In October 2015 the European Court of Justice made a ruling that challenges how we today transfer patient data from our studies to the U.S. The reason for these challenges is that the European Court of Justice do not see the U.S. data privacy laws (Safe Harbour Privacy Principles) on par with EU directive 95/46/EC. This has the unfortunate consequence that transfers to U.S.-based businesses under Safe Harbor are no longer valid. You can find more info here: http://europa.eu/rapid/press-release_IP-15-6015_en.htm
Therefore, when sponsors wants the data from clinics transmitted to the U.S., they must establish a contract with our sites in the EU using a standard contract from the EU, named Standard Contractual Clauses in order to be in compliance. Once sponsors (or designees) have entered into such an agreement with our sites, the sponsors can transmit the data to the U.S.
For more information, please read this Q&A: http://europa.eu/rapid/press-release_MEMO-15-6014_en.htm; The EU Commission is working hard on a better long term solution, but until then this is how we should proceed.