Clinical Data Standards Development & Implementation
The Healthcare Information Technology (HIT) standards development process is the result of a worldwide effort of Standards Development Organizations (SDOs). Many representatives from governments, private corporations, and non-profit organizations meet weekly in specialized workgroups to determine the data formats for information exchange. At these meetings, we work to reach a consensus on how clinical data elements may be designed for transmission in messages sent between healthcare providers, so that all recipients can utilize the data accurately and without ambiguity. The main underlying problem is that the actual bits and bytes in the data files of a given healthcare provider's database files are NOT interpretable by a different hospital system's EHR software. This is true even if the two hospitals have the same EHR system.
According to the Public Health Data Standards Consortium, data standards are "documented agreements on representations, formats, and definitions of common data. Clinical data standards provide a method to codify in valid, meaningful, comprehensive, and actionable ways information captured in the course of doing business." Without data standards, the data values stored in any two hospital's EHR data files for a given data element, such as blood type, would be coded in different ways. For example, for a field such as blood type, one EHR might store a coded number while others might store text.
One way to solve the discrepancies between EHRs of older non-standard data in two different hospitals is an expensive study of every single data element in every data file and the creation and validation of maps between the systems. If they want to share data, years of work have to be done. Every time one adds a new exchange partner, years of work have to be done. The solution is to have each hospital or provider's EHR system map to a common set of data fields and values worldwide. Then the data can be sent unambiguously.
We are liaisons sent by clients to these SDO international standards meetings. As these meetings are attended by people from all over the world, work groups may meet weekly in virtual meetings. The workgroups focus on a particular area like medical devices, vocabulary, patient care, document standards, or immunizations. Each quarter the SDOs convene in person.
These SDOs are similar to a legislative body in that they draw up ballots that specify what the data standard messages or documents should look like. SDO members analyze, debate, comment, and vote on the ballots. This cycle repeats after a ballot is passed. More changes are proposed, a discussion is held, all ramifications are debated, and the next ballot is compiled and voted on. The standards are not only U.S. standards but worldwide. The same HIT data standards in a work group's ballot have to work for New Zealand, Brazil, Germany, the UK, and Japan. Thus, our team's progress alone is inherently hard to measure as the whole world has input to these standards.
Designing messages with clinical data is a lot more complicated than designing e-commerce banking transactions. Thus, data standards are the foundation of standards development. These standards include semantics standards, with the underlying terminology standards to implement them, and message standards (such as those developed by HL7), to send the data and cause the desired resulting actions. Message standards encompass much more than just ordinary emails, as many messages require a response of a specific nature. A laboratory order message requests that a lab test is done. A prescription message sent to a pharmacy requests that a prescription is filled.
Finally, security standards are a major issue. A part of security policy design involves who is allowed to see what data is in an electronic healthcare patient record and when and how should that be overridden in an emergency. Many countries are cooperating to make these standards a reality.