Data Set International Patient Summary

ID: 2.16.840.1.113883.3.1937.777.13.1.1Version Label: 2018-08-29T11:43:19Concepts: 73 (Groups: 20 - Items: 53)

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Name ID[‑] Datatype[‑] Property[‑] Example[‑] Codes[‑] Description[‑] Source[‑] Rationale[‑] Operationalizations[‑] Comment[‑] Terminology[‑] Value Set[‑] Type[‑] Parent concept[‑] Inherit from[‑]
Common fragments hl7ips-dataelement-1.49 Collect information fragments that are reused across different sections / entries
      		Group
      Source of information hl7ips-dataelement-1.15 Collection of data Record who is the source of this information.
      This is important for the evaluation of the trustworthiness.

      For example the GP reports in the IPS that the patient asserts to have an allergy to nuts, might be different by the case in which the GP reports that there are evidences of allergy to nuts.


      NOTE: added for discussion
          		Item Common fragments
          Immunizations (Vaccinations) hl7ips-dataelement-1.59
              		Group
              Problem List hl7ips-dataelement-1.60
                  		Group
                  Problem hl7ips-dataelement-1.65
                      		Group Problem List
                      No known problems hl7ips-dataelement-1.66 Code
                          		Item Problem
                          Onset Date hl7ips-dataelement-1.70 Date
                          • Timestamp precision: at least year (YYYY)
                          		 Date of the first observation of adverse reactions SPECIFIC GUIDELINES FOR ELECTRONIC EXCHANGE OF HEALTH DATA UNDER THE CROSS-BORDER DIRECTIVE 2011/24/EU RELEASE 2 PATIENT SUMMARY FOR UNSCHEDULED CARE
                              		Item Problem hl7ips-dataelement-1.5
                              End date hl7ips-dataelement-1.71 Count
                              • Timestamp precision: at least day (DD), month (MM) and year (YYYY)
                              		 Problem resolution date
                                  		Item Problem
                                  Problem Code hl7ips-dataelement-1.72 Code Code identifying the problem (or more in general the condition)
                                      		Item Problem
                                      Problem status hl7ips-dataelement-1.73 Code
                                            		Item Problem
                                            Certainty hl7ips-dataelement-1.68 Code Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance
                                                		Item Problem hl7ips-dataelement-1.62
                                                Severity hl7ips-dataelement-1.69 Code A subjective assessment of the severity of the condition as evaluated by the clinician.
                                                    		Item Problem hl7ips-dataelement-1.67
                                                    No infos about conditions hl7ips-dataelement-1.64 Collection of data
                                                          		Item Problem List
                                                          History of Procedures hl7ips-dataelement-1.61
                                                              		Group
                                                              List of Allergies or Intolerances hl7ips-dataelement-1.13 It documents the relevant allergies or intolerances (conditions) for that patient, describing the kind of reaction (e.g. rush, anaphylaxis,..) and the agents (or classes of agents) that cause it.
                                                              If no information about allergies are available, or if no allergies are known this should be clearly documented in the section.
                                                                  		Group
                                                                  No infos about Allergies/Intolerances hl7ips-dataelement-1.52 Code This case describes the case in which information is not available (for any reason) to allow the assertion "no known allergies/intolerances" 
                                                                      		Item List of Allergies or Intolerances
                                                                      Allergy or Intolerance hl7ips-dataelement-1.4 Allergy or Intollerance
                                                                          		Group List of Allergies or Intolerances
                                                                          Criticality hl7ips-dataelement-1.63 Code
                                                                              		Item Allergy or Intolerance
                                                                              Certainty hl7ips-dataelement-1.62 Code Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance
                                                                                  		Item Allergy or Intolerance
                                                                                  No known Allergies/Intolerances hl7ips-dataelement-1.51 Code
                                                                                  • No known allergies or intolerances (No known propensity to adverse reactions)
                                                                                  • No known allergies
                                                                                  • No known intolerances
                                                                                  • GC: Moved under the Allergy entry in order to give the possibility to record who is the source of information that asserts this
                                                                                    		Item Allergy or Intolerance
                                                                                    Source of information hl7ips-dataelement-1.50 Collection of data Record who is the source of this information.
                                                                                    This is important for the evaluation of the trustworthiness.

                                                                                    For example the GP reports in the IPS that the patient asserts to have an allergy to nuts, might be different by the case in which the GP reports that there are evidences of allergy to nuts.


                                                                                    NOTE: added for discussion
                                                                                        		Item Allergy or Intolerance hl7ips-dataelement-1.15
                                                                                        Type hl7ips-dataelement-1.10 Code
                                                                                        • Allergy or Intolerance (Propensity to adverse reactions)
                                                                                        • Allergy
                                                                                        • Intolerance
                                                                                        		 Type of allergy or intolerance: e.g. allergy, intolerance, propensity to adverse reaction. ProposedCDA: single data element that combines kind of allergy and category of allergen FHIR: two distinct elements
                                                                                        • In this version of the data set the kind of propensity has been distinguished form the associated agent category, even though implementations might represent them with a unique element that convey suitable combined terms (e.g. allergy to drug).
                                                                                          		Item Allergy or Intolerance
                                                                                          Description hl7ips-dataelement-1.6 Text A textual description of the adverse reaction
                                                                                              		Item Allergy or Intolerance
                                                                                              Onset Date hl7ips-dataelement-1.5 Date
                                                                                              • Timestamp precision: at least year (YYYY)
                                                                                              		 Date of the first observation of adverse reactions SPECIFIC GUIDELINES FOR ELECTRONIC EXCHANGE OF HEALTH DATA UNDER THE CROSS-BORDER DIRECTIVE 2011/24/EU RELEASE 2 PATIENT SUMMARY FOR UNSCHEDULED CARE
                                                                                                  		Item Allergy or Intolerance
                                                                                                  Agent hl7ips-dataelement-1.1 The substance  (drug, food, chemical agent, etc.) that is responsible for the adverse reaction  eHealth DSI CDA Implementation Guide [Europe]
                                                                                                  • Clarify how to deal with adverse reactions to non-substances (sunlight) : e.g. consider them as a kind of substance ?
                                                                                                    		Group Allergy or Intolerance
                                                                                                    Category hl7ips-dataelement-1.55 Code
                                                                                                    • food
                                                                                                    • drug
                                                                                                    • animal
                                                                                                    • vegetable
                                                                                                    • environmental
                                                                                                    		 Kind of allergen: e.g. food; drug; environment;... Proposed CDA: single data element that combines kind of allergy and category of allergen  FHIR: two distinct elements
                                                                                                    • In this version of the data set the kind of propensity has been distinguished form the associated agent category, even though implementations might represent them with a unique element that convey suitable combined terms (e.g. allergy to drug).
                                                                                                      		Item Agent
                                                                                                      Agent code hl7ips-dataelement-1.3 Code
                                                                                                          		Item Agent
                                                                                                          Agent description hl7ips-dataelement-1.2 String Describes the agent (drug, food, chemical agent, etc) that is responsible for the adverse reaction
                                                                                                              		Item Agent
                                                                                                              Adverse Reaction Manifestation hl7ips-dataelement-1.7 Description of the clinical manifestation of the allergic reaction [Example: anaphylactic shock, angioedema (the clinical manifestation also gives information about the severity of the observed reaction) EU Guidelines 
                                                                                                                  		Group Allergy or Intolerance
                                                                                                                  Severity hl7ips-dataelement-1.67 Code A subjective assessment of the severity of the condition as evaluated by the clinician.
                                                                                                                      		Item Adverse Reaction Manifestation
                                                                                                                      Reaction Description hl7ips-dataelement-1.8 String
                                                                                                                          		Item Adverse Reaction Manifestation
                                                                                                                          Reaction Code hl7ips-dataelement-1.9 Count
                                                                                                                              		Item Adverse Reaction Manifestation
                                                                                                                              Medication Summary hl7ips-dataelement-1.12 List of the relevant medicines that have, or are planned to be, administered for that patient.
                                                                                                                              Depending on the jurisdiction this information can be derived from prescribed or dispensed medicines.                                                                                                                              		 SPECIFIC GUIDELINES FOR ELECTRONIC EXCHANGE OF HEALTH DATA UNDER THE CROSS-BORDER DIRECTIVE 2011/24/EU RELEASE 2 PATIENT SUMMARY FOR UNSCHEDULED CARE"List of current medicines (All prescribed medicines whose period of time indicated  for the treatment has not yet expired whether it has been dispensed or not)"
                                                                                                                                  		Group
                                                                                                                                  No infos about Medications hl7ips-dataelement-1.54 Code
                                                                                                                                      		Item Medication Summary
                                                                                                                                      Medication Statement hl7ips-dataelement-1.11
                                                                                                                                          		Group Medication Summary
                                                                                                                                          No known Medications hl7ips-dataelement-1.53 Code
                                                                                                                                          • GC: Moved under the Allergy entry in order to give the possibility to record who is the source of information that asserts this
                                                                                                                                            		Item Medication Statement
                                                                                                                                            Source of information hl7ips-dataelement-1.16 Collection of data Record who is the source of this information.
                                                                                                                                            This is important for the evaluation of the trustworthiness.

                                                                                                                                            For example the GP reports in the IPS that the patient asserts to have an allergy to nuts, might be different by the case in which the GP reports that there are evidences of allergy to nuts.


                                                                                                                                            NOTE: added for discussion
                                                                                                                                                		Item Medication Statement hl7ips-dataelement-1.15
                                                                                                                                                Duration of treatment hl7ips-dataelement-1.19 Quantity during 14 days Likely derived from the onset and end dates ?What about  continuous therapy ?
                                                                                                                                                • There has to be space for posology in free text with the possibility of a null flavor
                                                                                                                                                  		Item Medication Statement
                                                                                                                                                  Date of onset of treatment hl7ips-dataelement-1.20 Date/time Date when patient needs to start taking the medicine prescribed
                                                                                                                                                      		Item Medication Statement
                                                                                                                                                      Medicine Information hl7ips-dataelement-1.21
                                                                                                                                                          		Group Medication Statement
                                                                                                                                                          Product Code hl7ips-dataelement-1.58 Code A code identifying the medicine. 
                                                                                                                                                          • To be clarified if at this level we need to distiguish among the different types of "products" : e.g. packaged products; medicinal product; class of products; pharmaceutical products;...
                                                                                                                                                            		Item Medicine Information
                                                                                                                                                            IDMP Identifiers hl7ips-dataelement-1.40
                                                                                                                                                            • For future consideration
                                                                                                                                                              		Group Medicine Information
                                                                                                                                                              PCID hl7ips-dataelement-1.43 Identifier Medicinal Product Package Identifier: unique identifier allocated to a packaged Medicinal Product supplementary to any existing authorization number
                                                                                                                                                              as ascribed by a Medicines Regulatory Agency in a jurisdiction
                                                                                                                                                              NOTE This is for indexing purposes and to contribute to improving patient safety by allowing for the unique Identification
                                                                                                                                                              of Medicinal Products worldwide
                                                                                                                                                                  		Item IDMP Identifiers
                                                                                                                                                                  MPID hl7ips-dataelement-1.42 Identifier
                                                                                                                                                                    		Medicinal Product Identifier : unique identifier allocated to a Medicinal Product supplementary to any existing authorization number as
                                                                                                                                                                    ascribed by a Medicines Regulatory Agency in a jurisdiction
                                                                                                                                                                    NOTE This is for indexing purposes and to contribute to improved patient safety by allowing for the unique Identification
                                                                                                                                                                    of Medicinal Products worldwide.
                                                                                                                                                                    		 ISO 11615:2012
                                                                                                                                                                        		Item IDMP Identifiers
                                                                                                                                                                        PhPID Set hl7ips-dataelement-1.41 The PhPIDs are globally unique identifiers assigned to the pharmaceutical product(s).

                                                                                                                                                                        PhPIDs shall be represented within two strata (active substance stratum and specified substance stratum), both of
                                                                                                                                                                        which contain four PhPID identification levels, for each pharmaceutical product contained in a medicinal product.
                                                                                                                                                                        		 ISO 11616:2012
                                                                                                                                                                        • For the purpose of this document only the 4 PhpID of the PhPID Active Substance Stratum will be considered.
                                                                                                                                                                          		Group IDMP Identifiers
                                                                                                                                                                          PhPID (SUB_L1) hl7ips-dataelement-1.44 Identifier
                                                                                                                                                                          PhPID Active Substance Stratumn Level 1. It identifies the Substance(s)
                                                                                                                                                                          e.g. "pioglitazone + metformin"
                                                                                                                                                                              		Item PhPID Set
                                                                                                                                                                              PhPID (SUB_L2) hl7ips-dataelement-1.45 Identifier

                                                                                                                                                                              PhPID Active Substance Stratumn Level 2.
                                                                                                                                                                              It identifies Substance Term(s), Strength and Reference Strength
                                                                                                                                                                              e.g. pioglitazone 15 mg + metformin 850 mg
                                                                                                                                                                                  		Item PhPID Set
                                                                                                                                                                                  PhPID (SUB_L3) hl7ips-dataelement-1.46 Identifier PhPID Active Substance Stratum Level 2.
                                                                                                                                                                                  It identifies Substance Term(s) and Administrable Dose Form
                                                                                                                                                                                      		Item PhPID Set
                                                                                                                                                                                      PhPID (SUB_L4) hl7ips-dataelement-1.47 Identifier PhPID Active Substance Stratum Level 4.
                                                                                                                                                                                      It identifies  Substance(s) Term, Strength, Reference Strength and Administrable Dose Form

                                                                                                                                                                                      e.g. "pioglitazone 15 mg + metformin 850 mg capsule"
                                                                                                                                                                                          		Item PhPID Set
                                                                                                                                                                                          Medicine names hl7ips-dataelement-1.35
                                                                                                                                                                                              		Group Medicine Information
                                                                                                                                                                                              Strength (name part) (MPN Strength part) hl7ips-dataelement-1.38 String For the Medicinal Product Name “Drug K Forte Tablets”, the strength name part is “Forte”.; “SoothingMed 2,5 % Cream”, the strength name part is “2,5 %”.
                                                                                                                                                                                              The strength, if reflected in the Medicinal Product Name, shall be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 7.7. The use of decimal points shall be accommodated, if required.

                                                                                                                                                                                              		 ISO IDMP
                                                                                                                                                                                                  		Item Medicine names
                                                                                                                                                                                                  Invented name (trade name) hl7ips-dataelement-1.36 String For the Medicinal Product Name “Drug XYZ® Precisehaler 200 mg for adults” the invented (trade) name part is “Drug XYZ”.
                                                                                                                                                                                                  The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product Name can be specified as text, where applicable.
                                                                                                                                                                                                      		Item Medicine names
                                                                                                                                                                                                      Medicinal Product Name hl7ips-dataelement-1.33 String
                                                                                                                                                                                                      name as authorized by a Medicines Regulatory Agency
                                                                                                                                                                                                      NOTE This may be either an invented name not liable to be confused with the common name, or a common or a scientific name accompanied by a trade mark or any other applicable descriptor
                                                                                                                                                                                                      		 ISO IDMP
                                                                                                                                                                                                          		Item Medicine names
                                                                                                                                                                                                          Scientific name (generic name, common name) hl7ips-dataelement-1.34 String For the Medicinal Product Name “Irbesartan/Hydrochlorothiazide Pharma KK” the common (generic) name part is “Irbesartan/Hydrochlorothiazide”.
                                                                                                                                                                                                          international nonproprietary name recommended by the World Health Organization (WHO), or, if one does not exist, a nonproprietary name recommended by the jurisdiction within which the name is used

                                                                                                                                                                                                          		 ISO IDMP
                                                                                                                                                                                                              		Item Medicine names
                                                                                                                                                                                                              Dose form hl7ips-dataelement-1.32 Count
                                                                                                                                                                                                                Pharmaceutical dose form
                                                                                                                                                                                                                physical manifestation of a Medicinal Product that contains the active ingredient(s) and/or inactive ingredient(s)
                                                                                                                                                                                                                that are intended to be delivered to the patient
                                                                                                                                                                                                                NOTE 1 Dose form, dosage form and pharmaceutical dose form are synonymous.
                                                                                                                                                                                                                NOTE 2 “Pharmaceutical dose form” can refer to the administered dose form or the manufactured dose form.
                                                                                                                                                                                                                		 ISO IDMP
                                                                                                                                                                                                                • Restrict to Administered dose form ?
                                                                                                                                                                                                                  		Group Medicine Information
                                                                                                                                                                                                                  doseform description hl7ips-dataelement-1.57 String
                                                                                                                                                                                                                      		Item Dose form
                                                                                                                                                                                                                      doseform code hl7ips-dataelement-1.56 Code
                                                                                                                                                                                                                            		Item Dose form
                                                                                                                                                                                                                            Substance classifcation (ATC) hl7ips-dataelement-1.24
                                                                                                                                                                                                                                		Group Medicine Information
                                                                                                                                                                                                                                Substance classification (ATC code) hl7ips-dataelement-1.30 Code
                                                                                                                                                                                                                                    		Item Substance classifcation (ATC)
                                                                                                                                                                                                                                    Substance Classification (description) hl7ips-dataelement-1.29 Text
                                                                                                                                                                                                                                        		Item Substance classifcation (ATC)
                                                                                                                                                                                                                                        List of active substances and strengths hl7ips-dataelement-1.22
                                                                                                                                                                                                                                            		Group Medicine Information
                                                                                                                                                                                                                                            Strength (name part) (MPN Strength part) hl7ips-dataelement-1.39 String For the Medicinal Product Name “Drug K Forte Tablets”, the strength name part is “Forte”.; “SoothingMed 2,5 % Cream”, the strength name part is “2,5 %”.
                                                                                                                                                                                                                                            The strength, if reflected in the Medicinal Product Name, shall be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 7.7. The use of decimal points shall be accommodated, if required.

                                                                                                                                                                                                                                            		 ISO IDMP
                                                                                                                                                                                                                                                		Item List of active substances and strengths hl7ips-dataelement-1.38
                                                                                                                                                                                                                                                Scientific name (generic name, common name) hl7ips-dataelement-1.37 String For the Medicinal Product Name “Irbesartan/Hydrochlorothiazide Pharma KK” the common (generic) name part is “Irbesartan/Hydrochlorothiazide”.
                                                                                                                                                                                                                                                international nonproprietary name recommended by the World Health Organization (WHO), or, if one does not exist, a nonproprietary name recommended by the jurisdiction within which the name is used

                                                                                                                                                                                                                                                		 ISO IDMP
                                                                                                                                                                                                                                                    		Item List of active substances and strengths hl7ips-dataelement-1.34
                                                                                                                                                                                                                                                    Active Ingredient and Strength hl7ips-dataelement-1.23
                                                                                                                                                                                                                                                        		Group List of active substances and strengths
                                                                                                                                                                                                                                                        Active Ingredient Name hl7ips-dataelement-1.27 String
                                                                                                                                                                                                                                                            		Item Active Ingredient and Strength
                                                                                                                                                                                                                                                            Strength (text) hl7ips-dataelement-1.28 String
                                                                                                                                                                                                                                                                		Item Active Ingredient and Strength
                                                                                                                                                                                                                                                                Active Ingredient (code) hl7ips-dataelement-1.26 Code
                                                                                                                                                                                                                                                                    		Item Active Ingredient and Strength
                                                                                                                                                                                                                                                                    Strength (quantity) hl7ips-dataelement-1.25 Quantity
                                                                                                                                                                                                                                                                    Content of the substance(s) or specified substance(s), expressed quantitatively per dosage unit, unit of presentation, per unit of volume or mass, according to the dose form
                                                                                                                                                                                                                                                                    • no distinctions between strength and reference strength (see ISO IDMP)
                                                                                                                                                                                                                                                                      		Item Active Ingredient and Strength
                                                                                                                                                                                                                                                                      Dosage Instruction (SIG, Posology) hl7ips-dataelement-1.14
                                                                                                                                                                                                                                                                      • The term Posology seems not to be globally used: which name we can use instead ?
                                                                                                                                                                                                                                                                        		Group Medication Statement
                                                                                                                                                                                                                                                                        Frequency of intakes hl7ips-dataelement-1.48 Quantity each 24 hours Frequency of intakes (per hours/day/month/ week..)
                                                                                                                                                                                                                                                                        • There has to be space for posology in free text with the possibility of a null flavor
                                                                                                                                                                                                                                                                        • There has to be space for posology in free text with the possibility of a null flavor
                                                                                                                                                                                                                                                                          		Item Dosage Instruction
                                                                                                                                                                                                                                                                          Dose (Number of units per intake, Dosage) hl7ips-dataelement-1.18 Quantity
                                                                                                                                                                                                                                                                          • Unit: Unit of Presentation
                                                                                                                                                                                                                                                                          • Unit: UCUM
                                                                                                                                                                                                                                                                          		 1 tablet; 2 puffs; 200 ml
                                                                                                                                                                                                                                                                          Specified quantity of a medicine, to be taken at one time or at stated intervals (ISO IDMP)

                                                                                                                                                                                                                                                                          The number of units per intake that the patient is taking. (EU guidelines)



                                                                                                                                                                                                                                                                          		 PQ requires UCUM, how to deal with unit of presentation ?Approach suggested in epSOS: use the UCUM annotation e.g. {puff}This however doesn't allow to handle translations based on coded data ...
                                                                                                                                                                                                                                                                              		Item Dosage Instruction
                                                                                                                                                                                                                                                                              Description (Free text SIG) hl7ips-dataelement-1.17 Text Textual description of the dosage and frequency of intakes CCDA has a specific closed template for conveying the free text SIG...(2.16.840.1.113883.10.20.22.4.147)
                                                                                                                                                                                                                                                                              • Check if this cooresponds to the Free text SIG
                                                                                                                                                                                                                                                                                		Item Dosage Instruction