[Federal Register Volume 72, Number 106 (Monday, June 4, 2007)]
[Notices]
[Pages 30803-30805]
From the Federal Register Online via the Government Publishing 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:
[email protected]. 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
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http://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,
[email protected].
SUPPLEMENTARY INFORMATION: A primary purpose of this RFI is to gather
information that AHRQ can bring to the AQA (http://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 (http://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