Presentation by two employees of NEN, the Dutch normalization institute. Medical technology and data sharing are getting more a joined issue. Legislation for medical technology/ devices is in place or developed, but legislation for medical data sharing are not specified yet. There are multiple standards and legislation relevant for medical devices and data sharing such as standards and legislation for ICT, quality and risk management, EU legislation, information exchange, apps and social media. Currently, projects are ongoing nationally and internationally to provide an overview of the available standards (e.g. By Nictiz in the Netherlands).
An important issue is that software is regarded to be a medical device and should apply to the legislation. The NEN has developed a decision tree to determine whether the software is a medical device or not.
This means that most software used in healthcare should be confirming to the guidelines and thus be tested and validated. To determine if software should be regarded tot be a medical device, the Intended use of the software is an important issue. The risk level of the software will dictate the requirements for approval.
These risk levels are:
1. No injury or damage to health is possible.
2. Non serious injury is possible.
3. Death or serious injury is possible.
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