Summary
The Centers for Medicare & Medicaid Services (CMS) published a
final rule on February 6 that will allow patients to have direct
access to their laboratory test results. Both the Clinical
Laboratory Improvement Amendments (CLIA) and the Health Insurance
Portability and Accountability Act (HIPAA) govern a patient's
direct access to laboratory test results. The final rule amends
CLIA regulations and the HIPAA Privacy Rule in order to provide
patients with greater access to their health information and
thereby empower individuals to take an active role in their
healthcare.
Changes to CLIA Regulations
CLIA establishes uniform quality standards for all laboratory
testing to ensure the accuracy, reliability and timeliness of
patient test results. Under CLIA, a "laboratory" is any
facility that does testing on human specimens to provide
information for the diagnosis, prevention, or treatment of disease
or impairment, or the assessment of health.See42
