Promoting Interoperability Between In Vitro Devices, Database Systems

How can U.S. healthcare regulators encourage stakeholders to adopt standards related to the reporting of laboratory data? That question will be the focus of a fall workshop led by the FDA, Centers for Disease Control and Prevention and the National Library of Medicine.

Scheduled for Sept. 28 at the FDA’s White Oak campus in Silver Spring, Md., the workshop will focus on ways to promote the semantic interoperability of laboratory data between in vitrodiagnostic devices and database systems, including laboratory information systems and electronic health records.

Semantic interoperability refers to the ability of two or more systems to exchange and use information. It represents the highest level of interoperability, according to the Healthcare Information and Management Systems Society, a nonprofit focused on improving care through information technology.

Tracking Challenges

“Much of laboratory information is directly generated by medical devices and, as such, should be readily amenable to standardization that would enable semantic interoperability; however, significant challenges exist both in the adoption of standards by device manufacturers and implementation by clinical and public health laboratories,” according to an Aug. 3 Federal Register notice announcing the meeting.

The federal bodies are particularly interested in obtaining feedback from individuals representing laboratories, industry, government, academia and healthcare, as well as others involved in developing interoperability standards. Participants will discuss specific models for semantic interoperability, such as Logical Observation Identifiers Names and Codes for identifying laboratory tests, Systemized Nomenclature of Medicine-Clinical Terms coding sets for describing qualitative test results and Unified Code for Units of Measure for quantitative results. The use of unique device identifier codes, as well as mechanisms for distributing device coding information, such as Structured Product Labeling or Electronically Exchanging Directory of Services, also will be covered.

The FDA, CDC and NLM plan to develop a summary of issues to be discussed at the meeting to be posted online. Interested parties may submit comments for presentation through Sept. 18. Comments will be accepted for the Federal Register announcement through Sept. 28.

To view the notice, visit www.fdanews.com/081015-fda-workshop.pdf. — Elizabeth Hollis