The Office for Civil Rights (OCR) has been moving swiftly to provide guidance on addressing key regulatory issues to aid in the fight to contain and defeat COVID-19. Some of the latest developments include exercising its enforcement discretion on certain good faith disclosures of protected health information (PHI) by business associates, adding FAQs for telehealth providers, and a resource page on its website for COVID-19 issues.
A common thread through all of the federal and state governmental briefings on the COVID-19 is that understanding the spread; managing healthcare personnel, equipment, and personal protective equipment (PPE); and other necessary resources requires data. Roger Severino, OCR Director, recognized the need for “quick access to COVID-19 related health data to fight this pandemic.” Because business associates have limitations on the circumstances under which critical data can be used and disclosed, despite the critical role they often play in storing and analyzing data, “[g]ranting HIPAA business associates greater freedom to cooperate and exchange information with public health and oversight agencies can help flatten the curve and potentially save lives,” Severino added.
The HIPAA Privacy Rule already permits covered entities to provide the kind of data that is needed, however, current regulations allow a HIPAA business associate to use and disclose PHI for public health and health oversight purposes only if expressly permitted by its business associate agreement with a HIPAA covered entity. It is common for business associate agreements to be drafted very narrowly, permitting only specified uses and disclosure. Thus, when federal public health authorities and health oversight agencies, state and local health departments, and state emergency operations centers have requested PHI from HIPAA business associates (i.e., a disclosure of PHI), or requested that business associates perform public health data analytics on such PHI (i.e., a use of PHI by the business associate) for the purpose of ensuring the health and safety of the public during the COVID-19 national emergency, some HIPAA business associates have been unable to timely participate in these efforts because their BAAs do not expressly permit them to make such uses and disclosures of PHI.
To address this issue, OCR announced that it will not impose penalties for violations of certain provisions of the HIPAA Privacy Rule against health care providers or their business associates for the good faith uses and disclosures of PHI by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.
Specifically, the announcement provides that OCR will not impose penalties against a business associate or covered entity under certain Privacy Rule provisions if, and only if:
- the business associate makes a good faith use or disclosure of the covered entity’s PHI for public health activities (see 45 CFR 164.512(b)), or health oversight activities (see 45 CFR 164.512(d)); and
- the business associate informs the covered entity within ten (10) calendar days after the use or disclosure occurs (or commences, with respect to uses or disclosures that will repeat over time).
The OCR provides examples of good faith uses or disclosures:
- the Centers for Disease Control and Prevention (CDC), or a similar public health authority at the state level, for the purpose of preventing or controlling the spread of COVID-19, consistent with 45 CFR 164.512(b).
- the Centers for Medicare and Medicaid Services (CMS), or a similar health oversight agency at the state level, for the purpose of overseeing and providing assistance for the health care system as it relates to the COVID-19 response, consistent with 45 CFR 164.512(d).
It is important to note that while the OCR’s announcement provides some relief under HIPAA, it does not extend to other requirements or prohibitions under the Privacy Rule, or to any obligations under the HIPAA Security and Breach Notification Rules applicable to business associates and covered entities. This announcement also does not address other federal or state laws (including breach of contract claims) that might apply to the uses and disclosures of this information. Thus, business associates still need to be careful when using and disclosing PHI in these circumstances, although this announcement provides some welcomed relief and should aid the efforts to fight COVID-19.