There has been a longstanding recognition that despite an abundance of information technology standards for healthcare, IT systems that use those standards are rarely compatible or comparable due to a myriad of implementation variations across vendors and enterprises. Healthcare IT standards tend not to be unique in the solutions they offer and share an overlapping problem space with other standards, inducing competition rather than compatibility. Further, even using identical standards rarely yields identical implementations because of differences along dimensions such as differing versions of the standard, use of optional aspects of the standard, ambiguities in the standard, degrees of freedom in the standard, compromises required by the environment, and other such reasons. The Federal Government has taken the lead in trying to reconcile this widespread variation through the public endorsement of specific standards for specific uses. This is a useful development. However, the path to conformance for each vendor is different, and can cause purchasers of healthcare IT products to become out of step with the national direction. Further, the other factors in vendor variation are still present, so one must be vigilant in determining the difference between a vendor’s claims about conformance to national standards, and the practical reality.
When evaluating a healthcare IT solution, you need to consider several litmus indicators before concluding that you will be able to comply with Federal regulations as well as accomplish advanced care delivery through the meaningful usage of your IT systems. The following table lists some of these important considerations.
|
Litmus Indicator |
Description |
|
Use of Standards in the Intended Manner |
Healthcare IT standards, like those for clinical messaging of various kinds, are usually broadly applicable to a number of different scenarios. Thus, the same general messaging standard that is used for lab ordering can also be used for patient registration. Unfortunately, the precision in which the Federal Government makes its endorsements is not always fine grained enough to communicate its intent. Therefore, if regulations intend to endorse a standard for lab ordering, a vendor who uses the standard for another purpose may claim conformance. |
|
Portions of Endorsed Standards Actually Utilized |
Some standards that are endorsed in regulation encompass a large swath of clinical content that every vendor may not address. For example, both the Continuity of Care Record (CCR) and the Continuity of Care Document (CCD) have a number of modules corresponding to various kinds of data (family history, problems, allergies, medications, etc.). A number of vendors will be able to use the CCR or CCD in their products, but with a restricted set of data (e.g. an electronic health record system may only populate problems (diagnoses) and medications within a CCD). A purchaser of these healthcare applications should match the products’ capabilities with the purchaser’s objectives and also with any capabilities and expectations of any partners |
| Level of True Integration of the Standards into the Product | Some products have incorporated national standards in a superficial way which does not advance the goal of meaningful use of healthcare IT. For example, an IT system may allow the importing and viewing of a clinical document using a particular national standard, but not provide access to its component data elements in the same way as it does for other competing document standards. |
|
Implementation Guidance that Governed Standards Integration |
The specific instructions that guide how a standard is used are almost as important as the standard itself. There are many different sources that write manuals on how to properly use standards, sometimes coming from the standards development organization itself, and sometimes from third parties like Integrating the Healthcare Enterprise (IHE). Therefore, if product vendors use different implementation guides to incorporate the national standards into their products, they can have divergent implementations across vendors, thereby negating the impact of the standard. This is particularly important when undertaking system integration projects. |
GSI Health Can Help You! GSI Health has extensive experience in testing healthcare IT systems, and focuses on data-driven testing for understandable and thorough test batteries. Our consultants can assist you in navigating the issues discussed in this paper, and provide the professional IV&V services you need to properly test your healthcare IT applications and architecture. Our testing methods account for adherence to national standards, and are extensible to accommodate local requirements. To learn more about how GSI Health can help make you successful in deploying a strong quality assurance program as a part of your healthcare IT project, please contact us by phone at 1-888-206-4237 or email HITvision@gsihealth.com.