Developing a Working Definition for Consumer Diagnostics

Spurred on by a recent report from Cambridge Consultants (see: Balance between consumer and healthcare providers expected to shift as home medical testing expands), I thought that it would be useful to post a note about consumer diagnostics with a working definition of the term. Here is an excerpt from the report (boldface emphasis mine):

The shift in the relationship between patients and medical providers will continue to change the healthcare landscape as the ease of use and reliability of consumer self-diagnostic products advance....Yet, as the expansion of consumer diagnostics and monitoring products empower consumers to actively manage their own healthcare, new challenges and responsibilities for both consumers and the diagnostics technology industry are emerging.

Here is what I came up with as a first effort:

Consumer diagnostics can be defined as a product, service, or device purchased or managed by a healthcare consumer and intended for one of the two following purposes (1) to diagnose or assess the status of a disease or degree of wellness (2) to analyze the underlying physiological, biochemical, or genetic cause(s) of a current or future disease. The most common type of consumer diagnostics is laboratory consumer diagnostics. Another category that is not as well developed is imaging consumer diagnostics.

At the present time, there are four basic categories of laboratory consumer diagnostics:

• Direct access testing (DAT). I have posted many previous notes about DAT. Such testing is generally performed by the same national reference labs that provide clinical lab testing for physicians' offices. Therefore, the major differences between DAT and office testing is that the consumer initiates the test order, the results are sent directly to the consumer, and the consumer [currently] pays for such testing out-of-pocket. There will be few practical limits on the DAT test test menu because all tests offered to physicians are potentially available for direct purchase by consumers.
• Home-based lab test kits and instruments. The details of this form of consumer diagnostics are well-known, consisting of such common examples as the use of  glucometers for home testing by diabetic patients and home pregnancy testing. Thee key feature of this category of consumer diagnostics is that the test is both performed and "interpreted" by the consumer.
• Consumer-collected send-in lab specimens. The classic example here is home HIV testing. A finger-stick blood sample is mailed to the performing lab and the results are reported back to the consumer in about a week. Testing is anonymous with HIV testing and the customer is identified only by a code number that comes with the test kit.
• Walk-in point-of-care testing (POCT) centers. This is a category of consumer diagnostics that is still in the early stages of development but has been discussed for a number of years. One such example is the pharmacist-staffed coagulation clinics of the Geisinger Health System (see: Pharmacist-Staffed Coagulation Clinics in a Large Health System). I have also suggested that the walk-in clinics being developed by health systems to compete with those operating in retail pharmacies and big-box stores such as Wal-Mart might begin to offer POCT to enhance the quality of their services (see: Health Systems Launch Walk-In Clinics).