definiens: means all Laws regulating the design, development, testing, manufacturing, storing, labeling, packaging, transporting, marketing, importing, exporting, commercialization or reimbursement of pharmaceuticals, biologics, medical devices, diagnostics or combination products ; or the relationships with health care prof essionals ; or privacy matters, including, the FDCA, the Clinical Laboratory Improvement Amendments ( 42 U.S.C. § 263a ), 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 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(2 ) et seq . ), the exclusion laws ( 42 U.S.C. 1320a -7 ), cGCP, cGMP and cGLP and all implementing regulations thereunder, and all applicable substantially equivalent foreign Laws