IPS Appendix 1

Appendix (Informative)

Acronyms and abbreviations

CCD	Continuity of Care Document
C-CDA	Consolidated CDA
CDA	Clinical Document Architecture
CEN	Comité Européen de Normalisation (European Committee for Standardization)
CEN/TC 251	CEN Technical Committe 251
DSTU	Draft Standard for Trial Use
EC	European Commission
EDQM	European Directorate for the Quality of Medicines & Healthcare
eHDSI	Digital Service Infrastructure for eHealth
eHN	eHealth Network
EHR	Electronic Healthcare Record
EN	European Normative [or Standard] (CEN)
epSOS	European Patient Smart Open Services
EU	European; Europe
FDA	Food and Drug Administration (USA)
GP	General Practitioner
HL7	Health Level Seven
HP	Healthcare Professional
IDMP	IDentification of Medicinal Products (ISO Standard)
IHE	Integrating the Healthcare Enterprise
INTERPAS	International Patient Summary (HL7 International Project)
IPS	International Patient Summary
ISO	International Organization for Standardization
JAseHN	Joint Action to Support the eHealth Network
JIC	Joint Initiative Council on SDO Global Health Informatics Standardization
LOINC	Logical Observation Identifiers Names & Codes
MOU	Memorandum of Understanding (on cooperation surrounding health related information and communication technologies, that between EU and US)
MPID	Medicinal Product Identifier
ONC	Office of the National Coordinator for Health Information Technology (USA)
PCC	Patient Care Coordination
PCID	Medicinal Product Package Identifier
PhPID(s)	Pharmaceutical Product Identifier(s)
prEN	Draft European Normative [or Standard] (CEN)
prTS	Draft Technical Specifications (CEN)
PS	Patient Summary
S&I	Standards and Interoperability (S&I) Framework (run by ONC)
SAIF	Service Aware Interoperability Framework
SDO	Standards Developing Organization
STU	Standard for Trial Use
TS	Technical Specifications (CEN)
UCUM	Unified Code for Units of Measure
WHO	World Health Organization

Glossary

• Compliance. A standard or specification is compliant with another standard or specification if all propositions that are true in the initial standard are also true in the complying standard. The target artifact is compliant with the source artifact if and only if all conforming implementations of the target are also conforming with the source (RM-ODP). The term compliance is also used to state expectations as to how certain specifications need to satisfy possible legislative or regulatory constraints or requirements.
• Conformance relates an implementation to a standard. Any proposition that is true of the specification must be true in its implementation. (ISO, 2010).
• Conformance Assessment is a process whereby a given implementation instance is evaluated to determine which of its various Conformance Assertions are valid implementations of a given specification’s Conformance Statements.
• Conformance Statement is a statement that identifies testable requirements at a specified Conformance Point within a specification, explicitly defining the behavior which must be satisfied at these points. Conformance Statements will only occur in standard which are intended to constrain some feature of a real implementation, so that there exists, in principle, the possibility of testing.
• Conformance Assertion is a testable, verifiable statement made about a specific implementation instance against a corresponding Conformance Statement.
• Conformance Points are the evaluation of conformance at specific points in the implementation or specification. See Conformance.
• Electronic Patient Summary: electronic health record extract containing essential healthcare information intended for specific uses . (EN ISO 13940: 2016)
• International Patient Summary : electronic patient summary for use in the unscheduled, cross-border care scenario comprising at least the required elements of the IPS dataset.
• International Patient Summary dataset: a minimal and non-exhaustive patient summary dataset, specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care of a patient.

Real World User Stories

This section reports a series of real world user stories adapted from the Trillium Bridge project and the eHDSI initiative

IPS Storyboard 1: Martha, a traveling corporate executive

Martha, a 45-year old corporate executive and breast cancer survivor travels frequently on business between the US and EU countries. She carries a clinical summary on her mobile phone and on paper just in case she needs to seek medical care regarding recurring symptoms. Martha’s summary includes

• Breast cancer Stage II with no evidence of recurrence following treatment
• hot flashes as problems
• Anastrozole 1 mg. once daily
• Black Cohosh Extract herbal supplement as medications
• the indication of an allergy to Penicillin
• and finally as Plan of Care, to continue hormone medication with Anastrozole for total of 5 years
• and monitor for potential breast cancer recurrence.

During a visit in Austria, Martha walks up a hill and experiences shortness of breath, faints, and wakes up a few minutes later after hitting her head on a stone step. A passerby helps her get to the emergency department of a local hospital. An ambulance is called and she is brought to the emergency ward.

During registration and admission, Martha hands in her patient summary in a USB key. At the hospital, Martha is evaluated by an oncologist and a cardiologist.

Following care provision, Martha receives an encounter report. When back home she hands in the encounter report to her primary physician, who updates her record.

IPS Storyboard 2: Paolo, a retired businessman

Paolo Cerruti is a 67-year-old retired businessman, who normally lives in the outskirts Bergamo, near Lake Como, in Lombardy. He is generally healthy, but has long-standing hypertension. His regular physician changed his medication two weeks ago because of poor blood pressure control on his previous medication. He is on holiday going through New England, US, travelling on his own to enjoy the autumn foliage, and is presently in Boston, MA. He is nearing the end of his holiday, and will be returning to Italy in three days’ time. Two days ago he lost his day bag. The bag included his hypertension medication, and he has not been able to take his tablets for two days.

This morning he has woken up feeling dizzy and has blurred vision. The hotel is able to put him in urgent contact with a local general practitioner (GP). Having assessed him, the GP noted a raised blood pressure, but is uncertain about whether to attribute these symptoms to the raised blood pressure or a side effect of the new medication. Now, the GP in Boston needs to know the medication, and the past few blood pressure readings to determine how exceptional the present reading is and manage Paolo appropriately.

Immediate access to his International Patient Summary would be the perfect answer. Paolo may retrieve his online European Patient Summary for emergency access that is retrieved, transformed into an IPS and shown its content translated in English.

The GP notes that visual disturbances are a recognized side effect of this medication. No specific treatment is indicated, and Paolo is reassured that side effects will gradually subside, and his GP can prescribe a suitable antihypertensive medication upon his return to Lake Como.

IPS Storyboard 3: Diana, a pregnant woman

Diana is a 34-year-old pregnant woman from Lisbon with a past medical history of allergic asthma and thyroid cancer during adolescence; for the latter she had a surgical procedure done (thyroidectomy) and, as a consequence, suffers hypothyroidism which requires hormone replacement for life (levothyroxine). At the age of 31 she was diagnosed with a hereditary cardiac disorder – Brugada Syndrome – and had a cardioverter defibrillator implanted to control potentially lethal arrhythmias.

During the pregnancy of her first child (C-section delivery), she suffered gestational diabetes that developed into type 2 diabetes after giving birth and needs now to receive subcutaneous insulin. As chronic treatment she also needs nebulizations three-time per day for her asthma - this condition is condition is aggravated in her case by being a smoker (1 pack per day) as included in the Social History Section.

At this moment, she presents severe pre-eclampsia (hypertension during pregnancy) in treatment with two oral antihypertensive agents (a combination medication). Additionally, she is following a 14-day-course of antibiotic treatment due to an acute pyelonephritis (kidney infection more likely to be develop in pregnant women due to the physiological changes that may interfere with the flow of urine).

Other sections of her Summary include allergies to latex and kiwi (which are very often associated) and to aspirin, and intolerance to lactose; immunizations administered during childhood and adolescence are also present.

Although being real choices for the different diseases and conditions, the selection of the patient's current medication tries to present some easily described medication as well as not so easily ones: e.g. insulin degludec, amoxicilin+clavulanic acid, and the combination of ipratropium bromide+salbutamol for nebulization. For the oral treatment of the pre-eclampsia the agents selected would not be used in real practice during pregnancy.

Integrated examples

The IPS specification releases are published at ips.art-decor.org the Project Publication Page. The actual release has a link to the XML materials that the W3C schemas are part of; it also includes example CDA document instances. A set of use cases have been defined and represented in IPS format. Also multiple languages are covered.

It is likely that the publication site will move to hl7.org permanently, we will inform about that process.

Validation artifacts

You can test your implementation (instances) against the IPS specification. To download materials to your computer for local testing and validation consider...

• ...the W3C schemas (actually valid for any CDA specification) located at the Project Publication Page. The actual release has a link to the XML materials as which the W3C schemas are part of; it also includes example CDA document instances.
• ..the ISO schematron, automatically generated by the tool. These are files to do validation locally by associating IPS CDA instances with the main schematron using an XML editor or to use the derived XSLT conversions and apply the according XSLT derivation to your local IPS CDA instance.

For further information you can follow the documentation.

Operational information

• The IPS project has an official mailing list address ips(at)lists.hl7.org, hosted at the HL7 listserver. Visit your Listserv Subscriptions at hl7.org and subscribe to the International Patient Summary (IPS) that is summarised under the Structured Documents Work Group.
• We also offer to write an email to info(at)international-patient-summary.net for inquiries regarding the specification
• * The original specification is hosted on the logical ART-DECOR main server art-decor.org under the Governance Group HL7 International, the project is reachable at the Live Project Landing Page.
• Any IPS specification release in HTML format resides at Project Publication Page. It is likely that the publication site will move to hl7.org permanently, we will inform about that process.
• The IPS specification on the wiki is hosted here (international-patient-summary.net). It is likely that the publication site will move to hl7.org permanently, we will inform about that process.

Licenses

Following is a non-exhaustive list of third-party terminologies that may require a separate license:

• SNOMED CT: SNOMED International (formerly know as International Healthcare Terminology Standards Development Organization IHTSDO) or info@ihtsdo.org
• Logical Observation Identifiers Names & Codes (LOINC): The Regenstrief Institute, Inc.
• Unified Code for Units of Measure (UCUM) : Regenstrief Institute, Inc. and the UCUM Organization
• EDQM Standard Terms  : European Directorate for the Quality of Medicines & Healthcare (EDQM)

FAQ’s

This is a placeholder for future Frequently Asked Questions about the International Patient Summary.