The new article provides a general overview of the key points related to the inclusion of digital health products in the respective register.
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The German regulating authority, the Federal institute for Drugs and Medical Devices (BfArM) in the sphere of healthcare products has issued a guidance document dedicated to fast-track pathways for digital health products intended to be marketed and used in the country.
The document provides a general overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure thereto.
The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect the corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the inclusion of digital health applications (DiGA) and highlights the key points associated thereto.
Inclusion in the DiGA Directory: Key Points
According to the guidance, digital health applications, commonly referred to as DiGA, are a type of medical device with specific features and functions.
These applications play a significant role in the field of health and medicine. The present document provides additional details on the specifics of what constitutes a DiGA, the processes and requirements for their inclusion in the DiGA directory, and certain nuances that differentiate them from other digital applications.
DiGA stands for “Digital Health Applications”. To be classified as a DiGA, an application needs to satisfy several criteria:
- It must fall under risk class I or IIa, according to the Medical Device Regulation (MDR) or, in the transitional phase, the Medical Device Directive (MDD). This is expanded upon in Chapter 3.2 of the guidance which deals with safety and functionality.
- The primary function of a DiGA is to utilize digital technologies.
- It is not a mere application that reads or controls another device. The medical objective should fundamentally be achieved through the primary digital function of the application.
- A DiGA plays a role in various stages of health management, such as detecting, monitoring, treating, or alleviating diseases and injuries.
- These applications are not intended for primary prevention.
- Either the patient alone or both the patient and the service provider should be able to use a DiGA. Tools exclusive to doctors, defined as “practice equipment”, do not qualify as DiGA.
- Any service that is excluded based on the third chapter of SGB V or has been previously excluded by the Federal Joint Committee does not fall under DiGA.
Therefore, DiGA classification applies to products that were initially designed as digital allies for patients.
It is important to clarify that patients need to interact with the application. Passive data collection from other devices, such as smartphone sensors, would not be a suitable approach for an app to be qualified as DiGA.
The authority further explains that if a health application has previously been marketed on an ad-funded model in an app store, its inclusion as a DiGA is still possible.
The BfArM evaluates only the specific version being proposed for the DiGA directory, ignoring other versions following alternative business models.
Combination With Hardware
The document also covers the aspects related to the way the software product in question interacts with any hardware platform it is being used with.
By the applicable regulations, even though a DiGA can exist as a native app, desktop, or browser application, it can also be combined with hardware elements such as sensors, wearables, or other devices.
However, the authority additionally emphasizes that the primary function should predominantly be digital, and any hardware involved should be essential for the application’s purpose.
Everyday items, including smartphones or gymnastics mats, will not meet the respective qualification criteria.
At the same time, it is important to mention that a DiGA could still fetch data from a device such as a smartwatch, provided it is considered during the conformity assessment.
The authority further explicitly states that the conjunction of a DiGA with certain medical devices, e.g., blood pressure monitors or continuous glucose monitors, is not allowed because such devices are covered under different entitlements as per Section 33 SGB V.
Combination With Services
While the essence of a DiGA is a digital medical product, additional services can be offered alongside.
Examples include consultation, coaching, or private medical services. However, reimbursement does not take these additional services into account.
The key point is that any human intervention should only ensure the safe usage of the DiGA product and patient safety.
All services rendered by humans, whether they are diagnostic, therapeutic, or medical, fall under statutory medical services.
The provision of these services is restricted to those entitled under Sections 95 and 124 of SGB V.
Lastly, telemedical applications can be a component of a DiGA, provided their primary function is rooted in digital technologies.
However, standalone telemedicine platforms are excluded. In terms of service providers, only practising doctors or psychotherapists can bill for contract medical services within the DiGA scope, with the recent inclusion of medicine providers and midwives.
In summary, DiGA forms a significant part of the health landscape. Their inclusion in the directory is based on a set of criteria to ensure the quality and relevance of these digital applications in the healthcare sphere.
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