Why the medical software certification will revolutionise the market in EU

As foreseen by the new Medical Devices European Rules (UE 2017/45), to be operational from 26 May 2020, and by the Court of Justice sentence of 7 December 2017, medical software shall be certified as medical devices (MD) class IIA (with the exception of software aimed to archive, store and transmit data without any data elaboration and added value). This will have a great impact on the market.

Advanced prescription systems, smart EMR (see previous articles on this blog), repository and clinic portals with advanced visualisation functions and Clinic Decision Support Systems (CDSS) shall be then certified as MD IIA.

This circumstance will have many repercussions. Above all it will increase costs and complexity for designing and distributing a medical software, penalising the small enterprises to take this way.

The main aspect is related to the nature and mode of implementing this kind of software: to be MD IIA certified, they shall become absolutely software products, with a precisely defined and punctual life cycle (designing, developing and releasing). In case of hospital EMR, this means to abandon the “custom-made logic” (software realized to respond to custom needs, case by case). Nowadays it is conceived as generators of forms or pages which you draw the custom needs on. In the future designers shall choose and set up the way to represent the medical information managed by the EMR, through certified standard functions or specialized functions, as per cardiology, equally object of certification.

The focus will move then from software-generating tools to the contents. It shall not be possible to delegate contents to customers: operating chooses will be mandatory, creating the EMR as finished products. Software houses shall vary their resources competences: less engineers and more doctors, nurses and pharmacists.

This change is not limited to the offer; the demand shall also follow the legislation, expressing the needs through tenders and related technical specifications which refer to products instead of customised EMR. It will be a real epochal chance modifying the concept of EMR and, more in general, all healthcare software.

In my opinion this course will be positive either for software developers and for healthcare organizations. At last, the handmade arbitral act in developing medical software will evolve to an industrial mode, with higher quality and efficiency.

If we consider, the software used for diagnostic imaging, for example, realised by means of standard products logic, we can undoubtedly appreciate the advantage of this approach.

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