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The German regulating authority in the sphere of healthcare products, the Federal Institute for Drugs and Medical Devices (BfArM) has published a guidance document dedicated to the regulatory status of digital health applications (DiGA) as prescribed under the existing legal framework. 

The document provides an overview of the respective requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) and other parties involved in order to ensure compliance thereto. 

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.

 Furthermore, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation. 

Choosing between Provisional or Permanent Admission

Manufacturers intended to introduce a DiGA face a pivotal decision regarding the type of application they should opt for – provisional or permanent inclusion in the directory. 

According to the guidance, the primary factor driving this choice is the availability of empirical evidence: if the manufacturer has conducted a comparative study that showcases a DiGA’s positive supply effect, then it’s aligned with Sections 10 to 12 DiGAV, which is also detailed in Chapter 4 of the present guidance document.

Engaging with BfArM

The authority further explains that BfArM operates under strict regulations laid down in SGB V and the DiGAV.
This means that manufacturers cannot negotiate terms outside this set framework.

However, there is a provision for consultation regarding specific aspects of the application, such as the selection of the study design or clarifying the quality requirements.
For such purposes, the BfArM offers advisory services to guide applicants.

Multifunctional DiGA Products

The authority mentions that the system allows a single DiGA product to serve dual purposes.
A manufacturer might have a DiGA product that has already proven its effectiveness for one medical indication and can, therefore, be applied for a permanent listing. 

The same product, if suitable for another medical indication without prior evidence, can be considered for provisional inclusion. 

However, it is important to notice that these are treated as distinct DiGAs. They will be listed separately, may have different remuneration structures, and require individual applications.

Prerequisites for Permanent Admission

According to the present guidance, seeking permanent admission necessitates the submission of a fully completed study.

If a manufacturer is still in the midst of a study but can reasonably argue that the ongoing research will eventually validate the DiGA’s positive care impact, BfArM might accommodate by offering a reduced testing duration, shorter than the standard twelve months.

Benefits of DiGA Inclusion

Regardless of the type of inclusion (temporary for testing or permanent), the benefits manifest immediately upon listing.
Over 170,000 healthcare professionals, including doctors, dentists, and psychotherapists in Germany, get the authority to prescribe the DiGA. 

This covers approximately 73 million insured individuals.
The authority also mentions that even without explicit prescriptions, statutory health insurance companies can approve the DiGA based on proven indications.

Application for Permanent Inclusion in the DiGA Directory

Manufacturers with a DiGA that has already undergone a successful comparative study showcasing its positive supply effect can initiate an application for permanent inclusion.
If the application operates successfully, the DiGA will be featured in the directory within three months post a complete application submission, pending a favourable decision from BfArM.

In scenarios where applicants are uncertain about the validity of their study for demonstrating positive healthcare impacts, they are encouraged to consult BfArM (as per Chapter 5.3 of the present guidance).

However, should a manufacturer’s study be rejected due to inadequate evidence of beneficial healthcare effects during a permanent admission application, they cannot merely shift to a provisional application.
The initial application for permanent listing needs to be withdrawn first.

The entirely new application for provisional admission must then be presented. If a DiGA, once provisionally listed, fails to provide sufficient evidence during its testing phase, it will be delisted.

Any subsequent applications, even for provisional listing, are permissible only after a waiting period of one year.

Application for Provisional Inclusion in the DiGA Directory

According to the guidance, this approach could be utilized by manufacturers whose DiGA has not yet undergone a study to validate its positive supply effects.

In such cases, while the evidence of a positive care impact can be presented later, the DiGA must already satisfy all mandates stipulated in §3-6 DiGAV.

These appropriate requirements cover the aspects related to security, functionality, quality, data protection, data security, and interoperability.

As further explained by the authority, in order to ensure successful evidence presentation during the trial period, manufacturers are required to attach systematic data evaluation results for DiGA usage to their application.

Details on how the evidence will be provided must be structured in an evaluation concept. This concept, submitted to the BfArM, should be developed by an independent scientific institution and must reflect the data analysis results presented.

According to the guidance, after provisional listing, the study aiming to validate the DiGA’s positive healthcare effects, or any ongoing study during the provisional listing should be duly conducted.

The findings need to be submitted by the end of the trial period as specified by the authority. If, for any reason, study results are not provided within the said timeframe, or if the application faces rejection, the DiGA is delisted.

In such scenarios, manufacturers can only reapply after 12 months calculated from the initial BfArM decision. Furthermore, any reapplication is conditional to the presentation of new evidence of the positive healthcare effects associated with the software in question. 

In accordance with the applicable legislation, repeated provisional listings for testing aren’t permissible.

Engagement with Patients and Healthcare Professionals During Trials

During the trial period, there is no obligation for every doctor, psychotherapist, or patient who prescribes or utilizes a DiGA to participate in the study aimed at validating positive care effects.

The burden is on the manufacturer to engage the necessary test subjects for their study. Furthermore, there is no gap in the availability of the DiGA between the culmination of the trial and the final acceptance notification.

The DiGA remains active, prescribable, and reimbursable.

Manufacturers must, however, take into account a crucial financial implication.
While they will receive reimbursement for the product’s costs during the testing phase, the responsibility of funding the study lies with them.

Additionally, the price tag for a provisionally listed DiGA might be pegged lower compared to one that is permanently listed.
This pricing strategy arises from the regulations under the framework agreement between manufacturer associations and the GKV umbrella association for pricing. 

The framework might prescribe group-specific maximum prices for the first year, implying that provisionally listed DiGAs might have a reduced maximum price in comparison to permanently listed ones.

Extension of the Testing Period

In exceptional cases, the testing period might witness an extension, but only once and for a maximum of 12 months.
The manufacturer needs to prove, based on the test results, that a delayed validation is reasonable and justified.
The application for this extension, along with the necessary justification, must be submitted to the BfArM a minimum of three months before the test is scheduled to conclude. In total, the testing phase can be extended up to 24 months at most.

The BfArM offers preliminary information on both content and formal matters through its advisory services.
This assistance aids manufacturers even before the application process is commenced.

Conclusion

In summary, the present guidance provides an overview of the applicable regulatory requirements in terms of different registration pathways prescribed by the existing legal framework. 

By the virtue of the guidance, the authority describes the difference between them and highlights the key points to be taken into consideration by medical device manufacturers when making an appropriate decision. 

Source

https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/diga_leitfaden.pdf?__blob=publicationFile

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