| Common fragments |
hl7ips-dataelement-1.49 |
|
|
|
|
Collect information fragments that are reused across different sections / entries |
|
|
|
|
draft |
|
|
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 |
|
|
|
|
draft |
|
|
Item |
Common fragments |
|
| Immunizations (Vaccinations) |
hl7ips-dataelement-1.59 |
|
|
|
|
|
|
|
|
|
draft |
|
|
Group |
|
|
| Problem List |
hl7ips-dataelement-1.60 |
|
|
|
|
|
|
|
|
|
draft |
|
|
Group |
|
|
| Problem |
hl7ips-dataelement-1.65 |
|
|
|
|
|
|
|
|
|
draft |
|
|
Group |
Problem List |
|
| No known problems |
hl7ips-dataelement-1.66 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
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 |
|
|
|
|
draft |
|
|
Item |
Problem |
|
| Problem Code |
hl7ips-dataelement-1.72 |
Code |
|
|
|
Code identifying the problem (or more in general the condition) |
|
|
|
|
draft |
|
|
Item |
Problem |
|
| Problem status |
hl7ips-dataelement-1.73 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
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 |
|
|
|
|
draft |
|
|
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. |
|
|
|
|
draft |
|
|
Item |
Problem |
hl7ips-dataelement-1.67 |
| No infos about conditions |
hl7ips-dataelement-1.64 |
Collection of data |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Problem List |
|
| History of Procedures |
hl7ips-dataelement-1.61 |
|
|
|
|
|
|
|
|
|
draft |
|
|
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. |
|
|
|
|
draft |
|
|
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" |
|
|
|
|
draft |
|
|
Item |
List of Allergies or Intolerances |
|
| Allergy or Intolerance |
hl7ips-dataelement-1.4 |
|
|
|
|
Allergy or Intollerance |
|
|
|
|
draft |
|
|
Group |
List of Allergies or Intolerances |
|
| Criticality |
hl7ips-dataelement-1.63 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
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 |
|
|
|
|
draft |
|
|
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
|
draft |
|
|
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 |
|
|
|
|
draft |
|
|
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).
|
draft |
|
|
Item |
Allergy or Intolerance |
|
| Description |
hl7ips-dataelement-1.6 |
Text |
|
|
|
A textual description of the adverse reaction |
|
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
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 ?
|
draft |
|
|
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).
|
draft |
|
|
Item |
Agent |
|
| Agent code |
hl7ips-dataelement-1.3 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Agent |
|
| Agent description |
hl7ips-dataelement-1.2 |
String |
|
|
|
Describes the agent (drug, food, chemical agent, etc) that is responsible for the adverse reaction |
|
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
Group |
Allergy or Intolerance |
|
| Severity |
hl7ips-dataelement-1.67 |
Code |
|
|
|
A subjective assessment of the severity of the condition as evaluated by the clinician. |
|
|
|
|
draft |
|
|
Item |
Adverse Reaction Manifestation |
|
| Reaction Description |
hl7ips-dataelement-1.8 |
String |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Adverse Reaction Manifestation |
|
| Reaction Code |
hl7ips-dataelement-1.9 |
Count |
|
|
|
|
|
|
|
|
draft |
|
|
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)" |
|
|
|
draft |
|
|
Group |
|
|
| No infos about Medications |
hl7ips-dataelement-1.54 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Medication Summary |
|
| Medication Statement |
hl7ips-dataelement-1.11 |
|
|
|
|
|
|
|
|
|
draft |
|
|
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
|
draft |
|
|
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 |
|
|
|
|
draft |
|
|
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
|
draft |
|
|
Item |
Medication Statement |
|
| Date of onset of treatment |
hl7ips-dataelement-1.20 |
Date/time |
|
|
|
Date when patient needs to start taking the medicine prescribed |
|
|
|
|
draft |
|
|
Item |
Medication Statement |
|
| Medicine Information |
hl7ips-dataelement-1.21 |
|
|
|
|
|
|
|
|
|
draft |
|
|
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;...
|
draft |
|
|
Item |
Medicine Information |
|
| IDMP Identifiers |
hl7ips-dataelement-1.40 |
|
|
|
|
|
|
|
|
|
draft |
|
|
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
|
|
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
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.
|
draft |
|
|
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"
|
|
|
|
|
draft |
|
|
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
|
|
|
|
|
|
draft |
|
|
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 |
|
|
|
|
draft |
|
|
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" |
|
|
|
|
draft |
|
|
Item |
PhPID Set |
|
| Medicine names |
hl7ips-dataelement-1.35 |
|
|
|
|
|
|
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
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.
|
|
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
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 ?
|
draft |
|
|
Group |
Medicine Information |
|
| doseform description |
hl7ips-dataelement-1.57 |
String |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Dose form |
|
| doseform code |
hl7ips-dataelement-1.56 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Dose form |
|
| Substance classifcation (ATC) |
hl7ips-dataelement-1.24 |
|
|
|
|
|
|
|
|
|
draft |
|
|
Group |
Medicine Information |
|
| Substance classification (ATC code) |
hl7ips-dataelement-1.30 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Substance classifcation (ATC) |
|
| Substance Classification (description) |
hl7ips-dataelement-1.29 |
Text |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Substance classifcation (ATC) |
|
| List of active substances and strengths |
hl7ips-dataelement-1.22 |
|
|
|
|
|
|
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
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 |
|
|
|
draft |
|
|
Item |
List of active substances and strengths |
hl7ips-dataelement-1.34 |
| Active Ingredient and Strength |
hl7ips-dataelement-1.23 |
|
|
|
|
|
|
|
|
|
draft |
|
|
Group |
List of active substances and strengths |
|
| Active Ingredient Name |
hl7ips-dataelement-1.27 |
String |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Active Ingredient and Strength |
|
| Strength (text) |
hl7ips-dataelement-1.28 |
String |
|
|
|
|
|
|
|
|
draft |
|
|
Item |
Active Ingredient and Strength |
|
| Active Ingredient (code) |
hl7ips-dataelement-1.26 |
Code |
|
|
|
|
|
|
|
|
draft |
|
|
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)
|
draft |
|
|
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 ?
|
draft |
|
|
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
|
draft |
|
|
Item |
Dosage Instruction |
|
| Dose (Number of units per intake, Dosage) |
hl7ips-dataelement-1.18 |
Quantity |
- Unit: Unit of Presentation
|
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 ... |
|
draft |
|
|
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
|
draft |
|
|
Item |
Dosage Instruction |
|