In Scope ³Ô¹Ï±¬ÁÏ Applications: Vault eTMF, CTMS, Vault QualityDocs, Vault QMS, Vault SiteConnect, Vault MedComms, Vault SafetyDocs, Vault Safety, Vault EDC, Vault CDB, My³Ô¹Ï±¬ÁÏ for Patients, SiteVault elSF, eConsent, eCOA.

Pursuant to Requirement 28 of version 2.0 of the HDS Referential, customers that are subject to HDS are required to store their data in the EEA. ³Ô¹Ï±¬ÁÏ offers EEA storage options for its customers who are subject to the HDS.

Hosting activities of ³Ô¹Ï±¬ÁÏ and its sub-processors according to Requirement 31:

³Ô¹Ï±¬ÁÏ Application Business name of the actor Role in the hosting service (Host/processor of the Host) HDS certified (yes/no/exempted) SecNumCloud 3.2 qualified Hosting activities in which the player is involved Access to personal health data from countries outside the European Economic Area, by the Host or one of its processors (Requirement No 29 of the HDS framework) Host or processor subject to a risk of access to personal health data from countries outside the European Economic Area, imposed by the legislation of a third country in breach of EU law (Requirement no 30 of the HDS framework)
All in scope ³Ô¹Ï±¬ÁÏ Applications ³Ô¹Ï±¬ÁÏ Systems, Inc. Host Yes No
  1. The provision and maintenance in operational condition of the virtual infrastructure of the information system used to process the health data;
  2. The provision and maintenance in operational condition of the platform for hosting information system applications;
  3. The management and operation of the information system containing the health data;
  4. Backing up health data.

When Customers engage ³Ô¹Ï±¬ÁÏ¡¯s technical support, customers¡¯ personal health data uploaded to an in scope ³Ô¹Ï±¬ÁÏ Application, may be accessed by ³Ô¹Ï±¬ÁÏ personnel in one of the following affiliate locations:

Countries covered by an adequacy decision within the meaning of Article 45 of the GDPR:

  • United States

Countries not covered by an adequacy decision within the meaning of Article 45 of the GDPR:

  • China (covered by SCCs)
  • India (covered by SCCs)
Yes, however ³Ô¹Ï±¬ÁÏ offers technical and organizational security measures to mitigate the risks that could be reviewed here.
All in scope ³Ô¹Ï±¬ÁÏ Applications Amazon Web Services (AWS) Sub-processor of the Host No
  1. The provision and maintenance in operational condition of physical sites for hosting the hardware infrastructure of the information system used to process the health data;
  2. The provision and maintenance in operational condition of the hardware infrastructure of the information system used to process the health data.

Customers select the region where their personal health data will be hosted.

Additionally, ³Ô¹Ï±¬ÁÏ encrypts the data prior to storage and the personal health data fields are also encrypted.

Yes, however ³Ô¹Ï±¬ÁÏ offers technical and organizational security measures to mitigate the risks that could be reviewed here.

For more information on AWS¡¯s HDS compliance, see .

You can find our HDS certificate here.