EHR Software Requirements Specification

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Hospital Health Information System – EU HIS Contract No. IPA/2012/283-805

This document has been produced with the financial assistance of the European Union. The views expressed herein can in no way be taken to reflect the official opinion of the European Union.

EHR Software Requirements Specification

Final version – July 2015

Visibility: Public

Target Audience:

EU-IHIS Stakeholders EHR System Architects

EHR Developers EPR Systems Developers

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Abbreviation List

CIS Central Information Service

CDA Clinical Document Architecture

PHC Primary Health Care

EHR Electronic Health Record

EPR Electronic Patient Record

EPR IS Information system which contains electronic patient record (HIS or PHC IS)

HIS Hospital Information System

HL7 Health Level Seven

IS Information system

JMBG Unique citizen number (Jedinstven matični broj građanina)

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Table of

1. EHR Data Categorization

Data kept in the EHR system are personal data. They are divided to:

• Administrative data (person, identification and contact data about person including: name, surname, date and place of birth, personal identification number – JMBG, address etc),

• Socio-medical data (medical data such as: blood type and organ donor; and social status data such as: marital status and employment) and

• Health data, which are further divided to:

• Health data of standard sensitivity and

• Sensitive („hidden“) health data

Sensitive („hidden“) health data are classified into one of the five categories (in accordance with HL7 standards) and are identified in two ways:

• Recognized by diagnosis, which are:

• Data related to HIV and viral Hepatitis

• Data related to mental health

• Data related to circumstances, which are:

• Data related to substance abuse (drugs, alcohol etc.)

• Data related to sexual and domestic violence

• Data related to alternative lifestyle (alternative religions, beliefs, family structure, sexual orientation etc.)

Health data are available to all health workers, who need to have access to data. Access to sensitive (“hidden”) data requires special action by user. Sensitive data encompass certain diagnosis, services, institutions and medicaments.

2. Data Exchange

• EHR receives data from the linked source systems (HIS, PHC IS, NHIF IS, CIS etc.).

• Data is sent from sources system to the EHR when contact (encounter or hospitalization) in healthcare institution is finished.

• According to needs, the source systems can send bulk of data document to the EHR, and the reasons can be as follows:

• Initial login to the EHR

• Sending of documents that were never sent due to long term interruption of connection with the EHR

• Repopulating of the EHR (transition from evaluation to production environment; recovery of the EHR)

• Following entities can forward data and have the right to modify person data:

• NHIF

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• EHR administrator

• HIS of the hospital first visited by the patient, that primarily sent data to the EHR (this is important only in the initial phases of the use, when only HIS are linked with the EHR system)

• NHIF and chosen doctors’ PHC institution (PHC institution in which patient’s chosen doctor works) are equally authorized to modify person data.

• EHR does not display person data (except identification data such as name, surname, sex, personal ID), rather only health data of identified person.

3. Identification of Person

• Data on person who cannot be uniquely identified is not sent to the EHR.

• Following identifiers are used for unique identification of person, as per specified order:

• JMBG (national identifier is used for foreigners without JMBG)

• Other ID number of person (number of one of the following documents is used: passport, refugee legitimation, driving license)

• Data on newborns are not sent to the EHR until he/she receives personal identifier (JMBG etc.), separate from mother.

• JMBG and LBO are used for identification of health workers. Identification number of the registry of health workers is not used because it changes over time.

• EPR IS (PHC IS, HIS or other similar IS) sends data on health workers during initial connection with the EHR, and each time when registration of a new health worker occurs in EPR IS. Health worker for whom the data does not exist in the EHR cannot send or access EHR data on patients.

4. Identification of Institution

• Health institutions have their own identifier, while departments of the institution most probably do not have one.

5. Health Data Access Right – Proposal

• Health data are divided to data of standard sensitivity and sensitive (“hidden”) data.

• Patient has the right to see his/her health data. Patients under custody represent the only exception. Person is under custody until the certain age (children), as well as persons who are declared incompetent to make decisions and custodian was assigned through appropriate legal procedure.

• Each person can have several chosen doctors in the PHC, up to three. For children these are paediatrician and dentist, for men these are general practitioner (GP) (or occupational medicine specialist) and dentist, while for women these are GP (or occupational medicine specialist), gynaecologist and dentist.

• The responsible doctor represents the one for which the patient gives a consent to be treated by.

• Every doctor can see all health data of a patient. With future developments, the system will enable other health workers to see the data too (nurses, pharmacists,..). Each doctor who is

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accessing health data of a certain patient receives the short summary of the most important data, while access to sensitive data requires additional action by user. Record (log) of identity of person who accessed the data and time of access are being kept.

• Certain institutions can access all data in case they have a court order, which is also recorded (logged).

• Patient can see the log regarding all his/her data.

6. EHR Patient Status – Proposal

A patient can allow or deny others to see to its data. Unless he/she specifies otherwise, data are displayed. In case that the data display is not allowed, EPR system will send data to EHR, but no one will be able to access it.

7. Categorization of Diagnoses

Diagnoses that patient has in his/hers health record are categorized based on selected time interval for which data are being displayed and based on their importance for patient’s health.

Categorization is as follows:

• Active diagnoses are those that are (or were) active in any kind of way for selected time interval (pre-determined or specified), whether their validity starts, ends or lasts during the selected interval. They can be illustrated as:

• Previous diagnoses encompass two groups of diagnoses:

• Past diagnoses – relevant for patient’s health, but without recorded data on contact with health institution in the EHR.

• Highlighted diagnoses – data on contact recorded, are not active (ended), but are marked as important by a doctor.

When displaying diagnoses per selected time interval, active and past diagnosis for the selected interval are displayed, while highlighted diagnosis are displayed only if they belong to the selected interval or are older than its beginning.

8. Categorization of Health Interventions (Procedures)

Health interventions (procedures), unlike diagnoses, do not have time duration, but have a certain status.

Categorization of procedures is as follows:

• Past procedures – relevant for patient’s health, but without recorded data on contact with health institution in the EHR

Diagnosis 1 Diagnosis 2 Diagnosis 3 Diagnosis 4 time beginning of interval end of interval

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• Highlighted procedures – data on contact recorded, are implemented and marked as important by a doctor

Past procedures can also be highlighted.

When displaying procedures per selected time interval, all procedures implemented during the selected interval are displayed, regardless of their status, as well as highlighted procedures that belong to the selected interval or are older than its beginning.

9. Display of Administrative Data

9.1. Display of the Basic Administrative Data

The basic administrative data are available to health professionals for the purposes of identification of patient whose data is being accessed and for obtaining basic data, such as age, gender or eventual date of death. These data include:

Data name Mark in the PD*

Surname 1.1.1.

Name 1.1.2.

Name of one parent 1.1.3.

Sex 1.1.4.

Date and time of birth 1.1.7.

Date and time of death 1.1.8.

Personal ID number - JMBG 1.2.1.

Table 1 – Basic Administrative Data on Patient

*PD – Patient dataset in the Electronic Health Record (EHR)

9.2. Display of All Administrative Data

The full display of administrative data is available only to the system administrator and it encompasses all administrative data on patient. Besides basic administrative data, these data include:

Data name Mark in the PD*

Citizenship 1.1.5.

Place of birth 1.1.6.

Other ID numbers of person 1.2.2.

Contact person 1.3.1.

Address and phone of contact person 1.3.2.

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Address and phone of legal custodian 1.4.2.

Personal insuree number - LBO 1.5.1.

ID numbers of chosen doctor issued by NHIF 1.5.2.

Chosen doctors’ institution ID number 1.5.4.

Place of residence 1.6.1.

Home address 1.6.2.

Contact details 1.6.3.

Health insurance 1.7.1.

Type of health insurance 1.7.2.

Marital status 2.2.1.

Employment 2.2.2.

Table 2 – Additional Administrative Data on Patient

10. Patient Summary

Health worker has a possibility to choose the display of health data on patient based on:

• Display verbosity

• short patient summary

• extended patient summary

• Time interval

• for pre-defined time interval – last 6 or 12 months

• for specified time interval – health professional can define time interval beginning and end Based on the combination of the display scope and the time interval specified by the user, the health data that meet the desired criteria is displayed.

10.1. Short Patient Summary

Short patient summary is initially displayed to health worker accessing the EHR, in case that the health worker selects this type of data display, or does not make a selection. These data include:

Data name Mark in the PD* Comment

Blood type and Rh factor 2.1.1. not linked to time interval

Previous diagnoses 3.1.1. in relation to time interval

Previous performed health interventions (procedures)

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Allergies 3.2.1. not linked to time interval

Medical implants 3.2.2. not linked to time interval

Medical devices 3.2.3. not linked to time interval

Prescribed medicaments (generic name, brand name)

3.5.3. (3.5.1., 3.5.2.)

in relation to time interval

Dispensed medicaments (generic name, brand name)

3.5.4. (3.5.1., 3.5.2.)

in relation to time interval

Hospitalization beginning date and time

3.6.3.1. not linked to time interval

Hospitalization end date and time 3.6.3.2. not linked to time interval

Final diagnosis 3.6.4.2. refers to hospitalization

Treatment outcome 3.6.4.6. refers to hospitalization

Primary cause of death 3.8. not linked to time interval

Table 3 – Short Patient Summary

In other words, display of short patient summary enables healthcare professionals to see following data:

• Not linked to time interval:

• blood type and Rh factor

• allergies

• medical devices and medical implants

• highlighted diagnoses

• past diagnoses (without recorded data on contact with health institution)

• highlighted procedures

• past procedures

• primary cause of death

• Linked to specified time interval:

• active diagnoses

• all hospitalizations of a patient, including final diagnosis and treatment outcome

• list of procedures included in the specified time interval regardless their statuses

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10.2. Extended Patient Summary

Extended patient summary is displayed to health worker who selects this type of data display. These encompass, besides short patient summary, following data on patient:

Organ donor 2.1.2. not linked to time interval

Family history 3.1.1. not linked to time interval

Mandatory immunizations 3.3.1. not linked to time interval

Other immunizations 3.3.2. not linked to time interval

Smoking 3.4.1. not linked to time interval

Obesity 3.4.2. not linked to time interval

Malnutrition 3.4.3. not linked to time interval

BMI 3.4.4. not linked to time interval

Elevated cholesterol 3.4.5. not linked to time interval

Elevated triglycerides 3.4.6. not linked to time interval

Alcohol intake (abuse) 3.4.7. not linked to time interval

Intake (abuse) of opioids and

psycho-active substances

3.4.8. not linked to time interval

Encounter end date and time (not hospitalization)

3.6.2.2. linked to time interval

Hospitalization beginning date and time

3.6.3.1. linked to time interval

Hospitalization end date and time 3.6.3.2. linked to time interval

3.5.3. (3.5.1., 3.5.2.)

refers to hospitalization and encounter that occurred during the specified time interval

3.5.4. (3.5.1., 3.5.2.)

refers to hospitalization and encounter that occurred during the specified time interval

Final diagnosis 3.6.4.2. refers to hospitalization and contact in

out-patient room that occurred during the specified time interval

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Treatment outcome 3.6.4.6. refers to hospitalization and contact in out-patient room that occurred during the specified time interval

Organ recipient 3.7. not linked to time interval

Table 4 – Extended Patient Summary

In other words, display of extended patient summary includes following data:

• Not linked to time interval:

• blood type and Rh factor

• allergies

• medical devices and medical implants

• family history

• immunizations

• risk factors

• whether the patient is organ donor or recipient

• highlighted diagnoses that are valid during the specified time interval or are older than specified time interval

• past diagnoses (without recorded data on contact with health institution)

• highlighted procedures

• past procedures

• primary cause of death

• Linked to specified time interval:

• active diagnose

• all contacts (ambulatory and hospitalizations), including relevant final diagnosis and treatment outcome

• list of procedures included in the specified time interval regardless their statuses

• prescribed and dispensed medicaments

10.3. Encounter Summary

Health worker can see details of contact that patient had with healthcare institution (encounter or hospitalization). In that case, following data related to observed contact are displayed:

Encounter beginning date and time 3.6.2.1.,3.6.3.1. refers to observed contact, which could

be encounter or hospitalization

Encounter end date and time 3.6.2.2.,3.6.3.2. refers to observed contact, which could

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Institution in which contact occurred Doctor responsible for the contact

Referral diagnoses 3.6.4.1. refers to observed contact, which could

Final diagnoses 3.6.4.2. refers to observed contact, which could

Additional diagnoses 3.6.4.3. refers to observed contact, which could

Related diagnoses 3.6.4.5. refers to observed contact, which could

Treatment outcome 3.6.4.6. refers to observed contact, which could

Health interventions (procedures) 3.6.5.1. refers to observed contact, which could

Status of health intervention (procedure)

3.6.5.2. refers to observed contact, which could be encounter or hospitalization

3.5.3. (3.5.1., 3.5.2.)

refers to observed contact, which could be encounter or hospitalization

3.5.4. (3.5.1., 3.5.2.)

refers to observed contact, which could be encounter or hospitalization

Form of administration of dispensed medicament

3.5.5. refers to observed contact, which could be encounter or hospitalization

Adverse effect of dispensed medicament

3.5.6. refers to observed contact, which could be encounter or hospitalization

Table 5 – Details Related to Contact with Healthcare Institution

Details related to contact of patient with the healthcare institution refer to specific contact, either as encounter or as hospitalization, and following is displayed:

• contact beginning and end time

• responsible institution and doctor

• all diagnoses related to that specific contact, regardless if they are referral, final or additional

• treatment outcome

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• prescribed and dispensed medicaments, form of administration and adverse effects of dispensed medicament

• all other details of importance for contact, if applicable (implants, devices, immunizations etc.)

11. EHR Access

User can access the EHR in two ways:

• through EPR system

• through web portal

11.1. EHR Access through EPR System

• The trust is established between the EHR and EPR system from which data is sent.

• User signs up to EPR system and requests to access EHR data from the same system.

• EHR takes over the following data on person accessing the EHR from EPR:

• persons’ identity

• persons’ location (institution and department in which person works, whether it is a static location where person primarily works or a dynamic location, where person is situated at the time of access)

• purpose of EHR use (reason for requesting to access the EHR data)

• Based on the submitted data, the EHR system will determine the user role and grant or refuse data access.

11.2. EHR Access through Web Portal

Will be detailed in the future. Possible use by health workers and by patients.

12. Interactions Between Source Systems and EHR

• Excerpt of data on patients that exists in source systems are being sent to EHR.

• Initially, all patients in source systems are marked as “dirty” and that mark is removed when the patient data is sent to the EHR.

• LIFO system (Last In First Out) is used for data transfer, which means that the data on patients inserted/updated in the recent past (patients who recently were in health institution which transfers data) are initially transferred from source system to EHR .

13. Data Exchange Between Source Systems and EHR

13.1. Data Exchange and Their Validation

• Data are exchanged in .xml format.

• Each .xml file relates to one patient (patient chunk).

• Data exchange flow:

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• validation (not synchronized)

• archiving in database (not synchronized)

• Validation is performed in two steps:

• check whether the document complies with CDA rules

• check whether the content is correct

• Each document has its ID (documentID) and receives .xml status upon upload and ID/token that is being returned to the sender. Possible statuses:

• not valid

• valid without error

• valid with errors

• archived in the database

• If the error occurs, the entire document is being rejected (in initial phase). Subsequent document from the same sender about the same patient is not being received until the previous, corrected document is received.

• Document is archived in the database only if it passed validation process.

• Working assumption: all data from source systems are connected with contact (encounter or hospitalization).

• Data that are sent from EHR can be presented as one of the following documents:

• summary of the most important patient health data, for selected time interval (pre-determined or specified) – Short Patient Summary

• summary of additional patient health data, for selected time interval (pre-determined or specified) – Extended Patient Summary

• summary of individual contact (encounter or hospitalization) – Encounter Summary

• report on hospitalization, contains the same information as the proscribed form of the same name – Hospitalization Report

• When data are changed, it is not partial update, but the entire document is replaced.

13.2. Hospitalization Report

The Hospitalization Report contains the same proscribed data as the paper form of the same report

“Obr. br. 3-21-61/62/65-Sr – Izveštaj o hospitalizaciji”, and is used for communication with Institutes

of Public Health, whether on local or on national level. The definition of this type of a document, to be exchanged and generated from the source system or the EHR, contributes to unification and standardisation of interoperability of the Serbian healthcare system. The Hospitalization Report contains the following data:

Data name Mark in

the PD*

Name and number in the Hospitalization Report

Institution in which hospitalization occurred

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Admission department (2) No. of history of disease (3)

Hospitalization beginning date and time 3.6.3.1. Admission date (4)

Name, Surname 1.1.2.,

1.1.1.

Name and surname of patient (5)

Personal ID number – JMBG 1.2.1. JMBG (6)

Date and time of birth 1.1.7. Date of birth (7)

Citizenship 1.1.5. Citizenship (8)

Sex 1.1.4. Sex (9)

Home address, Place of residence 1.6.2.,

1.6.1.

Residence address and municipality (10)

Health insurance 1.7.1. Insurance (11)

Personal Insuree Number– LBO 1.5.1. LBO (12)

Referral diagnosis 3.6.4.1. Referral diagnosis (13)

Injury (14)

External cause of injury 3.6.4.4. External cause of injury according to MKB

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Final diagnosis 3.6.4.2. Primary cause of hospitalization (16)

Additional diagnoses 3.6.4.3. Additional diagnoses according to MKB (17)

Health interventions (procedures) 3.6.5.1. Procedure code according to nomenclature

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Weight upon admission (for newborns) (19) Number of hours of ventilation support (20)

Hospitalization end date and time 3.6.3.2. Discharge date (21)

Hospitalization beginning date and time, Hospitalization end date and time

3.6.3.1., 3.6.3.2.

Number of days of hospitalization (22) Discharge department (23)

Treatment outcome 3.6.4.5. Type of discharge (24)

Primary cause of death 3.8. Primary cause of death (25)

Table 6 – Hospitalization Report

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13.3. Patient Registration

This document is being sent to the EHR by source system and contains administrative and socio-medical data, but not health data on patient. The purpose is to register previously unregistered patients in the EHR, since health data can be received only for registered patients. Some data are mandatory while some are not, as described in the document „EU-IHIS HL7 CDA Implementation and Validation Guide“. Patient registration contains following data:

Name 1.1.2.

Surname 1.1.1.

Sex 1.1.4.

Citizenship 1.1.5.

Place of birth 1.1.6.

Other ID number of the person 1.2.2.

Type of ID document 1.2.3.

Place of residence 1.6.1.

Home address 1.6.2.

Contact details 1.6.3.

Type of health insurance 1.7.2.

Marital status 2.2.1.

Employment 2.2.2.

Organ donor 2.1.2.

Contact person 1.3.1.

Address and phone of contact person 1.3.2.

Legal custodian 1.4.1.

Address and phone of legal custodian 1.4.2.

Table 7 – Patient Registration

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13.4. Healthcare Professional (HCP) Registration

This document is being sent to the EHR by source system and contains administrative data on healthcare professional. The purpose is to register previously unregistered healthcare professional in the EHR, since health data can be received if they are authored only by registered healthcare professional. Some data are mandatory while some are not, as described in the document „EU-IHIS HL7 CDA Implementation and Validation Guide“. Healthcare professional registration contains following data:

Name 1.1.2.

Surname 1.1.1.

Sex 1.1.4.

Specijalization Healthcare institution Organizational unit

Table 8 – Healthcare Professional Registration

13.5. Referral Request to Specialist

This document is defined based on the official paper document "Obrazac_OZ-2 -

Uput_za_ambulantno-specijalisticki_pregled" currently used in a referral process to support a

referral request of a patient from one health care provider or organization to another provider or organization (specialist). Based on personal ID number (JMBG) and Personal insuree number (LBO) establishes a connection with other referral data related to health insurance of the National Health Insurance Fund. Referral Request to Specialist contains following data:

Data name Mark in the PD* Name in the Referral Request to

Specialist Referring health institution (from which

the patient is referred)

Healthcare institution

Number of health record protocol

Referred health institution (to which the patient is referred)

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Specialization To specialist for:

Name, Surname 1.1.2., 1.1.1. Refers – Name and surname

Name of one parent 1.1.3. Refers – Name of one parent

Personal ID number - JMBG 1.2.1. JMBG

Personal insuree number - LBO 1.5.1. LBO

Clinical reason for the referral Reference is made to a specialist

examination in order to:

Referral Date and Time Date

Name and surname of the referring healthcare professional

Signature and facsimile of MD

Table 9 – Referral Request to Specialist

Referral request to specialist contains reference(s) to a clinical document(s) in the EHR (e.g., associated Encounter Summary)

13.6. Referral Request for Stationary Treatment

This document is defined based on the official paper document "Obrazac_OZ-3 - Uput za stacionarno

lečenje" currently used in a referral process. Based on personal ID number (JMBG) and Personal

insuree number (LBO) establishes a connection with other referral data related to health insurance of the National Health Insurance Fund. Referral Request for Stationary Treatment contains following data:

Data name Mark in the PD* Name in the Referral Request for

Stationary Treatment Referring health institution (from which

the patient is referred)

Number of health record protocol

Referred health institution (to which the patient is referred)

To healthcare institution

Name, Surname 1.1.2., 1.1.1. Refers – Name and surname

Name of one parent 1.1.3. Refers – Name of one parent

Personal ID number - JMBG 1.2.1. JMBG

Personal insuree number - LBO 1.5.1. LBO

Referral diagnosis 3.6.4.1. Diagnosis

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Name and surname of the referring HCP Signature and facsimile of MD

Table 10 – Referral Request for Stationary Treatment

Referral request for stationary treatment contains reference(s) to a clinical document(s) in the EHR (e.g., associated Encounter Summary)

13.7. Referral Fulfilment

This document is used to record a referral response in case of both Referral request to specialist and Referal request for stationary treatment and it is based uppon corresponding report(s) in paper form. Referral Fulfilment contains following data:

Data name Mark in the PD* Name from Report

Healthcare institution that provides report

Signed in on the day ___ at ___ hrs Examination finished ___ at ___ hrs ** Evidence-based protocol number

Prezime, Ime 1.1.1., 1.1.2. Prezime i ime osiguranika

Referral response - Narrative description

I have found that he/she is suffering from

Findings and opinion

Referral rejection – Narrative description

Reason for not retaining in treatment ***

Fulfilment Date&Time Date

Name and surname of the referred HCP

Signature and facsimile of MD

Table 11 – Referral Fulfilment

** These data can be found only in responses to Referral Request to Specialist.

*** This data can be found only in responses to Referral Request for Stationary Treatment.

14. Metadata

Following is recorded for each data in the EHR:

• data source system

• package in which data was sent to the EHR

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• department/institution where data was created

• person who created data in the source system

• time of data transfer to EHR

• data validity period

• whether data was deleted (logical deletion, not physical)

15. Versioning

Modification of data in the EHR is being monitored and versions kept, through recording of source system from which each data item was sent to the EHR, while data on what was modified and time of modification for each modification is recorded (in separate data version).

EHR Software Requirements Specification