eHealth Network

GUIDELINE
on

the electronic exchange of health data under Cross-

Border Directive 2011/24/EU

Release 2

Patient Summary for unscheduled care

 eHealth Network

The eHealth Network is a voluntary network, set up under article 14 of Directive 2011/24/EU.
It provides a platform of Member States' competent authorities dealing with eHealth. The
Joint Action supporting the eHealth Network (JAseHN) provides scientific and technical
support to the Network.

Adopted by consensus by the eHealth Network, Brussels, 21 November 2016

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TABLE OF CONTENTS

1. USE CASE DESCRIPTION ...................................................................................................... 5

1.1. Cross-border Patient Summary for Unscheduled Care .................................................... 5
2. GUIDELINES FOR PATIENT DATASET .................................................................................. 7
Chapter I – General Considerations ....................................................................................... 7
Chapter II – Legal and Regulatory Considerations ................................................................ 7
Chapter III – Organisational and Policy Considerations ........................................................ 8
Chapter IV – Semantic Considerations .................................................................................. 8
Chapter V – Technical Considerations ................................................................................... 9
3. SUPPORTING INFORMATION ............................................................................................. 10
Chapter I - General Considerations ..................................................................................... 10
Chapter II – Legal and Regulatory Considerations .............................................................. 10
Chapter III – Organisational and Policy Considerations ...................................................... 11
Chapter IV – Semantic Considerations ................................................................................ 11
Chapter V – Technical Considerations ................................................................................. 12
4. PATIENT SUMMARY DATASET ......................................................................................... 13
5. STANDARDS AND PROTOCOLS .......................................................................................... 17

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1. USE CASE DESCRIPTION

1.1. Cross-border Patient Summary for Unscheduled Care

This Use Case represents a high level of consensus on what constitutes European eHealth
services, as this Use Case was described by Directive 2011/24/EU of 9 March 2011 on the
application of patients’ rights in cross-border healthcare.

Use Case description:

Title Patient Summary sharing on a cross-border scale
Purpose Sharing information about the medical background and history of a patient from
Country A (the patient’s country of affiliation) with a healthcare professional in
another Member State Country B (the country of treatment)
Relevance Many people request medical help when travelling, working or living abroad.
Medical information from the country of origin should be available to all citizens in
Europe (in their native language). The current solutions (if any) for obtaining
medical information from another country are often cumbersome, unsafe,
incomplete and non-standard. The treatment of patients without proper medical
background information is hazardous and should be avoided. Benefits can be
gained from increased quality of care (e.g. patient safety) (both medical and
economical) and from a decrease in the effort of gathering/exchanging health
information. This Use Case proposes a way towards solving this problem.
Domain Patient Summary
Situation Cross-border
Context The definition of a Patient Summary was laid down by the epSOS project as a
starting point for the development and pilot testing of a Patient Summary for
citizens who are travelling abroad and need medical help (unplanned).
Challenges are related to the level of data required and the quality of information
relevant to support patient treatment effectively across different participating
European countries. Different countries operate different health care systems,
support their own culture for healthcare provision, and may use a different (or
several different) language(s).
A Patient Summary provides background information on important aspects such as
allergies, current medication, previous illnesses and surgeries, etc. These are
necessary for the proper treatment of a patient abroad, especially when there is a
language barrier between the healthcare professional (HP) and the patient.
Two Use Cases are possible with regard to the Patient Summary (PS). The first is
the one in which an occasional visitor needs his/her PS in country B. The second is
the one in which the person is a regular visitor in country B (i.e. someone who lives
in one country but works in another country). The distinguishing characteristic is
that the HP may have some information available from previous encounters in this
type of occasional situation. Both a PS from country A and one from country B
need to be consulted. In this Use Case, the Use Case of the occasional visitor is
described.
Information Patient Summary (in patient’s language and country B language)
Patient consent
Participants Patient

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Health professional in patient’s country of origin/affiliation (country A)

Health professional in country of treatment (country B)
Functional process (With the reservation that preconditions are met)
steps The patient consults a health professional in country B
The patient is identified (identity confirmed by country A)
The health professional is identified, authenticated and authorised
The patient may have given consent before travelling to country B or in country B
to the health professional (except for emergency cases)
In the latter case, the health professional will then register this confirmation
The Patient Summary is electronically transferred from the patient’s country of
origin to the health professional in the country that s/he is visiting (the “visiting
country”) in a secure way. The health professional retrieves the Patient Summary
and uses it for the consultation.
The PS is received in both the language of the patient (PDF of original PS) and as a
translated version for the health professional.

Table 1: Patient Summary Use Case description

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2. GUIDELINES FOR PATIENT DATASET

THE MEMBER STATES in the eHealth Network HAVE ADOPTED THESE

supplementary clauses to the general guidelines for the electronic exchange of health data
under Cross-Border Directive 2011/24/EU to support the exchange of Patient Summary
data for unscheduled care.
Chapter I – General Considerations

Article 1: Objectives and scope

1. These guidelines, as adopted by the eHealth Network, are addressed to the Member States of
the European Union and apply to the implementation of a patient dataset for cross-border
exchange.
2. According to the primary responsibility of the Member States in the field of healthcare
provision, as laid down in Article 168 (7) of the Treaty on the Functioning of the European
Union, these guidelines are non-binding. In a cross-border context, interoperability is
essential to the provision of high quality care. Member States shall therefore engage in taking
appropriate measures to make their respective information systems interoperable, both
technically and semantically, for this Use Case.
Article 2: Definitions
1. For the purpose of this guideline, the definitions of the directives cited within the recitals of
this guideline and the following definitions shall apply:
a) A Patient Summary is an identifiable “dataset of essential and understandable health information”
that is made available “at the point of care to deliver safe patient care during unscheduled care [and
planned care] with its maximal impact in the unscheduled care”; it can also be defined at a high level
as: “the minimum set of information needed to assure Health Care Coordination and the continuity of care”.
Article 3: Concept and intended use
1. The provisions in the general guidelines apply.
2. The aim of the Use Case is to help support safe, high-quality cross-border care for
emergency or unplanned care events. This does not preclude the Patient Summary being
used for other purposes.
3. The Patient Summary may, by agreement, be used to share information such as that on
rare diseases.
Chapter II – Legal and Regulatory Considerations

Article 4: Data protection

There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.

Article 5: Authorisation, authentication and identification

1. Implementation of the patient dataset implies that each Member State has addressed enabling
activities such as:
a) Providing an official ID health number for each citizen (with a national federation of IDs if
numerous regional systems are available). For cross-border purposes, a unique patient

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identifier is a necessary requirement for each individual patient to be linked to the patient
record in the country of affiliation
b) Maintaining electronic registers of health professionals
c) Agreed levels of authentication of citizens and health professionals
Article 6: Patient safety
There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.

Chapter III – Organisational and Policy Considerations

Article 7: Enablers for implementation

The ability to populate this dataset implies the existence of a local electronic Patient
Summary. Some Member States have implemented, or are in the course of implementing,
national or regional Patient Summaries. Some Member States already have more detailed
summaries from which this summary data can be extracted. Other Member States may use
this guideline for reference for national implementation.
Article 8: Quality standards and validation
There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.
Article 9: Education, training and awareness
1. Effective sharing of Patient Summary data is dependent on the recording health professional
and the health professional retrieving the Patient Summary being able to share the
understanding of the patient’s condition. MS should therefore take care to ensure appropriate
awareness and training for all.
2. For instance, the presence of a rare disease code might indicate that specific action should be
taken; health professionals need to be aware of this.

Chapter IV – Semantic Considerations

Article 10: Data

1. The content of the Patient Summary dataset is shown in section 4. The Patient Summary data
comprises Patient Administrative Data and Patient Clinical Data.
2. It is the responsibility of the MS to provide data in compliance with these guidelines. Certain
fields may be empty because there is no data for a given patient.
Article 11: Terminology
1. Emergency or unplanned care situations require an ability to convey both meaning and
context in the Patient Summary to enable safe, high-quality care.
2. Member States wishing to engage in cross-border communication will need to use the
coding schemes as described in the dataset in section 4.
Article 12: Master Catalogue

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1. There is a particular issue regarding the identification of medicinal products. It is expected

that the coding schemes currently included within the dataset will be replaced by identifiers
developed using the IDMP set of standards. The European Medicines Agency is leading work
on this; further details will be provided in due course.
Chapter V – Technical Considerations

Article 13: Technical requirements

Member States are free to choose the technical implementation of their Patient Summary
dataset. Nonetheless, for cross-border exchange the format of the document for exchange
should be based on standards and profiles as agreed by the eHN. The cross-border
specification is described in section 5, which also refers to supporting requirements and
other relevant documentation.
Article 14: Security
Member States shall assure logging of cross-border transactions and make logs available for
legal purposes, e.g. a health professional request for a Patient Summary is important.
Article 15: Testing and audit
Member States wishing to engage in cross-border communication will need to demonstrate
their compliance to the specification in section 5.
Article 16: Amendments to the guidelines
The eHealth Network is responsible for updating the guidelines, which are addressed to
Member States.

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3. SUPPORTING INFORMATION

This chapter provides supporting information and explanatory text to aid understanding of
the guidelines, and the rationale behind the proposals. It therefore follows the same structure
as the general guidelines.
The material in this supporting document has built on earlier epSOS experiences, but cites
follow-on work in EXPAND, in the relevant Horizon 2020 projects and the joint EU/US
Trillium Bridge project.
Chapter I - General Considerations

Article 1: Objectives and scope

The focus on emergency or unplanned care is deliberate in that it requires agreement on
those data items needed when a patient previously unknown to the health professional (HP)
needs treatment. For planned care, additional referral information will typically be provided,
and hence is not within the scope of this release [Release 2] of the guideline.
More recently, the dataset has been reviewed by US stakeholders as part of the Trillium
Bridge project, in line with the EU-US roadmap and MoU collaboration agreement.
Article 2: Definitions
The definitions section has been extended to include a number of relevant definitions relating
to Patient Summaries.
Article 3: Concept and intended use
These guidelines are non-binding and Member States are considered to have the right to
choose freely their way of implementing Patient Summary data systems.
The Patient Summary guidelines focus on the content issues and the description of possible
ways to produce this content for cross-border exchange, taking existing national
implementations into consideration.
The dataset may be used to hold additional information, such as information about rare
diseases, using current data fields.
Chapter II – Legal and Regulatory Considerations

Article 4: Data protection

Each query about the personal data available through cross-border exchange should be for a
real need of access to specific information related to the care or treatment to be provided.
Article 5: Authorisation, authentication and identification
To be able to link patients with their patient records, the existence of a patient identifier is
necessary. For cross-border purposes, a unique patient identifier is also a necessary
requirement for each individual patient to be linked to the patient record in the country of
origin. Analysis of data shows that most Member States already have a national patient
identification number available. In some cases, Member States have a regional patient
identification number.
Official documents, such as a passport, ID card or driver’s licence, seem to be accepted
across MS for authentication. In cases where a patient does not have (access to) a national
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patient ID or an identification document, different kinds of personal information elements,

such as the patient’s last name and date of birth, are used to create a unique (temporary) form
of identification.
Article 6: Patient safety
There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.

Chapter III – Organisational and Policy Considerations

Article 7: Enablers for implementation

The aim of the dataset is to support cross-border care. However, the ability to populate this
dataset requires national activity. More advanced and elaborate Patient Summaries exist in
some Member States (MS), but the eHealth Network has agreed that the guideline could
serve as a common baseline for Patient Summaries at national level.
Article 8: Quality standards and validation
There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.

Article 9: Education, training and awareness

The use of the Patient Summary to record rare disease information has to be a clinical
decision, with leadership and direction from health professional organisations.
Chapter IV – Semantic Considerations

Article 10: Data

Many countries build their Patient Summary information from multiple sources, which
complicates the update of cross-border Patient Summary information. The content of the
dataset is version controlled, subject to change control through the eHMSEG. A number of
proposals have been made for amendments or additions to the dataset (e.g. a proposal from
ValueHealth to expand the “Vital signs” section); these would need to be assessed for impact
through the Change Control process for inclusion.
Article 11: Terminology
Successful sharing of information requires the effective use of standards to support accurate
and complete clinical documentation that is faithful to the patient's situation, and for
electronic health record (EHR) data to be transferred and structurally mapped into a
receiving repository in a way that enables its clinical content to be interpreted with a meaning
that is commonly understood – by computers as well as by persons.
Since code systems such as SNOMED-CT and ICD-10 (to name but two) contain a large
number of terms, it is not practical to use them in their entirety within the European context,
where some Member States might use different code systems which they will have to cross-
reference and/or translate. Certain criteria were used to choose between the most significant
terms and arrive at a reasonable manageable content. It is expected that the eHN will oversee
the process by which code systems are kept under review and ensure that appropriate
licensing arrangements are in place.

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Article 12: Master Catalogue

There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.

Chapter V – Technical Considerations

Article 13: Technical requirements

There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.
Article 14: Security
There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.
Article 15: Testing and audit
There being no specific additional requirements, reference is made to the provisions defined
in the general guidelines.

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4. PATIENT SUMMARY DATASET

PATIENT ADMINISTRATIVE DATA
Variable
Variables Variables
(nesting DEFINITION AND COMMENTS
(nesting level 2) (nesting level 3)
level 1)
National
Identification National healthcare Country ID, unique to the patient in that country.
healthcare patient
1 patient ID Example: ID for United Kingdom patient
ID
The patient’s first name (example: John). This field
Given name
can contain more than one element.
This field can contain more than one element.
Full name Example: Español Smith
Personal Family
Note: some countries require the surname to be the
information name/surname
birth name [to avoid potential problems with
married women’s surnames).
This field may contain only the year if the day and
Date of birth Date of birth
month are not available, e.g.: 01/01/2009
Gender Gender code This field must contain a recognised valid value
Street Example: Oxford Street
House number Example: 221
Address2 City Example: London
Post code Example: W1W 8LG
State or province Example: London
Country Example: UK
Telephone no. Telephone no. Example: +45 20 7025 6161
Email Email Example: [email protected]
Name of the HP that has been treating the patient.
[the structure of the name will be the same as
Name of the HP
described in ‘Full name’ (given name, family
Preferred HP to name/surname)]
contact3
Telephone no. Example: +45 20 7025 6161
Contact
information Email Email of the HP/legal organisation

Role of that person Legal guardian or contact person

The first name of the contact person/guardian

Given name (example: Peter). This field can contain more than
one element.
Contact person/
legal guardian Family This field can contain more than one element.
name/surname Example: Español Smith

Telephone no. Example: +45 20 7025 6161

Email Email of the contact person/legal guardian

Insurance
Insurance number Insurance number Example: QQ 12 34 56 A
information

Table 2: Patient Summary dataset for patient administrative data

1 Dataset that enables the univocal identification of the patient

2 May vary by country
3 A health professional in country A may need a contact (health professional/healthcare provider) who knows the

patient.

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PATIENT CLINICAL DATA

Variable Variables Variables DEFINITION AND COMMENTS
(nesting (nesting level 2) (nesting level 3)
level 1)
Alerts Allergy Allergy 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)
Allergy description Normalised identifier
ID code
Onset date Date of the observation of the reaction
Agent Describes the agent (drug, food, chemical agent, etc.) that is
responsible for the adverse reaction
Agent ID code Normalised identifier
Medical alert Healthcare alert Medical alert information: any other clinical information
information (other description that is imperative to know so that the life or health of the
alerts not included patient does not come under threat. Example 1: intolerance
in allergies) to aspirin due to gastrointestinal bleeding. Example 2:
intolerance to captopril because of cough (the patient is not
allergic but can't tolerate it because of persistent cough)

Healthcare alert ID Normalised identifier

code
Medical Vaccinations Vaccinations Contains each disease against which the patient has been
history immunised
Brand name
Vaccinations ID Normalised identifier
code
Vaccination date The date when the immunisation was given
List of resolved, Problem Problems or diagnoses not included in the definition of
closed or inactive description "current problems or diagnosis". Example: hepatic cyst (the
problems patient has been treated with an hepatic cystectomy that
solved the problem and the problem is therefore closed)

Problem ID code Normalised identifier

Onset time Date of problem onset
End date Problem resolution date
Resolution Describes the reason for which the status of the problem
circumstances changed from current to inactive (e.g. surgical procedure,
medical treatment, etc.). This field includes "free text" if the
resolution circumstances are not already included in other
fields such as surgical procedure, medical device, etc., e.g.
hepatic cystectomy (this will be the resolution circumstances
for the problem "hepatic cyst" and will be included in
surgical procedures).

Surgical Procedure Describes the type of procedure

procedures prior description
to the past six
months
Procedure ID Normalised identifier
(code)
Procedure date Date when procedure was performed

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PATIENT CLINICAL DATA

Variable Variables (nesting Variables (nesting DEFINITION AND COMMENTS
(nesting level 2) level 3)
level 1)
Medical List of current Problem/diagnosis Problems/diagnoses that fit these conditions: conditions
problems problems/diagnoses description that may have a chronic or relapsing course (e.g. irritable
bowel syndrome, otitis media), conditions for which the
patient receives repeat medications (e.g. diabetes
mellitus, hypertension) and conditions that are persistent
and serious contraindications for classes of medication
(e.g. dyspepsia, migraine and asthma)

Problem ID (code) Normalised identifier

Onset time Date of problem onset
Medical devices and Device and implant Describes the patient's implanted and external medical
implants description devices and equipment upon which their health status
depends. Includes devices such as cardiac pacemakers,
implantable fibrillator, prosthesis, ferromagnetic bone
implants, etc. of which the HP needs to be aware.
Device ID code Normalised identifier
Implant date Date when procedure was performed
Major surgical Procedure Describes the type of procedure
procedures in the description
past six months
Procedure ID Normalised identifier
(code)
Procedure date Date when procedure was performed
Treatment Recommendations Therapeutic recommendations that do not include drugs
recommendations description (diet, physical exercise constraints, etc.)

Recommendation Normalised identifier

ID (code)
Autonomy/invalidity Description Need for the patient to be continuously assessed by third
parties; invalidity status may influence decisions about
how to administer treatments

Invalidity ID code Normalised invalidity identifier (if any, otherwise free

text)
Medication List of current Active ingredient Substance that alone or in combination with one or
summary medicines lists more other ingredients produces the intended activity of
a medicinal product. Example: “paracetamol”
Brand name if a biological medicinal product or when
Exemption: brand justified by the health professional (ref. Commission
name Directive 2012/52/EU)
Active ingredient Code that identifies the active ingredient
ID code
(Relevant prescribed Strength The content of the active ingredient expressed
medicines whose quantifiably per dosage unit, per unit of volume or per
period of time unit of weight, according to the pharmaceutical dose
indicated for the form. Example: 500 mg per tablet
treatment has not
yet expired whether
it has been
dispensed or not)
Pharmaceutical The form in which a pharmaceutical product is
dose form presented in the medicinal product package (e.g. tablet,
syrup)

Number of units The number of units per intake that the patient is taking.
per intake Example: 1 tablet
Frequency of Frequency of intakes per hour/day/week/month.
intakes Example: every 24 hours
Duration of Example: 14 days
treatment
Date of onset of Date when patient needs to start taking the medicine
treatment prescribed

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Variable Variables (nesting Variables (nesting DEFINITION AND COMMENTS

(nesting level 2) level 3)
level 1)
Social Social history Social history Health related “lifestyle factors" or "lifestyle
history observations observations observations"
related to Example: cigarette smoker, alcohol consumption
smoking, alcohol
and diet
Reference date Example: from 1974 to 2004
range
Pregnancy Expected date of Expected date of Date on which the woman is due to give birth. Year,
history delivery delivery month and day are required (e.g. 01/01/2014).

Physical Vital signs Blood pressure One blood pressure value which includes: systolic
findings observations blood pressure and diastolic blood pressure

Date when blood Date when blood pressure was measured

pressure was
measured
Diagnostic Blood group Result of blood Result of blood group test performed on the patient
tests group
Date Date on which the blood group was performed. This
field may contain only the year if day and month are
not available (e.g. 01/01/2009).

Table 3: Patient Summary dataset for patient clinical data

METADATA
Variable Variables Variables DEFINITION AND COMMENTS
(nesting (nesting level 2) (nesting level 3)
level 1)

Country Country Country Name of country A

Patient Date created Date created Date on which PS was generated
Summary

Date of last update Date of last update Date on which PS was updated (date of most recent
version)

Nature of Nature of the PS Nature of the PS Defines the context in which it was generated.
the PS Distinguishes between three methodological approaches
for generating the PS: direct human intervention by an
HP, automatically generated approach and mixed
approach
Author Author Author At least one author organisation (HCP) shall be listed. In
organisation organisation organisation the event that there is no HCP, at least one HP shall be
listed

Table 4: Patient Summary dataset for metadata

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5. STANDARDS AND PROTOCOLS

Reference is made to three classes of material:

Background requirements and explanatory material

https://ec.europa.eu/cefdigital/wiki/x/30QZAg

Formal technical and semantic specifications

https://ec.europa.eu/cefdigital/wiki/x/30QZAg

Formal terminology bindings

https://ec.europa.eu/cefdigital/wiki/x/30QZAg

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