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Rabu, 21 September 2011

Patient Access To Health Information. What Are Some Of The Issues?

There are some interesting moves happening in the US with regard to the access, by patients, of their laboratory test data.
This is reported here:

New Rule: Individuals Can Get Test Results from Labs

HDM Breaking News, September 13, 2011
The Department of Health and Human Services has issued a proposed rule enabling patients to electronically access their laboratory test result reports directly from labs.
The rule, available here on Sept. 13 and being published Sept. 14 in the Federal Register with a 60-day comment period, affects labs that are covered entities under HIPAA. The rule amends the Clinical Laboratory Improvement Amendments of 1988 that exempted labs from provisions that give patients the right to access their protected health information.
The rule specifies that "upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient," the proposed rule states.
More here:
There is commentary here:

Caveats Abound on Patient Access

Health Data Management Blogs, September 15, 2011
The recent proposal from CMS to allow patients electronic access to test results via laboratories is another step in the inexorable march toward information transparency.  The agency is also trying to expand patient access rights to data disclosures (though the jury’s still out there) and has consistently chipped away at the long-standing tenet that medical data should stay in the hands of medical practitioners.
Patients should have full rights to the data generated and used to understand their health condition and develop treatments in response. But lifting the veil, while seemingly inevitable, is just as inevitably going to cause confusion and rachet up the tension between medical practitioners and those they serve.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) that a new proposed rule would amend currently limits  the disclosure of laboratory test results to three categories of individuals: the ‘‘authorized person,’’ the person responsible for using the test results in the treatment context, and, in the case of reference laboratories, the referring lab. “Authorized person” is defined in as the individual authorized under state law to order or receive test results, or both. In states that do not provide for individual access to the individual’s test results, the individual must receive his or her results through the ordering provider.
 The proposed rule states that “While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual’s active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.”
The issues with test results, as with any other data distribution, are context and interpretation. We’ve reported frequently on the development of personal health records, and a huge sticking point faced by patient-facing PHRs is providing meaningful information and context to those who don’t understand the languages spoken in health care. How many patients can interpret claims data and derive any insights from diagnosis codes and test results without plain English (or other languages, but that’s another point in an increasingly multi-linguistic society) explanations of what they mean. There’s value, and more value is being added as PHRs become more sophisticated, but without a medical editor, misinterpretation occurs pretty easily.
The dangers of misinterpretations are magnified in the arena of unfettered access to lab results. Providers are the current middleman in this data exchange, and they take pains to build context into results reporting, even if they’re doing it in an automated fashion.
Lots more here:
and here:

On lab results, it's "Show me—first"

By Joseph Conn
The CMS this week published what it described as a proposed rule that I'm calling the "Me First" Lab Rule.
Today, patients can obtain their laboratory test results from their healthcare providers under guarantees in the Heath Insurance Portability and Accountability Act of 1996. In a few more years, the CMS' own electronic health-record incentive programs should spur widespread provider adoption of interoperable EHRs, and that should speed up patient access to lab results considerably. By then, the torrent of an estimated 6.1 billion test results per year will pour automatically into those provider EHRs. From there, lab results should flow automatically to patients by way of personal health record systems "tethered" to providers' EHRs.
The CMS' proposed rule, however, reinterprets both the flow-controlling Clinical Laboratory Improvement Amendments of 1988 and the HIPAA privacy rule in a way that pre-empts many state lab-access laws and procedures. It changes who gets to see test results first, the physician or the patient.
Both CLIA and HIPAA now support a states'-rights approach to test results reporting. They look first to state law, and then, if none is applicable, to federal law. Thus, in 39 states and U.S. territories, lab test results must flow first to the ordering or using provider.
Only nine states have laws that permit a patient to receive test results directly from a lab. Seven states permit direct connections with the provider's permission.
It's a doc-centric system in most states, but one from which patients derive benefits. To give docs their due, sending lab results to them first supports the doc's role as the first interpreter of lab results' clinical meaning, the first counselor of bad news, and the first planner, with the patient, of a course of treatment. The CMS rule-writers didn't mention these important roles or analyze the potential impact the loss of the docs being first in line to receive lab values might have on patients.
More here:
I raise this issue as I am sure we will wind up having a similar discussion at some point in the future in Australia.
For what it is worth, while recognising the rights of patients to access their information, it seems to me that delivery and explanation of the implications of a test result - or results - should be left to the clinician ordering the investigations.
There are obvious and reasonable exceptions - especially when regular testing is done in the context of tracking chronic illness - where the patient will be as aware as the clinician as to the meaning of such a result - e.g. an INR or a blood sugar in a diabetic.
In this situation I would like to see a standing order (with agreement) be possible where patient access can be automatic for such tests.
That way the informed patient can be as empowered as they wish to be - and the unsuspecting or uninformed can avoid a possibly scary surprise which may have an easy explanation.
Bottom line is that there is a sensible balance here - and the Yanks seem to have gone just a tad too far to me!
David.

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