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).

The Healthcare Information Technology (HIT) standards development process reflects a global effort led by Standards Development Organizations (SDOs). Representatives from governments, corporations, and non-profits meet weekly in workgroups to define healthcare data exchange formats. These meetings aim to reach consensus on clinical data design for clear, consistent communication between healthcare systems. Without standards, raw data in one provider’s system becomes unreadable to another, even using the same EHR software.

According to the Public Health Data Standards Consortium, data standards ensure consistent, meaningful, and actionable healthcare information.

"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 them, data elements like blood type might appear as a number in one EHR and text in another. To align two hospitals’ outdated, non-standard data requires costly, time-consuming mapping of every single data element. If a provider wants to share data or add a partner, the work may take years. Instead, each EHR should map to a global set of standard data fields and values. With this approach, providers can exchange data clearly and unambiguously worldwide.

Our team attends international SDO standards meetings on behalf of our clients.
These global workgroups often meet weekly online and focus on areas like devices, vocabulary, care, documents, or immunizations. Each quarter, members gather in person to advance development through collaboration.

Like lawmakers, SDOs draft ballots detailing proposed data standard structures.
Members review, debate, revise, and vote on these ballots in a continuous cycle.
Once passed, ballots lead to new proposals, further discussion, and additional ballots. The result is not just a U.S. standard—it must work in Germany, Japan, Brazil, and beyond. Because of this global input, measuring any one team’s progress is inherently difficult.

Designing healthcare messages is far more complex than creating e-commerce or banking transactions. Thus, data standards are essential, including semantics, terminology, and message standards like those developed by HL7. These standards allow systems to send data and trigger correct responses, such as lab orders or prescriptions.

Security standards are equally important. They define who can access patient records and when emergency access should override standard restrictions. Many countries now collaborate to implement and enforce these crucial security standards.