The Recovery Act that initiated the process of providing incentive payments for the adoption and use of Electronic Health Records (EHR) included the provision that such systems support "meaningful use" if they are to be certified and funded. Of course if you have to have meaningful use, then meaningful use has to be defined, and them measured. After a round or two of proposals and comments, CMS issued an Interim Final Rule on December 30, 2009. (The idea that a Final Rule can be Interim is itself a masterwork of government speak.) The governments discussion of this process is available here. The Interim Final Rule itself (which runs over 30 pages) is entitled "Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Interim Final Rule" and it is available here.  A companion rule posted in the Federal Register (FR) on January 13, 2010, "Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule" is available here.  All of this is part of the Health Information Technology project in the Department of Health and Human Services which is lead by Dr. David Blumenthal who is the National Coordinator for Health IT.

These rules defines 25 functions that together constitute meaningful use. Each of these also has a level of performance that is required for ultimate certification (as listed in the January 13th FR). For example, the first use (see below) of "Use Computer Provider Order Entry (CPOE)" has the criteria that it is used for at least 80% of all orders; but only 10% for hospitals. How an EHR is actually used by the provider is an interesting and important distinction from what the system is capable of, i.e. if the system provides for CPOE but if the users don't use that capability to an adequate degree, then by these definitions meaningful use is not achieved. Thus what the EHR can do is a necessary but sufficient condition to establish its certifiablity.

The 25 elements and an abbreviated statement of the associated measures are:

1. Use Computer Provider Order Entry (CPOE) (80%/10% hospitals)

2. Implement drug/allergy checks (Enabled)

3. Maintain an up-to-date problem list of current and active diagnoses (80%)

4. E-prescribing (Eligible Professional (EP) only) (75%)

5. Maintain active medication/allergy list (80%)

6. Record demographics (80%)

7. Record and chart changes in vital signs (80%)

8. Record smoking status for patients 13 years old or older(80%)

9. Incorporate clinical lab-test results (50%)

10. Generate lists of patients by specific conditions(demonstrate)

11. Report ambulatory quality measures to CMS or the States (EP only) (attestation)

12. Send reminders to patients (50% of patients 50 and older)

13. Implement five clinical decision support rules relevant to specialty or high clinical priority (implement)

14. Check insurance eligibility electronically (80%)

15. Submit claims electronically to public and private payers (80%)

16. Provide patients with an electronic copy of their health information upon request (80%)

17. Provide patients with an electronic copy of their discharge instructions and procedures at time of discharge, upon request (Hospital only) (80%)

18. Provide patients with electronic access (10%)

19. Provide clinical summaries to patients for each office visit. (EP only)

20. Exchange key clinical information (80%)

21. Perform medication reconciliation (80%)

22. Submit electronic data to immunization registries (one test submission)

23. Provide electronic submission of reportable lab results to public health agencies (one test submission)

24. Provide electronic syndromic surveillance data to public health agencies (one tets submission)

25. Protect electronic health information (risk analysis)

Of the above there are at least a few that have the sense of decision by committee. For example in 8, why is smoking of unique interest? Why not obesity or other conditions? Why not 12 instead of 13? Some of the measures are also interesting. Why is 80% the most common? (Perhaps because in school it is a B and everyone wants to get at least a B.) However from a safety perspective, why is it acceptable for 20% of patients to not have an electronic copy of their discharge instructions, and who are these 20%? Even more curious, why is electronic access set at 10%, which hardly seems significant. If it is because of a low expectation of computer availability, then what are the 80% with electronic discharge instructions doing with them?

Number 13's implementing decision support rules is perhaps one of the issues that is closer to the core interests of readers here. This is intended to occur at the point of care, and is included to "facilitate disease and medication management; and reporting clinical quality measures and public health information". Further, decision support is described as "health information technology functionality that builds upon the foundation of an EHR to provide persons involved in care processes with general and person-specific information, intelligently filtered and organized, at appropriate times, to enhance health and health care". Filtering we can all understand. What makes it intelligent filtering is open to debate and validation.

In addition it is stated that research has shown that decision support must be targeted and actionable to be effective, and that "alert fatigue'' must be avoided". This suggests some important design issues.  These decision support rules are in addition to drug interactions and allergies and may include the use of demographic data, specific diagnoses, test results and/or medication lists. It is further suggested that this implementation might include automatic electronic messaging including pop-ups and sounds, other alerts, and (perhaps most interesting) "care suggestions" based on the rules and the evidence. Such advisory functions have significant issues with respect to the reliability and portability of advice on an individual patient basis, and the degree to which caregivers are expected to rely on that device (regardless of the manufacturer's disclaimers). On a different note, the potential for pop-ups and sounds littering the EHR suggests that destructive sabotage might soon follow.

The 25 elements are also captured (but not in order) in the 5 categories of: Improving quality, safety, efficiency and reducing health disparities; Engage patients and families in their healthcare; Improve care coordination; Improve population and public health; and Ensure adequate privacy and security protections for personal health information.

The effort to standardize and define EHR capability is clearly a daunting one, and perhaps ever more so when there is Recovery Act money on the table. Certainly some specific expectations are required because we want our tax dollars to be be spent wisely. However there is the associated risk that what you require is all you are going to get.

William Hyman is Professor Emeritus of the Department of Biomedical Engineering at Texas A&M University. He recently retired and has moved to New York City where he continues his professional activities.