Cities step up their efforts to combat the COVID-19 Delta variant. New York City, New Orleans, and San Francisco have all announced requirements for certain persons to produce evidence of COVID vaccination status in order to patronize or work indoors at certain establishments. Adding to an already complex patchwork of COVID-related regulation –
As the coronavirus spreads across the globe and in the United States, providers, businesses, employers, and others are struggling to understand what medical information they can collect and what information they can share. These are difficult questions the answers to which involve considering factors such as long-standing compliance requirements (e.g., HIPAA, ADA, GINA, state law), the unprecedented times we are in, business risk, and common sense. Government is trying to act to relieve some of these challenges, but questions still remain.
HIPAA Privacy Rule Waiver of Penalties and Sanctions
Effective March 15, 2020, for example, Secretary of the U.S. Department of Health and Human Services (HHS) Alex M. Azar (Secretary) waived certain penalties and sanctions under the HIPAA Privacy Rule against hospitals in its March 2020 COVID-19 and HIPAA Bulletin. These waivers were issued in response to President Donald J. Trump’s declaration of a nationwide emergency concerning COVID-19, and the Secretary’s earlier declaration of a public health emergency on January 31, 2020. The Secretary’s guidance makes clear that the Privacy Rule is not suspended during this crisis and provides guidance about the ability of entities covered by the HIPAA regulations to share information, including with friends and family, public health officials, and emergency personnel. But, in the following areas, the Secretary has waived sanctions and penalties against covered hospitals that do not comply with the following provisions of the HIPAA Privacy Rule:
- the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
- the requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
- the requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
- the patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
- the patient’s right to request confidential communications. See 45 CFR 164.522(b).
The waiver became effective on March 15, 2020, and there is more information and access to resources in the Bulletin about where it applies and for how long.
Reminder About What Entities Are Covered Entities and Business Associates
As part of its guidance on HIPAA privacy and disclosures in emergency situations, the Bulletin reminds readers what entities are covered by these rules – covered entities and business associates. There can be some tricky questions here, but these are the basic rules from the Bulletin:
The HIPAA Privacy Rule applies to disclosures made by employees, volunteers, and other members of a covered entity’s or business associate’s workforce. Covered entities are health plans, health care clearinghouses, and those health care providers that conduct one or more covered health care transactions electronically, such as transmitting health care claims to a health plan. Business associates generally are persons or entities (other than members of the workforce of a covered entity) that perform functions or activities on behalf of, or provide certain services to, a covered entity that involve creating, receiving, maintaining, or transmitting protected health information. Business associates also include subcontractors that create, receive, maintain, or transmit protected health information on behalf of another business associate. The Privacy Rule does not apply to disclosures made by entities or other persons who are not covered entities or business associates (although such persons or entities are free to follow the standards on a voluntary basis if desired). There may be other state or federal rules that apply.
Employers are Not Covered Entities or Business Associates – But Still Have Privacy and Confidentiality Obligations
When conducting its business, an organization can be a HIPAA covered entity and/or a business associate. However, when that business is functioning as an employer, it is neither a HIPAA covered entity nor a business associate, although it may sponsor a covered health plan subject to the HIPAA privacy and security rules. As organizations face the coronavirus threat to their workforce and their business, many questions arise about the collection, processing, and disclosure of medical information from employees, their family members, and visitors to their facilities. These can be thorny questions and organizations should seek qualified counsel, but here are some general rules:
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