Feb. 3—Patients will be able to directly access their test results without involvement of clinicians under a new tweak to federal patient privacy rules.
The Department of Health and Human Services (HHS) issued a final rule Monday to allow patients or their designees to obtain test results directly from laboratories, including those operated by hospitals.
The change involved modifying regulations implementing the Clinical Laboratory Improvement Amendments of 1988 and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The new rules give patients another option to access their test results other than obtaining the findings from their physicians, who fail to tell patients about abnormal test results seven percent of the time, according to a 2009 study.
HHS officials rejected the concerns of some providers that providing the information directly to patients without a physician’s interpretation could have adverse consequences for patients who misunderstand them.
“We expect that patients will continue to obtain test results and advice about what those test results mean, through their ordering or treating providers,” HHS officials wrote in the rule.
The rules clarified that laboratories are not required to interpret test results for patients—merely provide copies of completed test reports.
The department also rejected a request of some providers to exempt “reference laboratories,” such as hospital laboratories that run tests for non-hospitalized patients, due to the complex logistics involved.
HHS officials wrote n the rule that few such requests were expected because most patients were unlikely to know the identity of a reference lab conducting their tests.
Additionally, the rule allowed many hospital laboratories to continue to use already established information release mechanisms for patients, as long as they are HIPAA compliant.
“Finally, we do not believe that there will be significant operational issues for hospital laboratories as hospitals already have policies and procedures in place to comply with the existing HIPAA privacy rule access,” the rule stated.
Publication Date: Monday, February 03, 2014