definiens: shall mean any participant in a clinical trial and/or any other person about whom data may be collected in the performance of the Study shall mean Directive 95/46 / EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and the free movement of such data ; shall mean the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. § 1171, et seq ., and the regulations promulgated thereunder, as amended from time to time ; shallml3an the collection, use, disclosure, transfer, storag~, dl3letion, processing ( both by computer and manually ), combination or other use of personal data as contemplated by applicable privacy and data protection laws ; shall mean all data collected in any Study which identify or could be used to identify a Data 48 SLI 42621 Ov2/9564 1.003 Subject ; shall mean the United States of America ; and shall mean all countries in which Study Data is collected