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X12 transaction guide · Healthcare and insurance

EDI 500 Medical Event Reporting

The X12 document used to make voluntary, mandatory and periodic reports on adverse effects and product problems with medications and medical devices.

Sent by
Manufacturer, healthcare facility or reporter
Received by
Regulatory agency or manufacturer
Standard
ANSI ASC X12

What is an EDI 500?

The EDI 500 Medical Event Reporting is the ANSI X12 transaction set that can be used to make voluntary, mandatory, baseline, annual and semi-annual reports on adverse effects and product problems involving medications and medical devices.

Manufacturers and healthcare facilities must report certain adverse events to regulators, who use the reports to detect safety problems. Many regulators now prescribe specific electronic reporting formats, so implementers should confirm which format each authority accepts. Reports can be initial reports or follow-up reports with the results of investigations, and they help regulators identify safety signals across many sources.

How the EDI 500 worksDiagram of the EDI 500 Medical Event Reporting. Manufacturer, healthcare facility or reporter sends it to regulatory agency or manufacturer. It usually starts the exchange. It is usually followed by 997. Inside the ISA, GS and ST envelopes, X12 release 008010 requires, in the heading: BGN (Beginning Segment). 2 optional loops are listed by their first segment.How the EDI 500 worksMedical Event Reporting: who sends it, where it fits and what the standard marks required1 WHERE IT FITSUSUALLY FOLLOWSStarts the exchangeEDI 500SENDERManufacturer,healthcare facility orreporterRECEIVERRegulatory agency ormanufacturer997 or 999 acknowledgment back, if the partners agreeUSUALLY FOLLOWED BY997FunctionalAcknowledgment2 WHAT X12 RELEASE 008010 REQUIRESInterchange: sender and receiver IDsISA … IEAFunctional group, ID code MMGS … GETransaction set 500ST … SEHEADINGBGNBeginning Segment+ 1 optional loop, starting with:NM1DETAIL+ 1 optional loop, starting with:HLBlue box: required loop. Optional loops are listed by the segment that starts them; when a loop is used, that first segment is required. Optional segmentsoutside loops are not drawn.Structure: required segments and loops in the X12 008010 listing for the 500. Your trading partner's implementation guide adds its own requirements.
How the EDI 500 worksDiagram of the EDI 500 Medical Event Reporting. Manufacturer, healthcare facility or reporter sends it to regulatory agency or manufacturer. It usually starts the exchange. It is usually followed by 997. Inside the ISA, GS and ST envelopes, X12 release 008010 requires, in the heading: BGN (Beginning Segment). 2 optional loops are listed by their first segment.How the EDI 500 worksMedical Event Reporting: who sends it, where itfits and what the standard marks required1 WHERE IT FITSUSUALLY FOLLOWSStarts the exchangeEDI 500SENDERManufacturer,healthcarefacility orreporterRECEIVERRegulatoryagency ormanufacturer997 or 999 acknowledgment back, if the partnersagreeUSUALLY FOLLOWED BY997Functional Acknowledgment2 WHAT X12 RELEASE 008010 REQUIRESInterchange: sender and receiver IDs (ISA… IEA)Functional group, ID code MM (GS … GE)Transaction set 500 (ST … SE)HEADINGBGNBeginning Segment+ 1 optional loop, starting with:NM1DETAIL+ 1 optional loop, starting with:HLBlue box: required loop. Optional loops are listedby the segment that starts them; when a loop isused, that first segment is required. Optionalsegments outside loops are not drawn.Structure: required segments and loops in the X12008010 listing for the 500. Your trading partner'simplementation guide adds its own requirements.

How to read this diagram: the top row shows who sends the 500, to whom, and which documents usually come before and after it. The lower part shows what X12 release 008010 itself requires: the envelopes around the 500 and the segments and loops the standard marks as required, area by area. Optional loops are listed by the segment that starts them rather than drawn in full. This is the standard's minimum, not a trading partner's requirement: each partner's implementation guide usually makes some optional loops mandatory, restricts the codes and may use a different release.

Expand diagram Download SVG

When it is used

  • Reporting adverse drug reactions
  • Reporting medical device malfunctions
  • Submitting periodic safety reports

Where it fits in the document flow

This document 500 Medical Event Reporting
Usually followed by 997 Functional Acknowledgment

Structure

Mandatory segments in the 500 (X12 release 008010)

The segments X12 release 008010 marks as mandatory at their level, in order. Segments inside optional loops are needed only when the loop is used. This is the standard's requirement, not your trading partner's: each partner's implementation guide names the release it uses, adds the optional segments it requires and restricts the values. The requirement status comes from one published X12 reference listing and has not been checked against a second source.

  • ST
  • BGN
  • NM1
  • LM
  • LQ
  • HL
  • LIN
  • QTY
  • PID
  • MTX
  • SE

Practical example

The 500 in practice

A hospital's biomedical team finds that an infusion pump delivered an incorrect dose. The device manufacturer is informed and files a report with the regulator describing the device, the event, the patient outcome and its investigation. The regulator adds the report to its safety database.

Implementation

Implementation considerations for the 500

  • Confirm the reporting format each regulator requires.
  • Meet the mandatory reporting deadlines for each event.
  • Protect patients' personal data under applicable law.
  • Follow up initial reports with investigation results.

How ECOM helps

Automate the 500 with ECOM

Industry

Healthcare

Secure B2B integration and file transfer for providers, suppliers, distributors and healthcare partners.

Industry

Pharmaceuticals

Orders, ship notices, chargebacks and sales data exchange for pharma manufacturers and distributors.

Solution

EDI Integration

Exchange X12 and EDIFACT documents with partners and integrate them directly with your ERP.

More general questions about EDI are answered in the EDI FAQ.

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