Manufacturer Disclosure Statements for Medical Device Security RU

The MDS2 form provides information about the security controls, which are implemented in a medical device in order to protect the PROTECTED HEALTH INFORMATION (PHI) transmitted or stored by the medical device. Healthcare providers may use the MDS2 form during the risk analysis of their organization.

MDS2 is a joint effort of Healthcare Information and Management Systems Society (HIMSS) and The Association of Electrical and Medical Imaging Equipment Manufacturers (NEMA). More information about MDS2 can be found here.

To request an MDS2 form of an Agfa product, please contact