HHS Gives Patients Direct Access to Lab Results
The U.S. Department of Health and Human Services (HHS) has amended rules covering how laboratory test results are communicated to patients to allow patients to skip going through their physician to get access to their test results.
Patient personal health record systems linked to electronic health record systems that directly and securely deliver laboratory test results electronically to patients at the same time as their physicians get the results have proven popular with patients. However, physician organizations sometimes build delays into the system for specific test results to allow a patient’s doctor to communicate sensitive results personally and explain nuances in results that are on a range rather than a definitive positive or negative result.
It is unclear what if any effect the new rules will have on such arrangements as they do not require labs to provide access to test results immediately. Rather they allow labs to furnish results within 30 days for patients that request them and cover the cost of transmitting the results, either on paper or electronically.
Specifically, the final rule that was issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Office for Civil Rights (OCR) amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to give a patient, or a person designated by the patient, his or her “personal representative,” access to the patient’s completed test reports on the patient’s or patient’s personal representative’s request. In addition, it ends the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory.
The move was hailed by patient advocates as a significant development. David Harlow a health care lawyer and consultant at The Harlow Group LLC, who chairs the Society for Participatory Medicine’s public policy committee, called it a “notable development” because it was achieved through the persistence of patient advocates and over the “significant opposition to the rule from organized medicine on the grounds that unmediated information could be misinterpreted by patients and could otherwise be problematic.” (Read his post here.)
The final rule is available for review at: http://www.federalregister.gov. It will become effective in early October.
Contributor
Lena Kauffman is a contributing writer based in Ann Arbor, Michigan.