In Silico Liabilities Task Force
Mission: Investigate and document the liabilities and responsibilities for software and modeler developer of in silico solutions
Many organizations are hesitant before investing massively in the promising in silico approach:
- It is widely believed that this technology could improve, and potentially save, the lives of many people by providing additional information to decision-makers.
- It is also recognized that no model is perfect and that sometimes non-optimal decisions can be made.
This Task Force intends to answer the most frequently asked questions:
- Who would be responsible in this situation?
- Where are the liabilities?
- What should in silico technology providers do to demonstrate that they have done everything possible to maximize patient safety while providing digital evidence to decision makers?
Although we began these activities in 2023 and are still seeking a co-chair, we achieved our first deliverables by identifying several SMEs among our members and compiling an initial collection of existing literature. We have started working on an evergreen internal position paper to compile our existing knowledge, resources, and expertise to provide initial assistance and guidance to our members.
Our future activities will focus on a continued exploration and accumulation of existing literature, but also joining forces to engage with external experts and local authorities.
Goals
- Compile and review existing legal texts related to this topic.
- Provide PRELIMINARY guidance for software and model developers by sharing and explaining existing documents.
- Create a SMEs group among our members.
- Identify key stakeholders including specialized lawyers (EU – US).
