IHE USA Certification Program
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IHE USA Publishes Certification White Paper
In a joint initiative, IHE USA & ICSA Labs publish a white paper to explain the current state of industry conformance to IHE frameworks and the need for rigor, precision, and proof of correctness that certification achieves. IHE USA certification carries with it a broad range of benefits to clinical users, their IT vendors, and policy-makers who are aware of how crucial IT integration is to coordinating and improving people's health.
IHE USA, in partnership with ICSA Labs, is excited to announce the first round of IHE USA Certified products. Congratulations to the 8 vendors that have successfully completed the IHE USA Certification program, and are leading the industry in advancing interoperability. Well Done! Read the full press release to learn more.
IHE USA Certified Product Directory
See the IHE USA Certified Product Directory for more detailed information on the specific products, versions, and certification criteria.
IHE USA, and ICSA Labs are partnering on the creation of a new program that provides industry-accepted certification to complement existing testing of conformance to IHE integration profiles.
The program was created to bring technologies to market, which support healthcare providers and hospitals as they adapt to the increased emphasis on shared information and accountable care.
Certification is aimed at products and system developers looking to test interoperability and security requirements that build upon the baseline requirements set by the federal government for Stage 1 and Stage 2 Meaningful Use with an eye on Stage 3 and beyond. IHE USA and ICSA Labs developed this complementary certification program to expand the reach of testing and certification to not only include traditional EHR products that are the focus of current federal EHR adoption efforts, but allow Health Information Exchange (HIE) products, Patient Care Device (PCD) manufacturers, and other participants in the health IT ecosystem to pursue testing and certification based on mature, scalable, and industry-vetted specifications.
IHE Certification will provide purchasers of health IT products independent, third-party assurance that there is a credible, repeatable process that ensures quality, and that these products will exhibit the robust capabilities for optimal data exchange and security that are demanded by our industry.
The IHE IT Infrastructure (ITI) Domain supplies a standards based infrastructure for sharing healthcare information. Products that are certified under the ITI Domain are tested for capabilities from integration profiles related to document sharing, patient identification, audit logging and security. The specific profiles targeted for certification tested include:
- Audit Trail and Node Authentication (ATNA)
- Consistent Time (CT)
- Cross-Community Access (XCA)
- Cross-Enterprise Document Media Interchange (XDM)
- Cross-Enterprise Document Reliable Interchange (XDR)
- Cross-Enterprise Document Sharing (XDS.b)
- Patient Demographics Query (PDQ and PDQv3)
- Patient Identifier Cross-Referencing (PIX and PIXv3)
- Healthcare Provider Directory (HPD)
- Retrieve Form for Data Capture (RFD)
- Cross-Enterprise User Assertion (XUA)
The IHE Patient Care Device (PCD) Domain applies to specific integration scenarios that include at least one regulated medical device. Products certified under the PCD Domain are tested for interoperability capabilities related to receiving data from Patient Care Devices and/or communicating settings from an infusion order to an infusion device. More specifically the following IHE profiles are tested:
- Alert Communications Management (ACM)
- Device Enterprise Communication (DEC)
- Infusion Pump Event Communication (IPEC)
- Point-of-Care Infusion Verification (PIV)
- Pulse Oximetry (POI)
The IHE Patient Care Coordination (PCC) Domain deals with integration issues that cross providers, patient problems or time. It addresses general clinical care aspects such as document exchange, order processing, and coordination with other specialty domains. More specifically the following IHE profiles are tested:
- Immunization Content (IC)
- Cross-Enterprise Document Sharing - Medical Summary* (XDS-MS)
- Exchange of Personal Health Record Content* (XPHR)
The IHE Radiology (RAD) Domain address issues of interoperability and information sharing that impact the quality of care in medical imaging. More specifically the following IHE profiles are tested:
- Cross-Enterprise Document Sharing for Imaging (XDS-I.b)
- Scheduled Workflow (SWF)
The IHE Quality, Research, and Public Health (QRPH) Domain addresses the information exchange and electronic health record content standards necessary to share information relevant to quality improvement in patient care, clinical research and public health monitoring. More specifically the following IHE profiles are tested:
- Clinical Research Document (CRD)
The IHE Laboratory (LAB) Domain addresses information sharing and workflow related to in vitro diagnostic testing in clinical laboratories as well as on the point of care. More specifically the following IHE profiles are tested:
- Sharing Lab Report (XD-Lab)
**Profiles listed in italics are being offered for provisional testing**
Contact email@example.com to obtain more information about IHE USA Certification.
Have a Question? | Our FAQs Can Help!
Please visit the ICSA Labs' FAQ page, for an expanded list of questions.
|Q: Why should Health IT vendor choose to pursue IHE USA Certification?||A: IHE USA Certification is being offered to those product developers that are looking to further distinguish and differentiate health IT products that have integrated IHE capabilities and that offer advanced interoperability functions that go beyond minimum requirements for interoperability set by the government. IHE USA Certification expands certification beyond traditional EHR systems to HIEs and Patient Care Devices. It is the intent of IHE USA to expand certification to more IHE domains and profiles over time.|
|Q: Where can I find more information on getting our product IHE USA Certified?||
A: Right now you can go to http://www.icsalabs.com/ihe to get more information about certification and certified products. More information including an updated registration page and fee schedule will be forthcoming as we approach the IHE North American Connectathon 2016, scheduled for January 25 – 29, 2016 in Chicago, IL. Interested parties will be able to register for certification testing prior to and during the IHE NA Connectathon 2016.
|Q: What does IHE USA Certification testing entail?||
A: Testing is based on mature technical frameworks and specifications. Test tools leveraged will include the well-proven and familiar Gazelle and NIST tools that have been used at IHE Connectathons worldwide since 2000. In addition to tool testing, peer testing, and scenario testing will be required when possible to add to the rigor of testing and help ensure interoperability among disparate systems. The testing and certification will be guided by internationally accepted standards, ISO/IEC 17025 and ISO Guide 65.
Q: What is a testable unit? Is it an actor and a profile?
A: A“testable unit” is a vendor’s specific system being tested in a role (as an actor) within a profile. This is exactly the same as how systems are tested at the Connectathon. Typically, systems play a number of roles within a profile (eg “document source” and “document consumer”), and invoke several profiles (eg.CT, ATNA, XDS, PIX) simultaneously.
Q: What is the difference between the testing for the North American Connectathon and IHE USA Certification testing?
A: The Connectathon is a unique engineering event geared towards product development, where system developers can test and improve their latest IHE profile implementations against other systems. Connectathons are meant to be a collaborative event and testing is verified by volunteer monitors. Passing Connectathon testing allows a vendor to publish an integration statement where they can self-attest to the IHE profiles, actors, and options their product supports. IHE USA Certification is for production-ready systems to test and demonstrate IHE capabilities. Certification testing is conducted more formally by an independent third party test lab and certification body. The testing and certification framework is based on internationally accepted standards (IEC/ISO 17025 and Guide 65) and successful testing results in a specific product and version attaining certification for IHE profiles and actors. Certified products are also subject to ongoing surveillance requirements that verify that certified products stay in compliance with certification requirements over time.
Q: What about a vendor that isn’t participating in the Connectathon, can they pursue IHE USA Certification?
A: While the Connectathon process is separate from certification, IHE USA felt it was important to design a certification process that had a foundation in the testing processes used in the Connectathon and could leverage the time and effort expended in meeting Connectathon testing requirements. For the certification pilot it was important to work with vendors that had proven familiarity with IHE Profiles, some of the testing tools used, and the overall Connectathon process, so past participation in a Connectathon is a pre-requisite for the certification program.
Q: Why have the Connectathon and IHE USA Certification testing take place at the same time?
A: IHE USA piloted the certification program at the 2013 North American Connectathon, and is planning to do concurrently hold initial certification testing again at the 2016 IHE North American Connectathon. IHE USA felt it was important to try and take advantage of the fact that so many different vendors, systems, and development teams would be on site during the event. Certification testing also encompasses virtual testing to complete steps that aren’t completed at the Connectathon, or to extend testing that is started at the Connectathon. Holding additional events separate from the Connectathon events is also being considered in an effort to make certification testing more accessible.
Q: What is the obligation of the recipient of certification?
A: (1) the product must be manufactured in exactly the same way (with the same features, etc.) as the original sample that was tested and certified.
(2) the certification mark must be displayed with each product that is offered for sale, including any advertising and/or marketing collateral materials that are associated with the product.
(3) the product must comply with ongoing product surveillance requirements: if the certified product is changed in any significant way, or if there is any significant product failure, then the change or failure must be reported to the certification body, and use of the certification must be discontinued; the certification can be revoked, and the product must apply for new testing and certification.
Q: How long is my certification valid?
A: Certification is valid for 2 years from the date certification is issued.
|Q: Why is IHE USA partnering with ICSA Labs?||
A: ICSA Labs has over 20 years of proven experience around testing and certification. ICSA Labs is known for their expertise in testing and certification for information security products, and is also an Office of the National Coordinator Authorized Certification Body accredited by ANSI, as well as a NVLAP Accredited Health IT Test Lab for the government’s Meaningful Use Health IT Certification Program. ICSA Labs has brought on a number of experienced testing analysts well-versed in interoperability standards and conformance testing – and specifically with deep experience with IHE technical frameworks and Connectathon monitoring.
Content updated September 2015
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