This commentary first
published on 5-6-11 remains relevant, particularly in light of slow
progress in development of infrastructures for health information
exchange:
The Federal Health Information Technology Strategic Plan (2011-2015) lays out the HIT vision, mission and principles as well as goals, objectives and strategies to be implemented in the next five years. My commentary will address first the guiding principles for health IT at the foundation of the overall strategy and how these principles affect the five goals formulated in the plan: I – Adoption and information exchange through meaningful use, II – Improvement of care and population health as well as cost reduction, III - Promotion of confidence and trust in health IT, IV – Individual empowerment with health IT to improve care processes and the health care system, and V - Achievement of learning and technological advancement. In conclusion, some recommendations will be outlined.
The Federal Health Information Technology Strategic Plan (2011-2015) lays out the HIT vision, mission and principles as well as goals, objectives and strategies to be implemented in the next five years. My commentary will address first the guiding principles for health IT at the foundation of the overall strategy and how these principles affect the five goals formulated in the plan: I – Adoption and information exchange through meaningful use, II – Improvement of care and population health as well as cost reduction, III - Promotion of confidence and trust in health IT, IV – Individual empowerment with health IT to improve care processes and the health care system, and V - Achievement of learning and technological advancement. In conclusion, some recommendations will be outlined.
The
principles on page 8 emphasize the needs and rights of individuals and
the reliance “to the extent possible” on private markets to achieve
societal objectives - with intervention only “when necessary” to correct
market failures. This reliance on private markets is contrary to
international development experience as well as theory and research in
health economics demonstrating inadequacies of capital markets in
provision of social services.[1,2] It is important to distinguish
between competitive innovation in health services and the health
information infrastructure (the NHIN) required to support such
activities. While HIT infrastructure may be defined as a public good,
both public and private services markets may share the resulting
institutional ecology.
The
focus on outcomes is critical to the success of health care reform, but
this emphasis will not be adequate to motivate performance if national
system design remains fragmented. Private markets will not foster the
emergence of a system infrastructure as seems to be an implicit
principle. Furthermore, costs associated with extensive
micro-measurement of individual health care outcomes should not be
underestimated. (I have reviewed the concept of “value” in health care
outcomes as formulated by M. Porter on my blog
because it seems to me that his model is consistent with the
ideological viewpoint of the majority of the U.S. policy-making
community.[3,4])
Building
on “what works” is also an essential principle of any learning system,
but as I have suggested in earlier commentaries, the focus in the U.S.
health care system seems restricted to experiences within its
boundaries. There are virtual natural experiments in progress in
developing countries as well as industrialized nations around the world,
and the U.S. could learn valuable lessons and avoid expensive mistakes
through systematic analysis of selected national health care systems.
This approach would encourage evidence-based learning and innovation to
more rapidly close the significant lag in health care system
performance that threatens the competitive stance of the U.S. in the
global economy.
Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT (page 9) should be reformulated: Achieve Adoption and Meaningful Use of Health IT through Information Exchange.
The creation of infrastructure for health information exchange is
prerequisite to adoption of health information technology and its
meaningful use. For example the Veterans Administration (VA)
(mentioned on page 10) operates a single payer system through a
federally supported infrastructure that makes possible HIE. The
functionalities to exchange information integrated in EHRs and to report
data relevant to public health are some of the most important intrinsic
motivators for HIT adoption – affecting all stakeholders: providers,
payers, patients and consumers. The VA offers a demonstration of the
effectiveness of an integrated single payer system, as well as the
benefits of HIE. However, the VA is a subsystem distinct from other
segments of the health care sector, and thus will probably not
contribute to the critical mass (or tipping point) necessary for health
care system transformation as discussed on page 10. Principles guiding
the VA, Medicare and Medicaid are very different from those at the
foundation of private insurance markets for the majority of U.S.
citizens.
On page 11 Strategy I.A.2 proposes implementation support to help health care providers through the Regional Extension Center (REC) Program.
While funding for this program has been extended beyond the initial
two-year time horizon, these organizations will be required to develop
business models to become self sustainable. As is the case for Regional
Health Information Organizations (RHIOs) and State Designated Entities
(SDEs), such business models have not been identified.[5] Some
observers have further noted that funded RECs may favor selected
vendors for interoperability, thus introducing a significant conflict of
interest in the support they offer. (See SoftwareAdvice, 9-23-2010)
It may not be realistic to assume that RECs working with competing
vendor consultants will “collaborate with one another and with relevant
stakeholders to identify and share best practices in EHR adoption,
meaningful use, and provider support.” (page 11).
Consistent
with M. Porter, the strategic intention is to move away from the
process requirements formulated in stage one of meaningful use towards
improvements in outcomes and quality of care.[3,4] However, it should
not be assumed that such improvements will be correlated with meaningful
use of health information technology as in the Federal HIT Strategy.
In Canada, penetration of EHR is low, comparable to rates reported in
the U.S.[6], but health care system performance measured by public
health indicators and overall per capita cost is ranked higher .[7]
This would suggest that the superior performance of the Canadian system
is explained by other factors – possibly higher rates of sustained public investment in health IT infrastructures
[8]and the single payer model[9]. Furthermore, there may be a variety
of paths to improvements in outcomes and quality of care as a result,
for example, of major technological, institutional or medical paradigm
shifts – in progress but as yet unforeseen.
Strategy
I.A.5 emphasizes the process to certify EHR technology for meaningful
use. The strategy as formulated does not address the financial burden on software vendors to achieve certification of their products.
There is furthermore little clarification concerning validity of
certification over time and the business model to be associated with
continued certification: See CCHIT Town Call: ONC-ATCB 2011/2012 Certification Program (September 20,2010)
Do ONC-ATCB certified products have to undergo re-certification for each new release?
Following ONC/HHS Final Rules, Establishment of the Temporary Certification Program for Health Information Technology,
certification is completed with a specific version of the technology
that was tested by CCHIT and found compliant with the relevant
certification criteria. For the purpose of maintaining certification,
“minor product changes” are those modifications and updates to a
certified product that are unlikely to affect the product’s compliance
with the certification criteria. Retesting may not be required but the
vendor is required to notify the ONC-ATCB and provide self-attestation
that the changes are minor.
Modifications
with a significant risk of affecting the product’s compliance are
considered to be a “significant product change.” Retesting is required.
Applicants are required to self-classify their product modifications
and updates into one of these two categories.
Will software re-certification be required for each "meaningful use" stage?
Yes;
the criteria, standards and test procedures will change for each stage.
ONC has retained the right to change certification criteria at any
time, but it is most likely that this will not occur until the next
stage. The Final Rule states that the Temporary Certification Program is
scheduled to sunset on December 31, 2011, unless HHS/ONC decides to
extend it or hasn’t defined the permanent program.
Is
there an effective period for certification? For example, if an EHR is
certified in January 2011, when would the certification end and when
would the technology need to be retested?
The
effective period certification is determined by when ONCs publishes new
rules for standards and certification criteria. If you are selling your
software to providers who wish to meet the requirements of all three
stages of meaningful use, you will need to recertify your EHR technology
for 2013/2014 and 2015/2016.
The
process of re-certification will be costly to vendors and entities
implementing self-developed software products. The significant
uncertainties associated with certification also increase risk inherent
in such investments. Little data is available for evaluation of such
risks and published information, such as the CCHIT Toolkit is often
expensive as well. (The Toolkit – developed under federal funding -
costs $1000 unless the entity seeking access to the information is
committed to apply for certification. This policy discourages detailed
review by prospective CCHIT applicants as well as researchers and the
general public.)
I have already commented on policies regarding health information exchange (HIE) and meaningful use.
Objective I.B cites the lack of sustainable business model to support
HIE as well as fragmented policy-making at the federal, state and local
levels. The federal strategy mistakenly states that there are “many
sustainable exchange options … for certain providers and certain types
of information.” (page 15) The federal government will: 1-Foster
business models that create health information exchange, 2-Monitor
health information exchange options and fill the gaps for providers that
do not have viable options, and 3-Ensure that health information
exchange takes place across individual exchange models. (page 15) These
roles cannot be assumed by the federal government unless the necessary
infrastructure is redefined as a public good sustained by significant
public investment. In particular, it is not useful to propose “filling
the gaps” where no system exists. It would be more constructive to
leverage an existing program such as the National Information Exchange Model (NIEM), thus assuring integration with other systems for national security and disaster management- as suggested on page 18.
Another very important policy issue related to federal health IT strategy is broadband Internet access as mentioned on page 16. Comparative country analysis suggests
that the U.S. lags behind other OECD countries in pricing, speed,
penetration and access.[10] Some observers believe that the U.S. does
not now have adequate broadband infrastructure to support full
deployment of HIT meaningful use and health information exchange. The
infrastructures required for HIT implementation are prerequisite to most
of the policies formulated in the Federal Health IT Strategic Plan.
Moving forward without these infrastructures in place will result in
significant waste in funded efforts as well as loss of credibility and
trust at a critical time in health care system reform.
On
page 18 it is stated that the ONC is “tracking the activities of other
countries and learning from their experiences with health IT and health
information exchange.” There is very little evidence that this is the
case, particularly with regard to our closest neighbors, Canada and the
Latin American region. Regional collaboration needs to be extended across the hemisphere
to facilitate system integration for health information exchange,
research and education. (Large grid and cloud systems for basic and
translational research are discussed on pages 27-28, while there is no
mention of extension of such systems across regional boundaries.)
Goal
II of the Federal Strategic Plan (page 22) is to improve care, improve
population health, and reduce health care costs through the use of
health IT. Strategy
II.A.2 (page 24) calls for administrative efficiencies to reduce cost
and burden for providers, payers, and government health programs. This
is a very important but also very elusive objective as programs for
payment reform such as the formation of Accountable Care Organizations
call for additional administrative mechanisms to assure outcome
measurement and reporting as well as distribution of savings and
incentives to participants. The strategy also calls for “more
granular understanding of health care treatments and outcomes, and more
complete analyses of treatment costs, ultimately allowing for better
disease management and more efficient health care delivery.”(page
25) Such detailed analysis of treatment costs is aligned with multiple
private health insurers' requirements, and is often accomplished at the
expense of a system-level focus on population health. The public
funding of new health insurance exchanges -particularly in the absence
of a public health insurance option - also subsidizes the interests of
private health insurers by assuming the costs of infrastructure
benefiting for-profit enterprise in health care services. These costs
should be assigned to the private sector.
Strategy
II.D.3 (page 27) calls for a mechanism to support information exchange
for research and the translation of research findings back into clinical
practice. This strategy also emphasizes the importance of
infrastructure for HIE as well as large grid and cloud-based systems for
the exploration of the wealth of existing data on the human genome. As
mentioned above, extensive and sustainable public investments are
essential to assure the creation and maintenance of such national
infrastructures (including broadband) and to promote their
interconnection with larger regional systems.
Goal
III (page 29) calls for strategies to inspire confidence and trust in
health information technology by protecting confidentiality, integrity
and availability of health information, informing individuals of their
rights, and improving safety and effectiveness of IT. Central
to these issues is the assurance of an individual digital identity in
the health care services ecosystem. While the individual patient is the
central focus of health care system reform efforts, there is no
credible plan to provide a unique digital identity to every citizen.
(This is one of the most intriguing internal contradictions in the logic
of the U.S. model of reform.) Privacy protections as they are
currently designed are more consistent with the interests of private
health care insurers than those of the individuals they serve. These
protections pose obstacles to data aggregation as well as disclosure
relative to insurance plan performance.
The National Strategy for Trusted Identities in Cyberspace (April, 2011)[11] “recognizes
that trusted digital identity, authentication and authorization
processes are one part of layered security. Improvements in
identification and authentication are critical to attaining a trusted
online environment; however, they must be combined with other crucial
aspects of cybersecurity.” (page 8). While recognition of the critical
importance of individual digital identities represents an important
step, the proposed system calls for complex roles to be implemented by
multiple actors in both public and private sectors. While the federal
government plays a significant role in the early stages of the
initiative, it is expected that new and sustainable business models
will be developed for each of the service provider roles of the system
(page 37) so that the identity ecosystem will become a self- sustaining
market place.
This
strategy for trusted identities in cyberspace embodies the same errors
as federal policies for promotion of the Nation-wide Health Information
Network (NHIN) for health information exchange. A reliable and valid
digital identity cannot be the output of complex private sector market
dynamics. This policy principle assures that there will not be
universal access to reliable digital identity, and that the U.S. model
will probably not be interoperable with those of other countries. The
consequences of this stance for U.S competitive advantage in the global
economy should not be underestimated. Moreover, a market supporting
for-profit digital ID roles would be a fertile context for fraud and ID
theft as well as other illegal transactions based on digital ID
information.
Examples of strategies for unique citizen identification in other countries include the British NHS unique patient identifier,[12]and the Indian “Aadhaar”, a
12-digit unique number which the Unique Identification Authority of
India (UIDAI) will issue for all residents. The number will be stored in
a centralized database and linked to the basic demographics and
biometric information – photograph, ten fingerprints and iris – of each
individual. (The U.S. State Department has shown some interest
in the Indian system - for reasons related to National
Security-according to cable communications made public by
Wikileaks.[13])
Goal IV (page 36) calls for individual empowerment for improvement of health and the health care system.
The successful pursuit of this goal depends upon the public
infrastructures for digital identity and health information exchange as
discussed above – as well as health literacy
interventions to improve individual skills. [14][15] These studies
suggest that only one in ten adults in the U.S. may possess the
knowledge and skills required to perform at a high level of health
literacy. Population health literacy is prerequisite to individual
empowerment as well as to creation of a learning health system (Goal V).
Goal
V (page 42) calls for achievement of rapid learning and technological
advancement through creation of a learning health system to support
quality, research and population health, as well as increased capacity
for innovation and research. The
national capacity for innovation and research requires infrastructures
developed as a public good. Sustained public investments contribute to
the foundation for a learning health care system. Another important
aspect of learning systems and capacity for innovation and research is
open access to information. Some important steps have been taken in the
U.S. system to improve such access to federally funded research, such
as the National Institutes of Health Public Access Policy
applicable to any manuscript reporting research funded by the NIH -
accepted for peer-reviewed publication on or after April 7, 2008. “To
help advance science and improve human health, the policy requires that
these papers are accessible to the public on PubMed Central no later
than 12 months after publication.”
While this policy represents progress toward the goal of open access to
scientific information, the delay of 12 months allowed for compliance
significantly reduces its effectiveness.
The Latin-American and Caribbean Center on Health Sciences Information
(Bireme) illustrates a regional model for open access to health
information available through the Virtual Health Library. The model for
this library is published in the VHL Guide 2011
now available for comment and consultation. Background information is
available in the publications of A. Packer, former director of
Bireme.[16]. Dr. Pedro Urra, the new director of Bireme, has been responsible for the creation and development of INFOMED,[17-20]
the Cuban National Health Care Telecommunications Network and Portal.
[21] The U.S. should develop policies to join this important regional
initiative and to further promote open access to health sciences
research.
Summary recommendations
1. Public investment in a national health information infrastructure to promote interoperability for both public and private services - a single infrastructure does not necessarily imply a single payer design.
2. Federal government provision of goal oriented services and tools - rather than financial incentives.
3. Restriction of public reimbursement for basic health care products and services to not-for-profit enterprises.
4. Extension of open access policies governing availability of public health information and published research in medicine and the health sciences.
5. Collaboration across the Americas as a foundation for large scale grid and cloud infrastructures to support regional research and innovation through the Latin-American and Caribbean Center on Health Sciences Information – BIREME.
References
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[3] Porter ME. What Is Value in Health Care? N.Engl.J.Med. 2010;363(26):2477-2481.
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