Abstract
Perhaps the biggest impediment to achieving reliable and interoperable healthcare information systems is the absence of widespread standards adoption; and not just standards, but standards that are clear and unambiguous. These standards must provide precise specifications in a language that can be universally understood and interpreted—the language of conformance. This conformance language provides the means and constructs for defining requirements and solutions exactly and consistently so that systems, products, etc. can achieve conformance that ultimately leads to interoperability. These means and constructs are embodied in the principles of conformance, the subject and focus of this book.
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Notes
- 1.
Specified separately and independently.
- 2.
It is hard to assign a definitive value to the savings, but typical estimates found in the literature conservatively place the amount spent when issues are discovered during the operations phase at 100 times the amount spent for discovering and resolving the issues during the requirements definition phase. See the [2] study for details on the subject.
- 3.
Meaning the normative standard; intermediate standards for trial use (STU ) are integral parts of the standard’s development life-cycle.
- 4.
Although the term “required” is quite common in various data exchange standards, the detailed semantics varies. Sometimes it includes null values, sometimes not. Sometimes it refers to the presence of real data, sometimes the presence of the element (without) data is sufficient.
- 5.
In general, the concept of “RE” means that an implementation must support the capability but operationally data may or may not be present. The subtleties of this concept will be explained in-depth over the course of this book.
- 6.
In HL7 v2.x a methodology is provided for documenting constraints on a message. In other standards no such methodology is provided; authors are left to ad hoc solutions.
- 7.
IHE and other organizations most relevant to healthcare are introduced in greater depth in Chap. 3 (Healthcare Standards Landscape).
- 8.
Centers for Disease Control and Prevention in the United States.
- 9.
Office of the National Coordinator in the United States.
- 10.
The knowledge an actor such as a physician must have acquired through education and experience in the medical domain in order to participate in the information cycle is a different type of knowledge than the knowledge one can derive from receiving an appropriate amount of data (which is another topic and is certainly interesting and important).
- 11.
An example is the simple statement of a blood pressure measurement. An interpretation of “190/120” as “normal” is only possible if the interpreter knows that the patient is cycling on an ergometer. The simple observation value is meaningless or even misleading without the accompanying context.
- 12.
The term interface in this book refers to the software employed to exchange data between systems. Other notions of interfaces, such as a user interface, will be explicitly called out.
- 13.
For a non-trivial interface, proof of conformance is unattainable even with exhaustive testing. Thus, typically a tester will declare “a system is conformant with respect to a given set of tests”. Conformance testing strives to establish a degree of confidence in the conformity of a given entity based on the quantity and the quality of the tests performed.
- 14.
Compliance in this context has a different meaning as used in Sect. 1.9.
- 15.
Logical Observations Identifiers Names and Codes; See https://loinc.org.
- 16.
Indeed, this waterfall process model allows for repeating and updating every step, but to keep the figure simple, these aspects of the process are not made explicit.
- 17.
We use the term “derived specification” to denote a technical documentation that is based on another technical document or set of technical documents. Often the derived specification places constraints on the base specification.
- 18.
Often systems will implement to the same specification, and in such cases compatibility is not of concern.
- 19.
Even in the case of compatibility and interoperability, it can’t be assumed that the system implemented the specification correctly.
- 20.
Conformance is not a concept that can be proven except for the most simplistic specifications; see Chap. 11 for an in-depth discussion on this topic.
- 21.
The terms “required” and “mandatory” are used in most of the standards, but not always with the same meaning. The differences are explained in chapters that follow. An overview of different standards is provided in Chap. 4.
- 22.
Meaning the final normative standard; certainly draft standards are necessary as part of the standards development life-cycle.
- 23.
The different conformance constructs span a multi-dimensional test space where each point within must be tested individually, which is practically impossible.
- 24.
Automated test generation can help; however, in the opinion of the authors, this technology has not been proven to be reliable and comprehensive beyond a limited set of trials.
- 25.
Implementation is also a suitable term; however, a narrower focus is sought here.
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Oemig, F., Snelick, R. (2016). Introduction. In: Healthcare Interoperability Standards Compliance Handbook. Springer, Cham. https://doi.org/10.1007/978-3-319-44839-8_1
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