TeamEHR

CEHRT Disclosures

UDIXpress, version 1.5.0.0

CEHRT Certification Disclosures For ONC 2015 Edition Certification

Certification Number:         15.05.05.3045.TEAM.01.00.1.190521

Certification Date:              May 21, 2019

TeamEHR is proud to offer UDIXpress, pending certification 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, any respective offerings, product limitations, and cost information for each is described.  The Health IT Modules listed herein are 2015 Edition compliant and are pending 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 TeamEHR met the ONC 2015 Edition certification standards, please email info@TeamEHR.com.  You may also view current certification numbers and test reports, please review ONCs Certified Health IT Product List.

The TeamEHR applications are easy-to-implement, standalone tools which add barcode scanning, UDI and GUDID lookup to any healthcare (EHR) application.  UDIXpress 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 in real-time of the scanned Device Identifier (“DI”), and using the UDI-PI and returned GUDID information to automatically populate one or more forms in the target Healthcare Application.  A script and script editor is included to match the placement and order of fields in the target application.  A program is included to update the implant histories if required of the target application.


§ 170.315(a)(14) – Implantable Device List

Description of Capability & Additional Relied Upon Software

UDIXpress 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.  TeamEHR applications exceed this requirement by also providing immediate notification of Expired, Recalled or Adverse alert warnings, preventing use of dangerous or unapproved items. TeamEHR applications are able to eliminate any limitations identified by other EHR applications. TeamEHR applications bridge EHR and medical device management without adding workflow to any area. TeamEHR application read all FDA accredited GS1, HIBCC or IBBCA UDI-DI and UDI-PI barcodes.  All implantable medical devices write to the Implant History, CCDA and FHIR with GUDID query service included.  TeamEHR 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.

  • TeamEHR 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.  TeamEHR clients may elect additional support or services.

  • Limitations (Contractual/Business Practices): Limitations of a contractual nature (including developer policies and other business practices) that a user may encounter in the implementation or use of the capability or in connection with the data generated in the course of using the capability    

  • No contractual or business practice limitations

  • Limitations (Technical/Practical): Limitations of a technical, technological or practical nature that a user may encounter that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of the capability or prevent or limit the use, exchange, or portability of any data generated in the course of using the capability.

  • No technical or practical  limitations


§ 170.315(d)(1) Authentication, Access Control, Authorization

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: Primary EHR (example:  Cerner, EPIC, AllScripts, Meditech)

  • 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

  • Limitations (Contractual/Business Practices): Limitations of a contractual nature (including developer policies and other business practices) that a user may encounter in the implementation or use of the capability or in connection with the data generated in the course of using the capability    

  • No contractual or business practice limitations

  • Limitations (Technical/Practical):  Limitations of a technical, technological or practical nature that a user may encounter that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of the capability or prevent or limit the use, exchange, or portability of any data generated in the course of using the capability.

  • No technical or practical  limitations


§ 170.315(d)(2) Auditable Events and Tamper-Resistance

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: ntpd (Linux)

  • 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

  • Limitations (Contractual/Business Practices): Limitations of a contractual nature (including developer policies and other business practices) that a user may encounter in the implementation or use of the capability or in connection with the data generated in the course of using the capability    

  • No contractual or business practice limitations

  • Limitations (Technical/Practical):  Limitations of a technical, technological or practical nature that a user may encounter that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of the capability or prevent or limit the use, exchange, or portability of any data generated in the course of using the capability.

  • No technical or practical  limitations


§ 170.315(d)(3) Audit Report(s)

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: NTPD (Linux), EHR security example: Cerner Sentinel (Cloud Auditing)

  • 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

  • Limitations (Contractual/Business Practices): Limitations of a contractual nature (including developer policies and other business practices) that a user may encounter in the implementation or use of the capability or in connection with the data generated in the course of using the capability    

  • No contractual or business practice limitations

  • Limitations (Technical/Practical):  Limitations of a technical, technological or practical nature that a user may encounter that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of the capability or prevent or limit the use, exchange, or portability of any data generated in the course of using the capability.

  • No technical or practical  limitations


§ 170.315(d)(4) Amendments

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: N/A

  • 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

  • Limitations (Contractual/Business Practices): Limitations of a contractual nature (including developer policies and other business practices) that a user may encounter in the implementation or use of the capability or in connection with the data generated in the course of using the capability    

  • No contractual or business practice limitations

  • Limitations (Technical/Practical):  Limitations of a technical, technological or practical nature that a user may encounter that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of the capability or prevent or limit the use, exchange, or portability of any data generated in the course of using the capability.

  • No technical or practical  limitations