Interaction Room – together we work out your digital health application (DiGA)
In the DiGA interaction room, we work with you to develop an innovative concept for implementing your ideas for a digital health application (DiGA) that is eligible for approval by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). In addition, we also discuss the opportunities that the application would bring as well as individual options for your company.
Giving the digital health application room to mature
The Interaction Room is a physical or virtual project room for the targeted support of communication and brainstorming ideas for your DiGA. The interdisciplinary project teams that take part can be made up of different stakeholders, such as company management, medical professionals, care and mobile applications specialists, product management or marketing.
The aim of the Interaction Room: DiGA is the expansion and redesign of existing or new digital health applications, taking into account possible business models in the target markets. The needs of all relevant internal and external target groups are met.
We will work together with you to address the following questions in an Interaction Room workshop:
- Is your ‘digital assistant’ good enough to be approved as a DiGA by the BfArM?
- Is the medical purpose achieved by the main digital function?
- Where can or must your idea still be supplemented with innovative concepts – for example with artificial intelligence (AI) components?
- What are the detailed application scenarios for patients and/or providers using the application?
- What requirements does your ‘digital assistant’ already fulfil in terms of data protection and security as well as in terms of the specified quality requirements?
- Which medical device risk class (I or IIa) does your DiGA belong to? And what are the consequences of this for the development or further development process of a medical device that will receive approval?
The Interaction Rooms methods...
- ...enable the interactive exchange between groups to develop a common understanding and approach.
- ...creates dynamics by balancing differing interests and delivering useful results.
- ...provides simple instruments, modern methods (such as design thinking) and a comprehensible set of rules, in order to identify and develop important ideas and topics at a glance.
The DiGA Interaction Room, with its wide range of method modules, is an ideal tool for efficiently designing and planning a digital health application in a cross-functional team.
The second stage: Development and market approval
In order to be reimbursed as a DiGA, a mobile application must meet certain criteria for a medical device as defined by law. You will find out how to do this in the second stage.