FDA officials: Don't overlook the importance of health IT terminology

When it comes to data in healthcare, the correct use of terminology, while many times overlooked, is every bit as vital to industry success, according to U.S. Food and Drug Administration officials Robert Califf and Rachel Sherman.

In a recent post published to the FDAVoice blog, Califf, the FDA's deputy commissioner for medical products and tobacco, and Sherman, Califf's associate deputy commissioner, say that, all too often, terms such as "data," "information" and "evidence" are mistakenly seen as interchangeable.

"[T]hey are not [interchangeable terms]," Califf and Sherman write. "Data are best understood as raw measurements of some thing or process. By themselves they are meaningless; only when we add critical context about what is being measured and how do they become information. That information can then be analyzed and combined to yield evidence, which in turn, can be used to guide decision-making."

In addition, Califf and Sherman call the distinction between "real-world evidence" and clinical research an important one. While real-world evidence, they say, may paint a more realistic picture of a patient's health than clinical evidence, the latter should not be dismissed. "In considering comparisons of treatments, one must always consider the possibility that the treatments were not assigned randomly, but reflected some relevant patient characteristic," they say. "This is, of course, the reason for doing randomized clinical trials."

Gartner Research Director Michael Shanler last month wrote that mobile health wearables--often considered to be more reflective of patients' everyday lives--are not ready for prime time when it comes to use in clinical trials.

"Wearables are already pervasive in the consumer world for fitness and health, and they seem a logical fit in the world of clinical trials," Shanler said. "At this point, however, hype far outweighs solid examples of wearables in clinical trials."

The use of common and appropriate terminology is not a problem linked only to clinical trials. In April 2014, research published in Telemedicine and e-Health determined there to be at least seven unique definitions of telehealth in current use across the U.S. government.

To learn more:
- read the FDAVoice post

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