Since February of 2016, the INMETRO, the Brazilian Metrology Agency, has published the government ordinance number 54, to strength the regulatory and certification process of software embedded into medical devices at the brazilian territory. Currently, a set of documents compliant with the IEC 62304 standard are required from manufacturers in order to justify their main design decisions. After some interactions with ANVISA, the Brazilian Health Surveillance Agency, this research group identified the need of a set of examples on good development practices in order to support industry and labs to meet these new regulatory requirements.
The Health Aggregator Manager (HAM) project, developed by NUTES, aims to create a high-level system that serves as a managing interface of medical measurements, taken by devices that comply with the ISO/IEEE 11073 standard, using the Antidote, which is a set of free libraries that implement the standard, developed by Signove Technology. The contribution is to present a reference architecture and implementation for an open cyber-physical system, with sound documentation and practices. The HAM was developed using agile practices and a requirements-based engineering approach. This mixed approach satisfy safety requirements defined by this type of health/medical system and enables the demonstration of compliance with main software standards.
The next figure shows a Bus System (A) receiving data for smart manipulation, device configuration and system visualization. This system is implemented and is available in our repository as the REIS (Interoperable Electronic Health Records) system. In this scenario, an Integration System (B), is responsible for data gathering and device integration. This system is implemented and is available in our repository as the HAM system. It is important to notice that both systems are independent and can be physically separated.
New integrated clinical environments can be built using the tools available in this project, integrating existing medical device with new developed prototypes.
Through the use of some available embedded platforms, we provide tools for the clinical engineer to manage all the existing devices in the integrated clinical environment.
In the very end, new Health Information Systems can be developed using this infrastructure to collect, manage and analyze medical device data.