Clinical Data Standards Development & Implementation

What is FHIR?

Fast Healthcare Interoperability Resources® (FHIR®), developed by Health Level 7 (HL7), is a standard for electronic healthcare information exchange. Its modular architecture uses discrete "resources" like patients, medications, and observations, promoting flexibility and scalability. FHIR is built on modern web standards such as REpresentational State Transfer architecture (RESTful) Application Programming Interfaces (APIs), Java Script Object Notation (JSON), and eXtensible Markup Language (XML). Using FHIR simplifies the implementation of a real-time data exchange, enhancing interoperability and connecting data silos.

FHIR is Customizable to Accommodate Unique Organizational Needs

FHIR supports extensibility, allowing custom resources to meet specific needs. In support of the 21st Century Cures Act final rule mandating FHIR for interoperability, FHIR supports modern messaging frameworks (i.e., RESTFul APIs). The FHIR specification facilitates better informed clinical decisions due to its focus on specific clinical domains leading to better-informed clinical decisions, improved outcomes, and more efficient care delivery. 

What is an SDO?

The Healthcare Information Technology (HIT) standards development process is a global effort led by various Standards Development Organizations (SDOs). HL7 is the SDO organization that owns the FHIR Standard. Representatives from governments, corporations, and non-profits meet regularly in small focused workgroups to define healthcare data exchange formats. These meetings aim to reach consensus on clinical data design message structure conventions 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. 

Our team attends international SDO standards meetings on behalf of our clients.
These global workgroups often meet weekly online and focus on areas like FHIR, medical devices, vocabulary, patient care, documents, or immunizations. Each quarter, members gather in person to advance development through collaboration. The workgroups propose improvements to the data standards regularly and the members vote on the changes to the standards. 

Barriers to Interoperability from Legacy Data 

Legacy data is very difficult to standardize," says Galen Mulrooney, Executive VP of J P Systems. For example, in VA's legacy system, blood pressure is represented as a single string (e.g. "120/80"), whereas DoD's legacy system stored systolic and diastolic values as separate numbers. Both are valid, but neither system will understand the data from the other without some sort of conversion. There are standard LOINC codes for both representations, but they are different LOINC codes. Just because the data is mapped to a standard terminology, doesn't mean that they are interoperable. This is one small example among hundreds of data fields.

What is an Implementation Guide?

To prescribe the solution to the hundreds of disconnects in the way data is stored and exchanged, organizations develop an Implementation Guide to catalog the decisions. Without agreed upon data exchange standards, disconnects occur in the reconciliation of the meaning of the contents of data elements 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. 

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.

Here is the link to FHIR.org Implementation Guide registry Implementation Guide Registry

US Core is the base US National Implementation Guide.