oddb2xml 3.0.6 → 3.0.8

checksums.yaml

@@ -1,7 +1,7 @@
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data/CLAUDE.md

@@ -47,7 +47,7 @@ The system follows a **download → extract → build → compress** pipeline:
 
 6. **Compressor** (`lib/oddb2xml/compressor.rb`) — Optional ZIP/TAR.GZ output compression.
 
-7. **FHIR support** (`lib/oddb2xml/fhir_support.rb`) — Self-contained module providing `FhirDownloader` and FHIR NDJSON parsing. Activated via `--fhir` (or `--fhir-url=<URL>`). Downloads per-language NDJSON files (`foph-sl-export-latest-{de,fr,it}.ndjson`) from `epl.bag.admin.ch` to populate French and Italian product names/descriptions. Maps legal status codes `756005022007` and `756005022008` to Swissmedic category D.
+7. **FHIR support** (`lib/oddb2xml/fhir_support.rb`) — Self-contained module providing `FhirDownloader` and FHIR NDJSON parsing. Activated via `--fhir` (or `--fhir-url=<URL>`). Downloads per-language NDJSON files (`foph-sl-export-latest-{de,fr,it}.ndjson`) from `epl.bag.admin.ch` to populate French and Italian product names/descriptions. Maps legal status codes `756005022007` and `756005022008` to Swissmedic category D. Parses `ClinicalUseDefinition` resources and combines each indication's `.NN` id-suffix with the reimbursement RA's `FOPHDossierNumber` to construct the BAG **Indikationscode** (`XXXXX.NN`); exposed as `item[:indication_codes]` and per-package `:indication_codes` (each entry a `{code:, cud_id:, text:}` hash). From 3.0.7 onwards, `Builder#build_product` emits one `<INDICATION_CODE code="XXXXX.NN" cud_id="DRUG.NN">limitation text</INDICATION_CODE>` child per indication on every `<PRD>` in `oddb_product.xml`; live feed numbers: 539 products / 1,293 codes / 100 % with non-empty indication text. Mandatory on prescriptions/invoices for SL price-model drugs from 2026-07-01 — see issue [#113](https://github.com/zdavatz/oddb2xml/issues/113). **Limitation texts** (3.0.8 onwards): the `regulatedAuthorization-limitation` extension has no inline `limitationText` in the live BAG feed — it carries a `limitationIndication` reference to a `ClinicalUseDefinition` whose `indication.diseaseSymptomProcedure.concept.text` is the actual text. The parser stores the ref as `cud_ref` on each Limitation, `Bundle#cud_text_by_id` resolves DE, and `merge_language` propagates FR/IT from the per-language NDJSON files via the same CUD id. Coverage on the live feed jumped from 0 / 9'108 to 9'108 / 9'108 (issue [#116](https://github.com/zdavatz/oddb2xml/issues/116)).
 
 8. **Refdata cleanup** (`lib/oddb2xml/refdata_cleanup.rb`) — Compensates for known data-quality issues in upstream Refdata.Articles.xml before they reach the output. Each fix is guarded by a Swissmedic-side heuristic (e.g. comma in `substance_swissmedic` to distinguish mono products from real combinations). Currently fixes the doubled-dose template bug (`X mg / X mg / Stk`). Called from `Builder#apply_refdata_description_cleanups!` at the start of `prepare_articles`. See GitHub issue #112 for the catalogue.
 

data/Gemfile.lock

@@ -1,7 +1,7 @@
 PATH
   remote: .
   specs:
-    oddb2xml (3.0.6)
+    oddb2xml (3.0.8)
       csv
       htmlentities
       httpi
@@ -27,7 +27,7 @@ PATH
 GEM
   remote: https://rubygems.org/
   specs:
-    addressable (2.8.8)
+    addressable (2.9.0)
       public_suffix (>= 2.0.2, < 8.0)
     akami (1.3.3)
       base64
@@ -59,7 +59,7 @@ GEM
       rack
       socksify
     io-console (0.8.2)
-    json (2.18.1)
+    json (2.19.5)
     language_server-protocol (3.17.0.5)
     lint_roller (1.1.0)
     logger (1.7.0)
@@ -116,7 +116,7 @@ GEM
       pry (~> 0.11)
       yard (~> 0.9.21)
     psych (3.3.4)
-    public_suffix (7.0.2)
+    public_suffix (7.0.5)
     racc (1.8.1)
     rack (3.2.6)
     rainbow (3.1.1)
@@ -210,7 +210,7 @@ GEM
     webrobots (0.1.2)
     xml-simple (1.1.9)
       rexml
-    yard (0.9.38)
+    yard (0.9.43)
 
 PLATFORMS
   arm64-darwin-25

data/History.txt

@@ -1,3 +1,9 @@
+=== 3.0.8 / 28.05.2026
+* FHIR: fix empty <DescriptionDe/Fr/It> on every <Limitation>. The live BAG FHIR feed does not carry limitation text inline; it stores a `limitationIndication` reference to a `ClinicalUseDefinition` whose `indication.diseaseSymptomProcedure.concept.text` holds the actual text (one per language). FR/IT come from the per-language NDJSON files and are merged via the CUD id. Result on the live feed: 9'108 / 9'108 limitations (100%) now carry text, up from 0% (issue #116).
+
+=== 3.0.7 / 06.05.2026
+* oddb_product.xml: emit one <INDICATION_CODE code="XXXXX.NN" cud_id="DRUG.NN">limitation text</INDICATION_CODE> child per indication on each <PRD>. Source: FHIR ClinicalUseDefinition resources joined with the reimbursement RegulatedAuthorization's FOPHDossierNumber. Counted on the live FOPH feed: 539 products carry a total of 1,293 codes; all have non-empty indication text. Resolves the missing wiring between FhirExtractor and Builder noted in 3.0.6 (issue #113).
+
 === 3.0.6 / 06.05.2026
 * FHIR: extract Indikationscode (XXXXX.NN) from ClinicalUseDefinition resources by combining FOPHDossierNumber with each CUD's .NN id-suffix; expose as item[:indication_codes] (and per package) so downstream builders can include it on prescriptions and invoices as required by BAG from 2026-07-01 (issue #113)
 * Declare csv as a runtime dependency in the gemspec (csv was removed from Ruby's default gems in 3.4)

data/README.md

@@ -51,7 +51,7 @@ HIN (http://hin.ch) creates daily the actual file. They can be downloaded from `
 see `--help`.
 
 ```
-    /opt/src/oddb2xml/bin/oddb2xml version 3.0.5
+    /opt/src/oddb2xml/bin/oddb2xml version 3.0.8
     Usage:
     oddb2xml [option]
       produced files are found under data
@@ -292,6 +292,67 @@ We use the following files:
 * https://epl.bag.admin.ch/static/fhir/foph-sl-export-latest-{de,fr,it}.ndjson (FHIR NDJSON, used with `--fhir`)
 * https://id.gs1.ch/01/07612345000961 (GS1 Switzerland firstbase CSV — full barcode registry, used with `-b`/`--firstbase`)
 
+## Indikationscode (BAG XXXXX.NN)
+
+In `--fhir` mode, oddb2xml extracts the BAG **Indikationscode** for SL
+price-model drugs and emits one repeated `<INDICATION_CODE>` child per
+indication on each `<PRD>` in `oddb_product.xml`:
+
+```xml
+<PRD DT="...">
+  <GTIN>7680123456789</GTIN>
+  ...
+  <INDICATION_CODE code="20403.01" cud_id="CYRAMZA.01">In Kombination mit Paclitaxel für die Behandlung ...</INDICATION_CODE>
+  <INDICATION_CODE code="20403.02" cud_id="CYRAMZA.02">In Kombination mit FOLFIRI ...</INDICATION_CODE>
+  <PackGrSwissmedic>...</PackGrSwissmedic>
+</PRD>
+```
+
+The code is built per FHIR bundle by combining the
+`FOPHDossierNumber` from the reimbursement `RegulatedAuthorization`
+(`XXXXX`) with the `.NN` suffix of each sibling
+`ClinicalUseDefinition` whose `type == "indication"` (e.g.
+`CYRAMZA.01` / `CYRAMZA.02` → `20403.01` / `20403.02`).  The element
+body carries the human-readable indication text from
+`indication.diseaseSymptomProcedure.concept.text`.
+
+The same data is also exposed in-memory on each item and package as
+`item[:indication_codes]` (an array of `{code:, cud_id:, text:}`
+hashes) for downstream consumers that build their own emitters.
+
+Counted on the live FOPH feed (`foph-sl-export-latest-de.ndjson`,
+6'775 bundles): **539** products carry a total of **1'293** codes.
+
+Per BAG Rundschreiben vom 19. Februar 2026, the Indikationscode must
+be transmitted with every prescription and invoice for SL price-model
+drugs from **2026-07-01**; from **2027-01-01** insurers may reject
+invoices without it. See issue
+[#113](https://github.com/zdavatz/oddb2xml/issues/113).
+
+## Limitation texts in `--fhir` mode
+
+In 3.0.8 we fixed empty `<DescriptionDe/Fr/It>` on every `<Limitation>`
+in the FHIR-built output. The live BAG FHIR feed does **not** carry
+limitation text inline on the `regulatedAuthorization-limitation`
+extension. Instead the extension holds a `limitationIndication`
+reference to a `ClinicalUseDefinition` whose
+`indication.diseaseSymptomProcedure.concept.text` is the actual text:
+
+```
+RegulatedAuthorization/65839
+  └─ indication.extension[limitation]
+       ├─ status, statusDate, period, firstLimitationDate
+       └─ limitationIndication → ClinicalUseDefinition/NORDIMET
+                                  └─ concept.text = "Wird nicht ..."
+```
+
+The CUDs are identical in `id` across the three per-language NDJSON
+files (`foph-sl-export-latest-{de,fr,it}.ndjson`); only the
+`concept.text` differs. `FhirExtractor` resolves DE from the primary
+file and merges FR/IT in via the same CUD id. Coverage on the live
+feed went from 0 / 9'108 to 9'108 / 9'108 (100 %). See issue
+[#116](https://github.com/zdavatz/oddb2xml/issues/116).
+
 ## Refdata data-quality compensation
 
 Refdata.Articles.xml from `files.refdata.ch` ships with a number of recurring

data/lib/oddb2xml/builder.rb

@@ -780,6 +780,14 @@ module Oddb2xml
               # xml.REMD
               # xml.REMF
               # }
+              # BAG Indikationscode (XXXXX.NN) for SL price-model drugs.
+              # Mandatory on prescriptions/invoices from 2026-07-01 — see
+              # GitHub issue #113.
+              if seq && seq[:indication_codes].is_a?(Array)
+                seq[:indication_codes].each do |ic|
+                  xml.INDICATION_CODE ic[:text].to_s, code: ic[:code], cud_id: ic[:cud_id]
+                end
+              end
               xml.PackGrSwissmedic obj[:siz] unless obj[:siz].empty?
               xml.EinheitSwissmedic obj[:eht] unless obj[:eht].empty?
               xml.SubstanceSwissmedic obj[:sub] unless obj[:sub].empty?

data/lib/oddb2xml/fhir_support.rb

@@ -167,6 +167,16 @@ module Oddb2xml
         parse_entries
       end
 
+      # Lookup map: CUD id (e.g. "NORDIMET" or "GLIVEC.01") => indication text.
+      # Used to resolve limitation texts that are stored as a reference on
+      # the RegulatedAuthorization rather than inline.
+      def cud_text_by_id
+        @cud_text_by_id ||= @clinical_use_definitions.each_with_object({}) do |cud, acc|
+          next unless cud.id && cud.text
+          acc[cud.id] = cud.text
+        end
+      end
+
       private
 
       def parse_entries
@@ -383,7 +393,11 @@ module Oddb2xml
           when "statusDate"
             limitation[:status_date] = sub_ext["valueDate"]
           when "limitationText"
+            # Not present in the live FHIR feed — kept for forward-compat.
             limitation[:text] = sub_ext["valueString"]
+          when "limitationIndication"
+            ref = sub_ext.dig("valueReference", "reference")
+            limitation[:cud_ref] = ref&.sub(%r{\A.*ClinicalUseDefinition/}, "")
           when "period"
             limitation[:start_date] = sub_ext.dig("valuePeriod", "start")
             limitation[:end_date] = sub_ext.dig("valuePeriod", "end")
@@ -467,11 +481,15 @@ module Oddb2xml
 
           # Find prices and additional data for this package
           pack.Prices = create_prices_for_package(bundle, pkg)
-          
+
           # Add limitations and cost share
           pack.Limitations = create_limitations_for_package(bundle, pkg)
           pack.CostShare = get_cost_share_for_package(bundle, pkg)
 
+          # Per-language CUD text map so merge_language can fill in
+          # DescriptionFr / DescriptionIt for limitations without re-parsing.
+          pack.CudTextById = bundle.cud_text_by_id
+
           pack
         end
 
@@ -533,23 +551,32 @@ module Oddb2xml
 
         return nil unless reimbursement
         return nil if reimbursement.limitations.empty?
-        
+
+        cud_texts = bundle.cud_text_by_id
+
         # Convert FHIR limitations to OpenStruct format
         limitations = OpenStruct.new
         limitations.Limitation = reimbursement.limitations.map do |lim|
+          # The actual limitation text lives in the referenced
+          # ClinicalUseDefinition (limitationIndication reference) — the
+          # `limitationText` sub-extension is absent in the live BAG feed.
+          cud_ref = lim[:cud_ref]
+          text_de = lim[:text] || (cud_ref && cud_texts[cud_ref]) || ""
+
           limitation = OpenStruct.new
           limitation.LimitationCode = ""  # Not in FHIR
           limitation.LimitationType = ""  # Could derive from status
           limitation.LimitationNiveau = ""  # Not in FHIR
           limitation.LimitationValue = ""  # Not in FHIR
-          limitation.DescriptionDe = lim[:text] || ""
-          limitation.DescriptionFr = ""  # May need separate language version
-          limitation.DescriptionIt = ""  # May need separate language version
+          limitation.LimitationCudRef = cud_ref  # carried through for FR/IT resolution
+          limitation.DescriptionDe = text_de
+          limitation.DescriptionFr = ""  # filled by merge_language from FR bundle
+          limitation.DescriptionIt = ""  # filled by merge_language from IT bundle
           limitation.ValidFromDate = lim[:status_date] || lim[:start_date] || ""
           limitation.ValidThruDate = lim[:end_date] || ""
           limitation
         end
-        
+
         limitations
       end
       
@@ -751,6 +778,7 @@ module Oddb2xml
                   desc_de: lim.DescriptionDe || "",
                   desc_fr: lim.DescriptionFr || "",
                   desc_it: lim.DescriptionIt || "",
+                  cud_ref: lim.LimitationCudRef,
                   vdate: lim.ValidFromDate || "",
                   del: is_deleted
                 }
@@ -796,6 +824,7 @@ module Oddb2xml
       name_accessor = "Name#{lang.capitalize}"
       name_key = "name_#{lang}".to_sym
       desc_key = "desc_#{lang}".to_sym
+      lim_desc_key = "desc_#{lang}".to_sym
 
       result.Preparations.Preparation.each do |seq|
         next unless seq && seq.Packs && seq.Packs.Pack
@@ -822,6 +851,19 @@ module Oddb2xml
           if desc && !desc.empty? && item[:packages][ean13]
             item[:packages][ean13][desc_key] = desc
           end
+
+          # Resolve FR/IT limitation texts via the CUD reference captured
+          # during the DE pass. The CUD id (e.g. "NORDIMET") is identical
+          # across languages; only the text differs.
+          pkg_entry = item[:packages][ean13]
+          cud_texts = pac.respond_to?(:CudTextById) ? pac.CudTextById : nil
+          if pkg_entry && cud_texts && pkg_entry[:limitations]
+            pkg_entry[:limitations].each do |lim|
+              ref = lim[:cud_ref]
+              text = ref && cud_texts[ref]
+              lim[lim_desc_key] = text if text && !text.empty?
+            end
+          end
         end
       end
     end

data/lib/oddb2xml/version.rb

@@ -1,3 +1,3 @@
 module Oddb2xml
-  VERSION = "3.0.6"
+  VERSION = "3.0.8"
 end

data/spec/fhir_spec.rb

@@ -1,7 +1,10 @@
 require "spec_helper"
+require "json"
+require "tempfile"
 require "oddb2xml/downloader"
 require "oddb2xml/extractor"
 require "oddb2xml/fhir_support"
+require "oddb2xml/builder"
 
 describe "FHIR Indikationscode support" do
   let(:cyramza_fixture) { File.join(Oddb2xml::SpecData, "fhir", "cyramza.ndjson") }
@@ -50,4 +53,121 @@ describe "FHIR Indikationscode support" do
       expect(pkg[:indication_codes]).to eq(item[:indication_codes])
     end
   end
+
+  describe Oddb2xml::FhirExtractor, "limitation text resolution" do
+    # Build language-variant copies of the Cyramza fixture in-memory:
+    # the live FHIR feed never stores limitation text inline, only a
+    # reference to a ClinicalUseDefinition whose `concept.text` differs
+    # per language. We translate the CUD text + MPD product name and
+    # write the modified bundle to a Tempfile so the multi-language
+    # path can be exercised end-to-end.
+    def language_variant(source_path, lang_code, cud_texts, product_name)
+      bundle = JSON.parse(File.read(source_path))
+      bundle["entry"].each do |entry|
+        res = entry["resource"]
+        case res["resourceType"]
+        when "MedicinalProductDefinition"
+          res["name"].each do |name|
+            usage = name.dig("usage", 0, "language", "coding", 0)
+            usage["code"] = lang_code if usage
+            name["productName"] = product_name
+          end
+        when "ClinicalUseDefinition"
+          text = cud_texts[res["id"]]
+          if text
+            res["indication"]["diseaseSymptomProcedure"]["concept"]["text"] = text
+          end
+        end
+      end
+      file = Tempfile.new(["cyramza-#{lang_code}", ".ndjson"])
+      file.write(JSON.generate(bundle))
+      file.flush
+      file
+    end
+
+    let(:fr_file) do
+      language_variant(
+        cyramza_fixture, "fr-CH",
+        {
+          "CYRAMZA.01" => "FR limitation pour CYRAMZA.01",
+          "CYRAMZA.02" => "FR limitation pour CYRAMZA.02"
+        },
+        "Cyramza FR"
+      )
+    end
+
+    let(:it_file) do
+      language_variant(
+        cyramza_fixture, "it-CH",
+        {
+          "CYRAMZA.01" => "IT limitazione per CYRAMZA.01",
+          "CYRAMZA.02" => "IT limitazione per CYRAMZA.02"
+        },
+        "Cyramza IT"
+      )
+    end
+
+    after do
+      [fr_file, it_file].each do |f|
+        f.close
+        f.unlink
+      end
+    end
+
+    it "fills DescriptionDe from the referenced ClinicalUseDefinition" do
+      data = described_class.new(cyramza_fixture).to_hash
+      pkg = data.values.first[:packages].values.first
+      texts = pkg[:limitations].map { |l| l[:desc_de] }
+      expect(texts).to include(start_with("In Kombination mit Paclitaxel"))
+      expect(texts).to include(start_with("In Kombination mit FOLFIRI"))
+      # CUD reference is carried through so merge_language can resolve FR/IT.
+      expect(pkg[:limitations].map { |l| l[:cud_ref] }).to include("CYRAMZA.01", "CYRAMZA.02")
+    end
+
+    it "fills DescriptionFr / DescriptionIt from the language-specific bundles" do
+      files = {"de" => cyramza_fixture, "fr" => fr_file.path, "it" => it_file.path}
+      data = described_class.new(files).to_hash
+      pkg = data.values.first[:packages].values.first
+
+      by_ref = pkg[:limitations].each_with_object({}) { |l, h| h[l[:cud_ref]] = l }
+
+      expect(by_ref["CYRAMZA.01"][:desc_fr]).to eq("FR limitation pour CYRAMZA.01")
+      expect(by_ref["CYRAMZA.02"][:desc_fr]).to eq("FR limitation pour CYRAMZA.02")
+      expect(by_ref["CYRAMZA.01"][:desc_it]).to eq("IT limitazione per CYRAMZA.01")
+      expect(by_ref["CYRAMZA.02"][:desc_it]).to eq("IT limitazione per CYRAMZA.02")
+      # DE text is still there.
+      expect(by_ref["CYRAMZA.01"][:desc_de]).to start_with("In Kombination mit Paclitaxel")
+    end
+  end
+
+  describe Oddb2xml::Builder, "PRD INDICATION_CODE emission" do
+    it "emits one <INDICATION_CODE> child per indication on the PRD" do
+      items = Oddb2xml::FhirExtractor.new(cyramza_fixture).to_hash
+      builder = described_class.new
+      builder.instance_variable_set(:@items, items)
+      builder.instance_variable_set(:@refdata, {})
+      builder.instance_variable_set(:@packs, {})
+      builder.instance_variable_set(:@migel, {})
+      builder.instance_variable_set(:@interactions, [])
+      builder.instance_variable_set(:@flags, {})
+      builder.instance_variable_set(:@orphan, [])
+      builder.instance_variable_set(:@firstbase, {})
+      builder.instance_variable_set(:@substances, [])
+      builder.instance_variable_set(:@codes, {})
+      builder.instance_variable_set(:@missing, [])
+      builder.instance_variable_set(:@tag_suffix, nil)
+
+      xml = builder.send(:build_product)
+      expect(xml).to include("<INDICATION_CODE")
+      expect(xml).to include('code="20403.01"')
+      expect(xml).to include('code="20403.02"')
+      expect(xml).to include('cud_id="CYRAMZA.01"')
+      expect(xml).to include('cud_id="CYRAMZA.02"')
+      # The CUD's indication text travels into the element body so
+      # downstream consumers can show the human-readable indication
+      # next to the code.
+      expect(xml).to include("In Kombination mit Paclitaxel")
+      expect(xml).to include("In Kombination mit FOLFIRI")
+    end
+  end
 end

metadata

@@ -1,7 +1,7 @@
 --- !ruby/object:Gem::Specification
 name: oddb2xml
 version: !ruby/object:Gem::Version
-  version: 3.0.6
+  version: 3.0.8
 platform: ruby
 authors:
 - Yasuhiro Asaka, Zeno R.R. Davatz, Niklaus Giger