Lab Results for All! Of Data Liberation, Participatory Medicine, and Government 2.0

On September 14, HHS released for comment draft lab results regulations that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of ¡data liberación!  All lab results will be made available to patients, just like all other health data.  (See the HHS presser and draft lab results regulations that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of ¡data liberación!  All lab results will be made available to patients, just like all other health data.  (See the HHS presser and YouTube video from the recent consumer health summit.  Todd Park, HHS CTO, is also the chief activist for what he calls ¡data liberación!)

Forgive me for mixing my metaphors (or whatever it is I just did), but even though there are just a couple dozen words of regulations at issue here, this is a big deal.

When HIPAA established a federal right for each individual to obtain a copy of his or her health records, in paper or electronic format, there were a couple of types of records called out as specifically exempt from this general rule of data liberation, in the HIPAA Privacy Rule, 45 CFR § 164.524(a)(1): psychotherapy notes, information compiled for use in an administrative or court proceeding, and lab results from what is known as a CLIA lab or a CLIA-exempt lab (including  “reference labs,” as in your specimens get referred there by the lab that collects them, or freestanding labs that a patient may be referred to for a test; these are not the labs that are in-house at many doctors’ offices, hospitals and other health care facilities — the in-house labs are part of the “parent” provider organization and their results are part of the parents’ health records already subject to HIPAA).

(“CLIA” stands for the Clinical Laboratory Improvement Amendments of 1988, which established quality standards for certain laboratory testing.)

This carveout of lab results from patient-accessible records has long been a thorn in the side of the e-patient.  This month, the federales announced that they would step forward as Androcles to the e-patient lion (to jumble a reference or two), and pull out the thorn, by proposing to amend both the CLIA regs and the HIPAA regs.  The HIPAA regs include the exception described above: all records must be made accessible upon request except labs and a couple others.  The lab results exception will be deleted from the HIPAA regs if the change is finalized.  The CLIA regs prohibit lab delivery of results directly to patients.  The proposed amendment says that the labs “may” release the results directly to patients.  The net effect is that patients will have the right to request the results, and since labs will be permitted to release them, they will have to do so.

As some readers will recall, HIPAA regs were subjected to a state-by-state “pre-emption analysis” when they came out.  (Generally speaking, Federal law “pre-empts” state law unless state law is more protective of an individual’s rights or health.)  The feds note in the preamble to the proposed rule:

A number of States [most, actually] have laws that prohibit a laboratory from releasing a test report directly to the patient or that prohibit the release without the ordering provider’s consent. If adopted, the proposed changes to § 164.524 [of the HIPAA regs] would preempt any contrary State laws that prohibit the HIPAA-covered laboratory from directly providing access to the individual.

Thus, labs in most states have some work to do in figuring out how they will actually release results directly to patients once the regs are finalized and effective (which could be about a year, gang, so sit tight).

Here’s where it gets fun, folks:

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.

CMS goes on to say that the HIT Policy Committee at ONC, established by the HITECH Act, says that “CLIA regulations are perceived by some stakeholders as imposing barriers to the exchange of health information.  These stakeholders . . .  believe that the individual’s access to his or her own records is impeded, preventing patients from a more active role in their personal health care decisions ” … so we’re going to change them.  [Paraphrase and emphasis mine.]

Let me restate this, folks: the regs are being changed to give greater patient access to health data not because of a recent change in the law, but because patients and patient advocates spoke up, and the HIT Policy Committee got the message.  

I had the opportunity to hear Dr. Farzad Mostashari (National Coordinator for Health IT), Lygeia Ricciardi (Senior Policy Advisor for Consumer eHealth), and Jodi Daniel (Director, Office of Policy & Planning) speak at an ONC town meeting at last week’s Health 2.0 conference in San Francisco and they are nothing if not passionate about promoting patient access to health data. Please take a look at my mini video interviews with Dr. Mostashari and Ms. Ricciardi, if you need any confirmation.  For the wonks and insomniacs: you may be interested in listening to all or part of the ONC town hall meeting at Health 2.0 conference.  It is an unofficial recording, about 45 minutes long, and will start when you click the link; it offers a further window into the thinking of Mostashari, Ricciardi and Daniel, as they discuss ONC’s broadening of focus from providers to include patients (the very beginning of recording is clipped, but you didn’t miss much).  Another way in which this broader focus is demonstrated is by the redesign and expansion of the HealthIT.gov website, which now includes more robust patient-focused content. (“Putting the “I” in Health IT” … You can take the pledge to empower individuals to be partners in their health through health IT.)

This change may improve patient access to lab results, but only if the right to obtain the results is ushered in together with an education campaign that alerts patients to this new right, and if the results are presented in a manner that includes some minimal level of interpretation (and I recognize that too much interpretation will cross the line into the communication that needs to take place between the patient and his or her clinician).  On the question of how lab results should be presented to patients, at Health 2.0, Thomas Goetz, of Wired magazine, presented a patient-friendly lab report tool, to be rolled out soon by his company, 1 + 1 Labs.  Other approaches, of course, are possible, since numerous institutions already provide this data directly to patients.

A certain percentage of lab results never make their way to the patient — and the patient education piece of the rollout could result in that percentage being reduced, or even eliminated.

There is opposition to the proposed rule by some providers, who express a concern that a patient who receives lab results directly may well (a) misintepret a value that is “normal” for the population at large but that might not be “normal” for her and/or (b) fail to communicate with the clinician who ordered the test.  In our fee-for-service world, some cynics may say that some clinicians are being inappropriately incentivized to seek another billable patient encounter for discussion of results.  In the future of bundled, episodic, prospective payment systems, this would not be a concern.  In fact, since we will be asking the entire health care system to be doing more with less as a result of the nation’s fiscal and political environments, frictionless sharing of information should be welcomed by providers.  Providers will continue to receive lab results, and will continue to be expected to discuss them with their patients.

Comments on the draft rule are invited.

If you get a charge out of reading this post and thinking about the changes coming down the pike in access to health data, and you’d like to take part in future grassroots activity that can lead to real change, please consider joining up as an active member of the Society for Participatory Medicine — which is composed of poviders as well as patients — and also consider beocming active in the broader Patients 2.0 community.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 

A version of this post first appeared on e-patients.net, the blog of the Society for Particpatory Medicine.  I serve as Chair of the Society’s Public Policy Committee.