Today, Kepler Vision Technologies is proud to announce its Kepler Night Nurse software is officially registered in Europe as a medical device. But what does this mean exactly? Read the Questions and Answers below and find out!
What is the intended use of the medical device Kepler Night Nurse?
The official definition is: “To monitor the mobility of patients with reduced ability to maintain balance.”
In one sentence, what is the benefit for care providers that the Kepler Night Nurse has been registered as a medical device?
It proves that extra care has been taken to examine the correct operations of the software by extensively testing it during development and in practice.
What exactly does that mean that extra care has been taken to examine the correct operations?
It means three things:
- The software is built according to best practices.
Example: It has been established that the development of the Kepler Night Nurse software application executes the following steps: specification, plan, build, review, test, deploy, and then continuously monitoring of the quality.
- The functionality of the software has been tested to meet specifications, internally and then in practice.
Example: For each test, it was recorded which person performed the test, at which location, what was tested, and whether the software output was correct.
- A risk analysis has been carried out: what can go wrong and what measures are taken if that happens?
Example: An identified risk is that the software may crash. If that would happen, it is recorded that a warning message is sent to a predetermined contact person. This is also defined in Kepler’s SaaS agreement.
Is the Kepler Night Nurse allowed to make a diagnosis now it is a medical device?
No, this is not allowed. The software may report that a patient has fallen into room 13.
Is the Kepler Night Nurse allowed to write information to Electronic Health Record, now that it is registered as medical device?
Yes, this is allowed if a medical specialist considers it relevant. Registration as a medical device was not necessary for this.
Does it make sense to have the Kepler Night Nurse write to the HER?
This is up to the care organization. In general, a doctor prefers to be warned if a patient starts falling out of bed often. This may be a reason to subscribe medication for better night rest or to start focusing attention to the day and night rhythm of the patient.
Does the registration as a medical device automatically mean that Kepler has properly arranged the GDPR / AVG and the protection of client data?
No, this is not the case. Compliance by Kepler Vision to GDPR / AVG regulation and the security of client data is established through our ISO 27001 and NEN7510 certifications.