definiens: means all applicable laws, statutes, rules, regul ations and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or o ther political subdivision, agency or other body, domestic or fore ign, including any applicable rules, regulations, g uidelines, or other requirements of the Regulatory Authorities th at may be in effect from time to time, including th e United States Federal Food, Drug, and Cosmetic Act, as ame nded, GCP, GLP and GMP, anti - bribery laws, such as the United States Anti - Kickback Statute, Foreign Corrup t Practices Act and UK Bribery Act, as well as all applicable data protection and privacy laws, rules and regulations, including the United States Depart ment of Health and Human Services privacy rules under the H ealth Insurance Portability and Accountability Act, as amended, and the Health Information Technology for Economic and Clinical Health Act and the EU General Data Protection Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the pr ocessing of personal data and on the free movement of such data, and repealing Directive 95/46 / EC, along with other country - level data protection laws, as may be applicable