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July 12, 2023

Simplifying the Path to DiGA Certification

Simplifying the Path to DiGA Certification


Simplifying the Path to DiGA Certification

“Over 70% of DiGA applications still fail due to medical device regulation as well as data privacy and security-related issues.” 

This year, Build38 participated in DMEA Berlin 2023; one of the most significant events in the field of digital health and healthcare IT, which provides an ideal platform for industry leaders, experts, and innovators to showcase their cutting-edge technologies and discuss the latest trends in the healthcare sector.

As a  DiGA (Digital Health Application) provider or developer looking to navigate the complex process of DiGA certification, you’re likely aware of the challenges and hurdles that come with it. Financing, profitability, project risks, and meeting medical device requirements are just a few of the obstacles you’ll encounter. However, one of the most significant challenges lies in ensuring the security and compliance of your application, including data protection and data security in order to secure the listing on the DiGa directory.

While ensuring the protection of patient data is vital, the extensive scope of these security measures of the DiGa certification regulatory requirements can pose a significant challenge for companies. This often results in difficulties when attempting to obtain certification, potentially leading to delays or even abandonment of the process. These challenges arise because companies may struggle to meet the established security criteria in a comprehensive manner.

Build38 can address the regulatory aspects of DiGA applications

Build38 is dedicated to strengthening Mobile App security within the realm of digital healthcare. This commitment is demonstrated through their efforts to safeguard sensitive healthcare data, protect patients’ privacy, and ensure the secure operation of mobile applications in the healthcare sector.

As providers of Mobile App security solutions, Build38 specialises in addressing the security and regulatory aspects of DiGA Certification applications. We understand that handling security requirements on your own requires significant time, resources, and expertise. That’s why we offer our expertise to help future DiGA providers and developers overcome these challenges. 

Build38 can take care of the critical pain points related to data protection and data security, to help you eliminate the obstacles that hinder successful certification. At the beginning of the process, when your eHealth app is not yet DiGA certified, we provide you with our SDK and by implementing it we ensure that your app meets BSI and Gematik standards on the first attempt. Once your application is ready for DiGA listing, the BfArM conducts a three-month review. During this time, you no longer have to worry about the security requirements, as Build38 has you covered.

While many applications still face challenges, partnering with Build38 puts you on the home stretch towards listing in the DiGA directory. We simplify the process, save you time, and support a shorter time to market for your DiGA-certified app.

The Road to DiGA


Check out Build38’s insights on helping eHealth providers accelerate the application, compliance, and regulation requirements necessary to successfully being listed on the DiGA directory. 



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