definiens: shall mean any participant in a clinical trial and/or any other person aboutwhom data may be collected in the performance of this Agreement ; shall mean Directive 95/46 / EC of 24 October 1995 on the protection ofindividuals with regard to the processing of personal data and the free movement of suchdata ; : shall mean the Health Insurance Portability and Accountability Act of 1996, 42U.S.C. § 1171, et seq ., and the regulations promulgated thereunder, as amended fromtime to time ; shall mean the collection, use, disclosure, transfer, storage, deletion, processing ( both by computer and manually ), combination or other use of personal dataas contemplated by applicable privacy and data protection laws ; shall mean all data collected in any Study which identify or could be usedto identify a Data Subject ; : shall mean the United States of America ; and shall mean all countries in which Study Data is collected