In addition to parsing the UDI, a Health IT Module presented for certification would have to be able to retrieve the optional data element associated with the Device “device description” Identifier in the GUDID, if the data element has been populated. This could be accomplished using the web interface, web services, downloadable module, or any other method of GUDID’s retrieval permitted under GUDID guidance. FDA’s For each UDI in a implantable device list, a Health IT Module presented for patient’s certification would have to enable a user to access the UDI and the data elements identified above (including the if it exists). Also, in addition to enabling a user to “device description,” record and access UDIs for a implantable devices and as noted above, a Health IT patient’s Module would be required to provide the capability to change UDIs from a implantable patient’s device list in order to meet this criterion. This functionality would allow a user to delete erroneous or duplicative entries from a implantable device list and update the list in the patient’s event that a device were removed from the patient. We seek comment on whether such functionality is necessary and whether there is a safer or more effective way to maintain the accuracy of this information. We believe that, in addition to capturing UDIs, health IT should facilitate the exchange of UDIs in order to increase the overall availability and reliability of information about patients’ implantable and other devices. Therefore, we propose in a later section of this rule to include the 2015 Edition device certification criterion in the 2015 Edition Base EHR “implantable list” definition and propose to include a unique device identifier(s) as data within the patient’s Common Clinical Data Set definition for certification to the 2015 Edition. Please see section III.B of this preamble for further discussion of these associated proposals. We have also proposed to modify § 170.102 to include new definitions for “Device
In addition to parsing the UDI, a Health IT Module presented for certification would have to be able to retrieve the optional “device description” data element associated with the Device Identifier in the GUDID, if the data element has been populated. This could be accomplished using the GUDID’s web interface, web services, downloadable module, or any other method of retrieval permitted under FDA’s GUDID guidance. For each UDI in a patient’s implantable device list, a Health IT Module presented for certification would have to enable a user to access the UDI and the data elements identified above (including the “device description,” if it exists). Also, in addition to enabling a user to record and access UDIs for a patient’s implantable devices and as noted above, a Health IT Module would be required to provide the capability to change UDIs from a patient’s implantable device list in order to meet this criterion. This functionality would allow a user to delete erroneous or duplicative entries from a patient’s implantable device list and update the list in the event that a device were removed from the patient. We seek comment on whether such functionality is necessary and whether there is a safer or more effective way to maintain the accuracy of this information. We believe that, in addition to capturing UDIs, health IT should facilitate the exchange of UDIs in order to increase the overall availability and reliability of information about patients’ implantable and other devices. Therefore, we propose in a later section of this rule to include the 2015 Edition “implantable device list” certification criterion in the 2015 Edition Base EHR definition and propose to include a patient’s unique device identifier(s) as data within the Common Clinical Data Set definition for certification to the 2015 Edition. Please see section III.B of this preamble for further discussion of these associated proposals. We have also proposed to modify § 170.102 to include new definitions for “Device