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DiGA App Development Process

Our roadmap to success

Getting through the formalities and meeting required standards is a challenging task. That is where we enter with our precise process, to smoothen your journey right from conception, strategy, design till implementation and entry into the DiGA directory.

Ideation, Analysis and Feasibility

It all commences with your aspiration of having a health app. With a client-centered focus, we understand the idea and check for its feasibility in terms of technicalities and functionalities.

Our domain experts extract the possible opportunities that could be coming along the way after a thorough analysis of the idea and its futuristic insight.

Commencement and Project planning

Once the idea is approved, we, in alignment with your project and legal requirements, prepare a detailed plan for creating the design, development and testing roadmap.

As a healthcare app development company, our modern-day project management strategies clubbed with our expertise in the healthcare segment weave a robust and flexible plan in action.

UI/UX design and Prototyping

Our creative design taskforce comes up with an innovative DiGA app, reflecting a user interface and experience that offers the perfect look and feel of the application bundled with its working style.

As needed, we create a prototype or build a proof of concept to offer a primary visualization and get user feedback at an early stage.

Agile development & Testing

With a close observation on the regulations marked by BfArM, MDR, BSI and other relevant German authorities, our team creates a software application that is reliable and effective. It could be either mobile-based or web-based.

Our DiGA app programming follows the best industry standards that are applicable for digital healthcare, along with the fundamental agile principles. We also produce relevant images, texts, videos and other graphic components.

Implementation & Certification

Once we create a digital health application, we guide your app through the BSI certification process, ensuring it meets all necessary standards for data privacy, security and medical safety.

Once published, the application will be registered as a medical device according to the Medical Device Regulation (MDR) standards.

Registration & DiGA approval

Once the application is implemented, we take complete responsibility of submitting it to the BfArM for further testing and approval. Once the DiGA app is listed in the BfArM directory, it is all set to be prescribed by the doctors/ therapists and reimbursed by health insurance companies.

Post launch support & Promotion

We will be happy to help and support you with our technical and domain expertise on a continuous basis. Our support, software update and maintenance activities ensure a smooth functioning of your application.

We also offer expert marketing and promotional consultation for your app to reach out far and wide through pioneering campaigns and digital marketing.

Do you wish to go through details about DiGA and its implementation?

Here is a good and authentic read:
Important Information on DiGA - Guide Published by BfArM

Pre-requisites for DiGA apps

Figure in the BfArM directory - We are here to help!

For the app to enter the BfArM directory, there are certain fundamental requirements that needs adherence and we can help you achieve that. Here are those necessities:

The DiGA app must

  • serve the medical industry through digital healthcare technologies
  • assist patients and healthcare service providers with an intuitive user interface
  • be a medical device belonging to different risk classes - I, IIa, IIb according to MDR
  • perceive, monitor, treat and reimburse illnesses/injuries/disabilities
  • adhere to data privacy, security and protection standards
  • focus on a positive outlook towards healthcare offering medical advantages and patient-centric processes and care
  • offer patients with enriched and authentic software as a medical service, seamlessly synchronizing data between stakeholders
  • Be ISO 27001 certified (standard for Information Security Management Systems) and ISO 13485 (standard for Quality Management Systems in the medical device industry) certified
  • comply with GDPR standards while sharing private medical information of patients
  • follow the BSI standards for proving safety of the medical device

Now is the moment to empower users with a robust digital healthcare app!

Get your application created, implemented, certified and included into the DiGA directory with our superior DiGA - digital healthcare app development services.

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Frequently Asked Questions

What is a DiGA (Digital Health Application)?
DiGA stands for 'Digitale Gesundheitsanwendungen' in german. A DiGA app is a digital healthcare application on prescription that forms a significant element of the digital revolution in Germany.
What does BfArM stand for?
BfArM stands for 'The Federal Institute for Drugs and Medical Devices'. As a self-governing higher federal specialist within the group of the Federal Ministry of Health, it is in charge of approving all medicinal products and devices, along with its risk assessment.
What does the DiGA Directory comprise of?
The DiGA Directory comprises of all the DiGA - app on prescription that are approved by the BfArM. Once the app is listed in the directory, doctors can prescribe it further.
What are the different examples of DiGA applications?
Evident examples of such health apps could be apps dealing with medical situations like insomnia, diabetes, hypertension, speech therapy, anxiety and depression management, endometriosis, rehabilitation, digital obesity therapy, ambulatory psychotherapy, back pain management, multiple sclerosis, personality disorder and so on.
Can these health apps be connected with other devices or applications?
Yes, as required, these apps can be connected with third party devices such as fitness bands, fitness watch etc. But it is doubtful that insurance companies would bear the cost of those devices also.
How do we know if the digital healthcare prescription app is a DiGA?
An app is considered to be a DiGA if it is listed under the relevant directory owned and maintained by the BfArM.
How long does it take to create DiGA approved apps and what could be the DiGA app development costs?
It depends upon the nature of the requirements and the complexity of the application to come up with the timeline and cost estimates. It would be ideal to have a consultation meeting and discuss further.
What makes our organization ideal for DiGA app development?
As certified health app developers in Germany, our extensive experience into the German healthcare industry and other areas of Europe gives us a step ahead of the rest, when it comes to creating innovative and robust digital wellbeing apps.
Who is authorized to use a DiGA?
Anyone who has a statutory health insurance in Germany is authorized to use a DiGA. It can be prescribed by doctors/therapists and reimbursed by health insurance companies.
What data security and protection requirements must a DiGA abide by?
For data security, it must take care of the confidentiality, integrity and accessibility of data through different methods like access control mechanisms, encryption etc. For data protection, the app must comply with the GDPR regulations and the national ones.

The route to empower digital healthcare through a DiGA app is here!

The route to empower digital healthcare through a DiGA app is here!

Associate with us to leverage our years of healthcare domain experience and wide-ranging technology expertise. You can avail comprehensive DiGA services from us and we, as a competent healthcare app development company can ensure a smooth, well-regulated, lucrative app implementation. Let us connect for an initial discussion and pave way for a wonderful association together.

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