Two years ago, the Department of Health and Human Services released proposed regulations that would allow patients to obtain their clinical lab test results directly from the lab, rather than having to wait to receive the results from their health care provider. CDT and other consumer groups enthusiastically supported this proposed rule at the time of its release.
Yet an Administration largely characterized by increasing patient access to health information seems inexplicably unable to close the deal on this important access initiative. As a result, patients still must wait for their providers to contact them with test results.
Under the current regulations, known as the Clinical Laboratory Improvement Amendments (CLIA), laboratories are restricted from disclosing test results to patients directly. Instead, labs can only send the test results to health care providers, people authorized to receive test results under state law or other labs. Only a handful of states permit labs to send patients test results directly, and some of these states require the provider’s permission before patients can have the results. The HIPAA Privacy Rule reflects this restriction, exempting CLIA-regulated labs (which are the great majority of clinical labs) from patients’ existing right to access their health information.
This existing regime has put patients at risk. A 2009 study published in the Archive of Internal Medicine indicated that providers failed to notify patients (or document notification) of abnormal test results more than 7 percent of the time. The National Coordinator for Health IT recently put the figure at 20 percent. This failure rate is dangerous, as it could lead to more medical errors and missed opportunities for valuable early treatment.
The 2011 proposed regulations would modify CLIA to permit labs to send results directly to patients, and they would also modify the HIPAA Privacy Rule to give patients the right to access or receive their lab results. Contrary state laws would be preempted. Patients would have the ability to request their lab results in a particular form or format, as with their other health information; for example, patients could request a paper copy of their test results, or to have the results sent electronically to the their personal health records
Increasing the ability of patients to have direct access to all their medical information allows patients to more effectively manage their own health care and organize electronic copies of their own data – a major benefit of the health care system’s ongoing transition to digital records. Further, providing patients directly with a copy of their records can cut down on duplicate tests and may reduce the burden on providers to promptly route data to patients themselves. Most broadly, this expanded access gives patients the ability to be as engaged as they choose in their own health and care.
Importantly, although patients would no longer have to go to health care providers to receive their test results, this does not mean providers would be cut out of the conversation. Labs will almost certainly send providers the results as well as patients, so providers can still reach out to patients to explain or provide context to the test results. Further, patients are granted the choice as to whether to involve their providers by getting in touch with them for further information, context or analysis, and CDT is strongly supportive of this and other initiatives that give patients the ability to make their own decisions based on their own information.
We are far from the only ones: a year ago we joined a consensus letter drafted by Ann Waldo on behalf of O’Reilly Media and signed by 638 individuals and organizations[DM1] , all of which strongly support these important patient access provisions and urged HHS to stop delaying the release of a final rule.
The proposed regulations were a logical move for a health care system transitioning to digital records and increasingly focused on patient engagement, and finalizing them is long overdue. Patients deserve to enjoy greater access to and transparency of their records, not to mention they deserve to receive their test results more consistently. And they deserve it now. This delay cannot continue: HHS and OCR must move swiftly to finalize these important regulations.
Alice Leiter serves as policy counsel for the Center for Democracy and Technology. Deven McGraw is the director of the Health Privacy Project at the Center for Democracy & Technology.