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 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, Read more »
*This blog post was originally published at HealthBlawg :: David Harlow's Health Care Law Blog*