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 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.
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., but health care system performance measured by public health indicators and overall per capita cost is ranked higher . 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 and the single payer model. 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.
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. 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) “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,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.)
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.  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.. 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.  The U.S. should develop policies to join this important regional initiative and to further promote open access to health sciences research.
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.
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