Health Level Seven

Health Level 7 International (HL7) is a non-profit, standards development organization accredited by the American National Standards Institute (ANSI). The organization supports various health care practices by creating a framework for the transmission of electronic health information.

Health Level Seven (HL7) is developing Regulated Product Submissions (RPS) and previously developed the Structured Product Labeling (SPL) standard

HL7 membership includes representatives such as vendors, health care providers, government agencies and others who have a common interest in the advancement of standards for administrative and clinical health care. HL7 certification provides health IT departments a means to qualify that individuals have achieved an acceptable standard of proficiency within the standard tested.


Regulated Product Submissions (RPS)

Developed as an HL7 standard, Regulated Product Submission (RPS) is the next generation of eCTD. This format is designed to facilitate the processing and review of regulated product information. GlobalSubmit has taken an active role in the development of RPS. Chief Technology Officer, Jason Rock, served as a lead developer and chair of the RPS standard. RPS covers all regulated products and involves a single XML file. You can read an overview of RPS on the FDA’s website.

Even for experienced users, XML can be quite complicated. The complexities of the RPS standard make it extremely difficult to generate RPS XML by hand. Instead, you should use a system specifically designed to publish the RPS standard.

Structured Product Labeling (SPL)

Structured Product Labeling was the first HL7 standard adopted by the U.S. Food & Drug Administration. This XML-based data structure simplifies the process of sharing and storing drug product and facility information. The FDA chose SPL for the format’s many advantages including:

  • Search within the text of labeling content
  • Exchange information between computer systems
  • Comparison of drug information

Overall, SPL helps the life science community support electronic health initiatives.