[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Rules and Regulations]
[Pages 11139-11141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Parts 160 and 164


Enforcement Discretion Regarding Online or Web-Based Scheduling 
Applications for the Scheduling of Individual Appointments for COVID-19 
Vaccination During the COVID-19 Nationwide Public Health Emergency

AGENCY: Office of the Secretary, HHS.

ACTION: Notification of Enforcement Discretion.

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SUMMARY: This Notification is to inform the public that the Department 
of Health and Human Services (HHS) is exercising its discretion in how 
it applies the Privacy, Security, and Breach Notification Rules 
promulgated under the Health Insurance Portability and Accountability 
Act of 1996 and the Health Information Technology for Economic and 
Clinical Health (HITECH) Act (``HIPAA Rules''). As a matter of

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enforcement discretion, the HHS Office for Civil Rights (OCR) will not 
impose penalties for noncompliance with regulatory requirements under 
the HIPAA Rules against covered health care providers or their business 
associates in connection with the good faith use of online or web-based 
scheduling applications for the scheduling of individual appointments 
for COVID-19 vaccinations during the COVID-19 nationwide public health 
emergency.

DATES: This Notification of Enforcement Discretion went into effect on 
December 11, 2020, and will remain in effect until the Secretary of HHS 
determines that the public health emergency no longer exists, or upon 
the expiration date of the public health emergency, including any 
extensions (as determined by 42 U.S.C. 247d), whichever occurs first.

FOR FURTHER INFORMATION CONTACT: Rachel Seeger at (202) 619-0403 or 
(800) 537-7697 (TDD).

SUPPLEMENTARY INFORMATION: HHS is informing the public that it is 
exercising its discretion in how it applies the Privacy, Security, and 
Breach Notification Rules under the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) \1\ and the Health Information 
Technology for Economic and Clinical Health (HITECH) Act \2\ (``HIPAA 
Rules'') during the nationwide public health emergency declared by the 
Secretary of HHS.\3\
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    \1\ Public Law 104-191, 100 Stat. 2548 (August 21, 1996). Due to 
the public health emergency posed by COVID-19, the HHS Office for 
Civil Rights (OCR) is exercising its enforcement discretion under 
the conditions outlined herein. We believe that this guidance is a 
statement of agency policy not subject to the notice and comment 
requirements of the Administrative Procedure Act (APA). 5 U.S.C. 
553(b)(3)(A). OCR additionally finds that, even if this guidance 
were subject to the public participation provisions of the APA, 
prior notice and comment for this guidance is impracticable, and 
there is good cause to issue this guidance without prior public 
comment and without a delayed effective date. 5 U.S.C. 553(b)(3)(B) 
& (d)(3).
    \2\ Title XIII of the American Recovery and Reinvestment Act, 
Public Law 111-5, 123 Stat. 226 (February 17, 2009).
    \3\ See Determination that a Public Health Emergency Exists by 
the HHS Secretary, pursuant to Section 319 of the Public Health 
Service Act (January 31, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (Determination 
of January 31, 2020). See also Renewal of Determination That a 
Public Health Emergency Exists (January 7, 2021), available at 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-07Jan2021.aspx. For more information, see https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
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I. Background

    The Office for Civil Rights (OCR) at HHS is responsible for 
enforcing certain regulations issued under HIPAA and the HITECH Act, to 
protect the privacy and security of protected health information (PHI), 
namely the HIPAA Privacy, Security, and Breach Notification Rules 
(``HIPAA Rules'').
    During the COVID-19 national emergency,\4\ which also constitutes a 
nationwide public health emergency,\5\ certain covered health care 
providers,\6\ including some large pharmacy chains and public health 
authorities,\7\ or their business associates acting for or on behalf of 
such providers, may choose to use online or web-based scheduling 
applications (collectively, ``WBSAs'') for the limited purpose of 
scheduling individual appointments for COVID-19 vaccination. For the 
purposes of this Notification, a WBSA is a non-public facing online or 
web-based application that provides scheduling of individual 
appointments for services in connection with large-scale COVID-19 
vaccination. ``Non-public facing'' means that a WBSA, as a default, 
allows only the intended parties (e.g., a covered health care provider, 
the individual or personal representative scheduling the appointment, 
and a WBSA workforce member, if needed to provide technical support) to 
access data created, received, maintained, or transmitted by the WBSA. 
For the purposes of this Notification, a WBSA does not include 
appointment scheduling technology that connects directly to electronic 
health records (EHR) systems used by covered entities.
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    \4\ See Presidential Proclamation on Declaring a National 
Emergency Concerning the Novel Coronavirus Disease (COVID-19) 
Outbreak (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
    \5\ Determination of Jan. 31, 2020.
    \6\ See 45 CFR 160.103 (definition of ``covered entity'').
    \7\ See 45 CFR 164.501 (definition of ``public health 
authority''). The HIPAA Rules only apply to a public health 
authority if it is a HIPAA covered entity or business associate. For 
example, a county health department that administers a health plan, 
or provides health care services for which it conducts standard 
electronic transactions (e.g., checking eligibility for coverage, 
billing insurance), is a HIPAA covered entity. A public health 
authority that does not meet the definition of a covered entity or 
business associate is not subject to the HIPAA Rules. See also OCR 
FAQ, ``Are state, county or local health departments required to 
comply with the HIPAA Privacy Rule?'' https://www.hhs.gov/hipaa/for-professionals/faq/358/are-state-county-or-local-health-departments-required-to-comply-with-hipaa/index.html.
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    The HIPAA Privacy Rule permits a business associate of a HIPAA 
covered entity to use and disclose PHI to conduct certain activities or 
functions on behalf of the covered entity, or provide certain services 
to or for the covered entity, but only pursuant to the explicit terms 
of a business associate contract or other written agreement or 
arrangement under 45 CFR 164.502(e)(2) (collectively, ``business 
associate agreement'' or BAA), or as required by law. During the COVID-
19 public health emergency, covered health care providers need to 
quickly schedule large numbers of individuals for appointments for 
COVID-19 vaccination and may use WBSAs to do so. Some of these 
applications, and the manner in which HIPAA covered health care 
providers or their business associates use the applications, may not 
fully comply with the requirements of the HIPAA Rules. Additionally, 
the vendors of such applications may not be aware that HIPAA covered 
health care providers are using their products to create, receive, 
maintain, or transmit electronic protected health information (ePHI), 
and that a WBSA vendor may, as a result, meet the definition of 
business associate under the HIPAA Rules.\8\
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    \8\ See 45 CFR 160.103 (definition of ``electronic protected 
health information'').
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    OCR will exercise its enforcement discretion and will not impose 
penalties for noncompliance with regulatory requirements under the 
HIPAA Rules against covered health care providers and their business 
associates, including WBSA vendors meeting the definition of a business 
associate, in connection with the good faith use of a WBSA for 
scheduling appointments for individuals for COVID-19 vaccination during 
the COVID-19 nationwide public health emergency, as described below.

II. Who/what is covered by this Notification?

    This Notification applies to all HIPAA covered health care 
providers and their business associates \9\ when such entities are, in 
good faith, using WBSAs to schedule individual appointments for COVID-
19 vaccination.
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    \9\ See 45 CFR 160.103 (definition of ``business associate'').
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    This Notification also applies to all vendors of WBSAs whose 
technology is being used by a covered health care provider or its 
business associate to schedule individuals to receive a COVID-19 
vaccine. OCR will exercise enforcement discretion with regard to WBSA 
vendors regardless of whether the WBSA vendor has actual or 
constructive knowledge that it meets the definition of a business 
associate under the HIPAA Rules as described in this Notification.

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III. What are reasonable safeguards that covered health care providers 
and their business associates should consider implementing?

    OCR encourages covered health care providers and their business 
associates using WBSAs in good faith for the scheduling of individual 
appointments for COVID-19 vaccination to implement reasonable 
safeguards to protect the privacy and security of individuals' PHI. OCR 
recommends that covered health care providers and their business 
associates consider the following recommended reasonable safeguards:
    <bullet> Using and disclosing only the minimum PHI necessary for 
the purpose (e.g., an individual's name and phone number may be the 
minimum necessary PHI for scheduling the appointment).
    <bullet> Using encryption technology to protect PHI.
    <bullet> Enabling all available privacy settings (e.g., adjusting 
WSBA calendar display settings, as needed, to hide names or show only 
individuals' initials instead of full names on calendar screens).
    <bullet> Ensuring that storage of any PHI (including metadata that 
constitutes PHI) by the vendor is only temporary (e.g., the PHI is 
returned to the covered health care provider or destroyed as soon as 
practicable, but no later than 30 days after the appointment).\10\
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    \10\ Once the WBSA vendor securely returns or destroys the ePHI 
(as determined by its arrangements with the covered health care 
provider), the WBSA vendor is no longer a business associate to that 
covered health care provider.
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    <bullet> Ensuring the WBSA vendor does not use or disclose ePHI in 
a manner that is inconsistent with the HIPAA Rules (e.g., does not 
engage in the sale of ePHI \11\ collected from individuals using the 
WBSA to schedule a COVID-19 vaccination).
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    \11\ See 45 CFR 164.502(a)(5)(B)(2).
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    Although covered health care providers and business associates are 
encouraged to implement these reasonable safeguards when using a WBSA 
to schedule individuals for appointments for COVID-19 vaccination, OCR 
will exercise its enforcement discretion and not impose penalties for 
noncompliance with the regulatory requirements under the HIPAA Rules 
against covered health care providers or their business associates in 
connection with the good faith provision of COVID-19 vaccination during 
the COVID-19 nationwide public health emergency. Failure to implement 
the recommended reasonable safeguards above will not, in itself, cause 
OCR to determine that a covered health care provider or its business 
associate failed to act in good faith for purposes of this 
Notification.
    Covered health care providers and their business associates that 
seek additional privacy protections for ePHI collected while using 
WBSAs are encouraged to use application vendors that represent that 
their WBSAs support compliance with the HIPAA Rules and that the 
vendors will enter into BAAs in connection with the use of their WBSAs.

    Note:  OCR does not endorse, certify, or recommend specific 
technology, software, applications, or products.

IV. Who/what is not covered under this Notification?

    This Notification does not apply to activities of a covered health 
care provider and its business associates other than the scheduling of 
COVID-19 vaccinations. Other activities, such as the handling of PHI 
unrelated to the scheduling of COVID-19 vaccinations, are not included 
within the scope of this exercise of enforcement discretion. Potential 
HIPAA penalties still apply to all other HIPAA-covered operations of 
the covered health care provider and its business associates, unless 
otherwise stated by OCR.\12\
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    \12\ OCR's Notifications of Enforcement Discretion and other 
materials relating to the COVID-19 public health emergency are 
available at https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html.
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    Additionally, this Notification does not apply to a covered health 
care provider or business associate when it fails to act in good faith. 
For example, OCR will not consider a covered health care provider or 
business associate to be acting in good faith with respect to the use 
of a WBSA for the scheduling of individual appointments for COVID-19 
vaccination where the covered health care provider or business 
associate uses a WBSA:
    <bullet> Whose terms of service prohibit the use of the WBSA for 
scheduling health care services or state that the WBSA may sell 
personal information that it collects.
    <bullet> To conduct services other than scheduling appointments for 
COVID-19 vaccination (e.g., to determine individuals' eligibility for 
COVID-19 vaccination).
    <bullet> Without reasonable security safeguards (e.g., access 
controls) to prevent the PHI from being readily accessed or viewed by 
unauthorized persons.
    <bullet> To screen individuals for COVID-19 prior to individuals' 
in-person health care visits.

V. Collection of Information Requirements

    This Notification of Enforcement Discretion creates no legal 
obligations and no legal rights. Because this notice imposes no 
information collection requirements, it need not be reviewed by the 
Office of Management and Budget under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501 et seq.).

    Dated: February 12, 2021.
Robinsue Frohboese
Acting Director and Principal Deputy Director, Office for Civil Rights, 
U.S. Department of Health and Human Services.
[FR Doc. 2021-03348 Filed 2-23-21; 8:45 am]
BILLING CODE 4153-01-P