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Tuesday, December 4, 2012

Breaking News on IHE Certification

The following release found it's way into my inbox this morning. I got the paper copy yesterday at the IHE Interoperability Showcase at the mHealth Summit yesterday. If you want to learn more about it and are at the summit, stop by the Interoperability Showcase at #MHS12 and ask for Mike or Elliot.

-- Keith

ICSA Labs is very excited to join Integrating the Healthcare Enterprise (IHE) USA in announcing a new partnership to offer an IHE Certification track as a part of the 2013 IHE North American Connectathon and related testing events.

Earning IHE Certification will allow vendors who have developed advanced health IT the right to claim that their products have been tested and verified by an independent third party for interoperability and conformance to IHE technical specifications and profiles, utilizing an industry approved and recognized process that is based upon the stringent requirements of ISO Guide 65 and ISO/IEC 17025 that are used to test and certify health IT products that meet Meaningful Use requirements for the EHR Incentive programs today.

This is a major milestone for the healthcare industry. In addition to complementing Meaningful Use initiatives, IHE Certification by ICSA Labs will extend the availability of secure and interoperable health IT, advancing beyond the existing mechanisms that are required by the Office of the National Coordinator for Health IT under the Meaningful Use program.

More details will be announced shortly, including how vendors and heath information exchanges can sign up for testing and certification, beginning as early as January of 2013.
The text of the announcement follows.

ICSA Labs – IHE USA Certification Program

Industry Announcement

For Immediate Release

IHE USA is pleased to announce a new program that will provide industry-accepted certification to complement existing testing of conformance to IHE integration profiles. This new service will be delivered through a strategic partnership between IHE USA and ICSA Labs, and will commence at the 2013 North American Connectathon being held January 28 through February 1, 2013 in Chicago.

IHE USA and ICSA Labs both share the goal of accelerating the adoption of usable, secure, and interoperable health information technology, to further the goal of improving patient safety and delivering higher quality of care. To that end, these organizations have formed a collaborative partnership to advance the state of the industry. 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.

Founded in 1997 by the Healthcare Information and Management Systems Society (HIMSS) and the Radiological Society of North America (RSNA), IHE is a global non-profit organization that enables the collaboration of healthcare providers and industry leaders to work together to improve interoperability and exchange of health information. IHE utilizes a proven framework for standards based interoperability of health IT systems, which is being adopted and implemented worldwide by regional and national deployment affiliates such as IHE USA. Globally, IHE is founded upon a fully cooperative partnership model with over 500 member organizations that contribute over 2,000 individual volunteers to participate in IHE committees. IHE volunteers have a diverse background including clinicians, ambulatory practices, hospitals, medical societies, academic medicine, researchers, and vendors from across the globe. IHE has been testing conformance and interoperability of health IT systems for over a decade at annual events known as Connectathons, where teams of specialized technical experts monitor the testing of more than two hundred different participating systems. The ability to officially certify products for both interoperability and conformance will significantly extend the value for those systems that are successfully tested at the North American Connectathon, sponsored by IHE USA.

ICSA Labs brings to the partnership decades of experience as an independent and well-respected testing and certification entity, providing services for product certification of antivirus software, VPNs, firewalls, mobile applications, as well as FIPS cryptographic module validation, and malware analyses. ICSA Labs currently offers certification and testing under the authority of the Office of the National Coordinator's (ONC) Certified Health IT Program for Meaningful Use, and is designated as an ONC Authorized Certification Body (ONC-ACB), fully accredited by both the American National Standards Institute (ANSI) as a certification body, and by NIST as an Accredited Test Lab (ATL) for Health IT the National Voluntary Lab Accreditation Program (NVLAP).

“Implementing products certified to the IHE profiles will allow healthcare providers and hospitals to leverage more complex workflows, mature and scalable standards, and robust data exchange requirements as they build upon foundational standards that have been nationally recognized in the U.S.,” said Joyce Sensmeier, President of IHE USA and Vice President of Informatics at HIMSS. Certification will also be expanded to cover areas that have not been a focus of the CMS EHR incentive program to date, such as PACS imaging systems, Health Information Exchanges, and personal care devices. “This certification is meant to complement the existing ONC Health IT Certification program for Meaningful Use,” added ICSA Labs Managing Director, George Japak, “which was primarily designed qualify providers to receive monetary incentives.” The certification to IHE profiles, which also provide significant underpinnings to the ONC specifications, will offer decision makers the critical information and necessary confidence to properly evaluate the wide array of existing health IT products offered for purchase today.

Participants that are registered for the 2013 IHE North American Connectathon will be able to register for certification testing as an “add-on” track. Testing for Certification Track participants will be conducted by accredited Certification Testing Monitors, who will conform to the rigid requirements set forth by the ISO 17025 standard for the competence of testing and calibration laboratories. Results will be formally evaluated by the independent ICSA Labs Certification Body, which will grant certification based on requirements set forth by IHE USA, and the general principles covered by ISO/IEC Guide 65 for organizations providing product certification. Certification will also include industry-standard system surveillance activities that ensure that certified products continue to perform as tested in the field, as they are updated and enhanced over time.

Certified products will be published by IHE USA, as well as in the official ICSA Labs product directory. Three tiers of Certification will be awarded based on:

  • Tier 1: Conformance to IHE profiles
  • Tier 2: Demonstrated interoperability amongst disparate systems
  • Tier 3: Validated Implementations of deployed certified technology

ICSA Labs will also partner with IHE USA to offer certification services in conjunction with the new testing events slated to launch shortly: Projectathons and Virtual Connectathons.

“Certification will be a voluntary process… those certifying against the IHE profile specifications will not be doing so to obtain incentives, but rather because this is considered best practice to advance quality and patient safety in our nation,” added Sensmeier.

Vendors interested in learning more about having their products certified to IHE integration profiles should contact


IHE USA ( is a not for profit organization founded in 2010 that operates as a national deployment committee of IHE International®. IHE USA serves as a voice representing U.S. health IT interests and key partners in national health IT efforts for fostering the national adoption of a consistent set of information standards to enable interoperability of health IT systems. Learn more about IHE USA and their role in advancing health IT in the U.S.

About ICSA Labs

ICSA Labs, an independent division of Verizon, offers third-party testing and certification of security and health IT products, as well as network-connected devices, to measure product compliance, reliability and performance for many of the world’s top security vendors. ICSA Labs is an ISO/IEC 17025:2005 accredited and 9001:2008 registered organization. Visit and for more information.

1 comment:

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