[A3, P5] Assignment 3

Aufgaben

1. Define the goals of your data collection session.
Wer nutzt momentan bereits die Smoke Free App (Durchschnittsalter, Geschlecht, techn. Affinität, Dauer der Nutzung, Raucher-Anamnese, ...)? Welcher der Funktionen dieser App werden aktiv genutzt oder fehlen Funktionen? Gibt es Erfolge/Erfolgsgefühle, oder Frustration?


2. Based on your goal, derive the stakeholders you want to collect data from.
App-Nutzer: Nikotinabhängigkeit und Raucher.


3. Start with collecting information without approaching your stakeholders (secondary data collection). 
Die App ‘Smoke free’ wurde von David Crane entwickelt und am 12.08.2014 auch im Google App Store veröffentlicht. Als er bei seinen eigenen Bemühungen, mit dem Rauchen aufzuhören, keine passende App gefunden hat, entwickelte er ‘Smoke free’.
Die App hat Funktionen, die kostenfrei zur Verfügung stehen. Dazu gehören: 
- das Dashboard mit einem Smoke Free-, Gesundheits-, und einem Spar-Timer, einer Wall of Fame und einem kleinen Überblick über den Rest der Funktionen
- ein Tagebuch
- die Möglichkeit, Cravings zu notieren und managen 
- Aufgaben und
- Achievement Badges

Für ein einmaligen Preis von 6€ oder 1,10€ wöchentlich hat man Zugriff auf weitere Funktionen: 
- Techniken zum Ändern des eigenen Verhaltens (bez. Rauchen)
- Cravings-Analyse
- Quit Coach und 
- weitere Aufgaben und Achievement Badges

Zahlt man 28€ für einen Premium-Account, werden zusätzlich zu den Pro-Features folgende Leistungen angeboten: 
- Personalisierter Stop Smoking-Plan
- Check-ins (4x/wöchentl.)
- 24/7 Zugriff auf Ratgeber
- Virtuell stattfindende Diskussionen

4. Prepare an interview study with your primary stakeholders.
Stakeholders: 
Da wir uns auf die Usability der App fokussieren möchten, beschäftigen wir uns mit den Personen, die täglich und direkt mit der App interagieren; in diesem Fall die App-Nutzer: Nikotinabhängigkeit und Raucher. 

Interview: 
Struktur:
Wir haben uns für ein semi-structured Interview entschieden, da wir so einige grundlegende, vergleichbare Informationen zu unseren Stakeholdern erhalten, ohne unseren Blick auf die App und deren Nutzung einzuschränken. Wir haben noch immer eine beschränkte Vorstellung von der App, ein strukturiertes Interview kann daher leicht zu einem Tunnelblick führen. 

Ablauf:
Einleitung: 
Guten Tag, vielen Dank, dass Sie sich die Zeit für dieses Interview genommen haben. Ich bin [Name], Student an der FU Berlin im Bereich Informatik, und arbeite im Rahmen eines Projektes an einer Analyse der Smoke free-App von David Crane. Das Interview hat eine Dauer von ca. 15-20 min und wird mit Video aufgenommen. Persönliche Daten werden, wie in der Einverständniserklärung erklärt wurde, anonymisiert gespeichert und sind nur innerhalb unseres Projektes einsehbar. Gibt es bisher Fragen?
Dann fangen wir an.

Fragen: 
1) Können Sie mir etwas über sich erzählen? (Anamnese)
2) Wann und warum haben Sie mit dem Rauchen angefangen? 
3) Warum möchten Sie mit dem Rauchen aufhören? 
4) Wie sind Sie auf Smoke free gekommen? 
5) Was mögen und nutzen Sie gerne an der App? 
6) Was funktioniert nicht so gut? 
7) Wie fühlen Sie sich bei der Nutzung der App?

Schlussteil:
Vielen Dank für Ihre Teilnahme. Falls Sie uns noch etwas mitteilen möchten, können Sie uns gerne kontaktieren. 

Reflexion

Was habt ihr gelernt?
Es steckt eine Menge Arbeit hinter einem gut vorbereiteten Interview.

Wer hat welchen Beitrag geleistet?
Hendrik hat sich mit den Entwicklern/Vertreibern der App in Verbindung gesetzt und den Premium-Zugriff erhalten.
Clara hat die Aufgaben bearbeitet, die anderen haben korrigiert und hinzugefügt.  

Was lief gut?
Wir haben ziemlich schnell eine Antwort von den Betreibern der Smoke free-App und damit einen Premium-Zugriff erhalten.

Was möchtet ihr verbessern?
Kommunikation im Team und die Zeitplanung (teils durch mögliche Projektänderungen) ist noch etwas schwierig

[A3, T2] Thoughts on Assignment 3

Define the goals of your data collection session.
What do you want to find out? These goals should be based on your project goals.

1. Conducting a survey or interviews to identify the key factors that are important to people when choosing a health insurance company, and how ePA policies and practices fit into those factors.

2. Based on the insights from the survey or interviews, designing a set of questions that would help users compare different health insurance companies and make an informed decision. These questions could cover aspects such as the availability and accessibility of electronic patient records, data privacy and security policies, and the quality and accessibility of healthcare services.

3. Creating a digital tool or application (Wahl-O-Mat) that presents the user with a set of questions based on their preferences and priorities, and provides them with a recommendation on which health insurance company to choose.

4. Testing the effectiveness of the tool by dividing users into two groups – one group uses the tool to choose a health insurance company, while the other group relies on Google or other search engines to find information. You could then compare the outcomes between the two groups to determine the efficacy of the tool in helping people make an informed decision.

Based on your goal, derive the stakeholders you want to collect data from.
What are your stakeholders? Whom do you need to approach (i.e., who is indispensable for your achieving project goals)?

  1. health insurance companies
  2. people that are looking for a new health insurance company

Start with collecting information without approaching your stakeholders (so-called secondary data collection). Use existing websites, app information, and experience the app by yourself. Describe the app you are using in detail (who has developed the app, why, what functionality is available, how can people access the app, etc.)

The ePA  is a digital health record app developed by the Gematik, a German government organization responsible for the digitalization of the healthcare system. The ePA app is designed to provide users with a secure and centralized platform to manage their health records and interact with healthcare providers.

The app is available to all insured persons in the German health insurance system and can be downloaded for free from the app store on Android or iOS devices from the health insurance company. Once downloaded you can sign in using the approach given by the health insurance company.

The ePA app offers a range of functionalities, including the ability to view and manage personal health records, such as medical reports, vaccination records, and medication plans. The app also enables users to share their health records with healthcare providers and receive digital prescriptions directly to their ePA.

The app uses end-to-end encryption to protect users personal health information, and users have full control over who can access their records and for what purposes. There is also the option to cancel the ePA completely. 

Prepare an interview study with your primary stakeholders.
Name the stakeholders and explain, why they need to be interviewed. Explain, how you want to contact them.
Justify the type of interview (structured, unstructured, semi-structured).
Prepare the introduction and the closing session as well as the consent form as well as the questions (the interview should be 20 to 30 min long)
Describe how you plan to conduct the interview (Who is taking notes? How do you take notes? Who is asking questions?)

Stakeholders: Health insurance companies in Germany

Reason for interview or email: Health insurance companies are important stakeholders for the Wahl-O-Mat project as they provide healthcare services to the general public. By interviewing health insurance companies, we can gain insights into their ePA policies and practices, which can help the development of the Wahl-O-Mat tool and improve its usefulness for users.

Contact method: We plan to contact health insurance companies via email or webex, requesting a 20-30 minute interview with a representative of the company. We will explain the purpose of the interview and inform them that their responses will be published in our Wahl-O-Mat .

Interview type: Semi-structured interview, as it allows for a flexible conversation while still ensuring that the key topics are covered.

Introduction: We will introduce ourselves, explain the purpose of the interview, and ask for their consent to participate.

Questions:

1. How does your company approach the topic of ePA? 

2. How do you ensure the security and privacy of patient data in your ePA systems?

3. Have you or your IT service provider been the victim of a cyber attack in the past?

4. How do you make electronic patient records accessible to patients and healthcare providers?

5. How do you ensure the interoperability of your ePA systems with other healthcare providers?

6. What role do you see ePA playing in the future of healthcare?

7. On what OS versions are your ePA and APP running?

8. Do you have any tutorials on how to install and how to sign in into the ePA?

9. Do you provide a way to use the ePA without a smartphone?

10. Do you provide information about risks on the patients data?

In German (because the communication with the health insurance companies will be in German):

1. Wie wird das Thema ePA in Ihrem Unternehmen angegangen?

2. Wie gewährleisten Sie die Sicherheit und den Datenschutz von Patient*innendaten in Ihren ePA-Systemen?

3. Wurden Sie bzw. Ihr IT-Dienstleister in der Vergangenheit Opfer eines Cyberangriffs?

4. Wie machen Sie elektronische Patientenakten für Patient*innen und Gesundheitsdienstleister*innen zugänglich?

5. Wie stellen Sie die Interoperabilität Ihrer ePA-Systeme mit anderen Gesundheitsdienstleister*innen sicher?

6. Welche Rolle wird die ePA Ihrer Meinung nach zukünftig in der Gesundheitsversorgung spielen?

7. Auf welchen Betriebssystemversionen laufen Ihre ePA und Krankenkassen-App?

8. Stellen Sie Anleitungen für ePA-Registrierungs- und Anmeldungsprozesse zur Verfügung?

9. Bieten Sie eine Möglichkeit, die ePA ohne Smartphone zu nutzen?

10. Informieren Sie über die möglichen Sicherheitsrisiken bzgl. der Patient*innendaten?

Closing session: We will thank the interviewee for their time and input, and ask if they have any additional comments or insights they would like to share.

Consent form: We will use the consent form shown us in the lecture

Unsere Reflexion der letzten Woche:

Wer hat welchen Beitrag geleistet?

Christopher hat sich mit den Fragen befasst und den Ablauf grob geplant. Die anderen haben ergänzt.

Was habt ihr gelernt?

Es ist zeitaufwendig, sich Interviewfragen zu überlegen.

Was lief gut?

Wir haben uns schnell auf unser neues Thema einigen können. Wir hatten unterschiedliche Vorstellungen, welche Stakeholder wir in dem kommenden Interview kontaktieren möchten, die Diskussion darüber war aber sehr konstruktiv, sodass wir nun alle zufrieden mit dem Weg sind, den wir einschlagen wollen.

Was möchtet ihr verbessern?

Und ist nichts aufgefallen, was wir aktuell verbessern möchten

[A#2, T4] ePA or DiGA Part 2?

Reflection of last week

Instead of investigating a non existing DiGA or an existing Health app that is not registered as a DiGA tackling Asthma, we decided to go for an existing DiGA or even switch to the ePA. The ePA is more interesting to us three and also affects all of us. It will soon be relevant to the entire German society and thus have a big impact. Additionally, the ePA is easily (we all see about that) accessible to all of us and brings some interesting questions. Some points of interest are the acceptance and usage of the ePA among doctors and the meaning and consequences for the elderly or other groups not that are less familiar with or able to use digital services.

Humanity centered design

The main take away from the article is the concept of Humanity Centered Design, meaning a design approach that is not focused on the individual user but on the society or humanity as a whole. The goal of a humanity centred design is to benefit the global good and wellbeing. This concept is hard to apply to apps that are specifically developed to fit the German law that defines the DiGA.

The German laws regarding medical devices and DiGA’s create a narrow scope in which any software has to reside to be deemed eligable. Such constraints can cause friction with the concept of Humanity Centered Design.
An important area regarding our project goals is Monoculture. Since our DiGA is developed and distributed in Germany specifically, it is easy to fall into the trap of defaulting to a classic Western/German view on design and usability. But Germany is not a monocultural place but instead very diverse and increasingly so. Additionally health care is intended to impact and help every part of society, no matter their cultural background. Understanding the access to health care as a universal right, also implies that the health care service’s (i.e. the DIGA’s) usability is universal too.

The aim of the ePA itself is to benefit the German society, its health system and medical staff by making processes more efficient and transparent. Everyone living in Germany is a potential stakeholder of the ePA. As mentioned for the DiGA, the ePA should not be designed with a German/western focus because Germany is a diverse place and many people from different cultural and social backgrounds will be using the ePA apps.

Ressources

TK DiGA Report:

https://www.tk.de/resource/blob/2125136/dd3d3dbafcfaef0984dcf8576b1d7713/tk-diga-report-2022-data.pdf

AOK DiGA Umfrage:

https://www.aok.de/pk/cl/rh/inhalt/apps-auf-rezept-insgesamt-positiv-bewertet-aber-fuer-viele-verzichtbar/

LinkedIn zu UX in DiGAs:

https://de.linkedin.com/pulse/usability-und-user-experience-ux-von-digitalen-diga-hosun-lee?trk=articles_directory

Bewertung einiger DiGAs von Stiftung Warentest:

https://www.test.de/Digitale-Gesundheitsversorgung-Apps-vom-Arzt-verordnet-was-steckt-dahinter-5552344-0/

what?

We aim to improve the experience of the user that is interested in using the Kaia COPD application. Currently the app only allows users to create an account and either type in an authentication code provided by the users health insurance, or a print out to get a prescription for the app, that can directly be signed by the users doctor.
There is no way, to get additional information on the app itself and its features. Instead it feels more like an ad campaign within the app itself. This is especially off putting as the direct advertisement (i.e. tv/radio/… commercials) for prescription-mandated medicine is banned in Germany and therefor the approach by Kaia COPD feels misplaced.

Uns würde auch interessieren, wie Ärzt*innen, Praxispersonal oder Apotheken mit der ePa umgehen. Auch die Nutzung für ältere Menschen stellen wir uns schwierig vor – wie gehen Menschen mit einer solchen App um, die nicht zu den „digital natives“ zählen?

why?

Kaia COPD is currently the only DiGA in the respiratory disease category and therefore the first and only valid stop for patients diagnosed with COPD. Improving the registration and exploration phase can improve the satisfaction and trust of the user, especially since DiGA’s are not widely adopted yet.

We are interested in how well doctors are already handling the ePA, especially because they are overwhelmed by work most of the time and are using different and often old software to manage their patients. Elderly are an interesting group because they rely very strongly on the health system but at the same time are often insecure about using digital services.

who?

Direct stakeholders: patients with COPD diagnosis
Indirect stakeholders: doctors, health insurances

The stakeholders of our specific questions are doctors, pharmacists, elderly and people insured at TK.

where?

The user interacts with the software whenever the active component (i.e. exercising) is appropiate. This can include the gym, your own home on a yoga mat, in the park, or other sport friendly spaces.

The ePA, especially as an opt-out app, will be used by many people in many situations. Wether it is at the doctor, the dentist, the hospital, the pharmacy or at home.

Reflektion

Entscheidungsprozess nimmt viel Zeit ein. Auch weil uns die genauen Anforderungen etwas unklar sind.

Zeitmanagement muss besser werden. Arbeitsteilung läuft gut 🙂

Arbeit mit Trello hilft, weil man zusammenarbeiten kann.

Wir müssen unser Thema, Stakeholder etc stark einschränken bis nächste Woche.

[A2, P3] Assignment 2

Main insights


The article highlights the importance of designing products and services with a human-centered perspective that prioritizes the needs and experiences of the people who will use them. This approach requires a deep understanding of user behavior and preferences, as well as a focus on empathy, collaboration, and iteration. The points that are important for a humanity-centered design approach include solving the root issues, focusing on the entire ecosystem, taking a long-term approach, continually testing the designs, and working with the community.

In our project, it’s important not just to think about solving smoking habits itself but to understand the root issue – what’s putting back people who try to quit smoking. And as a result, to provide an app that supports users and knows which problems they are going to have on their journey.

Useful resources

Sicherheitslücke edupression: https://www.heise.de/news/DiGA-Hacker-offenbaren-Sicherheitsluecken-in-Depressions-App-8989065.html

FaQ Diga: https://www.bfarm.de/DE/Medizinprodukte/Aufgaben/DiGA-und-DiPA/DiGA/_node.html

Nebenwirkungen rauchen aufhören: https://www.barmer.de/gesundheit-verstehen/psyche/sucht/rauchen-aufhoeren-koerper-1055172

Rauchen aufhören: https://gesund.bund.de/rauchen#nach-dem-rauchstopp

ePA: https://www.bundesaerztekammer.de/themen/aerzte/digitalisierung/digitale-anwendungen/telematikinfrastruktur/epa

Research article about the relative effectiveness of a full versus reduced version of the ‚Smoke Free‘ app: https://www.researchgate.net/publication/327810529_Relative_effectiveness_of_a_full_versus_reduced_version_of_the_’Smoke_Free’_mobile_application_for_smoking_cessation_a_randomised_controlled_trial/fulltext/5ba5a410a6fdccd3cb69e679/Relative-effectiveness-of-a-full-versus-reduced-version-of-the-Smoke-Free-mobile-application-for-smoking-cessation-a-randomised-controlled-trial.pdf

Does the addition of a supportive chatbot promote user engagement with a smoking cessation app? An experimental study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6775545/pdf/10.1177_2055207619880676.pdf

W-questions

What is the challenge you would like to tackle?
First, we would like to provide a user with a short instruction on how to use the app. The content library and dashboards should be improved to make it less overwhelming and intuitively understandable. We want a person to feel the guidance, support, and efficiency of using the app. That’s why our goal is to connect the daily tracking with the motivation section and some advice – all of which are now separated.

Why do you expect your engagement to be useful?
The suggested changings in the app will make it more intuitive and supportive. As a result, people will be more likely to use it longer and quit smoking.

Who are your intended stakeholders?
Direct: smokers
Indirect: health institutions, doctors and hospitals, insurance companies, social circle of smokers, environment specialists, researchers, the tobacco industry, sustainability experts, human rights organizations (no more child labor on tobacco fields), government (regulation of cigarettes (see new zealand), fewer taxes), tobacco farmers, biodiversity experts (fewer tobacco fields mean more possible other plants on the fields), city cleaning service (don’t need to clean the waste of cigarettes)

Where is your user group interacting with your software?
At home, in the hospital, or on the go.

When is the user group interacting with your software?
Any time during the day when the user wants to fix the result, write some thoughts, see the progress, or get some advice. Possibly while being in the hospital.

Reflexion

Wer hat welchen Beitrag geleistet?

Wir haben gemeinsam zum Thema Rauchentwöhnung recherchiert und einige relevante Studien gesammelt.
Alexandra hat sich mit den für unsere App relevanten Stakeholder und den 5 W-Fragen beschäftigt.
Anna hat die Reflexion geschrieben und sich um die Aufbereitung der Informationen für den Blogpost gekümmert. Henry hat hilfreiche Informationen zum Zulassungsverfahren von DiGAs gesammelt.

Was habt ihr gelernt?

Wir haben uns mit der DiGA „Smoke Free“ intensiv beschäftigt und sowohl gelernt, welche Funktionen diese bietet, als auch wie ihr Bezahlmodell funktioniert. Ebenfalls haben wir gelernt, welche Voraussetzungen eine App mit sich bringen muss, um als DiGA zugelassen werden zu können, als auch was die Unterschiede zwischen einer vorläufigen und dauerhaften Aufnahme sind.

Was lief gut?

Wir konnten uns schnell auf eine konkrete DiGA festlegen. Ebenfalls haben wir ein Miro-Board angelegt, um stets einen guten Überblick über unsere gesammelten Quellen als auch gewonnenen Erkenntnisse zu haben.

Assignment 3

This assignment requires you to develop a better understanding of your project. We expect you to become an expert in your domain and understand existing challenges properly. In this assignment, you start with collecting data which will provide the foundation for the following weeks. Collecting data helps you describe the precise circumstances of the problem you are trying to solve. It is necessary to get to know your users and other stakeholders in depth.

Create the first part of your Data Collection Plan.

  1. Define the goals of your data collection session.
    What do you want to find out? These goals should be based on your project goals.
  2. Based on your goal, derive the stakeholders you want to collect data from.
    What are your stakeholders? Whom do you need to approach (i.e., who is indispensable for your achieving project goals)?
  3. Start with collecting information without approaching your stakeholders (so-called secondary data collection). Use existing websites, app information, and experience the app by yourself. Describe the app you are using in detail (who has developed the app, why, what functionality is available, how can people access the app, etc.)
  4. Prepare an interview study with your primary stakeholders.
    Name the stakeholders and explain, why they need to be interviewed. Explain, how you want to contact them.
    Justify the type of interview (structured, unstructured, semi-structured).
    Prepare the introduction and the closing session as well as the consent form as well as the questions (the interview should be 20 to 30 min long)
    Describe how you plan to conduct the interview (Who is taking notes? How do you take notes? Who is asking questions?)
  5. You will conduct a pilot study in the next exercise, thus, be prepared for this.

Deliverable: Summarize your answers in a blog post again! Use the provided template. Please ensure that the post is pleasantly layouted. For example, graphics and images are great (Lächeln)

[A2, P5] Assignment 2

Aufgaben

Teilaufgabe 2
Read the article on „Humanity-Centered Design„ and think about the main insights. What values are important for you and your team regarding your project goals. Please describe those in about 100 words.
The article on “Humanity-Centered Design” by Don Norman describes five core principles. Of these, the principles of ‘reiterating design tests and refining will show the focus and needs of ecosystem the system will reside in’ and ‘as you design the system for the community, integrating community in the design process will ensure that the system meets the needs of the community’ are heavily dependant of each other, and interest our team. ‘Consider as much of the ecosystem as possible when designing systems’ is important to these as well, seeing as the ecosystem it is the community and all that surrounds and impacts them.


Teilaufgabe 3
Interesting sources and data to our DiGA 'Smoke free':
1)https://smokefreeapp.com/
2)https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6347038/pdf/f1000research-7-19461.pdf
3)https://www.gesundesried.at/die-smoke-free-app-interview-mit-dr-david-crane/
4)https://makesmokinghistory.co.uk/latest/the-smoke-free-app-giving-you-the-motivation-you-need-to-quit-smoking/


Teilaufgabe 4
Please answer the following questions (by reflecting on the feedback received in the exercise):

What is the challenge you would like to tackle?
We’d still like to focus mainly on utility, usability and data security.

Why do you expect your engagement to be useful? Why is that an interesting problem?
Any issues examined in the context of this course can then be used to assist developers in further development of the examined, and similar, application. The better these applications are, the more they can help people struggling with a variety of health issues.

Who are your intended stakeholders? And who might be the indirect stakeholders?
As we examine the application for issues on security, utility and usability, one of our intended stakeholders is  the developer of ’Smoke free’, David Crane PhD. Another stakeholder are patients struggling with nicotine addiction said applications are intended to assist with easing the usage of the application.
Indirect stakeholders are Health insurance providers. They can profit from the increasing effects, as DiGAs can replace more costly treatment and illnesses, especially in matters of mental health, as well as the patient's immediate social circles, who gain from said patients‘ increased or more manageable health.

Where is your user group interacting with your software?
As the smoke free application is a smartphone app, any user can interact with the app wherever they go while carrying their smartphone.

When is the user group interacting with your software?
Users are advised to interact with the app both regularly and spontaneously. Daily diary entries, for example, recording their feelings and difficulties can help spot easy to miss patterns, while using the app to distract or motivate them during nicotine cravings can prevent relapses.

Reflexion:

Was habt ihr gelernt?
Der Artikel zu Humanity-Centered Design überraschte mit dem Ausmaß der Gesellschaft und Umgebung, die beim Design eines Systems betrachtet werden kann. Die cause-and-effect webs und das Betrachten von möglichen Ursachen der Probleme statt simple Symptombehandlung sollte auch nicht unterschätzt werden.

Wer hat welchen Beitrag geleistet?
Teilaufgabe 2 wurde von Clara zusammengefasst.
Wir haben alle unsere Krankenkassen kontaktiert, jedoch keinen Zugriff auf eine DiGA erhalten. Wir haben uns daher erstmal für die ‘Smoke free’ App entschieden, entscheiden uns bei Zugriff auf eine andere App möglicherweise um.

Was lief gut?
Die Konzepte des Artikels waren verständlich, wenn auch etwas abstrakt. Teilaufgabe 2 war dadurch schnell bearbeitet.

Was möchtet ihr verbessern?
Wir müssen an einer konkreteren Ablaufplanung der Übungsbewältigung arbeiten. Eine Umentscheidung auf eine andere App, falls möglich, ist angestrebt.

[A2, P6] – Narrowing down the vision

Insights


Humanity-Centered-Design

Humanity-Centered-Design ist ein Ansatz, der die Perspektive im Erschaffen von Software auf eine höher angeordnete Ebene hebt. Hierbei besteht der Anspruch der Designer darin, Probleme im Kontext der Systeme, in denen sie entstehen, zu erkennen und daran zu arbeiten, den Umgang der Menschen damit zu verbessern. Dementsprechend wird der Blick von den bloßen Nutzenden der Anwendung erweitert auf die Gesamtheit der Personen, die von der Software betroffen sein können.

Dabei ist es wichtig, sich der verschiedenen Verzerrungen der eigenen Perspektive bewusst zu werden, die unter anderem durch die eigene politische, wirtschaftliche, geographische und soziale Situation maßgeblich beeinflusst wird.

Wichtige Grundsätze dieses Ansatzes sind hierbei das Fokussieren auf die Gesellschaft als Ganzes, das Erkennen von Kernproblemen, lang anhaltenden statt sofortigen Erfolgen, kontinuierlichem Verbessern und Testen sowie aktives Arbeiten mit den letztendlich Betroffenen.

Unser Projekt wird sich voraussichtlich mit Personen beschäftigen, die gewisse Einschränkungen der visuellen Wahrnehmung aufweisen. Durch den Ansatz des Humanity-Centered-Design ergibt sich dabei für uns im Speziellen, dass wir mit direkt Betroffenen der ePA und unseres Projektes arbeiten. Somit können wir die Wünsche und Bedürfnisse unserer Zielgruppe direkt im Arbeitsprozess einbinden und validieren unsere Arbeit nicht erst im Nachhinein.

Dafür möchten wir zum Beispiel Kontakt mit Blinden- oder Sehbehinderten-Verbänden aufnehmen, um mit unserer Zielgruppe in Verbindung zu treten.


Insights

Our project will likely deal with individuals who have certain visual perception limitations. Through the Humanity-Centered-Design approach, the following learnings arise for us:

  1. Working with people affected by the ePA and our project and for this purpose, i.e. contacting associations for the blind or visually impaired

What is the challenge you would like to tackle?

The registration and activation of the ePA applications is difficult and sometimes not working at all. There are multiple steps to follow for creating an account and signing up for using the ePA. One of these steps included installing a separate app by a different company to authenticate via a government ID. If one has not went through that process before the ID will need some further configuration.

Additionally, at least one application of a major health insurance company is not working on an „old“ device with Android 8.

We are considering to use the desktop version of one specific ePA application for our project, but maybe we can find another mobile application, that we can use.

ePA desktop application on Windows 10

Why do you expect your engagement to be useful?
Why is that an interesting problem?

We want to create an easier process for activating the ePA. The current applications seem to be segregating non tech-savvy users. Especially elderly people could be overwhelmed by the process. This group of users can be considered as an integral part of the presumably targeted user group by ePA applications, considering Germany’s demography.

different age groups and percentage of smartphone users, 2021

Furthermore, this segregation could be intensified by the application, which is only being able to run on the newest operating systems.

We did not find studies connecting higher age and older android versions, but the relative percentage of android users peaks in the older user groups.

Android devices generally have shorter update and maintenance coverage timespans. Therefore depending on newer OS versions for functional applications either forces users to own the newest devices or not be able to use the applications at all.

https://de.statista.com/statistik/studie/id/71707/dokument/smartphone-nutzung-in-deutschland/

smartphone OS usage by age group in 2019

Who are your intended stakeholders?
And who might be the indirect stakeholders?

Given the challenges, the stakeholders benefiting the most would be the direct users, especially with non tech-savvy backgrounds. Elderly people can be considered a significant part of this group.

Indirect stakeholders for our goals would be the people benefiting by a better acceptance of the application and a wider use. This group consists of all stakeholders with the health of users in mind like hospital staff, physicists and emergency service employees.

We do not fully know how the data of the different ePA applications is used for „science“. There could be other parties benefiting from a wider use of the applications as well, like pharmaceutical companies, that want to use the gathered data to earn more money.

Where is your user group interacting with your software?

The main user group we would like to focus on will use the software either on their mobile devices, which can be used in all locations imaginable, or on stationary computers.

When is the user group interacting with your software?

The situations for interacting with the software is the day-to-day process of having health issues. Direct users are expected to access their ePA for managing their digital receipts, documents for and from physicians and paperwork regarding health in general.

The expected time of using the applications is probably during the day, but in fact the users can try to access them anytime.

Reflexion

We did some initial individual research and gathered our findings. We then came together again for writing this blogpost and deciding on how to continue with the project.

We learned that the ePA system holds a high potential of failure or impracticality by the way it is implemented. The decentral and self-sufficient approach results in an ununiform spectrum of usability and performance of the different systems.

In addition, we read of problems with hacking at „Bitmarck“, one service provider of health insurance companies, which is at least one explanation for currently not functional service and ePA applications.

We are not quite sure about our one specific project goal and need to work on that in the future.

There are various possibilities we could concentrate on: the registration process, the availability on different operating systems and their versions or the focus on one specific user/stakeholder group and its needs or wishes.

Eigenschaften der DiGa als Medizinprodukt

Artikel 2 des Digitale-Versorgung-Gesetz (DVG) beschreibt DiGA als „Medizinprodukte mit niedriger Risikoklasse […], die der Risikoklasse I oder IIa nach Artikel 51 in Verbindung mit Anhang VIII der Verordnung (EU) 2017/745 [über Medizinprodukte] […] zugeordnet und als solche bereits in den Verkehr gebracht sind. […]“

Welche Eigenschaften muss eine DiGA erfüllen und was bedeutet das genau?

EigenschaftErläuterung
Es handelt sich um Software als Medizinprodukt.Als Medizinprodukt muss die DiGA per Definition des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) entweder bei der Erkennung, Überwachung, Behandlung oder Linderung von Krankheiten oder der Erkennung, Behandlung, Linderung oder Kompensierung von Verletzungen oder Behinderungen unterstützen.
Die DiGA dient nicht der reinen (Primär-) Prävention.Auch wenn es sich bei Präventions-Apps prinzipiell um Medizinprodukte handeln kann, sind diese als DiGA Anwendung ausgeschlossen. Wie im DiGA-Leitfaden des BfArM beschrieben, muss es sich um eine digitale Anwendung handeln, welche ein Arzt im Falle einer Krankheitsdiagnose verschreiben kann.
Niedrige Risikoklasse nach Anhang VIII der Verordnung (EU) 2017/745 über Medizinprodukte (I oder IIa).Die 22 risikobasierten Regeln aus dem Anhang der Verordnung müssen gemäß der Zweckbestimmung der medizinischen Software beantwortet werden, um das Risikopotential und damit die Klasse zu bestimmen. Hilfe zur Klassifizierung der Software findet man in der Guidance der Medical Device Coordination Group (MDCG).
Die Hauptfunktion beruht auf digitalen Technologien.Mit einer App bzw. einer browserbasierten Anwendung, einer sogenannten Stand-alone Software ist dieses Kriterium bereits auf natürliche Weise erfüllt. Mit dieser Anforderung wird Hardware im Allgemeinen (z. B. Blutdruckmessgeräte) als DiGA ausgeschlossen.
Der medizinische Zweck wird wesentlich durch die digitale Hauptfunktion erreicht.Darunter ist zu verstehen, dass die medizinische Softwarelösung nicht nur zum Steuern eines Gerätes oder ausschließlich der Erfassung von Gesundheitsdaten (z. B. mittels eines Sensors) dient, sondern auf Basis von (erhobenen) Daten eine Diagnose oder sogar weiterführende Therapien berechnet.
Der Patient ist alleiniger oder Hauptnutzer.Die DiGA sollte so ausgelegt sein, dass diese vom Patienten allein oder gemeinsam mit dem Arzt verwendet werden kann. Der Arzt darf also bei der Nutzung mit einbezogen, aber nicht der alleinige Nutzer der digitalen Gesundheitsanwendung sein.

Registrierungsvoraussetzungen für die Listung im BfArM-Verzeichnis

  • Anforderungen an Sicherheit und Funktionstauglichkeit (Die Basis hierfür bildet die technische Dokumentation des Medizinprodukts nach Anhang II, der Verordnung (EU) 2017/745 über Medizinprodukte. Diese belegt die Grundlegenden Sicherheits- und Leistungsanforderungen des Anhang I selbiger Verordnung.)
  • Anforderungen an Datenschutz und Informationssicherheit (zentrale Vorschrift für die Verarbeitung von Gesundheitsdaten ist dabei § 22 BDSG (ggf. i. V. m. Art. 9 DSGVO).
  • Anforderungen an Interoperabilität
  • Anforderungen an Robustheit
  • Anforderungen an Verbraucherschutz (Anforderung Transparenz zum Leistungsumfang der DiGA, genaue Angabe der Zweckbestimmung und der Leistungsmerkmale, frei von Werbung, d.h. Sollten Herstellen In-App-Käufe bereitstellen, dürfen sie auf diese zwar sachlich hinweisen, sie aber nicht aktiv bewerben)

Quelle

https://www.devicemed.de/diga-das-wichtigste-auf-einen-blick-a-9fe3487c6f2b98d6fb071c8c858a7a6a/

[A2, T2] Thoughts on Assignment 2

Summary of the article:
“Humanity-Centered Design” cares less about designing small things and more about designing political systems that solve 21st-century problems like the climate crisis, world hunger, poverty, etc. Thus, in addition to Human-Centered design, the focus is not only on individuals but on all of humanity and all living beings and their environment.

Our main takeaways:
The most important principle is to design together with the community and not for the community. Unfortunately, this is not feasible for our small student project. What we can do, however, is to examine how the electronic health record has so far been developed past the needs of the community.
Another important principle of humanity-centered design that we would like to use for our project is to solve the root cause of the problems, not just the problem itself.
Continually testing the design isn’t feasible either, because we do not have a test group. We might show it to the other people in the course or friends and family, but those tests are not representative.

More useful resources:
• Telematics infrastructure of gematik:
https://www.gematik.de/telematikinfrastruktur
• Bitmarck’s plan for future versions of the ePA

Including a typo

• Disruptions in the gematik telematics infrastructure: https://fachportal.gematik.de/ti-status#c7551

Information of gematik regarding the cyber attack

More resources on the Cyber attack:
• Bitmarck’s FAQ on the cyber attack

• Tagesspiegel’s article on the cyber attack, in which interesting questions are asked:
“When one considers the major role that the ePA is to play in the future for the treatment of insured persons and also for health research, one can nevertheless ask whether it is really such a good thing that 80 out of 96 health insurance companies depend on Bitmarck for IT issues. Measured in terms of the number of insureds, the company is also systemically important, with a one-third share of the SHI market. However, the success of the ePA stands and falls with the security of the data stored there.”
(https://background.tagesspiegel.de/cybersecurity/systemrisiko-bitmarck; translated to English)

• Heise article on the cyber attack

• Especially interesting comments on the Heise article:
Umfangreicher Artikel zum Vorfall wünschenswert

Völlig vernachlässigt in der bisherigen Berichterstattung …

„Nachwirkungen“ ist völlige Untertreibung

• More than one week after the cyber attack, the health insurance company SBK is not even reachable via e-mail: https://www.sbk.org/

Warning label on the website of the SBK

The other W-questions:
1. What is the challenge you would like to tackle?
For example, the registration process is challenging, the privacy policy is not well explained, and the utility of the app is not transparent.

We aim to address the infrastructure supporting the ePA (electronic health record) across DAK, BKK24 and TK, and explore whether they share a common backend and infrastructure, as well as the associated risks.

2. Why do you expect your engagement to be useful?
Why is that an interesting problem?

We believe that this investigation could uncover potential challenges faced by ePA providers and offer recommendations for addressing them, while also fostering a more human-centered approach to the topic.
The investigation is also useful for the insured. For decades, the main reasons for choosing a health insurance company were the offers for insured persons: particularly favorable prices or reimbursements for certain examinations and medications that are not reimbursed by other health insurance companies. With the increase in cyber-attacks, one now also has to worry about the IT service providers of health insurance companies. Which service providers are frequent victims of attacks? What is the crisis communication of the service provider and the health insurance company? How secure is my data? How long does it take after an attack for everything to get back to normal?

3. Who are your intended stakeholders?
And who might be the indirect stakeholders?
For example, elderlies, parents, people with a certain illness, etc.

Intended stakeholders involved would encompass health insurance providers, medical personnel, patients and people who want to change their health insurance company or need to choose a health insurance company for the first time, such as foreigners who want to work in Germany.
Indirect stakeholders may include the government, developers, hackers, researchers, and more.

4. Where is your user group interacting with your software?
For example, at home, in the hospital, or on the go.

Whether in the hospital, at home, or on the go, the mobility of the app enables it to be used anywhere, making it especially valuable to have readily available in case of an accident.

5. When is the user group interacting with your software?
For example, only when being in the hospital, while biking, or daily in the morning.

Every time information regarding medications or patient data is required. Besides that, users might be interested in their data outside a specific incident. Users will normally not interact with their ePA daily unless they are receiving treatment over a couple of days or weeks and have to add/look up information on a regular basis.

Unsere Reflexion der letzen Woche:
Wer hat welchen Beitrag geleistet?
Lilli hat die Aufgabe mit dem Artikel über Humanity Centered Design gemacht und angefangen, über den Cyberangriff auf Bitmarck zu recherchieren. 
Christopher hat sich mit dem 5W´s beschäftigt, basierend auf dem Feedback aus dem letzten Tutorium.
Jan hat die Ergebnisse Aufgaben ergänzt und aufbereitet sowie den Blog Post veröffentlicht und einen Google Drive Ordner sowie zur Organisation erstellt.

Was habt ihr gelernt?

Der IT-Dienstleister Bitmarck hat gewaltige Macht und Verantwortung in der deutschen Gesundheitsinfrastruktur. Mehr als 80 Prozent der deutschen gesetzlichen Krankenkassen sind Kunden von Bitmarck, was insgesamt 25 Millionen Versicherte betrifft (https://www.bitmarck.de/unternehmen/ueber-uns/was-macht-bitmarck). 
Das wichtigste Prinzip von Humanity Centered Design ist es, zusammen mit der Community – statt für die Community – zu designen

Was lief gut?
Wir konnten uns schnell auf unser Projektthema einigen. Insbesondere durch den kürzlich erfolgten Cyberangriff auf Bitmarck ist das Thema für uns hochaktuell, spannend, wichtig und motivierend.
Außerdem haben wir jetzt einen Google Drive Ordner, in welchem wir alle Ressourcen sammeln können.

Was möchtet ihr verbessern?
Ich (Jan) würde gerne etwas zeitiger die Aufgaben bearbeiten, komme aber persönlich nicht dazu, weil ich noch zwei andere Abgaben am Montag bzw. Dienstag habe. Wenn ich das Wochenende effektiver nutze, sollte das aber möglich sein.