As COVID-19 swab (PCR) and blood (antibody) testing proceed to happen in larger numbers and numerous settings, it is very important acknowledge that the outcomes of such assessments are topic to HIPAA privateness and safety compliance guidelines. There’s a widespread public false impression that the declaration of a public well being emergency has created a broad exception for coated entities and enterprise associates to make use of and share COVID-19 testing outcomes. This isn’t the case.
COVID-19 Compliance for Well being Care Suppliers
First, it is very important acknowledge that the Division of Well being and Human Companies (HHS) has created an official web site for well being care suppliers which accommodates HIPAA-related info and steering pertaining to COVID-19. Among the many info accessible are notices issued by the HHS, such because the discover of enforcement discretion for telehealth companies regarding COVID-19, which was analyzed in our earlier weblog submit, “OCR Will Not Search Enforcement Motion for Use of Non-Compliance Telehealth Communications Throughout the Coronavirus (COVID-19) Nationwide Public Well being Emergency.”
In March, the HHS issued an especially restricted waiver of sure HIPAA necessities, which utilized narrowly to hospitals which have instituted a catastrophe protocol, after which just for as much as 72 hours after initiation of the protocol. Experiences of this waiver led to a typical public false impression that HHS was “stress-free” HIPAA guidelines. Notices and steering from the HHS have repeatedly emphasised the necessity to observe HIPAA guidelines in the course of the COVID-19 public well being emergency.
COVID-19 Testing and HIPAA Compliance
Underneath HIPAA, a coated entity could disclose COVID-19 check outcomes clearly to the person affected person, and can also use and disclose check outcomes as essential to deal with the affected person. There’s additionally an exception that permits disclosure with out authorization in circumstances of a critical and imminent risk to well being and security, to individuals able to minimize the risk. Disclosure of check outcomes to 3rd events, reminiscent of employers, should be performed in compliance with HIPAA privateness guidelines. As is well-known, a person affected person could authorize the discharge of COVID-19 check outcomes to a 3rd occasion in a written authorization that meets HIPAA necessities. Coated entities engaged in testing are well-advised to acquire such written authorization from the person affected person as a matter in fact if the check outcomes are to be disclosed to an employer. Written authorization can be advisable if the coated entity will use the check outcomes for contact tracing functions.
The general public well being actions provision of HIPAA permits coated entities to reveal COVID-19 check outcomes to an employer with out the person’s authorization in very restricted circumstances. The coated entity should present the testing to the person on the employer’s request, for info regarding a work-related sickness or harm or workplace-related medical surveillance, and since such info is required by the employer to adjust to OSHA, the Mine Security and Well being Administration (MHSA), or comparable state regulation necessities. Within the context of COVID-19 testing, the general public well being actions exception could apply when the employer is a licensed well being care facility, reminiscent of a talented nursing facility, provided that they might have such federal or state-mandated office security reporting necessities. The coated entity should present the worker with written discover of the disclosure to the employer in all such circumstances. It is very important acknowledge that this exception typically wouldn’t apply to fitness-for-duty examinations.
For employers who’ve applied COVID-19 testing as a part of a pre-placement or fitness-for-duty examination, coated entities could not disclose outcomes to the employer absent written authorization from the person affected person to take action.
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