The PANACEA Analysis Consortium offered the undertaking’s effects to a panel of mavens at the second one Finish-Customers Workshop, September 2020.
The workshop has been an excellent likelihood to collect comments earlier than progressing with the improvement of the Resolution and Supply Toolkit, in the second one mid-term of the undertaking.
This consultation is Section 1 of the PANACEA Safety via Design Framework.
PANACEA supplies clinical software producers, well being software suppliers and healthcare organisations (i.e. hospitals) a Safety-by-Design Framework (SbDF): A complete workflow together with processes, device answers and hyperlinks to laws. SbDF is designed to triumph over design boundaries of clinical gadgets, which recently don’t in particular – or poorly – come with security-engineering facets relating to cyber dangers. SbDF is in response to an ordinary evaluate and gadget tracking audit workflow with the strengthen of particular answers addressing conformity evaluate (thru compliance schemes) and chance evaluate (addressing cybersecurity and engineering facets). The objective appropriate fashion of PANACEA SbDF is the outlined software lifecycle fashion, which considers networked clinical gadgets classes, lifecycle stages and roles.
Centered members: Scientific Tool Producers/Builders, Data methods Suppliers/Builders, Scientific Engineering Dept. Officials, Data Generation Managers, Data Safety Officials, Possibility Managers
The Protected Design Reinforce Platform (SDSP), evolved via RHEA, is a chance evaluate platform to be used in healthcare environments. Its use for well being methods and/or clinical gadgets ease compliance with Safety-by-Design rules. The aim of this software is going past well being methods/clinical gadgets to hide the operatiional context during which they’re used, guiding the architectural and/or building alternatives thru detected essential chance stage eventualities and the protection controls had to lower their chance stage.