Meeting for Software Developers on the Common Formats for Patient Safety Data Collection
| Citation | 86 FR 63389 |
| Record Number | 2021-24888 |
| Published date | 16 November 2021 |
| Section | Notices |
| Court | Agency For Healthcare Research And Quality |
63389
Federal Register / Vol. 86, No. 218 / Tuesday, November 16, 2021 / Notices
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of maintaining records and
providing disclosures to consumers. All
comments must be received on or before
January 18, 2022.
You can file a comment online or on
paper. For the FTC to consider your
comment, we must receive it on or
before January 18, 2022. Write
‘‘Regulation V, subpart N; PRA
Comment: FTC File No. P072108’’ on
your comment. Your comment—
including your name and your state—
will be placed on the public record of
this proceeding, including the https://
www.regulations.gov website.
Due to the public health emergency in
response to the COVID–19 outbreak and
the agency’s heightened security
screening, postal mail addressed to the
Commission will be subject to delay. We
encourage you to submit your comments
online through the https://
www.regulations.gov website.
If you prefer to file your comment on
paper, write ‘‘Regulation V, subpart N;
PRA Comment: FTC File No. P072108’’
on your comment and on the envelope,
and mail your comment to the following
address: Federal Trade Commission,
Office of the Secretary, 600
Pennsylvania Avenue NW, Suite CC–
5610 (Annex J), Washington, DC 20580;
or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Because your comment will become
publicly available at https://
www.regulations.gov, you are solely
responsible for making sure that your
comment does not include any sensitive
or confidential information. In
particular, your comment should not
include any sensitive personal
information, such as your or anyone
else’s Social Security number; date of
birth; driver’s license number or other
state identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure that your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which .... is privileged or
confidential’’ —as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)
—including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted publicly at
www.regulations.gov, we cannot redact
or remove your comment unless you
submit a confidentiality request that
meets the requirements for such
treatment under FTC Rule 4.9(c), and
the General Counsel grants that request.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding, as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before January 18, 2022. For information
on the Commission’s privacy policy,
including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/
site-information/privacy-policy.
Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2021–25012 Filed 11–15–21; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Meeting for Software Developers on
the Common Formats for Patient
Safety Data Collection
AGENCY
: Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION
: Notice of public meeting.
SUMMARY
: AHRQ coordinates the
development of sets of standardized
definitions and formats (Common
Formats) that make it possible to collect,
aggregate, and analyze uniformly
structured information about health care
quality and patient safety for local,
regional, and national learning. The
Common Formats include technical
specifications to facilitate the collection
of electronically comparable data by
Patient Safety Organizations (PSOs) and
other entities. Additional information
about the Common Formats can be
obtained through AHRQ’s PSO website
at https://pso.ahrq.gov/common-formats
and the PSO Privacy Protection Center’s
website at https://www.psoppc.org/
psoppc_web/publicpages/
commonFormatsOverview.
The purpose of this notice is to
announce a meeting to discuss
implementation of the Common Formats
with software developers and other
interested parties. This meeting is
designed as an interactive forum where
software developers can provide input
on use of the formats. AHRQ especially
requests participation by and input from
those entities which have used AHRQ’s
technical specifications and
implemented, or plan to implement, the
Common Formats electronically.
DATES
: The meeting will be held from
1:00 to 3:30PM Eastern on Thursday,
December 16th, 2021.
ADDRESSES
: The meeting will be held
virtually.
FOR FURTHER INFORMATION CONTACT
: Dr.
Hamid Jalal, Medical Officer, Center for
Quality Improvement and Patient
Safety, AHRQ, 5600 Fishers Lane,
Rockville, MD 20857; Telephone (toll
free): (866) 403–3697; Telephone (local):
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION
:
Background
The Patient Safety and Quality
Improvement Act of 2005, 42 U.S.C.
299b–21 to 299b–26 (Patient Safety Act),
and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, 73 FR 70731–
70814, provide for the Federal listing of
Patient Safety Organizations (PSOs),
which collect, aggregate, and analyze
confidential information (patient safety
work product) regarding the quality and
safety of health care delivery.
The Patient Safety Act requires PSOs,
to the extent practical and appropriate,
to collect patient safety work product
from providers in a standardized
manner that permits valid comparisons
of similar cases among similar
providers. (42 U.S.C. 299b–24(b)(1)(F)).
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63390
Federal Register / Vol. 86, No. 218 / Tuesday, November 16, 2021 / Notices
The Patient Safety Act also authorizes
the development of data standards,
known as the Common Formats, to
facilitate the aggregation and analysis of
non-identifiable patient safety data
collected by PSOs and reported to the
network of patient safety databases
(NPSD). (42 U.S.C. 299b–23(b)). The
Patient Safety Act and Patient Safety
Rule can be accessed at: http://
www.pso.ahrq.gov/legislation/.
AHRQ has issued Common Formats
for Event Reporting for three settings of
care—hospitals, nursing homes, and
community pharmacies. As part of the
agency’s efforts to improve diagnostic
safety and quality in healthcare, AHRQ
is in the process of developing Common
Formats for Event Reporting—
Diagnostic Safety (CFER–DS). The
CFER–DS is intended to help healthcare
providers identify and report missed
opportunities in the diagnostic process
in a standardized manner across
healthcare settings and specialties.
Widespread use of the CFER–DS will
make it possible to collect, aggregate,
and analyze diagnostic safety-related
information from healthcare providers
across the country, which in turn can
accelerate learning in this vital area of
patient safety. Public comment has been
received on a version 0.1 of the CFER–
DS, and an Expert Panel convened by
the National Quality Forum (NQF) is
currently in the process of reviewing the
public comments and providing
feedback to AHRQ.
Federally listed PSOs can meet the
requirement to collect patient safety
work product in a standardized manner
to the extent practical and appropriate
by using AHRQ’s Common Formats. The
Common Formats are also available in
the public domain to encourage their
widespread adoption. An entity does
not need to be listed as a PSO or
working with one to use the Common
Formats. However, the Federal privilege
and confidentiality protections only
apply to information developed as
patient safety work product by
providers and PSOs working under the
Patient Safety Act.
Each version of the Common Formats
is released with accompanying technical
specifications, intended to provide
direction to software developers and to
PSOs that plan to submit data to the
Patient Safety Organization Privacy
Protection Center (PSOPPC) to ensure
non-identification for transmission to
the NPSD. For existing Common
Formats for Event Reporting, technical
specifications include the following:
•Data dictionary—defines data
elements and their attributes (data
element name, answer values, field
length, guide for use, etc.) included in
Common Formats;
•Clinical document architecture
(CDA) implementation guide—provides
instructions for developing a file to
transmit the data from the PSO to the
PSOPPC using the Common Formats;
•Validation rules and errors
document—specifies and defines the
validation rules that will be applied to
the Common Formats data elements
submitted to the PSOPPC;
•Common Formats flow charts—
diagrams the valid paths to complete the
formats (a complete event report);
•Local specifications—provides
specifications for processing, linking,
and reporting on events and details
specifications for reports; and
•Metadata registry—includes
descriptive facts about information
contained in the data dictionary to
illustrate how such data corresponds
with similar data elements used by
other Federal agencies and standards
development organizations (e.g., HL—7,
International Standards Organization
(ISO)).
Agenda, Registration, and Other
Information About the Meeting
The December 16, 2021 meeting will
be an interactive forum designed to
allow meeting participants not only to
provide input but also to respond to the
input provided by others. The meeting
agenda will include: An update of
Federal efforts related to the PSO
Program and Common Formats;
discussion of the CFER–DS, including
requesting feedback on planned
technical support materials and general
integration/implementation; and,
planning for future meetings, including
discussing potential topics of interest
for regular future meetings with
software developers. AHRQ requests
that interested persons send an email to
SDMeetings@infinityconferences.com
for registration information. Before the
meeting, an agenda and logistical
information will be provided to
registrants. Prior to the meeting, AHRQ
invites review of the CFER–DS which
can be accessed through NQF’s website
at https://www.qualityforum.org/
Common_Formats_for_Patient_Safety_
Data.aspx.
Dated: November 9, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–24888 Filed 11–15–21; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[60 Day–2–0059; Docket No. ATSDR–2021–
0008]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
AGENCY
: Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION
: Notice with comment period.
SUMMARY
: The Agency for Toxic
Substances and Disease Registry
(ATSDR), as part of its continuing effort
to reduce public burden and maximize
the utility of government information,
invites the general public and other
Federal agencies the opportunity to
comment on a proposed and/or
continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Per-or-
Polyfluoroalkyl Substances Exposure
Assessments (PFAS EAs). This Revision
information collection request (ICR) will
allow ATSDR/NCEH to continue to
conduct additional Exposure
Assessments (EAs) that may be
requested at military or non-military
installations.
DATES
: ATSDR must receive written
comments on or before January 18,
2022.
ADDRESSES
: You may submit comments,
identified by Docket No. ATSDR–2021–
0008 by any of the following methods:
•Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
•Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. ATSDR will post,
without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT
: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
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