AEGIS Responds to the FDASIA Report

AEGIS provided comments on the Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report: Proposed Risk Based Regulatory Framework (the “FDASIA Report”). We are assisting the Food and Drug Administration (FDA), the Office of The National Coordinator (ONC), the Federal Communications Commission (FCC) and other government, public and industry stakeholders as they move from the initial FDASIA Report to the final one. Our response focused specifically on one of the four Priority Areas named in the report: “Leverage Conformity Assessment Tools.”

The benefits of conformity assessment tools (Conformation Testing, Interoperability Testing, Compliance Testing, etc.) include but are not limited to:

• Products from different vendors that have been tested for conformance to the same standards have a higher likelihood of interoperability.
• Different vendors can independently implement standards with higher assurance of product interoperability.
• Customers can buy products that will interoperate with previously purchased equipment from different vendors.
• Supports the ultimate objective that independent implementations of the same standard will interoperate.
• Conformance testing improves success of interoperability initiatives, while interoperability testing confirms at a user level that interoperability has been achieved.
• Conformance needs to be achieved first and should not be compromised during interoperability testing. Without conformance, two implementations can be made to interoperate by destroying interoperation with all other systems.
• Implemented correctly, Conformance and Interoperability Testing consists of advanced automated testing labs to help automate and execute test cases created by organizations, providing an easy-to-use system for performing conformance and interoperability tests against published SDO specifications, standards, and profiles, including templates and implementation guides.
• Likewise, a well-implemented program offers Continuous Interoperability testing, preventing the false security of “one and done” testing. In an interoperable ecosystem, interoperability must be tested regularly, even after certification is achieved, because the potential points of failure across interoperable systems span multiple systems, organizations, even countries.
• The most advanced test lab is able to support testing conformance and rules all the way from micro (or discrete) elements of a message to segments of message to messages which integrate numerous standards (e.g., NwHIN which implements multiple standards within a single message such as W3C, OMG SAML Oasis, IHE, and HL7) thereby achieving a macro Cross Community Patient Discovery XCPD which is a portion of the Patient Resource Locator-PRL Service message suite.

Entire vendor communities benefit from cloud-based, shared testing services of conformity assessment tools. Participating in these types of programs takes the burden off of vendors to validate technical interoperability and offers them a major market differentiator. This effort also builds upon and accelerates consensus toward national standards, EHR certification criteria, and testing procedures for Stage 2 of Meaningful Use and beyond.

Interoperability is tremendously challenging from a technical perspective as the industry now realizes. Interoperability testing approaches lend themselves naturally to not only test for problems, but also to support investigation into such problems and to problem solving efforts. That points to perhaps the greatest benefit of conformity assessment tools and the interoperability and conformance testing they enable – that is, avoiding significant RISK to Continuous Interoperability at a National level.


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