definiens: means any law promulgated by any Governmental Entity ( including multi - countryorganizations ), as amended from time to time, and any 61 regulations issued thereunder, pertaining to medicines, pharmaceuticals, biological products, and similarhealth care products, including, without limitation, those laws and regulations relating the following : ( a ) thesafety, efficacy, quality, classification, design, investigation, research, development, manufacturing, licensure, registration, approval, clearance, handling, storage, security, labeling, recordkeeping, reporting, marketing, sale, or distribution of such products, including, for example, the FDCA, the Public Health ServiceAct, and the Controlled Substances Act ; ( b ) the privacy and security of personal health information and data, including, for example, the Health Insurance Portability and Accountability Act ; ( c ) the billing, coding, coverage, payment, purchase, or reimbursement of a health care product or service by a Governmental Entityor private payor, including, for example, Title XVIII and Title XIX of the Social Security Act ; ( d ) interactionswith health care professionals, customers, and referral sources in a position to recommend, purchase, prescribe, or use health care products or services, including, for example, the Physician Self - Referral Lawand federal Anti - Kickback Statute ; or ( e ) the making of false or fraudulent statements or claims relating to ahealth care product or service to a Governmental Entity or private payor, including, for example, the civil andcriminal false claims statutes