DiGA in a nutshell – Not yet fully arrived in the German healthcare system despite the launch of the DiGA directory

Digital Oxygen publishes discussion paper on critical challenges and success factors for suppliers of Digital Health Applications (DiGA)

Munich, February 17th 2021. It just took eleven months: more time did not elapse between the vote on the Digital Healthcare Act (DVG) and the launch of the DiGA directory in October 2020. The introduction of digital applications into the German public healthcare system thus took place much faster than many expected. The rapid implementation proved that the "apps on prescription" are one of the top priorities of the Germany Federal Ministry of Health.

In a recently published discussion paper, the management consultancy Digital Oxygen highlights resulting challenges and strategic approaches for DiGA suppliers. DiGAs are much more than simple health apps: they are professionally developed therapies or therapy supplements with proven benefits. Therefore, they offer the possibility to close existing gaps in patient care. While classical therapies depend heavily on visits to the doctor and support the patient rather selectively, DiGA can enable a continuous patient treatment.

The positive starting position for DiGA and their great potential could suggest that the launch of the DiGA directory was a great success story. However, this is not the case. In particular, one thing has become clear in recent months: with the introduction of digital solutions into the public healthcare systems, all those involved are entering uncharted territory - with all the associated hurdles. It is therefore not surprising that DiGA are not yet able to develop their full potential. For the manufacturers, there are essentially three challenges that need to be mastered:

1. Meeting Regulatory Requirements
Even though the BfArM's fast-track procedure represents a pragmatic approval process in the medical technology sector, the complexity of the procedure should not be underestimated. Especially for newcomers to the German digital healthcare system, the requirements regarding safety, functionality, quality, and data protection represent a hurdle that should not be underestimated. Although the DiGA guide covers all relevant areas, it is in some parts vague and often refers to other norms, standards, and technical profiles.

2. Marketing of Approved DiGA
After the successful admission to the DiGA directory, DiGA manufacturers are usually busy developing and refining their marketing strategy. The main objective here is to identify an approach that can be used to convince healthcare system stakeholders of the DiGA, answering two questions: Does this DiGA even entail a positive effect for patient care? Can DiGA manufacturers prove the benefit of their applications with sufficient evidence?

3. Pricing of Approved DiGA
In addition to doubts about the medical benefits of DiGA, large parts of the medical community appear also skeptical about the economic efficiency of the digital solutions. DiGA providers should therefore set the manufacturer’s price, that is valid in the first year after admission to the DiGA directory, with care. In addition, they need good and evidence-based arguments for justifying the reimbursement price towards the public at an early stage.

While the size of challenges appears complex, there are clear recommendations on success factors to follow. The full discussion paper is available at: https://digital-oxygen.com/diga/

Alexander Voigt
Digital Oxygen GmbH
Weißenburger Straße 25
81667 München
info@diox.de
www.digital-oxygen.de

Digital Oxygen is an owner-operated management consultancy focusing on the development and implementation of digital transformation and digital product strategies. The experienced team supports leaders of the TMT industry, medical technology companies and international start-ups on their way to a digital future. The joint success is based on a critical team and customers who see themselves as partners – who question and challenge and are open to breaking new ground.

This release was published on openPR.