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draft Data Set International Patient Summary 2.16.840.1.113883.3.1937.777.13.1.1

Name Id
draft International Patient Summary 2.16.840.1.113883.3.1937.777.13.1.1
Version / effective date Expiration date
2016‑10‑24 11:46:38
Description
This data set is to be minimal and non-exhaustive. It is appreciated that different treatment contexts might require a subset of the defined dataset, or additional data not defined by this standard. However, the contents of the dataset are to be a robust, well defined set of items that are specialty-agnostic, condition-independent but readily usable by all clinicians for the unscheduled care of a patient.
Name Details [‑]
folder draft Common fragments
hl7ips-dataelement-49
Id hl7ips-dataelement-49 (2016‑11‑03 16:48:48)
Description Collect information fragments that are reused across different sections / entries
draft Source of information
hl7ips-dataelement-15
Id hl7ips-dataelement-15 (2016‑10‑28 15:52:25)
Description 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
Value Domain Collection of data
target Used by 0 transactions, 0 templates, inherited 2 times
 
folder draft Immunizations
hl7ips-dataelement-59
Id hl7ips-dataelement-59 (2017‑01‑25 15:34:25)
Synonym
Vaccinations
folder draft Problem List
hl7ips-dataelement-60
Id hl7ips-dataelement-60 (2017‑01‑25 15:34:55)
folder draft Problem
hl7ips-dataelement-65
Id hl7ips-dataelement-65 (2017‑04‑07 10:58:15)
draft No known problems
hl7ips-dataelement-66
Id hl7ips-dataelement-66 (2017‑04‑07 10:58:46)
Value Domain Code
draft Onset Date
hl7ips-dataelement-70
Id hl7ips-dataelement-70 (2017‑04‑07 11:01:21)
Concept inherits from hl7ips-dataelement-5 (2016‑10‑28 12:41:37)
Description Date of the first observation of adverse reactions
Source SPECIFIC GUIDELINES FOR ELECTRONIC EXCHANGE OF HEALTH DATA UNDER THE CROSS-BORDER DIRECTIVE 2011/24/EU  RELEASE 2 PATIENT SUMMARY FOR UNSCHEDULED CARE
Value Domain Date
Property
Timestamp precision
at least year
draft End date
hl7ips-dataelement-71
Id hl7ips-dataelement-71 (2017‑04‑07 11:02:58)
Description Problem resolution date
Relationship
Specialization epsos-dataelement-174 - 2013‑10‑16 14:07:46
Value Domain Count
Value Domain Date
Property
Timestamp precision
at least day, month and year
draft Problem Code
hl7ips-dataelement-72
Id hl7ips-dataelement-72 (2017‑04‑07 11:04:28)
Description Code identifying the problem (or more in general the condition)
Value Domain Code
Value Domain Code
draft Problem status
hl7ips-dataelement-73
Id hl7ips-dataelement-73 (2017‑04‑07 11:06:22)
Value Domain Code
draft Certainty
hl7ips-dataelement-68
Id hl7ips-dataelement-68 (2017‑04‑07 11:00:14)
Concept inherits from hl7ips-dataelement-62 (2017‑02‑21 12:53:42)
Description Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance
Value Domain Code
draft Severity
hl7ips-dataelement-69
Id hl7ips-dataelement-69 (2017‑04‑07 11:00:42)
Concept inherits from hl7ips-dataelement-67 (2017‑04‑07 10:59:33)
Description A subjective assessment of the severity of the condition as evaluated by the clinician.
Value Domain Code
draft No infos about conditions
hl7ips-dataelement-64
Id hl7ips-dataelement-64 (2017‑04‑07 10:57:19)
Value Domain Collection of data
folder draft History of Procedures
hl7ips-dataelement-61
Id hl7ips-dataelement-61 (2017‑01‑25 15:39:43)
folder draft List of Allergies or Intolerances
hl7ips-dataelement-13
Id hl7ips-dataelement-13 (2016‑10‑28 13:42:54)
Description 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.
draft No infos about Allergies/Intolerances
hl7ips-dataelement-52
Id hl7ips-dataelement-52 (2016‑11‑06 17:43:43)
Description This case describes the case in which information is not available (for any reason) to allow the assertion "no known allergies/intolerances" 
Value Domain Count
folder draft Allergy or Intolerance
hl7ips-dataelement-4
Id hl7ips-dataelement-4 (2016‑10‑28 12:37:13)
Description Allergy or Intollerance
draft Criticality
hl7ips-dataelement-63
Id hl7ips-dataelement-63 (2017‑03‑23 10:23:58)
Value Domain Count
draft Certainty
hl7ips-dataelement-62
Id hl7ips-dataelement-62 (2017‑02‑21 12:53:42)
Description Assertion about certainty associated with the propensity, or potential risk, of a reaction to the identified substance
Value Domain Code
target Used by 0 transactions, 0 templates, inherited once
 
draft No known Allergies/Intolerances
hl7ips-dataelement-51
Id hl7ips-dataelement-51 (2016‑11‑06 11:55:31)
Comment GC: Moved under the Allergy entry in order to give the possibility to record who is the source of information that asserts this
Value Domain Code
Choice list
Concept List
Concept Synonyms Description Assigned references
No known allergies or intolerances
No known propensity to adverse reactions
No known allergies
No known intolerances
draft Source of information
hl7ips-dataelement-50
Id hl7ips-dataelement-50 (2016‑11‑03 16:50:30)
Concept inherits from hl7ips-dataelement-15 (2016‑10‑28 15:52:25)
Description 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
Value Domain Collection of data
draft Type
hl7ips-dataelement-10
Id hl7ips-dataelement-10 (2016‑10‑28 13:14:34)
Description Type of allergy or intolerance: e.g. allergy, intolerance, propensity to adverse reaction.
Comment 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).
Operationalization Proposed

CDA: single data element that combines kind of allergy and category of allergen 

FHIR: two distinct elements
Value Domain Code
Choice list
Concept List
Concept Synonyms Description Assigned references
Allergy or Intolerance
Propensity to adverse reactions
Allergy
Intolerance
draft Description
hl7ips-dataelement-6
Id hl7ips-dataelement-6 (2016‑10‑28 12:45:08)
Description A textual description of the adverse reaction
Value Domain Text
draft Onset Date
hl7ips-dataelement-5
Id hl7ips-dataelement-5 (2016‑10‑28 12:41:37)
Description Date of the first observation of adverse reactions
Source SPECIFIC GUIDELINES FOR ELECTRONIC EXCHANGE OF HEALTH DATA UNDER THE CROSS-BORDER DIRECTIVE 2011/24/EU  RELEASE 2 PATIENT SUMMARY FOR UNSCHEDULED CARE
Value Domain Date
Property
Timestamp precision
at least year
target Used by 0 transactions, 0 templates, inherited once
 
folder draft Agent
hl7ips-dataelement-1
Id hl7ips-dataelement-1 (2016‑10‑24 11:46:38)
Description The substance  (drug, food, chemical agent, etc.) that is responsible for the adverse reaction 
Source eHealth DSI CDA Implementation Guide [Europe]
Comment Clarify how to deal with adverse reactions to non-substances (sunlight) : e.g. consider them as a kind of substance ?
draft Category
hl7ips-dataelement-55
Id hl7ips-dataelement-55 (2016‑11‑08 14:57:52)
Description Kind of allergen: e.g. food; drug; environment;...
Comment
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).
Operationalization Proposed

CDA: single data element that combines kind of allergy and category of allergen 

FHIR: two distinct elements
Value Domain Code
Choice list
Concept List
Concept Synonyms Description Assigned references
food
drug
animal
vegetable
environmental
draft Agent code
hl7ips-dataelement-3
Id hl7ips-dataelement-3 (2016‑10‑28 12:35:43)
Value Domain Code
draft Agent description
hl7ips-dataelement-2
Id hl7ips-dataelement-2 (2016‑10‑28 12:30:58)
Description Describes the agent (drug, food, chemical agent, etc) that is responsible for the adverse reaction
Value Domain String
folder draft Adverse Reaction Manifestation
hl7ips-dataelement-7
Id hl7ips-dataelement-7 (2016‑10‑28 12:46:45)
Description 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)
Source EU Guidelines 
draft Severity
hl7ips-dataelement-67
Id hl7ips-dataelement-67 (2017‑04‑07 10:59:33)
Description A subjective assessment of the severity of the condition as evaluated by the clinician.
Value Domain Code
target Used by 0 transactions, 0 templates, inherited once
 
draft Reaction Description
hl7ips-dataelement-8
Id hl7ips-dataelement-8 (2016‑10‑28 12:47:39)
Value Domain String
draft Reaction Code
hl7ips-dataelement-9
Id hl7ips-dataelement-9 (2016‑10‑28 12:48:50)
Value Domain Count
folder draft Medication Summary
hl7ips-dataelement-12
Id hl7ips-dataelement-12 (2016‑10‑28 13:33:14)
Description 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.
Source

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)"

draft No infos about Medications
hl7ips-dataelement-54
Id hl7ips-dataelement-54 (2016‑11‑06 17:47:40)
Value Domain Code
folder draft Medication Statement
hl7ips-dataelement-11
Id hl7ips-dataelement-11 (2016‑10‑28 13:30:50)
draft No known Medications
hl7ips-dataelement-53
Id hl7ips-dataelement-53 (2016‑11‑06 17:46:26)
Comment GC: Moved under the Allergy entry in order to give the possibility to record who is the source of information that asserts this

Value Domain Code
draft Source of information
hl7ips-dataelement-16
Id hl7ips-dataelement-16 (2016‑10‑28 15:53:41)
Concept inherits from hl7ips-dataelement-15 (2016‑10‑28 15:52:25)
Description 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
Value Domain Collection of data
draft Duration of treatment
hl7ips-dataelement-19
Id hl7ips-dataelement-19 (2016‑10‑28 15:58:22)
Comment There has to be space for posology in free text with the possibility of a null flavor
Operationalization Likely derived from the onset and end dates ?

What about  continuous therapy ?
Value Domain Quantity
Example during 14 days
draft Date of onset of treatment
hl7ips-dataelement-20
Id hl7ips-dataelement-20 (2016‑10‑28 15:59:07)
Description Date when patient needs to start taking the medicine prescribed
Value Domain Date+time
folder draft Medicine Information
hl7ips-dataelement-21
Id hl7ips-dataelement-21 (2016‑10‑28 16:00:24)
draft Product Code
hl7ips-dataelement-58
Id hl7ips-dataelement-58 (2017‑01‑11 15:15:43)
Description A code identifying the medicine. 
Comment 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;...
Value Domain Code
folder draft IDMP Identifiers
hl7ips-dataelement-40
Id hl7ips-dataelement-40 (2016‑10‑30 07:10:55)
Comment For future consideration
draft PCID
hl7ips-dataelement-43
Id hl7ips-dataelement-43 (2016‑10‑30 07:21:00)
Description 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
Value Domain Identifier
draft MPID
hl7ips-dataelement-42
Id hl7ips-dataelement-42 (2016‑10‑30 07:18:53)
Description 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.
Source ISO 11615:2012
Value Domain Identifier
folder draft PhPID Set
hl7ips-dataelement-41
Id hl7ips-dataelement-41 (2016‑10‑30 07:12:31)
Description 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.
Source ISO 11616:2012
Comment For the purpose of this document only the 4 PhpID of the PhPID Active Substance Stratum will be considered.
draft PhPID (SUB_L1)
hl7ips-dataelement-44
Id hl7ips-dataelement-44 (2016‑10‑30 07:28:11)
Description
PhPID Active Substance Stratumn Level 1. It identifies the Substance(s)
e.g. "pioglitazone + metformin"
Value Domain Identifier
draft PhPID (SUB_L2)
hl7ips-dataelement-45
Id hl7ips-dataelement-45 (2016‑10‑30 07:34:50)
Description

PhPID Active Substance Stratumn Level 2.
It identifies Substance Term(s), Strength and Reference Strength
e.g. pioglitazone 15 mg + metformin 850 mg
Value Domain Identifier
draft PhPID (SUB_L3)
hl7ips-dataelement-46
Id hl7ips-dataelement-46 (2016‑10‑30 07:38:31)
Description PhPID Active Substance Stratum Level 2.
It identifies Substance Term(s) and Administrable Dose Form
Value Domain Identifier
draft PhPID (SUB_L4)
hl7ips-dataelement-47
Id hl7ips-dataelement-47 (2016‑10‑30 07:40:51)
Description 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"
Value Domain Identifier
folder draft Medicine names
hl7ips-dataelement-35
Id hl7ips-dataelement-35 (2016‑10‑28 16:49:15)
draft Strength (name part)
hl7ips-dataelement-38
Id hl7ips-dataelement-38 (2016‑10‑28 17:06:27)
Synonym
MPN Strength part
Description
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.

Source ISO IDMP
Value Domain String
Example For the Medicinal Product Name “Drug K Forte Tablets”, the strength name part is “Forte”.
Example “SoothingMed 2,5 % Cream”, the strength name part is “2,5 %”.
target Used by 0 transactions, 0 templates, inherited once
 
draft Invented name
hl7ips-dataelement-36
Id hl7ips-dataelement-36 (2016‑10‑28 16:55:53)
Synonym
trade name
Description
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.

Value Domain String
Example For the Medicinal Product Name “Drug XYZ® Precisehaler 200 mg for adults” the invented (trade) name part is “Drug XYZ”.
draft Medicinal Product Name
hl7ips-dataelement-33
Id hl7ips-dataelement-33 (2016‑10‑28 16:43:30)
Description
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
Source ISO IDMP
Value Domain String
draft Scientific name
hl7ips-dataelement-34
Id hl7ips-dataelement-34 (2016‑10‑28 16:47:42)
Synonyms
generic name
common name
Description
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
Source ISO IDMP
Value Domain String
Example For the Medicinal Product Name “Irbesartan/Hydrochlorothiazide Pharma KK” the common (generic) name part is “Irbesartan/Hydrochlorothiazide”.
target Used by 0 transactions, 0 templates, inherited once
 
folder draft Dose form
hl7ips-dataelement-32
Id hl7ips-dataelement-32 (2016‑10‑28 16:26:04)
Description
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.
Source ISO IDMP
Comment Restrict to Administered dose form ?
Value Domain Count
draft doseform description
hl7ips-dataelement-57
Id hl7ips-dataelement-57 (2016‑12‑28 15:40:58)
Value Domain String
draft doseform code
hl7ips-dataelement-56
Id hl7ips-dataelement-56 (2016‑12‑28 15:40:38)
Value Domain Code
cancelled Product Description
hl7ips-dataelement-31
Id hl7ips-dataelement-31 (2016‑10‑28 16:20:25)
Value Domain String
folder draft Substance classifcation (ATC)
hl7ips-dataelement-24
Id hl7ips-dataelement-24 (2016‑10‑28 16:04:49)
draft Substance classification (ATC code)
hl7ips-dataelement-30
Id hl7ips-dataelement-30 (2016‑10‑28 16:18:27)
Value Domain Code
draft Substance Classification (description)
hl7ips-dataelement-29
Id hl7ips-dataelement-29 (2016‑10‑28 16:18:07)
Value Domain Text
folder draft List of active substances and strengths
hl7ips-dataelement-22
Id hl7ips-dataelement-22 (2016‑10‑28 16:01:25)
draft Strength (name part)
hl7ips-dataelement-39
Id hl7ips-dataelement-39 (2016‑10‑28 17:08:32)
Concept inherits from hl7ips-dataelement-38 (2016‑10‑28 17:06:27)
Synonym
MPN Strength part
Description
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.

Source ISO IDMP
Value Domain String
Example For the Medicinal Product Name “Drug K Forte Tablets”, the strength name part is “Forte”.
Example “SoothingMed 2,5 % Cream”, the strength name part is “2,5 %”.
draft Scientific name
hl7ips-dataelement-37
Id hl7ips-dataelement-37 (2016‑10‑28 17:04:56)
Concept inherits from hl7ips-dataelement-34 (2016‑10‑28 16:47:42)
Synonyms
generic name
common name
Description
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
Source ISO IDMP
Value Domain String
Example For the Medicinal Product Name “Irbesartan/Hydrochlorothiazide Pharma KK” the common (generic) name part is “Irbesartan/Hydrochlorothiazide”.
folder draft Active Ingredient and Strength
hl7ips-dataelement-23
Id hl7ips-dataelement-23 (2016‑10‑28 16:03:20)
draft Active Ingredient Name
hl7ips-dataelement-27
Id hl7ips-dataelement-27 (2016‑10‑28 16:13:24)
Value Domain String
draft Strength (text)
hl7ips-dataelement-28
Id hl7ips-dataelement-28 (2016‑10‑28 16:14:39)
Value Domain String
draft Active Ingredient (code)
hl7ips-dataelement-26
Id hl7ips-dataelement-26 (2016‑10‑28 16:12:07)
Value Domain Code
draft Strength (quantity)
hl7ips-dataelement-25
Id hl7ips-dataelement-25 (2016‑10‑28 16:07:26)
Description
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
Comment no distinctions between strength and reference strength (see ISO IDMP)
Value Domain Quantity
folder draft Dosage Instruction
hl7ips-dataelement-14
Id hl7ips-dataelement-14 (2016‑10‑28 15:51:25)
Synonyms
SIG
Posology
Comment The term Posology seems not to be globally used: which name we can use instead ?
draft Frequency of intakes
hl7ips-dataelement-48
Id hl7ips-dataelement-48 (2016‑10‑30 15:49:17)
Description Frequency of intakes (per hours/day/month/ week..)
Comment There has to be space for posology in free text with the possibility of a null flavor
Comment There has to be space for posology in free text with the possibility of a null flavor
Value Domain Quantity
Example each 24 hours
draft Dose
hl7ips-dataelement-18
Id hl7ips-dataelement-18 (2016‑10‑28 15:56:45)
Synonyms
Number of units per intake
Dosage
Description
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)
Operationalization 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 ...
Value Domain Quantity
Property
min include max include unit min. fraction digits default fixed
min include max include        
Unit of Presentation  
min include max include unit min. fraction digits default fixed
min include max include        
UCUM  
Example 1 tablet
Example 2 puffs
Example 200 ml
draft Description
hl7ips-dataelement-17
Id hl7ips-dataelement-17 (2016‑10‑28 15:55:51)
Synonym
Free text SIG
Description Textual description of the dosage and frequency of intakes
Comment Check if this cooresponds to the Free text SIG
Operationalization CCDA has a specific closed template for conveying the free text SIG...(2.16.840.1.113883.10.20.22.4.147)
Value Domain Text