PikeOS and ELinOS in Medical Applications
Hospital, Diagnosis and Information Center
A hospital ecosystem is comprised by several IT components that need to communicate with each other transferring data and device status, Cyber Security should be an item to be considered in all these different components. It should be part of all different stages of the procurement process and architectural definition. The use of crypto engines as well as secure update mechanisms are required according to the latest Medical device ordinance. The data need to be provided in real time to all stations and the devices need to be monitored as well as the software to be updated where needed. This will help the doctor get his patient data and increase information transparency for the hospital over all.
Hospital-portable and Home Ventilators
Especially since the COVID-19 virus spread breathing ventilators got highly important to help patients heal their lungs and help them getting back to normal breath rhythm. Ventilators are used in hospital but also in home area as portable devices. Any Malfunction can endanger life. Therefore those device must be:
- Scalable across different type of devices
- Must have mixed criticality with Safety measures
- Keep patient data and device information secure
- Follow industry specific standard for medical devices, such as IEC 61508 / IEC 62304
- Compliance to MPG (Medizinproduktegesetz - Medical Devices Act)
Blood Infusion Pump
A blood infusion pump device is needed for intensive care in infirmary stations of a hospital. Its software architecture must be consider safety and security aspects while providing always online connectivity interfaces at the same time. With PikeOS, you can:
- Separate the application implementing the functional safety by means of resource and time partitioning
- Isolate and encrypt patient sensitive data from the communication stack
- Use secure communication channels
- Provide convenient functions by means of non-critical partitions
Safety-critical Medical applications must be certified to Safety standards such as IEC 62304 and/or follow FDA Device Classification. PikeOS is the best certification solution for three reasons: small size, virtualization, and unparalleled company support for the certification process.
The PikeOS partitioning concept makes it possible for applications of various levels of criticality to be certified for their individual required Safety levels while running securely in parallel on the same hardware platform. Even more important for certification is a competent and reliable partner when it comes to documentation, requirements and tests.
The PikeOS separation kernel itself is small in terms of implementation and its little number of system calls allows comprehensive evaluation and validation. As a matter of fact, PikeOS (4.2.3 Build S5577 x86_64, ARM v7/8) has passed the Common Criteria EAL3+ certification.
Medical devices for critical treatments must comply with Safety as well as Security regulations. Of prime importance, the life and health of patients must not be endangered. Furthermore, their personal data must be protected against unauthorized access. Its unique properties make PikeOS a reliable and efficient foundation for Medical applications:
Support for a broad Variety of Guest OS allows Consolidation
PikeOS supports mixed-critical setups with precise roles, e.g. Linux-based graphic or network functionalities run concurrently with POSIX-based Safety-critical and time-critical medication applications. The applications are isolated from each other by means of strict partitioning
Integrated Safety and Security reduce Certification Cost
Applications of various levels of criticality and Security are safely separated from each other in distinct partitions and can be certified separately
IEC 62304 Industry Standard
PikeOS supports the process, the necessary artefacts, as well as analysis and tooling for a successful certification
Using MILS Platform to increase Safety and Security standards
ElinOS Embedded Linux Distribution
ELinOS is an ideal embedded Linux platform that has low memory footprint and secure elements fitting the medical use cases