Data Modeling for Electronic Health Records (EHR) Systems

Getting the data model right is of paramount importance for an Electronic Health Records (EHR) system. The factors that drive the data model include but are not limited to:

• Patient safety
  
• Support for clinical workflows
  
• Different uses of the data such as input to clinical decision support systems
  
• Reporting and analytics
  
• Regulatory requirements such as Meaningful Use criteria.
  

Model First

Proven methodologies like contract-first web service design and model driven development (MDD) put the emphasis on deriving application code from the data model and not the other way around. Thousands of line of code can be auto-generated from the model, so it's important to get the model right.


Requirements Gathering

The objective here is to determine the entities, their attributes, and the relationships between those entities. For example, what are the attributes that are necessary to describe a patient's condition and how do you express the fact that a condition is a manifestation of an allergy? The data modeler should work closely with clinicians to gather those requirements. Industry standards should be leveraged as well. For example, HITSP C32 defines the data elements for each EHR data module such as conditions, medications, allergies, and lab results. These data elements are then mapped to the HL7 Continuity of Care Document (CCD) XML schema.

The HL7 CCD is itself derived from the HL7 Reference Information Model (RIM). The latter is expressed as a set of UML class diagrams and is the foundation model for health care and clinical data. A simpler alternative to the CCD is the ASTM Continuity of Care Records (CCR). Both the CCD and CCR provide an XML schema for data exchange and are Meaningful Use criteria. Another relevant data model is the HL7 vMR (Virtual Medical Record) which aims to define a data model for the input and output of Clinical Decision Support Systems (CDSS).

These standards can be cumbersome to use as such from a software development perspective. Nonetheless, they can inform the design of the data model for an EHR system. Alignment with the CCD and CCR will facilitate data exchange with other providers and organizations. The following are Meaningful Use criteria for data exchange:

1. Electronically receive a patient summary record, from other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations, and procedures and upon receipt of a patient summary record formatted in an alternative standard specified in Table 2A row 1, displaying it in human readable format.
   
   
2. Enable a user to electronically transmit a patient summary record to other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, immunizations, and procedures in accordance with the standards specified in Table 2A row 1.
   

Applying Data Modeling Patterns

Applying data modeling patterns allows model consistency and quality. Relational data modeling is a well established discipline. My favorite resource for relational data modeling patterns is: The Data Model Resource Book, Vol. 3: Universal Patterns for Data Modeling.

Some XML Schema best practices can be found here.


Data Stores

Today, options for data store are no longer limited to relational databases. Alternatives include: native XML databases (e.g. DB2 pureXML), Entity-Attribute-Value with Classes and Relationships (EAV/CR), and Resource Description Framework (RDF) stores.

Native XML databases are more resilient to schema changes and do not require handling the impedance mismatch between XML documents, Java objects, and relational tables which can introduce design complexity, performance, and maintainability issues.

Storing EHRs in an RDF store can enable the inference of medical facts based on existing explicit medical facts. Such inferences can be driven by an ontology expressed in OWL or a set of rules expressed in a rule language such SWRL. Semantic Web technologies can also be helpful in checking the consistency of a model, data and knowledge integration across domains (e.g. the genomics and clinical domains), and for managing classification schemes like medical terminologies. RDF, OWL, and SWRL have been successfully implemented in Clinical Decision Support Systems (CDSS).

The data modeling notation used should be independent of the storage model or at least compatible with the latter. For example, if native XML storage is used, then a relational modeling notation might not be appropriate. In general, UML provides the right level of abstraction for implementation-agnostic modeling.


Due Diligence

When adopting a "noSQL" storage model, it is important to ensure that (a) the database can meet performance and scalability criteria and (b) the team has the skills to develop and maintain the database. Due diligence should be performed through benchmarking using a tool such as the IBM Transaction Processing over XML (TpoX). The team might need formal training in a new query language like XQuery or SPARQL.


A Longitudinal View of the Patient Health

Maintaining an up-to-date and truly longitudinal view of a patient's medical history requires merging and reconciling data from heterogeneous sources including providers' EMR systems, lab companies, medical devices, and payers' claim transaction repositories. The data model should facilitate the assembly of data from such diverse sources. XML tools based on XSLT, XQuery, or XQuery Update can be used to automate the merging.


The Importance of Data Validation

Data validation can be performed at the database layer, the application layer, and the UI layer. The data model should support the validation of the data. The following are examples of techniques that can be used for data validation:

• XML Schema for structural validation of XML documents
  
• ISO Schematron (based on XPath 2.0 and XSLT 2.0) for business rules validation of XML documents
  
• A business rules engine like Drools
  
• A data processing framework like Smooks
  
• The validation features of a UI framework such as JSF2
  
• The built-in validation features of the database.
  

The Future: Modeling with the NIEM IEPD

The HHS ONC issued an RFP for using the National Information Exchange Model (NIEM) Information Exchange Package Documentation (IEPD) process for healthcare data exchange. The ONC will release a NIEM Concept of Operations (ConOps). The NIEM IEPD process is explained here.