The following text is a commentary on stage 2 meaningful use objectives, criteria and measures - mainly from the perspectives of social and organizational sciences - in response to the call for public comment issued by the HIT Policy Committee. My previous commentaries on MU, Regional Health Information Organizations (and update) and Extension Centers also remain pertinent to the discussion context.
Commentary on the MU stage 2 matrix (with page references to the call for public comment):
On page 6, MU objectives refer to "unique patients" for recording vital signs and smoking status. This criterion raises a question concerning the definition of "unique patient". (It is somewhat ironic that in the US system that purports to focus on empowering the individual patient and his or her needs/choices, a unique patient identifier seems to be out of the question.) On December 9, 2010, a Patient Linking Hearing hosted by the ONC Health Information Technology Policy Committee heard testimony on idividual patient identification. Paul Oates of Cigna pointed out that in the US patient ID (and that of his/her family) is generally tied to an employer. When patients lose their jobs or move from one employment to another, their identification may be compromised. Oates further clarifies:
"The historical purpose of keeping person data was to derive eligibility for benefits and pay claims, not primarily to improve care or service an individual. So, the primary data attributes linked to a person largely revolved around tying a person to their dates of eligibility, their plan type and features."(Page 1-See oates-patient-linking-hearing-tigerteam.pdf)
This testimony suggests the tenuous relationship between clinical and claims information resulting in a dual view of patient/consumer identity. Problems in linking patient ID to relevant data further hamper the integrity of research efforts in medicine and public health. Some of these difficulties and possible solutions were suggested at the hearing by Assistant Professor Bradley Malin of the Department of Biomedical Informatics, School of Medicine, Vanderbilt University.
(The logical conclusion to this discussion would be a call for a unique biometric patient identifier, similar to that being implemented in India.)
On page 7 formulary checks are prescribed for MU, but accomplishment of this objective depends on the collaboration of multiple health plans which may or may not offer the necessary electronic support. Care must be taken to assure that this provision does not result in an excessive administrative burden to meaningful users of EHRs and health information technology.
Also on page 7, where it is stipulated that lab results should be entered into EHRs as structured data, it may be important to distinguish between test results and their interpretation. For example, where digital images are not included in the EHR, lab results constitute interpretation rather than original data. The lack of available raw data may contribute to requirements for unnecessary repetition of clinical tests in some clinical decision processes.
On page 10, the new requirement that secure online patient messaging be in use depends on the existence of supporting infrastructures and health information exchange. Individual EHR users cannot be responsible for the availability of such infrastructures. Also on page 10, the requirement that patient preferences for communication medium be recorded is not really useful under real operational contingencies. Availability of media depends on the context and may change as a patient moves from one facility or geographical area to another. Communication also frequently requires a dynamic suite of synchronous as well as asynchronous media.
Electronic self management tools (page 10) require content beyond the functions of the EHR. Patients choose such tools depending on their health care culture and provider affiliations as well as their ability to invest time and other resources in self management. The patient has access to his or her health information, but content other than that within the patient-specific EHR should not be included in criteria for MU.
For care coordination it is suggested in stage 2 (page 11) that the meaningful user connect to at least three external providers in "primary referral network" (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange. As I have frequently mentioned in other commentaries, requirements for health information exchange imposed on meaningful users assume the existance of effective telecommunications infrastructures and institutions such as RHIOs. Such assumptions are invalid. While policies to promote RHIOs, state health information exchanges and the Nationwide Health Information Network (NHIN) are in place, they are so far not sustainable, and public investments remain inadequate.
Submission of data including clinical and patient generated information to public health agencies (pages12-13) also depends on the availability of telecommunications infrastructures for such health information exchange. There are not necessarily any preparatory steps to be taken by health care practitioners for these stage 3 objectives. Public initiatives and investment are required rather than individual EHR user steps in stage 2 of MU. Privacy and security protections also depend significantly on design of infrastructures for health information exchange.
Section D-questions 3, 5, 6, 9, and 10 (pages 14-15):Question 3: What strategies should be used to ensure that barriers to patient access – whether secondary to limited internet access, low health literacy and/or disability – are appropriately addressed? Strategies to promote patient access to their EHRs and other electronic health information are outside the criteria for MU. However, I would like to suggest the possible usefulness of mentoring among patients and patient support groups focused on competencies necessary for access to and meaningful use of electronic health information. These programs could be offered by public or private entities, including health plans, health care providers, and patient advocacy groups. Physical access to the Internet might further be facilitated through the use of self-service kiosks designed to guide patients lacking experience in the use of electronic information and the Internet. Such kiosks could be set up in medical centers, hospitals, clinics and offices of physicians as well as other health care service providers.
Question 5: For future stages of meaningful use assessment, should CMS provide an alternative way to achieve meaningful use based on demonstration of high performance on clinical quality measures? This would be an important strategy to recognize that there may be many paths to high performance in clinical quality - with or without meaningful use of EHRs. Measurement of clinical quality is also more accessible than assessment of complex and dynamic processes of meaningful use. This strategy would focus users' motivation on the quality objective rather than the means to its achievement - and open the door to incentivize innovative methods other than meaningful use.
Question 6 : Should Stage 2 allow for a group reporting option to allow group practices to demonstrate meaningful use at the group level for all EPs in that group? The answer to this question depends on the organizational and infrastructural health care context. Groups might be defined as medical homes or accountable care organizations. Some EPs may perform part of their practice within such organizational structures. How might such participation be taken into account? Physicians and other health care professionals have multi-affiliated practices and they may also be highly mobile, moving from one US region to another - or even outside the country. It is difficult to imagine how the MU objectives, criteria and measures can take this dynamic context into account.
Question 9: What additional meaningful-use criteria could be applied to stimulate robust information exchange? As mentioned above with reference to page 11 of the MU matrix, requirements for health information exchange imposed on meaningful users assume the existence of effective telecommunications infrastructures and institutions such as RHIOs. Such assumptions are invalid. While policies to promote RHIOs, state health information exchanges and the Nationwide Health Information Network (NHIN) are in place, they are so far not sustainable, and public investments remain inadequate. EHR users cannot participate in electronic HIE without these infrastructures.
Question 10: There are some new objectives being considered for stage 3 where there is no precursor objective being proposed for stage 2 in the current matrix. We invite suggestions on appropriate stage 2 objectives that would be meaningful stepping-stone criteria for the new stage 3 objectives. The achievement of MU is not a linear process due to its complexity as well as the high rates of technological change and innovation. It may not be necessary to define stage 2 "stepping stones" towards achievement of stage 3 objectives.
The evidence base (Section E, page 15):
The list of studies presented to justify formulation of new MU objectives illustrates the difficulty in the linear (and static) definition of meaningful use. These studies represent single data points in the literature review and meta-analysis required for the propositions guiding meaningful use - under the assumption that these research results will continue to be relevant irregardless of fast moving processes of health care system reform and technological innovation. Meaningful use will also be affected by institutional evolution in the formation of regional (RHIOs) and state organizations for health information exchange as well as accountable care organizations (ACOs) and medical homes. There is little or no research evidence (or other policy information) to substantiate any scenario describing the development of these institutions - while they lie at the foundation of meaningful use.
Concluding thoughts and references:Much progress has been made in development of national policies for implementation of health information technology in the US.  However, as I have mentioned in earlier commentaries, rapid change and innovation[2,3,4] may result in new policy models - invalidating or competing with the current policy model of MU. The significant risk of a technological paradigm shift may compromise the credibility of MU policies as well as user motivation to accomplish early stage 1 and 2 steps to satisfy MU criteria at stage 3 - after 2015. Unfortunately, even though Blumenthal describes the adoption of EHRs in the US as “inevitable,” recent research on effectiveness of EHRs (as well as ehealth more generally) has shown inconclusive results regarding both improved quality of care and cost effectiveness. [6-8] These studies suffer from a paucity of theoretical frameworks as well as many methodological weaknesses. The absence of an evidence base substantiating the benefits of EHR implementation tends to discredit current policy discourse and undermine efforts to incentivize EHR adoption and meaningful use in the US. It would be useful in this regard to broaden focus on EHR context to include social networks and global telecommunications, and to consider the benefits of enhanced international collaboration for health care service delivery as well as for research in medicine and the health sciences. 
 Buntin MB, Jain SH, Blumenthal D. Health Information Technology: Laying The Infrastructure For National Health Reform. Health Affairs 2010 June 01;29(6):1214-1219.
 Sittig DF, Singh H. A new sociotechnical model for studying health information technology in complex adaptive healthcare systems. Quality and Safety in Health Care 2010 October 01;19(Suppl 3):i68-i74.
 Golembiewski RT, Billingsley K, Yeager S. Measuring Change and Persistence in Human Affairs: Types of Change Generated by OD Designs. The Journal of Applied Behavioral Science 1976 April 01;12(2):133-157.
 Millsap R, Hartog S. Alpha, Beta, and Gamma Change in Evaluation Research: A Structural Equation Approach. Journal of Applied Psychology 1988;73(3):574-585.
 Blumenthal D, Tavenner M. The “Meaningful Use” Regulation for Electronic Health Records. N.Engl.J.Med. 2010 08/05;363(6):501-504.
 Romano MJ, Stafford RS. Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality. Arch.Intern.Med. 2011 January 24.
 Black A, Car J, Pagliari C, et al. The Impact of EHealth on the Quality and Safety of Health Care: A Systematic Overview. PLoS Medicine 2011;8(1):e1000387.
 Jones S, Adams J, Schneider E, et al. Electronic Health Record Adoption and Quality Improvement in US Hospitals. American Journal of Managed Care 2010;16(12).
 Pingree S, Hawkins R, Baker T, DuBenske L, Roberts LJ, Gustafson DH. The Value of Theory for Enhancing and Understanding e-Health Interventions. Am.J.Prev.Med. 2010 1;38(1):103-109.
 Shachak A, Jadad AR. Electronic Health Records in the Age of Social Networks and Global Telecommunications. JAMA: The Journal of the American Medical Association 2010 February 03;303(5):452-453.
Addendum: Other significant issues raised in response to the call for public comment:Issues raised concerning MU objectives, critera and measures include (1) the integration of digital imaging in EHRs and (2) consistency of public policies to promote eprescribing. These are mentioned below:
In a recent policy document, the Medical Imaging and Technology Alliance (MITA) deplores the absence of MU criteria regarding formats and electronic transmission of medical imaging. The criteria so far only address data that may be entered into the record by descriptive text or numerical data - while software certification and meaningful use of EHRs will not take medical imaging into consideration until after 2015. MITA points out the need for EHR standards to support sharing digital images generated by equipment made by different manufacturers. The Digital Imaging and Communications in Medicine (DICOM) Standard was developed by the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA). The current standard, DICOM 3.0 is nearly universally accepted to enable data exchange among DICOM compliant systems, either on CDs or through available transfer functions. An industry and professional initiative, Integrating the Healthcare Enterprise (IHE), further promotes adoption of EHRs by facilitating service coordination and data exchange among health care information systems. IHE tests more than 100 systems for compliance every year. These efforts supporting DICOM and health information exchange should be an integral part of the EHR MU scenario.
Another important issue is the lack of coherency between two CMS incentive programs promoting use of electronic prescriptions and EHRs. The GAO has published an analysis of program inconsistencies and their consequences.(See Electronic Prescribing: CMS Should Address Inconsistencies in Its Two Incentive Programs that Encourage Use of Health Information Technology - February 2011 - GAO-11-159)