definiens: means all Laws, enforced or issu ed by a Governmental Authority related to the manufacturing, development, testing, labeling, mark eting, packaging, holding, import, export, advertis ing or distribution of medical device products, kickbacks, patient or program charges, recordkeeping, documen tation requirements, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, qual ity, safety, privacy, security, or licensure, inclu ding, without limitation : ( a ) the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. § § 301 et seq . ) and the re gulations promulgated thereunder ; ( b ) the Public Health Servi ce Act ( 42 U.S.C. § 201 et seq . ) ; ( c ) all applicabl e federal, state, local and all applicable foreign health care related fraud and abuse, false claims, and anti - ki ckback Laws, including, without limitation, the U.S. Anti - Kickba ck Statute ( 42 U.S.C. § 1320a-7b(b ) ), the U.S. Phys ician Payment Sunshine Act ( 42 U.S.C. § 1320a-7h ), the U. S. Civil False Claims Act ( 31 U.S.C. § 3729 et seq . ), the criminal False Statements Law ( 42 U.S.C. § 1320a-7b ( a ) ), all criminal Laws relating to health care fra ud and abuse, including but not limited to 18 U.S.C. § § 28 6 and 287, and the health care fraud criminal provi sions under the U.S. Health Insurance Portability and Accountab ility Act of 1996 ( 42 U.S.C. § 1320d et seq . ) as am ended by the Health Information Technology for Economic and Clinical Health Act ( 42 U.S.C. § 17921 et seq . ) ( collectively, ), the exclusion Laws ( 42 U.S .C. § 1320a-7 ), and the civil monetary penalties La w ( 42 U.S.C. § 1320a-7a ) ; ( iv ) HIPAA and analogous state Laws pertaining to privacy, data protection and inf ormation security, and the regulations promulgated pursuant to such statutes ; ( v ) Medicare ( Title XVIII of the Social Security Act ) and ( vi ) Medicaid ( Title XIX of the S ocial Security Act ), each as amended from time to t ime the regulations promulgated pursuant to such Laws