HHS Issues Rule Granting Patients Direct Access to Lab Test Results

A new federal rule on the exchange of health data removes legal barriers that stop medical laboratories from providing lab test results directly to patients and their designees, such as developers of their personal health records systems. The rule preempts laws in 13 states and lifts a federal exemption effective in 26 more states.

A new federal rule on the exchange of health data removes legal barriers that stop medical laboratories from providing lab test results directly to patients and their designees, such as developers of their personal health records systems. The rule preempts laws in 13 states and lifts a federal exemption effective in 26 more states.

Previously, in those 39 states, patients could receive or view their lab test results only through their physician or other authorized healthcare provider, or by their provider's leave. The 101-page final regulation amends the Clinical Laboratory Improvement Act, which regulates 239,000 healthcare testing labs.

Some patient advocates and healthcare organizations, particularly laboratories and health-record system vendors, have long seen the laboratory regulations, known as CLIA, as unnecessarily preventing patients from playing a more active role in healthcare decisions.

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Source: Modern Healthcare