[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Rules and Regulations]
[Pages 29637-29638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09099]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Parts 160 and 164
Enforcement Discretion Regarding COVID-19 Community-Based Testing
Sites (CBTS) 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 under
the Health Insurance Portability and Accountability Act of 1996
(HIPAA). As a matter of enforcement discretion, the HHS Office for
Civil Rights (OCR) will 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 participation in the operation of a COVID-19 Community-Based
Testing Site (CBTS) during the COVID-19 nationwide public health
emergency.
DATES: The notification of enforcement discretion was effective on
April 9, 2020, and had a retroactive effect to March 13, 2020, and will
remain in effect until the Secretary of HHS declares that the public
health emergency no longer exists, or upon the expiration date of the
declared public health emergency, including any extensions, (as
determined by 42 U.S.C. 247d),\1\ whichever occurs first.
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\1\ Public Health Emergency Declaration issued by HHS Secretary,
pursuant to Section 319 of the Public Health Service Act, on January
31, 2020, with retroactive effective date of January 27, 2020. For
more information, see https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
FOR FURTHER INFORMATION CONTACT: Rachel Seeger at (202) 619-0403 or
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(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) \2\ during the nationwide public
health emergency declared by the Secretary of HHS.\3\
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\2\ 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).
\3\ 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 the U.S. Department of Health
and Human Services (HHS) is responsible for enforcing certain
regulations issued under the Health Insurance Portability and
Accountability Act of 1996 (HIPAA), and the Health Information
Technology for Economic and Clinical Health (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, including some large pharmacy chains, and their business
associates may choose to participate in the operation of COVID-19
specimen collection and testing sites (Community-Based Testing Sites,
or CBTS). For purposes of this notification, a CBTS includes mobile,
drive-through, or walk-up sites that only provide COVID-19 specimen
collection or testing services to the public.
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\4\ 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\ Secretary of HHS Alex M. Azar, Determination that a Public
Health Emergency Exists (Jan. 31, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
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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 in connection with the good faith participation in the
operation of a CBTS 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 when such entities are, in good
faith, participating in the operation of a CBTS. The operation of a
CBTS includes all activities that support the collection of specimens
from individuals for COVID-19 testing.
III. Covered Health Care Providers and Their Business Associates Should
Implement Reasonable Safeguards
OCR encourages covered health care providers participating in the
good faith operation of a CBTS to implement reasonable safeguards to
protect the privacy and security of individuals' PHI. Reasonable
safeguards include the following:
Using and disclosing only the minimum PHI necessary except
when disclosing PHI for treatment.
[[Page 29638]]
Setting up canopies or similar opaque barriers at a CBTS
to provide some privacy to individuals during the collection of
samples.
Controlling foot and car traffic to create adequate
distancing at the point of service to minimize the ability of persons
to see or overhear screening interactions at a CBTS. (A six foot
distance would serve this purpose as well as supporting recommended
social distancing measures to minimize the risk of spreading COVID-19.)
Establishing a ``buffer zone'' to prevent members of the
media or public from observing or filming individuals who approach a
CBTS, and posting signs prohibiting filming.
Using secure technology at a CBTS to record and transmit
electronic PHI.
Posting a Notice of Privacy Practices (NPP), or
information about how to find the NPP online, if applicable, in a place
that is readily viewable by individuals who approach a CBTS.
Although covered health care providers and business associates are
encouraged to implement these reasonable safeguards at a CBTS, OCR will
not impose penalties for violations of the HIPAA Privacy, Security, and
Breach Notification Rules that occur in connection with the good faith
operation of a CBTS.
IV. Who/what is not covered by this notification?
This notification does not apply to health plans or health care
clearinghouses when they are performing health plan and clearinghouse
functions. To the extent that an entity performs both plan and provider
functions, the Notification applies to the entity only in its role as a
covered health care provider and only to the extent that it
participates in a CBTS.
This notification also does not apply to covered health care
providers or their business associates when such entities are
performing non-CBTS related activities, including the handling of PHI
outside of the operation of a CBTS. Potential HIPAA penalties still
apply to all other HIPAA-covered operations of the covered health care
provider or business associate, unless otherwise stated by OCR.\6\
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\6\ 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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For example:
A pharmacy that participates in the operation of a CBTS in
the parking lot of its retail facility could be subject to a civil
money penalty for HIPAA violations that occur inside its retail
facility at that location that are unrelated to the CBTS.
A covered clinical laboratory that has workforce members
working on site at a CBTS could be subject to a civil money penalty for
HIPAA violations that occur at the laboratory itself.
A covered health care provider that experiences a breach
of PHI in its existing electronic health record system, which includes
PHI gathered from the operation of a CBTS, could be subject to a civil
money penalty for violations of the HIPAA Breach Notification Rule if
it fails to notify all individuals affected by the breach (including
individuals whose PHI was created or received from the operation of a
CBTS).
V. Collection of Information Requirements
This notification of enforcement discretion creates no legal
obligations and no legal rights. Because this document 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: April 14, 2020.
Roger T. Severino
Director, Office for Civil Rights Department of Health and Human
Services.
[FR Doc. 2020-09099 Filed 5-15-20; 8:45 am]
BILLING CODE 4153-01-P