We're inching closer to promulgation of final regulations that will likely make all lab test results more easily accessible to patients, by making them subject to the HIPAA rules ensuring patient access. (Currently, lab test results and psychiatric notes are the two lone categories of patient data not subject to HIPAA; however "in-house" labs drawn at a health care facility or medical practice are already accessible to patients under HIPAA.) This change is significant in no small part because there was no change in the law that prompted the change in regulation -- the only thing that changed was the rising voice of patients insisting on access ... and a more receptive set of ears in Washington. The proposed change in the regulation was first published two years ago. As I wrote then in a post on lab test results and proposed changes to the HIPAA rules:
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.