The new article addresses the aspects related to the directory containing information about any and all digital health applications available in Germany.
Table of Contents
The German regulating authority in the sphere of healthcare products (BfArM) has published a guidance document dedicated to the fast-track pathway for digital health applications (DiGA) intended to be marketed and used in the country.
The document describes in detail the applicable regulatory requirements and also provides 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, it is important to mention that provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
The authority also reverses 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.
DiGA Directory Overview
According to the guidance, the DiGA directory is a crucial tool to support the adoption and understanding of DiGA within the healthcare industry.
Instituted by BfArM, it was created to streamline the integration of DiGA into healthcare processes and structures, both on an organizational and practical scale.
The main objective of the DiGA directory is to promote the trustworthy use of DiGA by healthcare patients and providers.
BfArM, recognizing the directory’s potential to foster trust and smooth integration, made it available to the public on October 6th, 2020, at https://diga.bfarm.de.
Structure and Usability
A central feature of the DiGA directory is its user-friendliness.
Designed with particular attention to different target audiences such as policyholders or doctors, it presents relevant information in a manner that is easily digestible.
The structure of this web portal facilitates easy searching and filtering, which aids in information discovery and supports the comparison and selection of different DiGA.
Furthermore, the directory accounts for dynamic data, such as browser compatibility or interoperable export interface information.
This type of data, which may change over time, is maintained by the manufacturers on the DiGA application website and is appropriately linked within the directory.
The directory’s inclusiveness ensures that users have a clear understanding of DiGA requirements, encompassing both positive care impacts, data protection standards, and compliance with any and all applicable medical device regulations.
Contents of the DiGA Directory
The document further describes in detail the content of entries included in the directory.
- Basic Data & Medical Device Information: This section of the directory provides foundational data about the DiGA and its respective manufacturer.
It includes details such as the manufacturer’s name, the product name, and a unique DiGA directory number (which is automatically generated during the application process by the BfArM).
Crucial information concerning the DiGA as a medical device is also provided, which can be pivotal for prescribers and those insured. Some examples of this data are:- Medical intended purpose as per the medical device law
- Instructions for use
- Data specifics from aids and implants
- Manufacturer’s liability insurance details
- DiGA profile and its classification within the supply path.
- Information for Insured Persons and Patients : DiGA can be approved by health insurance firms even without doctor prescriptions.
The directory offers essential information to support insured individuals in identifying and possibly comparing similar DiGA.
It includes a general description of the DiGA, its functions, a checklist for data protection, and data security.
Information about additional costs, such as in-app purchases, and data processing locations are also highlighted. As a continuous update feature, manufacturers can update product descriptions following any product changes. - Information for Service Providers: This section is relevant to those who prescribe DiGA, ensuring they have the necessary information to determine the most fitting DiGA for specific situations. According to the guidance, it lists crucial decision-making information like:
- Trial period duration
- Indication of the patient group
- Proven positive care effects
- Sensitivity and specificity (if applicable)
- Usage duration recommendations
- Necessary services linked to DiGA usage
- Intended user roles explanations
- Pricing Information
When prescribing, doctors and psychotherapists must factor in cost-effectiveness, potentially favoring the more economical DiGA in cases where multiple options offer similar therapeutic benefits.
Summary
In summary, based on the explanations provided by the authority, the DiGA directory is a comprehensive, user-friendly web portal aimed at facilitating the understanding and adoption of DiGA within healthcare.
Its structured presentation of essential information applies to a range of stakeholders, from manufacturers and prescribers to insured individuals.
Doing so, not only promotes trust in DiGA but also ensures that the parties involved in operations within the healthcare sector have all the necessary resources to integrate DiGA seamlessly into their practices and procedures.
How Can RegDesk Help?
RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.
