In response to my note yesterday about direct-access-testing (DAT) (see: New Definition for DTC Lab Testing Prompted by EverlyWell Business Model), Andrea Pitkin, Ph.D., commented in the form of a presentation she had made at the last ASCLS annual meeting. She makes a number of important observations that I hope to comment on in upcoming days. For this note, I will address the following point copied from her comment:
How are consumer testing and Patient Generated Health Data (PGHD) integrated and used within the medical record?
Some apps allow upload to the physician's EHR. They should not be comingled with laboratory performed testing as they are different. The largest issue is one of trust. Does the physician trust from a medical and legal perspective, results performed by consumers (who may have invalidated the home pregnancy test when dropped in the toilet) versus health professional performed testing? How are results kept separate in EHR modules and clinical displays? These new methods and perhaps specimens or transcutaneous analysis should have different LOINC codes so all users can identify these differences in health data.
I personally think that it's time for one of the various lab standards/accreditation agencies to begin to grapple with what Andrea refers to as Patient Generated Health Data (PGHD). To what extent should it be be integrated, but not comingled, with test results generated in accredited clinical laboratories? This topic is not always straightforward. For example, patient-generated blood pressure readings may be more accurate than those taken in the physician's office due to white coat hypertension (see: White coat hypertension: When blood pressure rises at the doctor's office).
It's not too early to begin this PGHD discussion because I and others can already view hospital-generated test results in the MyChart app "powered by Epic" which is accessible on my smartphone. I expect this trend to continue in the "opposite direction" (i.e., transfer of data from the consumer to healthcare providers). Consider, for example, AliveCor's six-lead ECG device generates data that is clinically valid and thus transferable to a patient's cardiologist (see: This is your heart × 6). In terms of some ideas that could be incorporated into standards pertaining to PGHD, I would make the following suggestions:
- I have previously blogged what what I referred to as the "diagnostic results package" (DRP) for each lab result or set of lab results which I likened to the provenance of an antique (see: The "Diagnostic Results Package": A New Way to Envision Results Reporting). This idea is relevant for the current discussion. For example, if a patient were to order a set of tests via the web and they were performed by an accredited national reference laboratory, the DRP would include, at the very least, the lab test results, the name of the performing lab, and the reference ranges by test. The results would need to be in an unalterable format like PDF. Interestingly enough and although ordered by a consumer, these results would have a validity comparable to those generated by a hospital lab.
- Alternatively, the DRP for, say, a home pregnancy test would include the name of the consumer performing the test, the manufacturer of the kit test, and the result. Such a result, performed by the health consumer, would need to be confirmed in an accredited lab.
- There now exists what I will call two domains for the storage/access of health information for a consumer/patient: (1) the hospital controlled EHR domain that is accessible by the patient via the patient portal; and (2) the patient-controlled personal health domain using a smartphone as "command central" and linked to various apps and wearables such as an Apple Watch (see: Smartphones Provide a Key Element in Our Personal Health Management Systems).
- As noted above, a consumer can now transmit selected health data like ECG data to a healthcare professional. There is thus perhaps the need now for a third domain for consumers, a general-propose, personal health data repository in the cloud via which a consumer could provide personal health data access to healthcare providers and other relevant hospital personnel.
Comments