Laboratory Release of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) and Sexually Transmitted Disease (STD) Laboratory Results to Patients

Frequently Asked Questions

Sections 58-1.8, 58-8.4 and 34-2.11 of Title 10, NYCRR

On December 23, 2015, specific regulations were enacted amending Sections 58-1.8, 58-8.4 and 34-2.11 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York (NYCRR).

What do the new regulations allow?

Previously, NYSDOH regulations did not allow a laboratory that tests samples originating from New York State to release laboratory test results directly to a patient unless written consent was first provided by the physician or other authorized person. The December 23, 2015, revisions allow laboratories to provide patients with access to test reports without any consent from the practitioner who ordered the test.

Why were these changes made?

On February 6, 2014, the U.S. Department of Health and Human Services published amendments to federal regulations at 42 CFR Part 493 and 45 CFR Part 164 which give patients a right to access medical records directly from clinical laboratories, including completed laboratory test reports. The new Federal rule became effective on April 7, 2014, with a compliance date of October 6, 2014. The revised NYSDOH regulations eliminate State restrictions that were inconsistent with this federal rule.

What does the Federal rule require of laboratories?

The Federal rule allows an individual or an individual’s personal representative to request and receive completed test reports directly from a laboratory that is a Health Insurance Portability and Accountability Act (HIPAA) covered entity. The Federal rule states that HIPAA covered laboratories will generally be required to provide individuals with access to their laboratory test reports within 30 days of the request from the patient. The laboratory may provide reports prior to the 30 days. Additional information is available in the Federal rule (See 45 CFR § 164.524).

Under NYSDOH regulations, are laboratories and hospitals required to manage HIV, HCV, and STD test results differently in electronic systems than other types of test results?

No.  As long as laboratories and hospitals are compliant with existing laws and regulations, they may choose to manage these test results differently in electronic systems, but they are not required to do so.

Abnormal HIV, HCV, and/or STD test results may be life-changing for patients. What should laboratories and hospitals consider as they develop and maintain policies in response to this regulation, the Federal rule, and other initiatives that seek to provide patients with ready access to their medical records?

The NYSDOH recommends that laboratories and/or electronic health record systems have a mechanism to ensure that practitioners who order laboratory tests, especially diagnostic tests, have the opportunity to review and discuss the test results with the patient before the results are made directly available to the patient.

Thirty days provides the practitioner who ordered the test with enough time to communicate with the patient about the test results. Linkage to HIV care within 30 days of diagnosis is a standard of the National HIV/AIDS Strategy and is important for patient health as well as prevention of HIV transmission.  Prompt treatment of STDs is essential for disease control.  Similarly, prompt assessment of patients for HCV is appropriate given the recent availability of well-tolerated curative therapies.

Are there circumstances where access to reports may be denied to patients?

Yes. Federal law provides grounds for health care professionals to deny patients access to laboratory test results.  Additional resources are available from the federal government to provide guidance should laboratories or institutions wish to explore denying access to laboratory results under HIPAA.


Institutions or laboratories should consult their legal counsel.