, including, without limitation, the federal Anti - Kickback Statute ( 42U.S.C. § 1320a-7b(b ) and 41 U.S.C. § § 51 - 58 ), the civil False Claims Act ( 31 U.S.C. § 3729 etseq . ), the Exclusion Laws ( 42 U.S.C.§§ 1320a-7 and 1320a-7a ), the Program Fraud CivilRemedies Act ( 31 U.S.C. § § 3801 - 3812 ), the Civil Monetary Penalties Law ( including thosepertaining to beneficiary inducements ) ( 42 U.S.C. § § 1320a and 1320a-7b, and the regulationspromulgated pursuant to such statutes ; ( b ) the federal Food, Drug & Cosmetic Act ( 21 U.S.C. § § 301 et seq . ), the Federal Health Care Fraud Law ( 18 U.S.C. § 1347 ) and all federal and statelaws related to pharmacology, pharmacy, and dispensing medicines or controlled substances, and the regulations promulgated thereunder, including without limitation, the federal ControlledSubstances Act ( 21 U.S.C. § 801 ), as well as those related to the wholesale distribution ofproducts, including the Prescription Drug Marketing Act ( 21 U.S.C. § 353 ) and the regulationspromulgated thereunder ; ( c ) any and all federal, state and local Laws concerning privacy anddata security for patient information, including the Health Insurance Portability and AccountabilityAct of 1996 ( 42 U.S.C. § § 1320d-1329d-8 ), as amended, and all federal and state lawsapplicable to medical record retention, privacy, security, patient confidentiality and informedconsent, and the regulations promulgated thereunder ; ( d ) Medicare ( Title XVIII of the SocialSecurity Act ), as amended and the regulations promulgated thereunder ; ( e ) Medicaid ( Title XIX ofthe Social Security Act ) and the regulations promulgated thereunder ; ( f ) the MedicarePrescription Drug, Improvement, and Modernization Act of 2003 ( Pub . L. No . 108 - 173 ) and theregulations promulgated thereunder ; ( g ) the Patient Protection5and Affordable Care Act ( Pub . L. 111 - 148 ) as amended by the Health Care and EducationReconciliation Act of 2010 ( Pub . L. 111 - 152 ) ; ( h ) quality, safety and accreditation standards andrequirements of all applicable state Laws, regulatory bodies, or quasi - governmental accreditingbodies ; ( i ) federal, state and local Laws regulating the ownership, operation or licensure of ahealth care business, or assets used in connection therewith, including pharmacies andwholesale distributors ; ( j ) federal, state and local Laws relating to the provision of management oradministrative services in connection with practice of pharmacy and other health careprofessions, employment of professionals by non - professionals, professional fee splitting, patientbrokering, patient or program charges, claims submission, record retention, certificates ofoperations and authority ; ( k ) federal and state Laws with respect to financial relationshipsbetween referral sources and referral recipients, including, but not limited to, the federal StarkLaw ( 42 U.S.C. 1395nn et . seq . ) and the regulations promulgated thereunder ; ( l ) life safety codes;and ( m ) any and all other applicable health care related Laws