Community-Based Testing & HIPAA

Community-Based Testing Sites (CBTS) are the latest entity to be excluded from HIPAA enforcement penalties by the Office for Civil Rights (OCR) for their participation in regard to COVID-19 specimen collection and testing.  This “exercise of enforcement discretion is effective immediately (April 9, 2020), but has a retroactive effect to March 13, 2020.” These mobile sites must ONLY be providing COVID-19 services and the exception to HIPAA enforcement is only applicable to the collection of such data and testing.

This means that some large pharmacy chains, business associates, and some healthcare providers will now be able to participate in the operation of a CBTS.  These can include drive-through, walk-up, and mobile sites that will provide COVID-19 testing ONLY services to the general public.

This move will allow the OCR to contribute to the growth of mobile testing sites for quicker testing and coverage in more areas.

Reasonable Safeguards

While HIPAA covered entities are given leeway during this time, they must still provide reasonable safeguard measures as they set up and operate a CBTS.  This should include the following measures:

1. Maintain social distancing onsite and at the point of service; this should be done by controlling foot and car traffic to create adequate distancing at the point of service; this is to minimize people overhearing or seeing screening interactions with other individuals
2. Disclose and use the minimum amount of protected health information (PHI) necessary except when disclosing PHI for treatment
3. Canopies or similar opaque barriers must be set up at CBTS to provide privacy during the collection of samples

This is yet another move by the government as they continue to have to make temporary changes to the existing rules in place to accommodate these extraordinary circumstances.  Full details and the HHS approved document can be found here.

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