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Ex. AGY-FED-HEALTH-OTHER-003 Order Primary source read

Enforcement Discretion Regarding COVID-19 Community-Based Testing Sites (CBTS) During the COVID-19 Nationwide Public Health Emergency, 85 Fed. Reg. 29637 (May 18, 2020)

Enforcement Discretion Regarding COVID-19 Community-Based Testing Sites (CBTS) During the COVID-19 Nationwide Public Health Emergency

Roger T. Severino, Director, Office for Civil Rights, HHS · United States (federal); Department of Health and Human Services, Office for Civil Rights (Federal)

The COVID Project

The record

Jurisdiction
United States (federal); Department of Health and Human Services, Office for Civil Rights
Level
Federal
Authority
HIPAA Privacy, Security and Breach Notification Rules, 45 C.F.R. parts 160 and 164; enforcement discretion
Issued
2020-04-09 Apr. 9, 2020
Effective
2020-04-09, with retroactive effect to 2020-03-13 (read as 2020-04-09)
End
2023-05-11
In force
Apr. 9, 2020 to May 11, 2023
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Health care ordersOther
Addressees
  • covered health care providers including large pharmacy chains
  • business associates operating mobile, drive-through and walk-up testing sites
Functions reached
  • DX diagnostics (specimen collection)
  • SF sales floor / parking lots converted to testing
  • CB patients
  • HR staffing of testing sites
Collection
Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

The notification of enforcement discretion was effective on April 9, 2020, and had a retroactive effect to March 13, 2020, and will remain in effect until the Secretary of HHS declares that the public health emergency no longer exists... Although covered health care providers and business associates are encouraged to implement these reasonable safeguards at a CBTS, OCR will not impose penalties for violations of the HIPAA Privacy, Security, and Breach Notification Rules that occur in connection with the good faith operation of a CBTS.

Enforcement

HIPAA civil money penalties suspended for good-faith CBTS operation; penalties continue for non-CBTS activities

Notes

Defines a CBTS as mobile, drive-through or walk-up sites that only provide COVID-19 specimen collection or testing; reaches pharmacy chains, urgent-care operators, laboratories and their staffing contractors.