OCR HIPAA Guidance

To clear up previously released guidance, the Office for Civil (OCR) released new guidance regarding contacting recovered COVID-19 patients for plasma donation. The OCR HIPAA guidance reinforces the allowance of covered entities to contact recovered patients.

OCR HIPAA Guidance: Contacting Recovered COVID-19 Patients

In June, OCR HIPAA guidance was released stating that HIPAA covered entities are permitted to contact recovered COVID-19 patients to inform them about plasma donation. However, many covered entities still believed this to be a HIPAA Privacy Rule violation. As such, OCR released further guidance regarding plasma donation.

OCR Director Roger Severino stated, “We’re making sure misconceptions about HIPAA do not get in the way of a promising COVID-19 response. This guidance explains how health care providers can connect COVID-19 survivors with blood and plasma donation opportunities and further public health consistent with patient privacy. In response to the president’s call for Americans who have recovered from COVID-19 to donate their plasma, OCR clarified how HIPAA permits health plans to contact their beneficiaries about plasma donation opportunities. We will continue to use every tool at our disposal to beat this virus and keep Americans healthy.”

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FDA Plasma Treatment Guidance

There has been much debate regarding effective COVID-19 treatment methods, however, the FDA issued an emergency use authorization for the use of convalescent plasma for COVID-19. The FDA has also released guidance for the use of convalescent plasma with the following:

Pathways for use of investigational COVID-19 convalescent plasma;

Patient eligibility;

Collection of COVID-19 convalescent plasma, including donor eligibility; and donor qualifications

Labeling; and

Record keeping.