Migration of Telemedicine Applications to National Telematics

Infrastructure using Epilepsy Treatment as an Example

Salima Houta

1 a

, Tim Wilking

, Marcel Kl

otgen

1 b

and Falk Howar

2 c

Fraunhofer Institute for Software and Systems Engineering, Dortmund, Germany

Department of Computer Science, TU Dortmund University Dortmund, Dortmund, Germany

Keywords:

Telematics Infrastructure, IHE, HL7 FHIR, Epilepsy, Electronic Case Record, Electronic Patient Record.

Abstract:

Digitization in epilepsy treatment, which usually is an intersectoral effort, offers great potential. Aggregated

healthcare information from different actors involved in the treatment process provides an important basis for

therapy decisions. More and more telemedicine solutions for the treatment of patients with epilepsy focus in

particular on patient involvement via a digital seizure diary. This is intended to replace the currently mostly

paper-based diaries. However, there is no widespread use in practice. The introduction of the national telem-

atics infrastructure (TI) offers the opportunity to make telemedical applications accessible to a larger group

of patients and medical institutions in Germany. The E-Health Act, which came into force on December 29,

2015, deﬁnes a roadmap for the gradual introduction of a telematics infrastructure in the German healthcare

system. In addition to the speciﬁed TI components for secure and standardized data exchange, health IT ser-

vice providers can migrate their existing digital solutions for healthcare in the TI. This article describes the

migration of a developed telemedical infrastructure for epilepsy care into the national telematics infrastruc-

ture. First, an analysis of the telemedicine infrastructure is made with regard to supported integration options.

Then, considering the chosen approach, an integration concept is designed using an example scenario.

1 INTRODUCTION

Epilepsy is considered a complex chronic disorder

that is highly prevalent worldwide (Beghi, 2020) and

requires treatment by multiple healthcare providers

(Bast et al., 2017). In addition, patient self-

management and family involvement can be critical

to identify and optimize an appropriate diagnosis and

treatment (Kobau and DiIorio, 2003). Telemedicine

can support the coordination of epilepsy care among

stakeholders by using communication and informa-

tion technologies in order to share relevant data for

diagnosis and treatment. A major leap in the develop-

ment of telemedicine solutions for epilepsy patients

was triggered by the Corona pandemic (Power et al.,

2020; Cross et al., 2021; Datta et al., 2021; Banks

et al., 2021). Previously, there were few studies de-

scribing the use of telemedicine health technologies

in epilepsy care, mainly with the aim of providing

consistent care in rural and geographically isolated ar-

eas (Ahmed et al., 2008; Rasmusson and Hartshorn,

https://orcid.org/0000-0001-8452-4263

https://orcid.org/0000-0003-4109-8641

https://orcid.org/0000-0002-9524-4459

2005; Haddad et al., 2015; Lua and Neni, 2013).

Most of them cite beneﬁts in terms of patient satis-

faction and lower treatment costs. Although improv-

ing the quality and performance of care through in-

tegrated and comprehensive data collection as a basis

for therapeutic interventions is obvious, health tech-

nologies for cross-sector communication with elec-

tronic health records are not consistently used in

epilepsy care. Recent studies also emphasize that the

implementation of a solution is not sufﬁcient, but its

integration into existing processes and systems is es-

sential to achieve adoption by clinicians. Integrat-

ing epilepsy self-management applications into the

treatment process can also create beneﬁts. Typically,

these applications include modules such as seizure di-

aries, medication adherence protocols, medication re-

minders, medication allergy diaries, and support in

emergency situations (Alzamanan et al., 2021; Es-

coffery et al., 2018; Liu et al., 2016; Ranganathan

et al., 2015). Page et al. (2018) criticizes that the

information collected by self-management applica-

tions cannot be transferred easily to the clinical sys-

tem and must be recorded in a redundant and time-

consuming manner. In contrast to this, he positively

Houta, S., Wilking, T., Klötgen, M. and Howar, F.

Migration of Telemedicine Applications to National Telematics Infrastructure using Epilepsy Treatment as an Example.

DOI: 10.5220/0010904000003123

In Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2022) - Volume 5: HEALTHINF, pages 697-704

ISBN: 978-989-758-552-4; ISSN: 2184-4305

697

highlights that a health record co-authored by the pa-

tient has the potential to reduce effort. Technologies

for seamless data integration increase the acceptance

of such solutions. Changing existing ways of collabo-

ration supported by new technologies is challenging,

and the management of separated electronic health

records consumes additional effort if they are not in-

tegrated in the medical process and existing technol-

ogy (Page et al., 2018). Project MOND, funded by

the Ministry of Health, aims to integrate a developed

telemedicine infrastructure for epilepsy treatment into

the existing system infrastructure. This includes an

epilepsy self-management application, a web portal

for patient (and family) communication with physi-

cians, and solutions for physician-to-physician com-

munication based on international standards (Houta

et al., 2020). Standardized integration into existing

system landscapes has not yet been implemented and

are subject of this paper.

In this paper we contribute integration approaches

for telemedicine infrastructures into existing system

landscapes. We use the national telematics infras-

tructure (TI), which has created the prerequisites for

a nationwide exchange of medical data (Jorzig and

Sarangi, 2020). In the Background section, this ar-

ticle ﬁrst describes our telemedical solution to be in-

tegrated. Then, in the same chapter, Digital Health

Applications and the TI, which are both regulated by

law, are presented. Afterwards, the applied methods

are explained in detail. In the Results section, deci-

sions on the classiﬁcation of our solution as well as

different integration settings are presented using an

epilepsy reference scenario as an example. This is fol-

lowed by a discussion of the different integration ap-

proaches. The paper concludes with a summary and

an outlook on the next steps.

2 BACKGROUND

2.1 Telemedical Infrastructure for

Epilepsy Treatment with Electronic

Case Record Integration

In a project funded by the German Federal Ministry of

Education and Research, hospitals, technical partners,

scientists as well as patients and relatives have jointly

designed a telemedical infrastructure for epilepsy care

with Electronic Case Record integration (TEPI). The

compontents of TEPI (Figure 1) are described in more

detail in the following sections.

2.1.1 Sensor-based Mobile Application

The sensor-based mobile application is a daily com-

panion for the patient. The patient can record data

(e.g., seizures, side effects, medication use, and

mood) and share it with their therapists and family

members via secure sharing mechanisms. In addition,

the patient can receive data from their therapists. If

a shared structured medication schedule is available,

it can be used in the patient application as a basis for

medication reminders. The mobile application is con-

nected to a sensor that measures vital signs and events

(e.g., seizure events). It uses the security and data

exchange services of the telemedicine infrastructure

to securely edit, store and share data. The developed

mobile application is currently being restructured ac-

cording to the guidelines of a Digital Health Applica-

tion (BfArM, 2020).

2.1.2 Web Portal

Depending on the user role, the web portal either in-

tegrates just the services of the telemedicine infras-

tructure (e.g., if the user is a patient or informal care-

giver), or the services of the ECR infrastructure (e.g.,

if the user is a physician) in addition. The portal

provides authenticated physicians with a view of all

epilepsy case records from their medical institution

that are stored in the ECR infrastructure. The case

records are created after the patient has provided a

valid consent. Physicians can store various medi-

cal information relevant to intersectoral epilepsy care

within the ECR and share it with other medical in-

stitutions involved in the treatment, provided they are

also authorized by the patient to access the ECR. The

portal allows storage of both unstructured information

such as physician letters in PDF format and structured

data such as the structured medication plan based on

the FHIR format. Physicians can share medical infor-

mation (e.g., medication plan) with the patient, and

they can see if new data has been received from the

patient (e.g., seizure documentation) and store that

data in their own medical data management system.

The web portal can also be used by patients and infor-

mal caregivers (e.g., parents) with the telemedicine

infrastructure.

2.1.3 FHIR-based Telemedical Infrastructure

The patient as well as relatives are connected via the

telemedicine infrastructure. The implementation is

based on the lightweight HL7 FHIR standard, as the

focus is on the connection of mobile devices as well

as the transmission of structured data collected via the

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698

Figure 1: Telemedical Infrastructure for Epilepsy Treatment.

app or transmitted by the sensor. The telemedicine in-

frastructure includes both data exchange and security

services. Security mechanisms ensure that authenti-

cated patients can give selected healthcare providers

access to therapy-relevant data. Access is possible

both via the mobile application and the web portal.

Authenticated and authorized healthcare providers

can use the web portal to retrieve patient data or share

data with the patient.

2.1.4 IHE-based ECR Infrastructure

For the exchange between medical stakeholders in-

volved in the treatment we use the Electronic Case

Record (ECR). The ECR was developed in Germany

to support communication between physicians in-

volved in a treatment case (Kuhlisch et al., 2012).

It targets the treatment of diseases involving multi-

ple physicians and focuses in particular on ”long-term

patients” with severe or chronic diseases, whose treat-

ment progress needs to be tracked and regularly coor-

dinated by multiple stakeholders. The architecture of

the ECR is based on Integrating the Healthcare Enter-

prises (IHE) proﬁles and takes into account national

privacy and data security requirements. Case records

are tied to a diagnosis or purpose and thus are not

non-speciﬁc data collections. The ECR is ”physician-

led,” meaning it is authored and controlled by physi-

cians, and thus, unlike patient-managed records, pro-

vides a reliable basis for treatment decisions. The

ECR infrastructure includes data exchange and secu-

rity services. In order to involve non-medical actors

in the data exchange, the ECR Infrastructure can be

connected with the telemedical services (Deiters and

Houta, 2015).

2.2 Digital Health Applications

Digital health applications (DiGA) are medical de-

vices of risk class I and IIa according to the Medi-

cal Device Regulation (MDR). Physicians and phys-

iotherapists can prescribe DiGAs for health insur-

ance beneﬁts as a part of a therapy since the Digital

Health Care Act (DVG) came into force on Decem-

ber 19, 2019. Patients and physicians are the target

users of the developed DiGA. Thus, physicians will

receive additional remuneration if additional services

become necessary with the use of the DiGA. For a

DiGA to be prescribed, it must be listed in the so-

called DiGA directory. Manufacturers must provide

scientiﬁc evidence of a positive supply effect of the

application. After inclusion in the DiGA directory,

the medical reimbursement system is adjusted with

the medical services required in connection with the

DiGA. In addition to demonstrating a positive care

effect, manufacturers of DiGAs must meet require-

ments including security and functional suitability,

conformity with the General Data Protection Regu-

lation, user-friendliness, and compatibility commit-

ments regarding support for standards and the telem-

atics infrastructure. (BfArM, 2020)

2.3 National Telematics Infrastructure

in Germany

According to § 291a (7) (2) SGB V, the company

Gesellschaft f

ur Telematikanwendungen der Gesund-

heitskarte mbH (gematik) creates an interoperable

and compatible TI and coordinates its operation. The

TI is a closed network that can only be used by reg-

Migration of Telemedicine Applications to National Telematics Infrastructure using Epilepsy Treatment as an Example

699

istered users with special ID cards and connectors or

access gateways (Figure 2). It connects stakeholders

in the ﬁeld of health (e.g. doctors, hospitals, phar-

macies, patients) and ensures the cross-system and

secure exchange of information (Jorzig and Sarangi,

2020). The complete speciﬁcation is available on the

gematik portal. The rough architecture is described

below.

2.3.1 Consumer Zone

The Consumer Zone is located in healthcare organi-

zations and consists of information systems and their

interaction logic. TI applications can be integrated via

client modules (e.g., medication add on) into existing

systems.

2.3.2 TI Core - Decentralized and Central Zone

The core of the TI infrastructure is comprised of the

decentralized zone and the central zone. The compo-

nents of the decentralized zone include all TI compo-

nents that are set up and installed in a healthcare or-

ganization to enable the secured use of the TI. These

are, for example, smart cards, card terminals and

the connectors. Smartcards are issued to individuals

or healthcare organizations and aim to ensure secure

data exchange through authentication and encryption.

Speciﬁc e-Health Card terminals for use with the TI

can be connected to the TI connector. Each time a

connection between an e-Health card terminal and a

connector is established, the terminals must authenti-

cate themselves to the connector. Access to a patient’s

medical data located in the Provider Zone of the TI is

only possible via a two-factor authentication process.

Both the physician and the patient must authenticate

themselves with their smartcard using the card termi-

nals. The connector then represents a gateway to the

TI network with security features such as a ﬁrewall

and VPN connections. It enables information sys-

tems of the healthcare organizations to securely ac-

cess smart cards and the e-Health card terminal. The

TI connector also ensures that systems in the medical

organisations are protected against attacks originating

from the TI network. The central zone hosts central

services of the TI that are essential for communica-

tion and data exchange. These include, among others,

the OSCP responder and the conﬁguration services as

well as a healthcare directory service.

2.3.3 Provider Zone

The Provider Zone is directly connected to the Cen-

tral Zone and includes all TI applications. Appli-

cations of the TI are standardized solutions that ad-

dress central and modular use cases in healthcare.

The goal of this approach is to create uniform imple-

mentations of these use cases in the health IT land-

scape and thus to facilitate and support development

of added value and interoperability. The TI deﬁnes

the following applications: Electronic Prescription,

Electronic Patient Record (ePA), KIM - Communica-

tion in Medicine, Electronic Medication Plan, Emer-

gency Data Management, Qualiﬁed Electronic Signa-

ture, Management of Patient Data and TI Messenger.

All TI applications must comply with the speciﬁca-

tions of the TI platform to ensure secure and standard-

ized operation. Applications are accessed via client

modules that are part of the Consumer Zone.

The core application of the TI is the ePA, which

supports data exchange between the patient and the

healthcare provider, but also data exchange between

several healthcare providers. The patient can use the

ePA via an access gateway of the ePA front end, which

is provided by the patient’s health insurance company.

Healthcare providers can access the ePA via the TI

connector, but must be authorized to access data by

the patient using an identiﬁcation card. The connec-

tor establishes the secure and standardized exchange

of systems in medical organisations with the ePA sys-

tem in the TI. A new draft law from the German Fed-

eral Ministry of Health stipulates that patients should

be able to send data from DiGAs to the ePA and vice

versa from April 2023 (

Arzteblatt, 2021). Prerequi-

sites for this are created with the ongoing speciﬁca-

tion of HL7 FHIR-based medical information objects

(MIO) (Weber and Heitmann, 2021).

2.3.4 Existing Application Zone

gematik intends to ensure the use of the telematics

infrastructure for other applications of the healthcare

system as well as health research in accordance with §

291a (7) sentence 3 SGB V. For this purpose, gematik

sets the conditions for the use of TI by other appli-

cations to be met by providers, as well as the de-

tails of the conﬁrmation process as well as the neces-

sary test criteria. These “other applications” (“Weit-

ere Anwendungen f

ur den Datenaustausch in der TI”,

WANDA) are distinguished into the WANDA Basic

and WANDA Smart applications. WANDA Smart ad-

dresses other health care applications which are em-

bedded in the Provider Zone of the TI. These appli-

cations have access to TI services. WANDA Basic

are other health care applications without access to

services of the TI in connected healthcare networks.

The difference between these application types is the

degree of integration into the TI. The deeper the inte-

gration, the more complex the approval process. After

a successful approval, an application is listed in the

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700

Figure 2: German National Telematics Infrastructure.

interoperability directory vesta (Grode and L

uckhof,

2021).

2.3.5 Personal Zone

The patient’s applications are located in the personal

zone and are also under the patient’s control there.

Access to the TI (e.g. via the ePA front end) is se-

cured via access gateways.

3 METHOD

With the analysis of the legally regulated DiGAs and

TI, we were able to identify basically two integration

paths for TEPI.

• Integration as a WANDA

• Integration via the ePA

To conceptualize the integration as a WANDA, we

ﬁrst applied gematik’s criteria to TEPI to determine

which type of application best represented our appli-

cation. Subsequently, based on the medical guide-

line for epilepsy (Bast et al., 2017), we formulated

an example scenario describing different sections in

the treatment process in different participating insti-

tutions and considering patient involvement via an

epilepsy self-management application. Along the sce-

nario, we have outlined a hybrid integration design

considering integration as a WANDA and integration

via the ePA.

4 RESULTS

4.1 Classiﬁcation

Since we develop and operate several telemedical ap-

plications with ECR integration that we intend to mi-

grate to the TI, we are pursuing the integration of an

Existing Application Zone in the TI. For the use case

we are developing, using TI services does not add sig-

niﬁcant value to interoperability. For example, the TI

directory service does not map all the groups of peo-

ple that should have access to the epilepsy data in our

use case, and therefore cannot be used. Thus, our inte-

gration strategy follows the WANDA Basic approach.

4.2 Integration Settings

With the approval as WANDA Basic, the TEPI re-

mains in its own network, but is accessible via the TI

for other TI users. Moreover, linking the ePA with our

Mobile Application, which is intended to be approved

as a DiGA, enables the exchange of structured data,

such as seizure documentation via the ePA. Thus, sev-

eral integration settings are conceivable, which are

outlined in Figure 3 and discussed below.

4.2.1 WANDA Basic - Loose Integration

This integration solution uses the TEPI, which is in-

tegrated in the TI as WANDA, for data exchange in

the context of epilepsy treatment. All TI users have

the option of using the TEPI applications, provided

this is deﬁned organizationally. In this solution, only

the web portal and the mobile app are used for the

Migration of Telemedicine Applications to National Telematics Infrastructure using Epilepsy Treatment as an Example

701

Figure 3: Integration Settings in Epilepsy Treatment. 1: WANDA - loose integration; 2: WANDA - deep integration; 3:

DiGA-ePA integration.

exchange via TEPI. This enables cross-institutional

secure exchange between care providers involved in

treatment and between care providers and patients via

the TI for all TI users. However, requirements for

seamless communication without media disruptions

are not met. Data must be recorded redundantly and

time-consumingly by the service providers in order

to get from the TEPI to the existing systems or vice

versa, since there is no integration in the existing sys-

tem landscape in this setting.

4.2.2 WANDA Basic - Deep Integration

In this setting, a greater depth of integration is sought.

Since TEPI is based on IHE and ECR, systems sup-

porting these standards can easily be extended with

client functionalities for importing or exporting data.

For example, seizure documentation from TEPI can

be displayed via a hospital information system and

transferred to the local patient record after validation

by healthcare providers. Similarly, data originating

from hospital information systems can be shared with

additional healthcare providers or the patient. In addi-

tion to the interfaces for sending data, security func-

tions (e.g., authentication to TEPI) must be consid-

ered in the primary systems separately, since the au-

thentication services of the TI are not used for TEPI.

4.2.3 WANDA Basic - DIGA-ePA Integration

In this setting, the mobile application (DiGA) is in-

tegrated via the ePA. The patient sends data (MIOs)

from his DiGA to his ePA and authorizes relevant

healthcare providers for access via the ePA front end

(Figure 4). Authorized physicians can view and use

the patient’s data via the ePA module in the medical

facility. The implementation of integrating DiGAs

and ePAs is still in its early stages, but promises to

be far-reaching as data from the DiGA reaches physi-

cians who do not (want to) use other systems besides

the ePA to exchange data with other physicians or pa-

tients.

4.2.4 Discussion

This paper discussed the importance of integrating

existing telemedicine solutions into the existing sys-

tem landscape in medical facilities. The basis for in-

tegration is the legally required TI. The integration

approaches described are not mutually exclusive, but

represent approaches that can be operated in parallel.

While the loose integration of WANDA can be de-

ployed quickly with little effort and adaptation of ex-

isting systems, the other integration settings involve

greater implementation effort. This The additional

effort is beneﬁcial, since a deeper integration of pa-

tient co-authored data supports the medical and orga-

nizational process by avoiding redundant documenta-

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702

Figure 4: Sequence Diagram Send Data from DIGA to ePA.

tion. For a short time-to-market, it is advisable to start

with loose integration and, if the system manufactur-

ers are willing to implement appropriate interfaces, to

replace the loose integration with deep integration.

We decided to take a hybrid approach, as both

ePA and ECR-based solutions like TEPI have differ-

ent goals. While ePA pursues a digital aggregation of

all patient data from different medical facilities and is

patient-driven, ECR addresses case-related commu-

nication between service providers and is controlled

by them. Thus, TEPI can be used as a WANDA in

the narrow treatment concept of epilepsy and can be

speciﬁcally used and coordinated by physicians in-

volved in the treatment of epilepsy. Nevertheless,

there are information objects that are also relevant in

other treatment contexts (e.g., medications). Here, the

integration to the ePA offers a possibility to exchange

them across treatment cases.

A restriction with regard to the integration of all

actors in our use case via the TI still exists due to the

restriction of the possibility of also connecting infor-

mal caregivers to the TI. Therefore, an informal care-

giver can only be integrated into the data exchange via

the patient as an intermediary.

5 CONCLUSION

Our goal in this paper was to present a concept for

integrating a telemedicine infrastructure with the TI.

A detailed analysis of the types of systems (DiGA) or

infrastructures (TI) in healthcare driven by law was

our starting point. Using an example scenario, we de-

veloped and discussed integration settings for TEPI.

There is no solution that can be applied to all medical

facilities. Here, depending on the willingness of sys-

tem vendors to adapt their systems as well as on the

treatment context, it has to be decided which integra-

tion setting is suitable in a medical organization.

We are currently working on a regulatory roadmap

for the introduction of the developed system solutions

into the healthcare market. A prerequisite for the op-

erationalization of our solution is the successful com-

pletion of the conﬁrmation procedure, taking into ac-

count the gematik approval criteria, as well as the ap-

proval of the mobile application as a DiGA. A com-

plete implementation of our integration approach is

not yet possible, as concepts for the integration of

DiGA and ePA still have to be awaited. Here, we

want to get involved in the development of MIOs to

harmonize epilepsy data nationwide. Another impor-

tant step is to approach the manufacturers of the sys-

tems of the participating hospitals in order to pre-

pare a deep integration into their systems. Ideally,

this should also be based on already established user-

centered concepts of process support in epilepsy treat-

ment by technical systems in order to promote accep-

tance by users.

ACKNOWLEDGEMENTS

The authors acknowledgement the ﬁnancial support

by the Federal Ministry of Health in the framework of

MOND (project number G512F11007).

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