HHS Announces New COVID-19 Testing Laboratory Data Reporting Guidance

King & Spalding

On June 4, 2020, HHS released new guidance detailing what additional data laboratories must report to HHS along with COVID-19 test results. HHS explained that the new guidance standardizes reporting requirements in an effort to ensure that public health officials have timely access to comprehensive data to inform decision making related to COVID-19.

The HHS guidance specifies that demographic data including patient age, race, ethnicity, sex, and patient zip code must be collected and reported to the CDC. HHS states that such demographic data will enable the agency to ensure that all groups have access to testing, better monitor disease incidence and trends, and assess availability of resources, among other benefits. The guidance also specifies that additional patient demographic data elements, such as name, date of birth and complete address, should also be collected and reported to state or local public health departments, but will not be collected by CDC. Additionally, the guidance addresses methods for submission of required data, as well as data reporting and transmission requirements.

The HHS press release is available here. The full guidance document is available here and the frequently asked questions document about laboratory data reporting is available here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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