An Overview of the New Federal Standards Governing Health Information Technology (Part 1)

Those hoping for health reform have recently had a bad stretch of luck. I am here to report that movement in the reform process is certain in one area: health information technology (HIT). It may not be the sexiest topic in health care, but as David Blumental, the director of the Office of the National Coordinator for Health Information Technology (ONC),  noted in his piece for the New England Journal of Medicine, “[i]nformation is the lifeblood of modern medicine. Health information technology (HIT) is destined to be its circulatory system.” The ONC recently released an interim final rule (IFR) for HIT standards. CMS released a notice of proposed rule making (NPRM) that describes how Electronic Health Records (EHRs) are to be put to “meaningful use.” The context of both of these rules is the incentive-based program that the federal government has created. The goal of this program is to spur the creation of a sustainable and interoperable nationwide network of EHRs.

As opposed to describing every detail of the ONC’s interim final rule, I think it would be more valuable to broadly discuss the general standards that the government has decided upon, and then describe those standards so that the reader has a general idea of what these standards are.

Two Tables are Primary Reference for Understanding the Rule

So what did the ONC determine? The easiest way to tease out the big picture is to refer to two tables (Table 1 and Table 2A) that are buried within the IFR.

The two tables have been extracted from the pdf for ease of reference. Table 1 can be found here (pdf). Table 2A can be found here (pdf).

Preview of Table 1 - Click Thumbnail Above to View All of Table 1

Preview of Table 2A - Click Thumbnail Above to View All of Table 2A

For the full IFR, it can be found here in pdf or here in html.

Using the tables to decode the IFR

Table 1 has three columns. The column on the left consists of the stage 1 meaningful use objectives that were issued by CMS and which serve to govern the purpose and capabilities of EHRs at a broad level. (For background on CMS’s proposed guidelines for meaningful use, see my earlier post here). The two columns on the right of Table 1 are the ONC’s certification criteria. These criteria have been created in order to support CMS’s meaningful use objectives. The middle column corresponds to the criteria for non-hospital providers–referred to as eligible professionals–such non-hospital-based physicians. The rightmost column corresponds to the criteria for hospitals (referred to as eligible hospitals). These two groups, eligible professionals and eligible hospitals, are eligible in the sense that they are eligible for reimbursement in exchange for the meaningful use of EHR technology.

Table 2 is the final piece of the puzzle, laying out the standards that the ONC has adopted. The standards are the nitty gritty details of the broader certification criteria that support the even broader meaningful use objectives.  Thus, we have a framework for our standards: start with the meaningful use objectives, establish certification criteria for these objectives, and then specify the standards that would allow for an objective determination of whether the criteria has been met.

With these tables in hand, it is possible to delve a bit deeper into the ONC’s vision of HIT.

Three Important Phrases: “Certified EHR Technology”, “Complete EHR”, and “EHR Module”

The regulations utilize the phrases “Certified EHR Technology”, “Complete EHR,” and “EHR Module” in an effort to implement flexible standards that can evolve as the standards continue to evolve. This idea of the rules evolving is a common theme, and it cannot be stressed enough that the ONC has gone through great pains in balancing the predictability of constrained EHR standards with the dynamism of the evolving standards landscape.

Terms

• Qualified EHR: an electronic record of health-related information on an individual that:
  • (A) Includes patient demographic and clinical health information, such as medical history and problem lists; and
  • (B) has the capacity:
    • (i) To provide clinical decision support;
    • (ii) to support physician order entry;
    • (iii) to capture and query information relevant to health care quality; and
    • (iv) to exchange electronic health information with, and integrate such information from, other sources.’
• Certified EHR Technology: A Complete EHR or a combination of EHR Modules, each of which:
  1. Meets the requirements included in the definition of a Qualified EHR; and
  2. has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary.
• Complete EHR: EHR technology that has been developed to meet all applicable certification criteria adopted by the Secretary.
• EHR Module:  any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary. Examples:  Interface or other software program that provides the capability to exchange electronic health information; An open source software program that enables individuals online access to certain health information maintained by EHR technology; A clinical decision support rules engine; A software program used to submit public health information to public health authorities; and, A quality measure reporting service or software program.

In order to allow for flexibility, the ONC does not require that “Certified EHR technology” is a complete “turn key” system. Rather, the ONC allows for two different types of “Certified EHR Technology.” On the one hand you have “Complete EHRs” which are  “turn key” solutions in that a complete EHR meets the broad functional requirements of a qualified EHR and all of the  certification criteria listed in Table 1 (see link to Table 1 pdf above). On the other hand, “Certified EHR Technology” may also consist of a combination of modules, as long as the combination of modules meets the broad functional requirements of a “Qualified EHR,” and the modules together satisfy all of the certification criteria. Thus, physicians and hospitals retain flexibility in how they implement technology to achieve meaningful use.

The Adopted Standards

The ONC has grouped the standards into four groups:

1. Vocabulary Standards — The standardized nomenclatures and code sets used to describe clinical problems and procedures, medications and allergies.
2. Content Exchange Standards –  The standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents.
3. Transport Standards — The standards used to establish a common, predictable, secure communication protocol between systems.
4. Privacy and Security Standards — Standards relating to authentication, access control, transmission security which relate to and span across all of the other types of standards.

Content Exchange Standards

Table 2A describes the first 2 categories. It is actually most helpful to initially discuss the second category: the content exchange standards. The content exchange standard can be thought of as the rules that constrain the shape and form of the data. In other words, it concerns how the data is structured. A standardization  of the structure is necessary so that different computer systems can predictably send and receive data that is organized in a predictable format. A rough analogy can be made to the Bluebook citation standards which specify the organization of legal citations. Regardless of the court reporter being used, all bluebook citations to federal court cases have the same basic organization (e.g. case name in italics, followed by the reporter, starting page, etc). Whereas a law school journal may only accept the Bluebook standard, the ONC has decided to allow for two standards:  Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2 (R2) Level 2 CCD or ASTM CCR.  Again, the ONC has sought flexibility in the initial stage of the certification process by allowing for multiple standards to be used. As noted in Table 2A, the ONC will eventually decide on one of these standards. It should be noted that if HL7 is picked, the ASTM standard can be “mapped” onto HL7 so that systems using ASTM can become interoperable with HL7-based systems.

The first standard is referred to as HL7 CDA R2 CCD. Though the name is intimidating, it is not very difficult to explain. HL7 is an international health care standards organization. The Clinical Data Architecture part of the name serves to identify that we are dealing with HL7’s standards regarding the organization of clinical documents that are sent and received electronically. It is necessary to specify CDA because HL7 has released other standards. The R2 refers to the fact that it is a second version of the standard. The CCD stands for Continuity of Care Document, and identifies that the standard deals with a constrained amount of health information–specifically, the information necessary to create a summary of a patient’s medical history.

Vocabulary Standards

To go back to the Bluebook analogy, the Bluebook must do more than specify the organization of the information in a citation. Additionally, it must specify the actual content that can be represented. For example,  the vocabulary of the reporter of a federal appeals case consists of F. or F.2d or F. 3d. Likewise, the vocabulary of EHRs must be standardized. The standards adopted for the vocabulary are listed in Table 2A.  There are a variety of different standards that have been adopted, including ICD-9, SNOMED, and LOINC. Some of these standards are in competition, and as Table 2A shows, the ONC’s position on competing standards will change in Stage 2 of Meaningful Use. For example, the vocabulary for medications will become more restrictive in Stage 2. However, some standards are not in competition, but are independent and describe wholly different aspects of medicine. For example, RxNorm describes medications but says nothing about laboratory test results, which is the domain of the LOINC vocabulary.

Hopefully the above discussion of the ONC’s adopted standards offers a foundation that allows for closer inspection of the IFR. The second part in this series will detail the two additional categories of standards, as well as other salient details of the IFR.

For additional information on the ONC’s rules, the following resources may be of interest:

The ONC’s most recent meeting, including mp3s of the meeting, can be found here.

General information about the ONC’s efforts with respect to the new standards can be found here.

Information about Clinical Data Architecture can be found here.

A solid overview of the new standards can be found here.