DataBox – the safe and secure Health Data Management for more patient autonomy

"DataBox" is for patients with lung cancer who are already in treatment within the "National Network Genomic Medicine (nNGM) Lung Cancer". With the "DataBox"-App they get the opportunity to save all the relevant health data and documents on their smartphone or tablet. Patients are thus able to completely manage their health data and documents digitally as well as being able to share these electronically with others, such as doctors. Furthermore, patients can decide autonomously which additional relevant information about their current health status they want to document in their personal user profile, by using the Patient Reported Outcome Measures (PROMs), and which they might wish to share with others. PROMs give additional information about one’s current health status in the form of quality-of-life questionnaires and they are put in the "DataBox"-App for use by the patients themselves.

As well as enabling the use of medical data for research purposes, "DataBox" also allows the retracing of patients via a process of pseudonymization, rather than anonymizing (re-identification and re-contacting). New research findings can thus flow directly into the clinical treatment (translational medicine – bench, bedside, bench) and allow for a faster, better, and more patient-tailored therapy (personalized therapy).

And "DataBox" is

• free of charge,
• completely voluntary,
• a scientific research project.

The "National Network Genomic Medicine (nNGM) Lung Cancer" is an extension of the Cologne-based "Network for Genomic Medicine (NGM) Lung Cancer". It was founded in March 2010 by the Lung Cancer Group Cologne and the Institute of Pathology at the Center for Integrated Oncology at the University Hospital Cologne.

It is envisaged that future patients with advanced lung cancer shall be able to profit from molecular diagnosis and innovative therapies via a national network. To achieve this, 20 university-based cancer centers are joining forces to merge into the "nNGM" – among those are all 13 top oncological centers, which are being funded by the German Cancer Aid. The Website of "nNGM" provides an overview of these centers.

At the "nNGM" there are hospitals and doctors’ surgeries from all over Germany and from various medical specialities such as haematology, oncology, pneumology, thoracic surgery and radiology working together – so that all lung-cancer patients can gain access to modern precision medicine of the future, even as part of clinical research projects.

The primary aim is to offer all patients with advanced lung cancer a comprehensive molecular diagnosis to further the implementation of personalized therapies within the regular health care system.

Benefits for the patients

Patients gain an advantage by having all their health data and documents combined and ordered in one space as well as having the individual information about their quality of life via the PROMs. Patients can send their data or make it available to other doctors or treatment centers on their own accord, for second opinions or further investigations. Unnecessary double investigations can thus be prevented; more precise diagnoses and access to individualized, continuous and relevant therapies are being made easier. This allows for a time- and cost-efficient health care without any loss of data, even when changing doctors, in emergency situations or when moving.

By documenting the quality of life parameters via the PROMs one gains the possibility to incorporate those into the therapy decisions. It therefore becomes possible to balance and conciliate crucial therapies with quality of life considerations in a situation of reduced life expectancy due to cancer.

Benefits for scientific research

By pseudonymizing data, rather than anonymizing it, less data is being lost in the process. It smoothes the path to use this data for (genomic) research (at the "nNGM"). The possibility to then re-identify patients allows those research results to enter into the personalized patient care. Thereby, side effects and less effective therapies can be reduced; one can initiate evidence-based therapies according to the different types of lung cancer and thus increase quality of life.

Benefits for the health care system

The provision of an individual data space for each patient allows the sharing of the complete set of medical data concerning any of this patient’s health episodes longitudinally and transsectorially with the various health providers. This potentially reduces the interface problems between the inpatient and outpatient sectors as well as the resulting negative effects on the health insurance system.

This signifies a growing modernizing digital health management for the health care systems and the civil society at large as well as for the patient as integral part of this society.

The research results will provide answers to what patients with lung cancer need to manage their health data autonomously within the health system setting.

After the actual research period has ended, these results can then be used to further develop an app, which patients with lung cancer could use within the Charité-setting and throughout Germany. Furthermore, the aim is to make this app available for other entities and other medical indications as well as coupling it with other digital patient apps in the future while ensuring interoperability and the highest security standards concerning data safety.

As a patient with lung cancer, you can participate in the research project named "DataBox"-Study and use the "DataBox"-App if you are already a participant in the "nNGM" project. All you need is an email-address, an internet connection and a smartphone or tablet. The operating system version of your smartphone or tablet must not be older than iOS 12.0 or Android 7.0. The "DataBox" study team will gladly assist you in checking the compatibility of your smartphone or tablet with the "DataBox"-App.

Equally, the "DataBox" study team of your treatment center will be happy to support you with the login procedure, the installation of the "DataBox"-App, and the implementation of your personal health data platform.

Do you want to use the "DataBox"-App? Then please contact us via the contact data below!

• "DataBox" is a digital data platform made available via the "DataBox"-App for smartphones and tablets, and it is for patients with lung cancer who are being treated within the "nNGM"-setting.
• Within "DataBox", patients can store and manage their complete health data and documents and share them with others, such as doctors, for example.
• Via PROMs (patient reported outcome measures) patients can also document additional information about their health status.
• With “DataBox”, patients can make their health data available for further research purposes.
• Within the setting of translational medicine research, findings can flow directly into the treatment of patients (personalized medicine).
• "DataBox" is free of charge, completely voluntary and a scientific research project.
• "DataBox" is beneficial for patients, society, and research.
• The findings from the "DataBox"-Study research project can be used to further the development of an app for lung-cancer patients within the Charité-setting as well as throughout Germany.
• As a patient with lung cancer, you may take part in the "DataBox"-Study research project and use the "DataBox"-App if you are already being treated within "nNGM", if you have an email-address, internet access and a smartphone or tablet not older than iOS 12.0 or Android 7.0.