Patients, Caregivers Will Have Direct Access to Lab
Test Results Due to New Rule by HHS Agencies
Now patients and their designated
care-givers can not only get info from physicians, but
also directly from laboratories
Feb. 3, 2014 - Patients or someone they designate
will soon have direct access to completed laboratory test reports from
the lab performing the test. As part of an ongoing effort to
empower patients to be informed partners with their
health care providers, the Centers for Medicare &
Medicaid Services (CMS) and two other agencies in the Department of Health and
Human Services (HHS) joined forces to issue the new
While patients can continue to get access to their
laboratory test reports from their doctors, these changes give patients
a new option to obtain their test reports directly from the laboratory
while maintaining strong protections for patients’ privacy.
Editor’s Note: There are over 360
Accountable Care Organizations working with Medicare to provide
higher-quality coordinated care for seniors. Doctors, hospitals and health care
providers establish ACOs to work together to provide better health care, while working to
slow the growth of health care cost.
By Jessie Gruman,
President, Center for Advancing Health
“The right to access personal
health information is a cornerstone of the Health
Insurance Portability and Accountability Act (HIPAA)
Privacy Rule,” said HHS Secretary Kathleen Sebelius.
“Information like lab results can empower patients to
track their health progress, make decisions with their
health care professionals, and adhere to important
The final rule announced today
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.
At the same time, the
final rule eliminates 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 final rule is issued jointly by
CMS, which is generally responsible for laboratory
regulation under CLIA, and
two other agencies within HHS: the Centers for
Disease Control and Prevention (CDC), which provides
scientific and technical advice to CMS related to CLIA,
and the Office for Civil Rights (OCR), which is
responsible for enforcing the HIPAA Privacy Rule.
Under the HIPAA Privacy Rule,
patients, patient’s designees and patient’s personal
representatives can see or be given a copy of the
patient’s protected health information, including an
electronic copy, with limited exceptions. In doing so,
the patient or the personal representative may have to
put their request in writing and pay for the cost of
copying, mailing, or electronic media on which the
information is provided, such as a CD or flash drive. In
most cases, copies must be given to the patient within
30 days of his or her request.
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