FAQs Archive

Q: Does an individual have a right under HIPAA to access more than just test results from a clinical laboratory?

Yes. Under the HIPAA Privacy Rule , an individual has a general right to access, upon request, PHI about the individual in a designated record set maintained by or for a clinical laboratory that is a covered entity. A test result or test report is only part of the designated record set a clinical laboratory may hold. To the extent an individual requests access to all of her information held by the laboratory, the laboratory is required to provide access to all of the PHI about the individual in its designated record set. This could include, for example, completed test reports and the underlying data used to generate the reports, test orders, ordering provider information, billing information, and insurance information.

Q: Does an individual have a right under HIPAA to access from a clinical laboratory the genomic information the laboratory has generated about the individual?

Yes. An individual has a right under the HIPAA Privacy Rule to access, upon request, PHI about the individual in a designated record set maintained by or for a clinical laboratory that is a covered entity. The designated record set includes not only the laboratory test reports but also the underlying information generated as part of the test, as well as other information concerning tests a laboratory runs on an individual. For example, a clinical laboratory that is a HIPAA covered entity and that conducts next generation sequencing (NGS) of DNA on an individual must provide the individual, upon the individual’s request for PHI concerning the NGS, with a copy of the completed test report, the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test.

Q: Does the individual have a right to access PHI about themselves maintained by a covered entity that is very old or is archived?

Yes. An individual has a right to access PHI about themselves in a medical record or other designated record set maintained by a covered entity, regardless of the date the information was created or whether the information is maintained onsite, remotely, or is archived. There are only very limited grounds under which a covered entity may deny an individual access to PHI about herself in a designated record set, which do not include the age or location of the information. See 45 CFR 164.524(a) (2) – (a)(3).

Q: Does an individual’s right under HIPAA to access their health information apply only to the information a health care provider maintains about the individual in an Electronic Health Record (EHR), or paper medical record?

No. An individual has a broad right under the HIPAA Privacy Rule to access the PHI about the individual in all designated record sets maintained by or for a covered entity, whether in electronic or paper form, not just the designated record set that comprises the “medical record.” See 45 CFR 164.524(a) . (However, if the same PHI is maintained in more than one designated record set, a covered entity need only produce the information once in response to a request for access.) A designated record set also includes billing and payment records, claims and insurance information, as well as other records that are used, in whole or in part, by or for the covered entity to make decisions about individuals. See the definition of “designated record set” at 45 CFR 164.501 .