definiens: means any and all Applicable Laws relating to the regulation of the health care andmedical device industry or to payment for items or services rendered, provided, dispensed or furnished by health careproviders or suppliers, including, without limitation, the following laws : ( i ) the federal Medicare and Medicaid statutes(which include, but are not limited to, 42 U.S.C. § § 1320a-7, 1320a-7a, 1320a-7b and 1320a-7h ), the federal TRICAREstatute, the Federal False Claims Act ( 31 U.S.C. § 3729 - 33 ), 18 U.S.C. § § 286 and, with respect to each of theabove, any ordinance, rule, regulation or order issued thereunder or with respect thereto ; ( ii ) all international, multinational, foreign, federal or state laws or regulations applicable to medical device manufacture, registration, approval, importation, sale, use, distribution, dispensing, marketing and security, ( iii ) any prohibition on the defraudingof or making any false claim, false statement or misrepresentation of material facts to any third - party payer ( includingcommercial and private payers ) or any Governmental Authority that administers a Federal Health Care Program orstate health care program ( including, but not limited to, Medicare, Medicaid and state Medicaid Waiver Programs andTRICARE ) ; ( iv ) the licensure, certification or registration requirements of health care facilities, services, equipment orhealth care providers, suppliers of device manufacturers ; ( v ) all state anti - kickback and illegal remuneration laws;(vi ) all federal or state laws pertaining to patient confidentiality and privacy and the confidentiality, privacy or securityof Protected Health Information or Personal Data, including, but not limited to, the Health Insurance Portability andAccountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act of2009 6 and ( vii ) The Federal Food Drug, and Cosmetic Act, 21 U.S.C. § 321 et seq ., and its implementing regulations