[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Notices]
[Pages 31894-31895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Committee on Vital and Health Statistics

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, the Department 
of Health and Human Services (HHS) announces the following advisory 
committee meeting. This meeting is open to the public. The public is 
welcome to obtain the link to attend this meeting by following the 
instructions posted on the Committee website: https://ncvhs.hhs.gov/meetings/standards-subcommittee-meeting-3/.

NAME:  National Committee on Vital and Health Statistics (NCVHS), 
Meeting of the Subcommittee on Standards.

DATES: The meeting will be held Thursday, June 9, 2022: 10:00 a.m.-5:30 
p.m. EDT.

ADDRESSES: Virtual open meeting.

FOR FURTHER INFORMATION CONTACT: Substantive program information may be 
obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National 
Center for Health Statistics, Centers for Disease Control and 
Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, or via 
electronic mail to [email protected]; or by telephone (301) 458-4715. 
Summaries of meetings and a roster of Committee members are available 
on the home page of the NCVHS website https://ncvhs.hhs.gov/, where 
further information including an agenda and instructions to access the 
broadcast of the meeting will be posted.
    Should you require reasonable accommodation, please telephone the 
CDC Office of Equal Employment Opportunity at (770) 488-3210 as soon as 
possible.

SUPPLEMENTARY INFORMATION:
    Purpose: As outlined in its Charter, the National Committee on 
Vital and Health Statistics assists and advises the Secretary of HHS on 
health data, data standards, statistics, privacy, national health 
information policy, and the Department's strategy to best address those 
issues. This includes the adoption and implementation of transaction 
standards, unique identifiers, and code sets adopted under the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA),\1\ and 
operating rules adopted under the Patient Protection and Affordable 
Care Act (ACA).\2\
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    \1\ Public Law 104-191, 110 Stat. 1936 (Aug. 21, 1996), 
available at: https://www.congress.gov/104/plaws/publ191/PLAW-104publ191.pdf.
    \2\ Public Law 111-148, 124 Stat. 119 (Mar. 23, 2010), available 
at https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf.
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    Based on input and information gathered during its current project, 
``Standardization of Information for Burden Reduction and Post-Pandemic 
America'' (Convergence 2.0), NCVHS is working to finalize strategic 
concepts for health information technology standards to support more 
expansive health data flows than are currently encompassed under HIPAA 
and other federal legislation.\3\ Data flows common today did not exist 
at the time the HIPAA frameworks were adopted in regulation, e.g., 
HIPAA is statutorily limited to Covered Entities, but patient data now 
flows routinely to other parties who are not Covered Entities. The 
NCVHS Subcommittee on Standards' Convergence 2.0 work also assessed the 
strengths and weaknesses of the current standards development and 
federal rulemaking processes and would set the

[[Page 31895]]

stage for future directions toward the strategic vision.
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    \3\ NCVHS Standards Subcommittee Project Scope: Standardization 
of Information for Burden Reduction and Post-Pandemic America 
(``Convergence 2.0''), available at https://ncvhs.hhs.gov/wp-content/uploads/2021/07/NCVHS-SS-project-scoping-convergence-2021-06-21-508.pdf. NCVHS Predictability Roadmap work, which addressed 
the need for the HIPAA standards to be adopted on a regular cadence, 
has evolved into a convergence project with a broader scope. The 
Subcommittee has been considering whether opportunities exist for 
updates to the HIPAA regulatory framework as well as standards 
adoption. In addition to these foundational topics, the Committee 
has incorporated the harmonization of public health and clinical 
standards in its scope, particularly with their relevance to 
interoperable data exchange. Underlying the data flows are privacy 
and security considerations.
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    The Subcommittee on Standards drafted a suite of potential actions 
for consideration for near-term improvement of the current standards 
development and rulemaking processes informed by the August 21, 2021, 
Listening Session.\4\ The Committee is seeking reaction to this draft 
set of actions from potential end-users, standards development 
organizations (SDOs), trade and professional organizations, and other 
members of the public. The purpose of this meeting is to provide a 
public forum to obtain this feedback. Based on that input, the 
Subcommittee anticipates developing recommendations for consideration 
by the full Committee. The draft considerations and supporting context 
may be viewed on the NCVHS website at https://ncvhs.hhs.gov/Draft-Convergence-2-dot-0.
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    \4\ NCVHS Listening Session on Healthcare Standards Development, 
Adoption and Implementation, Aug. 25, 2021. Agenda, audio recording, 
transcript, and other meeting materials are available at: https://ncvhs.hhs.gov/meetings/standards-subcommittee-listening-session/.
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Summary

    Subtitle F (Administrative Simplification) of HIPAA promoted the 
transition of routine business processes of health care from mailing 
and faxing of paper documents to electronic exchange of standardized 
data. Health data flows, standards, technology, and communications 
infrastructure have all evolved radically since HIPAA introduced the 
concept of national standards to health care administration. Consistent 
with the Office of the National Coordinator for Health Information 
Technology's (ONC) Federal Health Information Technology Strategic 
Plan,\5\ the Subcommittee is investigating what would be necessary to 
prepare the U.S. health care system for its next leap forward. The 
Subcommittee is proposing for industry feedback actions to further a 
comprehensive, integrated health information ecosystem that 
incorporates claims, administrative records, digital medical records, 
public health data, and data about a patient's social risk. These 
proposed actions include specific updating of standardization processes 
under HIPAA to accommodate new business models, technologies, and 
information needs, while protecting investments in legacy standards 
that have demonstrably succeeded in producing HIPAA's intended 
efficiencies and cost reductions.
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    \5\ ONC, Ofc. of the Sec'y, U.S. Dept. of Health & Human 
Services, 2020-2025 Federal Health IT Strategic Plan (Oct. 2020), 
available at https://www.healthit.gov/topic/2020-2025-federal-health-it-strategic-plan.
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    As noted above, to inform this rethinking and updating, NCVHS' 
Convergence 2.0 project solicited input from industry on the HIPAA 
regulatory framework and the standards update processes in a public 
Listening Session on August 25, 2021. During the Listening Session, 
representatives of industry testified that current processes do not fit 
with the cadence needed to meet their business needs. They further 
advocated that options and alternatives for a modernized framework 
should be considered to support current and future needs, including 
additional harmonization of clinical, public health (including vital 
records), and other standards with HIPAA standards. The implication is 
that options or alternatives would need to consider significant 
portions of work done by ONC and its Health Information Technology 
Advisory Committee on electronic health records, data exchange 
networks, and an interoperability framework.
    Based on its analysis of the input of expert panels and members of 
the public who responded to a Request for Public Comment,\6\ the 
Committee continues to investigate whether the HIPAA framework is in 
need of modernization.
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    \6\ See U.S. Dept. of Health & Human Svcs., NCVHS, Notice of 
Meeting and Request for Public Comment, 86 FR 33318 (June 24, 2021), 
available at https://www.govinfo.gov/content/pkg/FR-2021-06-24/pdf/2021-13334.pdf; ``Comments Received in Response to Request for 
Comment: Federal Register Notice: 86 FR 33318,'' available at 
https://ncvhs.hhs.gov/wp-content/uploads/2021/08/Public-Comments-Standards-Subcommittee-Listening-Session-August-25-2021.pdf.
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    The Committee will invite statements from representatives of 
stakeholder organizations, and the agenda also will include time for 
public comment. Meeting times and topics are subject to change. Please 
refer to the agenda posted at the NCVHS website for this meeting for 
updates at: https://ncvhs.hhs.gov/meetings/standards-subcommittee-meeting-3/.

Sharon Arnold,
Associate Deputy Assistant Secretary, Science and Data Policy, Office 
of the Assistant Secretary for Planning and Evaluation.
[FR Doc. 2022-11251 Filed 5-24-22; 8:45 am]
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