BfArM Guidance on Fast-Track Process for Digital Health Applications: Evidence Studies | RegDesk

Table of content

The German regulating authority in the sphere of healthcare products (BfArM) has published a guidance document dedicated to the regulatory requirements related to the fast-track process for digital health applications (DiGA) intended to be marketed and used in the country.

The document provides an overview of the requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) to ensure compliance thereto.

At the same time, the authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.

General Requirements for Evidence Studies

To prove the positive health care effects (pVE) of digital health applications, manufacturers are expected to conduct comprehensive comparative studies. These studies must be presented in a final report that complies with the recognized scientific standards.

The core objective of these studies is to establish that using DiGA results in better health outcomes compared to not using it or compared to other forms of treatments.

The comparison groups in these studies are critical; they can include patients who do not use DiGAs, those receiving different treatments, or no treatment at all.

This comparison must be based on the reality of the care situation, taking into account scenarios where patients would otherwise remain untreated without access to DiGA.

Clinical Assessment and Conformity Procedure

The methodology employed in these studies to demonstrate pVE is not restricted to a single approach. It can cover a range of research methods, including clinical, epidemiological, health services, social, or behavioural research.

The key requirement is that these studies are quantitative and comparative, effectively aligning with the subject of investigation.

The chosen methodology must be adequate and appropriate for the research question and endpoints examined.

Methodology of Studies

The methodology employed in these studies to demonstrate pVE is not restricted to a single approach. It can cover a range of research methods, including clinical, epidemiological, health services, social, or behavioural research.

The key requirement is that these studies are quantitative and comparative, effectively aligning with the subject of investigation.

External Validity and Consistency of Results

In these studies, it is imperative that the study population closely represents the underlying patient population, ensuring external validity.

The consistency of the results is another critical aspect, particularly within relevant subgroups such as age, gender, care context, and indications.

If the results show inconsistency in these subgroups, or if the patient numbers in these groups are insufficient, the BfArM may impose restrictions on prescribing.

The transferability of results to these subgroups must be justified, either through additional data collection or a systematic literature search.

Implementation in Germany

According to the guidance, the requirement that studies be conducted in Germany is vitally important for ensuring that the results are relevant and meaningful within the context of the German healthcare system.

This is especially important since DiGAs often involve interactions between patients and service providers, incorporating specific processes in healthcare.

However, in instances where evidence of comparability with the German care situation is provided, studies conducted partially or entirely outside of Germany may also be recognized.

Study Registration and Publication

All studies must be registered in a public study register, such as the German Register of Clinical Studies at the BfArM or a WHO International Clinical Trials Registry Platform partner register.

This registration process is important for ensuring the quality and comparability of the collected information.

Moreover, the publication of complete study results, including negative findings, is important as well.

These results must be submitted for inclusion in the directory, but not published until at least twelve months after the study’s completion.

This approach ensures transparency and maintains trust in the DiGA testing procedure.

International Standards for Study Reports

The study reports must adhere to international standards for comprehensiveness.

A detailed and complete report is essential for accurately representing the study’s quality.

Incomplete reports could lead to misunderstandings about the study’s findings and quality. The Consort Statement provides guidelines for correct study presentation and reporting.

The presentation of results, including the discussion section, should comprehensively cover clinical and patient relevance, and draw comparisons with existing literature and other therapeutic measures.

Conclusion

In summary, the present BfArM guidance describes in detail the requirements to be applied when it comes to clinical studies conducted in order to demonstrate positive care effects associated with the use of the digital health application in question. The document also highlights the key aspects to be taken into consideration in order to ensure the accuracy and reliability of study results.

Source

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

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