CEHRT Disclosures & Costs
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Description of Capability & Additional Relied Upon Software
UDIVerify is an independent windows application that allows scanning and reading of UDI barcode labels using a barcode scanner, automatically performing a lookup of the FDA GUDID database using the scanned Device Identifier (“DI”), and using the UDI, PI, and returned GUDID information to automatically populate the implantable device log in the target Healthcare Application using keyboard emulation. A script and script editor is included to match the placement and order of fields in the target application.
UDI-DI, UDI-PI, GUDID, and HCT/P serial number parsing is now required for CEHRT. Xcelrate UDIs’ applications exceed this requirement by also providing immediate notification of Expired, Recalled, or Adverse alert warnings, preventing the use of dangerous or unapproved items. Xcelrate UDIs’ applications are able to eliminate any limitations identified by other EHR applications. Xcelrate UDIs’ applications bridge EHR and medical device management without adding workflow to any area. Xcelrate UDIs’ application read all FDA-accredited GS1, HIBCC, and ICCBBAs UDI, UDI-DI, and UDI-PI barcodes. All implantable medical devices write to the Implant History and CCDA with GUDID query service included. Xcelrate UDIs’ applications eliminated any technical limitations or pre-build of medical devices or items used.
Relied upon software: None
Types of Costs/Fees: To be paid by a provider for the capability
Required subscription costs which include scanning devices, 24/7 support, implementation, and training.
Additional Types of Costs or Fees: Additional types of costs or fees that a user may be required to pay to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of the capability or any data generated in the course of using the capability.
Xcelrate UDIs’ applications may incur additional costs related to professional services to support new design implementations and upgrades if out of the scope of the initial contract. Xcelrate UDIs’ clients may elect additional support or services.
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Description of Capability & Additional Relied Upon Software
Support unique user identification, enables authentication against unique identifiers (i.e. username/password) to gain access to electronic health information and includes the ability to control the specific access and privilege rights a user is granted.
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: To be paid by a provider for the capability
No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: Additional types of costs or fees that a user may be required to pay to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of the capability or any data generated in the course of using the capability.
No required costs or fees
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Description of Capability & Additional Relied Upon Software
Supports event creation capabilities for security auditing of access to and actions on ePHI via the EHR including integrity protection of recorded audit logs. Auditing of access to health information is separately certified under the 170.315(d)(10) criterion with the EHR.
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: To be paid by a provider for the capability
No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: Additional types of costs or fees that a user may be required to pay to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of the capability or any data generated in the course of using the capability.
No required costs or fees
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Description of Capability & Additional Relied Upon Software
Enables creation of sortable audit reports for specific time frames, and based on specific parameters such as user ID, patient ID, type of action, etc.
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: To be paid by a provider for the capability
No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: Additional types of costs or fees that a user may be required to pay to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of the capability or any data generated in the course of using the capability.
No required costs or fees
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Description of Capability & Additional Relied Upon Software
Enables recording of an amendment to a patient record based on a patient request, as well as the patient requests for amendment to their health record, including identification of whether the amendment was approved or denied.
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: To be paid by a provider for the capability
No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: Additional types of costs or fees that a user may be required to pay to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of the capability or any data generated in the course of using the capability.
No required costs or fees
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Description of Capability & Additional Relied Upon Software
Enables automatic termination of a user session after a specified period of inactivity requiring re-authentication.
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: To be paid by a provider for the capability
No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: Additional types of costs or fees that a user may be required to pay to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of the capability or any data generated in the course of using the capability.
No required costs or fees
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Description of Capability & Additional Relied Upon Software
Enables a limited set of specified users to access electronic health information in emergency scenarios.
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: To be paid by a provider for the capability
No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: No required costs or fees
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Description of Capability & Additional Relied Upon Software
The certified product is designed to prevent any persistent storage of electronic health information processed in the EHR application locally to end-user devices (e.g. temp files, cookies, caches).
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: To be paid by a provider for the capability
No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: No required costs or fees
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Description of Capability & Additional Relied Upon Software
The certified products documentation demonstrates that the Health IT Module stores authentication credentials in accordance with standards adopted in § 170.210(a)(2).
Relied upon software: EHR or clinical application. One of: Allscripts, Oracle (Cerner) eClinicalWorks, EPIC, GE Healthcare, NextGen
Types of Costs/Fees: No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: No required costs or fees
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The certified products documentation demonstrates that the Health IT Module does not support authentication, through multiple elements, of the user’s identity with the use of industry-recognized standards.
Relied upon software: N/A
Types of Costs/Fees: No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: No required costs or fees
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Description of Capability & Additional Relied Upon Software
The certified products documentation demonstrates that user-centered design (UCD) process(es) were applied to all of the safety-enhanced design referenced certification criteria for which these corresponding capabilities are being presented for certification.
Relied upon software: N/A
Types of Costs/Fees: No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: No required costs or fees
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Description of Capability & Additional Relied Upon Software
The certified products verified that the QMS used is one of those that have been established by the Federal Government or an SDO, including, but not limited to, FDA’s quality system regulation in 21 CFR part 820, ISO 9001, ISO 14971, ISO 13485, and IEC 62304.
Relied upon software: None
Types of Costs/Fees: No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: No required costs or fees
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Description of Capability & Additional Relied Upon Software
The certified products identified a single accessibility-centered design standard or law used in the development, testing, implementation, and maintenance of capabilities for which certification is being sought.
Relied upon software: N/A
Types of Costs/Fees: No required costs or fees – the capabilities are considered a core component of the Health IT EHR itself, and no separate licensing is required for the certified capability apart from the licensing required for the EHR module.
Additional Types of Costs or Fees: No required costs or fees
ONC CERTIFIED HIT® is a registered trademark of HHS.
UDIVerify, version 1.7.2
CEHRT Certification Disclosures
Certification Number: 15.05.05.3045.XCEL.01.01.1.221221
Certification Date: Dec 21, 2022
Developer: Xcelrate UDI, Inc.
Xcelrate UDI, Inc is proud to offer UDIVerify, certified under the Office of the National Coordinator (ONC) for Health Information Technology (HIT). The information provided identifies the certified Health IT Module that our applications support, and any respective offerings and cost information for each is described. This Health IT Module is compliant with the ONC Certification Criteria for Health IT and has been certified by an ONC-ACB in accordance with the applicable certification criteria adopted by the Secretary of Health and Human Services. This certification does not represent an endorsement by the U.S. Department of Health and Human Services. To obtain more information about how Xcelrate UDI met the ONCs certification standards, please email info@XcelrateUDI.com. You may also view current certification numbers and test reports on the ONCs Certified Health IT Product List (https://chpl.healthit.gov/#/listing/11107).
Xcelrate UDIs applications are easy-to-implement, standalone tools that provide barcode scanning of any medical device or biologics barcode at the point of care, on receipt, or on inventory. To meet the CEHRT, Implantable Device List regulation, the UDI and GUDID look-up is parsed directly into the patient’s EHR. UDIVerify, an independent windows application, reads the UDI or other manufacturers’ barcodes and performs a lookup of the FDA’s GUDID database in real-time for medical devices. The scanned Device Identifier (“UDI-DI”) returns GUDID information to automatically populate one or more forms in the target EHR. A script and script editor is included to match the placement and order of fields in the target ERP and/or EHR applications.