definiens: means the FDCA, Medicare ( Title XVIII of the Social Security Act ) and Medicaid(Title XIX of the Social Security Act ), the federal Anti - Kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), the Stark Anti - Self - Referral Law ( 42 U.S.C. § § 1395nn ), the Anti - Inducement Law ( 42 U.S.C. § 1320a-7a(a)(5 ) ), the civil False Claims Act(31 U.S.C. § § 3729 et seq . ), the administrative False Claims Law ( 42 U.S.C. § 1320a-7b(a ) ), the Health InsurancePortability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq . ), as amended by the Health InformationTechnology for Economic and Clinical Health Act ( 42 U.S.C. § § 17921 et seq . ), the exclusion laws ( 42 U.S.C. § 1320a-7 ), the European Medical Device Directives ( Directive 93/42 / EEC, 90/385 / EEC, and 98/79 / EC as amended)(the ) and any European Economic Area Member State laws implementing the provisionsof these directives, the Misleading and Comparative Advertising Directive ( 2006/114 / EC ), the Unfair CommercialPractices Directive ( 2005/29 / EC ), and any European Economic Area Member State laws implementing the provisionsof these directives, all regulations or guidance promulgated pursuant to such Laws, and any other foreign, federal, orstate Law that regulates the design, development, testing, studying, manufacturing, processing, storing, importing orexporting, licensing, labeling or packaging, advertising, distributing or marketing of medical device products, or that isrelated to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have beenexcluded from government health care programs, quality, safety, privacy, licensure or any other aspect of providinghealth care services