20/14198: Draft Law to Improve the Framework Conditions for the Testing of Innovations in Real-World Laboratories and to Promote Regulatory Learning (Real-World Laboratories Act – ReallaboreG) (PDF)
Summary
This draft law aims to improve the framework conditions for testing innovations in real-world laboratories (RWLs) and to promote regulatory learning. RWLs are defined as “real-world testing environments, which are delimited spatially and temporally, in which innovations can be tested under real conditions, and in which data can be collected and evaluated to gain insights into the effects of the innovation and the interaction between the innovation and the environment.”
The draft law includes the following key provisions:
- Definition of RWLs: Provides a legal definition of RWLs and clarifies their purpose and scope.
- Principles for RWLs: Establishes principles for the design and operation of RWLs, including transparency, participation, and scientific evaluation.
- Regulatory sandboxes: Introduces a regulatory sandbox mechanism to allow for the temporary suspension of certain regulations in RWLs.
- Data protection: Provides for the protection of personal data collected in RWLs, including the establishment of a data protection officer.
- Evaluation and reporting: Requires the evaluation of RWLs and the submission of regular reports to parliament.
Background
The draft law is part of the German government’s efforts to promote innovation and digitalization. RWLs are seen as a key tool for testing and evaluating new technologies and services before they are released to the general public. By providing a safe and controlled environment, RWLs can help to accelerate the development and adoption of new ideas.
Significance
The draft law is a significant step towards creating a more favorable environment for innovation in Germany. By providing a clear legal framework for RWLs, the law will help to remove some of the barriers to testing and evaluating new technologies. This is likely to lead to increased investment in innovation and the development of new products and services.
Next Steps
The draft law is currently being debated in the German parliament. It is expected to be passed in the coming months.
Additional Information
The AI has provided us with the news.
I’ve asked Google Gemini the following question, and here’s its response.
Drucksachen a new article on 2024-12-13 11:00 titled “20/14198: Gesetzentwurf Entwurf eines Gesetzes zur Verbesserung der Rahmenbedingungen für die Erprobung von Innovationen in Reallaboren und zur Förderung des regulatorischen Lernens (Reallabore-Gesetz – ReallaboreG) (PDF)”. Please write a detailed article on this news item, including any relevant information. Answers should be in English.
35