definiens: means, to the extent related to the conduct of a Person ’s business as of the date hereof, Federal, state, and foreign Laws injurisdictions where such Person operates relating to health care products and services, including ( each as amended from time to time ): 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 ( 31U.S.C. § § 3729 et seq . ), the administrative False Claims Law ( 42 U.S.C. § 1320a-7b(a ) ), the Health Insurance Portability and Accountability Act of 1996(42 U.S.C. § 1320d et seq . ), as amended by the Health Information Technology for Economic and Clinical Health Act ( 42 U.S.C. § § 17921 et seq . ) andthe exclusion laws ( 42 U.S.C. § 1320a-7 ), the Aﬀordable Care Act ( Public Law 111 - 148 ), all regulations or guidance promulgated pursuant to such Laws, and any other federal, or state Law that regulates the design, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, advertising, distributing or marketing of medical device products, or that is related to kickbacks, patient or programcharges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services orsupplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or anyother aspect of providing health care services