Clinical Software Architectures · well as ordering of drugs. POE systems support formulation of...

Clinical Software Architectures

Benjamin Bergner

Data Management for Digital HealthWinter term 2018/19

Agenda

Data Management forDigital Health, Winter term 2018/19


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DataSources

DataFormats

BusinessProcesses

Processing and

Analysis

Oncology Nephrology Intensive Care

Additional Topics

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BiologyRecap

Agenda



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DataSources

DataFormats

BusinessProcesses

Processing and

Analysis

Oncology Nephrology Intensive Care

Additional Topics

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BiologyRecap

■ Only 60% of German clinics use EMR for internal access1

■ Germany occupies 10th place among 20 EU countries2

■ Leaders: Denmark, Sweden and Estonia

■ In Denmark: 99% of discharge letters are digital3

Electronic Medical Records (EMR) in Germany



4[1] https://www.presseportal.de/pm/8664/2723540[2] http://www.stiftung-muench.org/studie-zur-elektronischen-patientenakte-im-ausland-klare-vorgaben-des-gesetzgebers-sind-voraussetzung-fuer-erfolgreiche-implementierung/[3] http://www.sum.dk/~/media/Filer%20-%20Publikationer_i_pdf/2012/Sundheds-IT/Sundheds_IT_juni_web.ashx[4] https://e-estonia.com/solutions/healthcare/e-health-record/

Stiftung Münch, study of electronic

patient records in Europe (2015)4

■ Measures the adoption and utilization of EMR functions required to achieve a paperless environment that harness technology to support optimized patient care.

■ Shows progress against other healthcare organizations

EMR Adoption Model (EMRAM)



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http://www.himss.eu/healthcare-providers/emram

EMR Adoption Model (EMRAM)



6http://www.himss.eu/healthcare-providers/emram

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Economic Benefits of Healthcare Digitalization in Germany



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https://www.mckinsey.de/publikationen/2018-09-27-digitalisierung-im-gesundheitswesen

■ Electronic Medical Record (EMR):

□ Digitized versions of paperwork in a clinician’s office including medical history, diagnoses, medications, immunization dates, allergies

□ Transferring data out of the practice from EMRs is not convenient; patient records have to be printed or mailed for consultations.

■ Electronic Health Record (EHR):

□ Focus is on a patient’s total health, not just the standard clinical data

□ Broader view of care including overall past medical history, EMR data, lab data, imaging reports.

□ Can contain other relevant information such as insurance information, demographics, even data imported from personal wellness devices.

□ Facilitates data sharing outside the practice with other health care providers such as laboratories and specialists.

EMR vs EHR



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Processed Data in Hospitals: Patient Care



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Entity type Description

Patient is a person being subject of care; information about a patient includes the patient identification number (PIN)

Case mostly comprises a patient’s stay in a hospital from patient admission to patient discharge or several ambulatory treatments related to one disease; information about a case includes the case identification number (CIN)

Order is a request for a diagnostic, therapeutic or drug service, e.g. a laboratory order or a radiological order

Diagnosis is the identified cause or nature of a disease or medical condition

Processed Data in Hospitals: Resources



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Appointment determines what persons have to be at a certain place at a given time. Examples are appointment for patient admission, examination or surgery.

Bed must be managed according to its occupation.

Health care professional

a health care professional who treats according to his or her specialization (e. g. nephrology or pediatrics) patients with certain diagnoses. Health care professionals are for example physicians and nurses.

Drug is a substance administered to a patient for treatment, diagnosis orprevention

RxNorm - Contains all Medications Available on US Market.



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Processed Data in Hospitals: Administration



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Patient record archive

describes how and where the electronic or paper-based patient record can be found.

Classification of diagnoses

e.g. the International Classification of Diseases (ICD).

Cost unit information about a person or an institution responsible for bearing the costs

Processed Data in Hospitals: Management



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Business strategy defines the hospital’s long-term strategic goals

Strategicinformationmanagement plan

a strategic plan, which gives directives for the construction and development of a hospitalinformation system

Project a unique undertaking that is characterized by management objectives, restrictions with regard to available time and resources, and a specific project organization (DIN 69901)

Quality report openly published report about a hospital’s performance

Main Hospital Enterprise Functions



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■ Patient admission (short: admission) aims at recording and distributing the patient demographics and insurance data as well as medical and nursing data of the patient history. Each patient must have a unique identifier and be assigned to a unique case.

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■ Appointment scheduling, also in case of emergencies

■ Patient identification and checking for recurrent, using health insurance card

■ Administrative admission, creates a case summarizing hospital stay

■ Medical admission, done by physician, comprises patient history, admission diagnosis is stated as a result

■ Nursing admission, information like communication ability, nutrition, mobility

■ Visitor and information services, where is patient located?

Patient Admission



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■ Decision must be made upon diagnostic and therapeutic procedures

■ Must be able to consult internal/external experts, e.g. with tumor boards in cancer treatment

Decision Making, Planning, Organization of Patient Treatment



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Example for Planning: Molecular Tumor Board Software



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■ Preparatory work like researching on medications for mutations from literature and (curated) databases




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■ Presentation of patient research during the meeting




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■ Documentation of decided upon medication that can be given back to the treating physician




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■ Follow-up of treated patients for cancer registry


■ Must be able to consult internal/external experts, e.g. with tumor boards

■ Medication prescription may be supported by providing knowledge about adverse drug events




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Canada Vigilance Adverse Reaction Online Database



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■ Must be able to consult internal/external experts, e.g. with tumor boards

■ Medication prescription may be supported by providing knowledge about adverse drug events

■ Diagnostic/therapeutic procedures should be explained to the patient, documentation of the patient‘s informed consent and the decision making




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■ Diagnostic and therapeutic procedures must often be ordered at specialized service units (e.g. laboratory, radiology, or pathology). These units execute the ordered procedures and communicate the findings or results back to the ordering department

■ Preparation of an Order: specimen collection and assignment to patient

■ Appointment Scheduling, e.g. time slot for image modality, patient transport

Order Entry



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Paper Order Entry



25Paper-based order entrysystem for laboratory testing

■ Hospital must plan to offer adequate tools/resources (staff, room, equipment) for the execution of the necessary procedures.

■ All clinically relevant patient data (vital signs, orders, results, decisions) must be recorded and made available among involved persons, but also for legal justification.

■ Findings and reports must be transmitted to the ordering unit as fast as necessary

■ Data should be recorded in a structured way enabling statistics, computerized decision support and data retrieval

■ Data must always be linked to PIN and CIN

Execution of Diagnostic, Therapeutic and Nursing Procedures



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■ The hospital must be able to document and code all diagnoses stated

■ Are the basis for the hospital's billing!

■ Coding in a standardized way ICD-10

Coding of Diagnoses and Procedures



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International Classificationof Diseases (ICD)

■ Patient is discharged after treatment is terminated. Sometimes, patient is referred to other institutions

■ Administrative Discharge: Final billing happens, based on Diagnosis Related Groups (DRG): Criteria like diagnosis, procedures, patient age used for calculation

Patient Discharge



28Billing in Germany

■ Patient is discharged after treatment is terminated. Sometimes, patient is referred to other institutions

■ Administrative Discharge: Final billing happens, based on Diagnosis Related Groups (DRG): Criteria like diagnosis, procedures, patient age used for calculation

■ Medical Discharge: Attending physician writes a medical report including:

□ The relevant diagnosis

□ Important findings

□ Therapeutic procedures

□ The current patient state

□ Recommandations for further treatment

■ Nursing Discharge: Report is written including information like activity level, diet, wound care, etc.

Patient Discharge



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■ Hospital Information Systems:

□ Enables administrative functions around patient billing

■ Clinical Information Systems:

□ Enables patient management (e.g. documentation, scheduling)

■ Decision Support Systems:

□ e.g. regarding diagnoses, treatment decisions

Different Terms for Software Components



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■ Especially used for patient admission, discharge and billing

■ It must provide correct, complete and up-to-date administrative patient data for all other application components

■ In addition, all other application components must be able to transmit relevant administrative patient data (e.g., diagnoses) to the patient administration system

Application Components: Patient Administration System



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Application Components: Patient Administration System



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Screenshot of a patient administration system showing the patient list of a department of neurosurgery in the background and a window for assigning an appointment to a patient in the front

■ Supports specific documentation tasks with modules for different medical fields

■ Provides functions like speech-to-text, reuse of already documented data

■ Coding of diagnoses and procedures, must provide an easy search system

■ Is the basis for decision making and planning

Application Components: Medical Documentation System



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Application Components: Medical Documentation System



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A screenshot of a medical documentation system showing a list of patient-related documents on the left and an opened discharge letter on the right

■ A provider or physician order entry system (POE) (computer-supported POE systems are called CPOE) supports order entry.

■ This can comprise both order entry of diagnostic or therapeutic procedures as well as ordering of drugs.

■ POE systems support formulation of the order, appointment scheduling, printing of labels, and the communication of the order to the service unit

Application Components: Physician Order Entry System



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Application Components: Physician Order Entry System



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Screenshot of a lab order entry system. An order set of electrolyte has been chosen to see details (lower right). If available, results can already be reviewed (lower left).

■ Monitors, stores, and clearly presents a vast amount of patient-related clinical data in intensive care units (ICU)

■ May offer features for real-time decision-support and statistical analyses

■ Provide means for patient discharge and transfer to other wards or institutions, e.g. a short summary of the therapy on the ICU

Application Components: Patient Data Mangement System (PDMS)



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Application Components: Patient Data Mangement System (PDMS)



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Screenshot of a patient data management system showing a patient’s vital parameters and given drugs during a day

■ Supports operation planning and operation documentation as a specialization of execution of diagnostic and therapeutic procedures

■ It allows assigning of operation date and time, and therefore should be available on the wards as well as in the offices and management units of the operating rooms

■ During each operation, a vast amount of data has to be documented, including the members of the operating team, the operative procedure, the date and time, duration of the operation, materials (e.g. implants) used, and other necessary data to describe the operation and its results

Application Components: Operation Management System



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Application Components: Operation Management System



40The operation management system shows the surgeons as well as thepatients that are assigned to them. For each patient, the planned procedure and the status of the operation is displayed.

■ The enterprise resource planning system (often: ERP system) enables a hospital to manage its financial, human and material resources

■ One major goal is the documentation and billing of all accountable services.

■ It thus supports hospital functions such as:

□ controlling,

□ financial accounting,□ facility management,□ human resources management,□ quality management and□ supply and disposal management

Application Components: Enterprise Resource Planning System



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■ Contains data which have been extracted from other application components

■ The data have been aggregated and transferred into a suitable format and then actively loaded into the data warehouse (push-principle)

■ Can be used for hospital management or for research

■ Sample questions: What are the top ten diagnoses of the patients treated in our hospital? Which department of the hospital causes the highest material costs? In which department do patients stay longest on average?

■ Analyzing these data by data mining techniques

■ A data warehouse system supporting hospital management is often called business intelligence system

Note: There is an ISO standard (ISO TR 22221) on “Good principles and practices for a clinical data warehouse

(CDW)” which provides implementation guidance for data warehouses in HIS

Data Warehouse System



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Data Warehouse System



43Screenshot of a data warehouse system. The diagram shows a target/actual comparison for the bed occupation of a university hospital

■ Retains all data independent of whether it will be used someday

■ Also unstructured data like sensor data, text and images are stored without transformation

■ Are designed for low-cost storage and fast ingestion of new types of data

Data Lake



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https://www.searchtechnologies.com/blog/search-data-lake-with-big-data

■ HL7

■ FIHR

■ DICOM

■ ISO/IEEE 11073

■ CCOW

■ IHE

■ EDIFACT

■ CDA

■ …

Medical Data FormatsStandards for Data Exchange



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■ Describes message and event types exchanged between application components

■ Event-driven communication

■ Example messages:

□ ADT (Admission Discharge Transfer)

□ ORM (Order entry message)

Health Level 7 (HL7)



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Message

Event

Acknowledgement

■ ADT (Admission Discharge Transfer)

■ 51 different types of ADT messages

Health Level 7 (HL7)



47https://corepointhealth.com/resource-center/hl7-resources/hl7-adt

■ Builds on HL7 version 2.x and HL7 version 3.x

■ Supports both XML and JSON (RESTful API)

■ Building blocks: Resources, References and Profiles

■ Reasoning: 80/20 information model

Fast Healthcare Interoperability Resources (FHIR)



48https://www.hl7.org/fhir/

■ Building blocks: archetypes (define meaning), templates (assemble packages of data)

■ AQL – language for querying into the data

■ Clinical Knowledge Manager – online archetype manager

■ Reasoning: Maximal information model

openEHR



49https://www.openehr.org/

More on the Use of openEHR and FHIR



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https://www.youtube.com/watch?v=A5MujeGGeqY

https://www.youtube.com/watch?v=QnRgQ_dvkqc

Standards for Data Exchange: IHE



51Source: http://www.ihe.net/

■ Specifications, tools and services for interoperability

■ Sharing of health information across systems

■ Coordinated use of established standards (DICOM, HL7)

■ Addresses clinical needs described in domains such as pathology or eye care

■ Targets care provision workflows in profiles describing actors, their transactions and messaging formats

■ Operational Data Model (ODM)-XML

■ Enables exchange of clinical study data

■ Models a Case Report Form (CRF)

Data Formats for Clinical Studies: CDISC ODM



52https://www.cdisc.org/

Clinical Data Interchange Standards Consortium

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■ Operational Data Model (ODM)-XML

■ Enables exchange of clinical study data

■ Models a Case Report Form (CRF)

Data Formats for Clinical Studies: CDISC ODM



53https://www.cdisc.org/

Clinical Data Interchange Standards Consortium

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■ Digital Imaging and Communications in Medicine

■ Stored in a Picture Archiving and Communication System (PACS)

Standards for Data Exchange: DICOM



54http://www.santesoft.com/win/sante-dicom-viewer-free/img/modalities.png

■ Number of databases being used to store data

■ Number of application components

■ Number of different software products and vendors

■ Patterns of communication

■ Types of integration

Architectual Characteristics



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■ DB1:

□ often called the central database, one DB that stores all data

□ Schema and methods for access/storage of data must be known

□ Application components typically stem from the same vendor

■ DBn:

□ Several application components have their own

databases

□ Data is stored redundantly

Number of Databases: Central vs. Distributed



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Number of Application Components: Monolithic vs. Modular



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■ AC1:

□ One application component supporting all hospital functions

□ Usually not sufficient, typically specialized software

■ ACn

□ Modular architecture with more than one application component

□ Applications might share a single database

DB1, AC1 architecture

(DB1, ACn) architecture with multiple computer-based application components

Number of software products and vendors: all-in-one vs best-off-breed



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■ V1:

□ One vendor, homogenous all-in-one architecture

□ Independent from AC

■ Vn:

□ Several vendors, heterogeneous best-of-breed architecture

□ Typically DBn

Communication Pattern: Spaghetti vs Star



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■ Application components being part of an ACn architecture have to be connected to achieve integration

■ Spaghetti Communication Pattern, CPn :

□ Directly connect to ACs that need to exchange data

□ Increasing number of bidirectional

communication interfaces

(DBn, ACn, Vn, CPn) architecture

Communication Pattern: Spaghetti vs Star



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■ Star Communication Pattern, CP1:

□ Most DBn systems use a communication server as middleware

□ n interfaces for n applications

(DBn, ACn, Vn, CP1)

Integrity and Integration

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■ Object Identity: Patient gets a unique PIN, for each case a CIN

■ Referential Integrity: Correct assignment of CIN to patient or results to case

■ Consistency: Redundant data in DBn systems must be kept identical

■ Data Integration: Data is available wherever needed, no double recording/change

■ Semantic Integration: Sender and receiver interpret data in the same way,

e.g. ICD-10 for diagnoses, SNOMED for medical terms, LOINC for lab procedures

■ Access Integration: Applications are accessible where they are needed

■ Presentation Integration: Applications present data in the same way

■ Contextual Integration: e.g. non-repeated sign-on and patient selection

■ Functional Integration: Functions used by several applications are implemented once

■ Process Integration: uses all other integration types to conform to business processes

1. Patient admission event results in “A01“ HL7 event

2. Arrange data about patient and case in a HL7 message

3. Sending of message to communication server

4. Multicasting of message to all applications that need it

5. Applications receive message and store data in their DB systems

6. When updating patient/case over master application, “A08“ HL7 event is triggered

7-9. Arrange updated data in a HL7 message, send it to communication server and multicast to respective applications

10. All applications receive message and update DBs, data integrity is ensured.

Communication Server Example in a (DBn, ACn) Environment



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Medical Data Integration Center to leverage data between hospitals



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Medical Data Integration Center Components



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HiGHmed–an open platform approach to enhance care and research acrossinstitutional boundaries, Haarbrandt et. Al, 2018

Gesundheitscloud Architecture



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■ Storage of encrypted personal health data

■ Display your own data

■ Provide access to your data

■ User apps on top e.g. for analytics

■ Research platform leverages de-identified

data

What to Take Home?



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■ Medical informatics is a broad field with many different standards, terminologies and applications

■ There is an abundance of data and processes in hospitals

■ You know about the challenges involved in transforming clinical needs into IT solutions

Chapter 6

Reading Materials



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Clinical Software Architectures · well as ordering of drugs. POE systems support formulation of...

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