definiens: means all applicable laws, statutes, rules, regul ations, orders, judgments, or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city, or other political subdivision, including, to the extent app licable but without limitation, GCP, GLP, and GMP, as well as all applicable data protection and privacy laws, ru les, and regulations, including, to the extent appl icable, the United States Department of Health and Human Servic es privacy rules under the Health Insurance Portabi lity and Accountability Act ( HIPAA ) and the Health Infor mation Technology for Economic and Clinical Health Act ( HITECH ) and the EU Data Protection Directive ( Coun cil Directive 95/46 / EC ) and applicable laws implementing the EU Data Protection Directive and t he General Data Protection Regulation ( 2016/679 )