National Health Data Stewardship, 30803-30805 [07-2733]

Agencies

• Agency for Healthcare Research and Quality
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 106 (Monday, June 4, 2007)]
[Notices]
[Pages 30803-30805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


National Health Data Stewardship

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for information.

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SUMMARY: There is a growing demand for healthcare data from many 
sectors. Key drivers for this demand have been surging interest in 
healthcare performance measurement and the information systems needed 
to aggregate, process and transmit healthcare data from which measures 
of health care quality may be derived and to which the measures could 
be applied. This need has raised the question of responsibility for 
safeguarding the data beyond the original care setting. This issue has 
led various stakeholders to propose the formation of a public-private 
national health care data stewardship organization with oversight of 
the various uses of healthcare data, as described below.
    For the purpose of achieving a broader understanding of the issues 
that establishment of such an entity may present, input is requested 
from the public and private sectors on the concept of a national health 
data stewardship entity (NHDSE). The primary purpose of this RFI is to 
gather information to foster broad stakeholder discussion; there are no 
current plans to issue a related request for proposals (RFP).

DATES: Responses to this RFI are due no later than July 27, 2007.

ADDRESSES: Electronic responses are preferred and may be addressed to: 
steward@ahrq.hhs.gov. Written responses should be addressed to: P. Jon 
White, MD, 540 Gaither Road, Rockville, MD 20850.
    A copy of this RFI is also available on the AHRQ and AQA Web sites. 
Please follow the instructions for submitting responses.
    If a response to this RFI is planned, notification is requested in 
advance by a simple response to one of the above addresses. Such 
notification is nonbinding and will not be made public.
    The submission of written materials in response to the RFI should 
not exceed 50 pages, including appendices and supplemental documents. 
Responders may submit other forms of electronic materials to 
demonstrate or exhibit key concepts of their written responses. If the 
response is over 20 pages, an executive summary is requested of the 
comments, no longer than 5 pages.
    Public access: Responses to this RFI will be available to the 
public at AHRQ. Please call 301-427-1505 between 9 a.m. and 5 p.m. to 
arrange access. The RFI and all responses will also be made available 
on the AHRQ Web site at

[[Page 30804]]

https://healthit.ahrq.gov. Any information submitted will be made 
public.
    Do not send proprietary, commercial, financial, business 
confidential, trade secret, or personal information that should not be 
made public.

FOR FURTHER INFORMATION CONTACT: P. Jon White, MD, Health IT Director, 
Agency for Healthcare Research and Quality, 
jonathan.white@ahrq.hhs.gov.

SUPPLEMENTARY INFORMATION: A primary purpose of this RFI is to gather 
information that AHRQ can bring to the AQA (https://
www.aqaalliance.org), a multistakeholder health care improvement 
organization formed to advance and implement clinician-level 
performance measurement. To carry out its statutory mandates to improve 
health care quality and specifically through quality measurement, AHRQ 
was a primary convener and has been a participant in AQA alliance from 
its inception. A full list of AQA participants is available at its Web 
site, referenced above. The AAQ (https://www.aqaalliance.org) has 
extensively discussed, in relation to its activities and objectives, 
the utility of having a NHDSE. The AQA has outlined and recommended 
processes for performance of quality measure selection, as well as for 
the underlying data sharing and data aggregation activities necessary 
to develop and apply performance measures, and public reporting of 
performance data. The following framed text contains excerpts from AQA 
proposal documents.

National Health Data Stewardship Entity

Proposed Mission

    The public/private entity will set uniform operating rules and 
standards for sharing and aggregating public and private sector data on 
quality and efficiency; offer guidance on implementation of such 
national operating rules and standards; and provide a framework for 
collecting, aggregating and analyzing data, to afford means of more 
effective oversight of health care data analyses and reporting in the 
United States.

Proposed Precepts

    In performing activities, the entity shall follow certain precepts:
     To be objective in its decision making.
     To weigh carefully the views of its constituents in 
developing concepts and operating rules and standards.
     To bring about needed changes in ways that minimizes 
disruption to current aggregation efforts.
     To review the effects of past decisions and interpret, 
amend or replace operating rules, standards and processes in a timely 
fashion when such action is indicated.
     To follow an open, orderly process for setting policies, 
operating rules and standards that precludes placing any particular 
interest above the interests of the many stakeholders who rely on 
health care information.

Proposed Scope of Work

    As previously noted, a wide range of activities need to be 
undertaken to advance health data exchange and use, including the 
development of measures and setting data transmission/lT technical 
standards. While all of these activities are important, the entity's 
responsibilities would primarily focus on specific issues relating to 
data collection, aggregation, analysis, and sharing.
    The scope of work shall include setting policies, rules and 
standards for:
     Data aggregation--Should address various data aggregation 
issues including required characteristics of aggregators (e.g., they 
should be trusted and respected entities), transparency of aggregation 
processes, control and ownership rights of the data, potential 
liability within data aggregation processes, and issues that arise when 
competing aggregation efforts are in a single market area; should 
ensure that the experience of existing aggregation efforts are 
leveraged.
     Data collection (includes identification of data 
sources)--Should set policies, rules and standards for collecting 
public and private sector data from relevant stakeholders, including 
providers, employers, health insurance plans and others based on an 
agreed-upon measurement set; should assess the pros and cons of using 
data derived from administrative data (e.g., claims, pharmacy and lab 
data), medical record review and surveys, and develop policies that 
prioritize data sources based on various dimensions.
     Attribution--Should address at what specific level(s) data 
should be aggregated (e.g., individual physician level or group 
practice level). When making this determination, should consider sample 
size issues and physician/practice identifier issues.
     Methodologies--Should set methodological rules and 
standards for aggregating data, including those addressing risk 
adjustment, measure weights and sample size.
     Data analysis--Should set data analysis rules and 
standards, including those relating to trending, benchmarking, 
distribution, outlier analysis, correlation analysis and stratified 
analysis (variance between regions and states).
     Data validation (audits)--Should set policies, rules and 
standards to ensure that the validity of the data submitted is 
independently audited.
     Uses of data--Based on current law, should recommend 
allowable and nonallowable uses of data. Allowable data uses may 
include quality and efficiency improvement, consumer reporting, 
accountability, and pay for performance programs; also should, address 
allowable secondary uses of raw/primary data.
     Data access--Should specify who should have access to data 
and applicable limitations, such as confidentiality and privacy rules; 
should consider policies which allow contributors, including both 
public and private sector entities, to have access to their own data as 
well as information which allows them to compare their data against 
benchmarks.
     Data sharing and reporting--Should develop guiding 
principles for public reporting and reporting back information to 
clinicians. Screening processes to ensure valid reporting also should 
be addressed.

Proposed Characteristics

    1. Objective--Be objective in its decision-making and have the 
ability to preclude placing any particular interest above the interests 
of many.
    2. Independent--Have a governing structure that is independent of 
all other business and professional organizations.
    3. Knowledgeable--Demonstrates knowledge and expertise in the area 
of health care delivery, data management, and security or acceptable 
proxy for this.
    4. Responsive--Insure input and use from key experts who possess 
knowledge of health care quality assessment, health data transmission, 
IT standards, physician and hospital systems design and a concern for 
the public interest in matters of health care quality analysis, 
reporting, and patient privacy. Represent key stakeholder groups that 
are measured and users of this information.
    5. Trustworthy--Is recognized as a trustworthy organization by 
multi stakeholder groups.
    6. Adaptable--Be flexible enough to address issues and key 
stakeholder needs as the market evolves.
    7. Transparent--Have an existing stable infrastructure for 
consensus

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decision making that is transparent and involves the broad stakeholder 
communities.
    8. Timely--Have the ability to carry out activities and achieve 
goals in a timely manner.
    9. Collaborative--Have the ability to engage and work with other 
organizations to ensure effective implementation of rules and 
standards.
    10. Sustainable--Have adequate resources to meet long and short 
term goals.
    The concept of a national entity responsible for setting rules and 
standards for sharing and using healthcare quality measurement data has 
also been supported by the Institute of Medicine in their 2005 report 
Performance Measurement. IOM additionally proposed that this entity 
would be responsible for several other roles in performance 
measurement, including articulation of national goals, selection of 
measures, aggregation of data, reporting of results and performance 
measurement research. It is recognized that the role of a NHDSE might 
extend to domains beyond health care performance measurement. 
Respondents are encouraged to describe such domains and provide 
information relating to NHDSE roles and characteristics, with the 
understanding that any such information will be considered and will be 
presented by AHRQ to AQA but may not be acted on in the immediate 
future.

Information Requested

    For the purpose of achieving a broader understanding of the need 
for a nationwide health data stewardship entity, and what form it might 
take, input is requested from interested parties. It is not necessary 
to answer all questions. In your response, please indicate which 
question you are addressing in your comments. Specific areas for 
comment include:
    1. Whether or not there is a need for a national health data 
stewardship entity with reasons, including value such an entity might 
bring and issues it might solve
    2. Desirable governmental and private sector roles in such an 
organization or in health data stewardship more generally
    3. The roles and responsibilities currently assumed by other 
existing entities that might be addressed by a NHDSE, as well as roles 
that should not be fulfilled by a NHDSE
    4. The relationship of a NHDSE and its work to other quality 
improvement organizations and activities
    5. The relationship of a NHDSE and its work to other initiatives 
which set national standards for health information, such as the ANSI 
Health IT Standards Panel (HITSP)
    6. Key challenges to creation and maintenance of a NHDSE
    7. The risks of creating a NHDSE
    8. The appropriate role(s) of a NHDSE in advancing quality 
measurement
    9. The appropriate role(s) of a NHDSE in characterization and 
evaluation of the comprehensiveness, accuracy and reliability of shared 
and aggregated health care quality measurement data
    10. The appropriate role(s) of a NHDSE regarding the transmission 
of shared and aggregated data
    11. The appropriate scope of activities for a NHDSE beyond quality 
measurement (in such domains as research and population health)
    12. The key stakeholders that would be impacted by a NHDSE and how 
to structure interactions with a NHDSE
    13. Appropriate governance model(s) for a NHDSE
    14. Means to assure NHDSE objectivity and independence
    15. Means to achieve trustworthiness or trust in a NHDSE, and how 
that would best be achieved
     16. Recommendations for achieving timeliness in NHDSE decision 
making
    17. Recommendations for achieving compliance with NHDSE 
recommendations, rules or standards
    18. The essential external inputs to a NHDSE
    19. Recommendations for achieving organizational flexibility for a 
NHDSE
    20. The potential organizational infrastructure needs of a NHDSE
    21. Potential funding requirements and sources of funding for a 
NHDSE
    22. The organizational skill set required of a NDHSE
    23. Priority activities for NHDSE to support data sharing and 
aggregation
    24. Issues concerning the above-excerpted AQA characterizations of 
a NHDSE
     25. The suitability of one or more existing organizations to 
fulfill the role of a NHDSE

Potential Responders

    Responses are both requested and anticipated from a broad range of 
individual organizations that have interests in healthcare data. 
Examples of commenters from whom we would hope to hear include, but are 
not limited to:

Health care professional societies
Payers, including public and private insurers
Health maintenance organizations
Purchasers, including employers and healthcare consumers
Consumer and patient interest groups
Community health delivery systems
State and local health agencies
Interested Federal agencies
University-based health systems
Advocacy groups and public interest organizations
Trade industry organizations
Health information technology industry vendors
Regional health information organizations
Interested individuals

    We look forward to receiving constructive comments representing 
diverse perspectives.

    Dated: May 25, 2007.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 07-2733 Filed 6-1-07; 8:45 am]
BILLING CODE 4160-90-M