AGENCY:
Centers for Disease Control and Prevention, HHS.
ACTION:
Notice of meeting.
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 vgh4@cdc.gov; 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), and operating rules adopted under the Patient Protection and Affordable Care Act (ACA).
Public Law 104-191, 110 Stat. 1936 (Aug. 21, 1996), available at: https://www.congress.gov/104/plaws/publ191/PLAW-104publ191.pdf.
Public Law 111-148, 124 Stat. 119 (Mar. 23, 2010), available at https://www.congress.gov/111/plaws/publ148/PLAW-111publ148.pdf.
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. 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 stage for future directions toward the strategic vision.
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.
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. 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 .
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/.
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, 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.
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.
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, the Committee continues to investigate whether the HIPAA framework is in need of modernization.
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.
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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