Neonatology Referential

A niche sector to standardise with digital solutions

What is the neonatology referential?

A key priority to the ANS is to develop security in the sector of neonatology and paediatric reanimation. We defined a set of good practices to cater for these vulnerable patients.

There's a great need for digital solutions in the neonatology and paediatric reanimation sectors. Therefore, the necessary functionalities had to be formalised in a neonatology referential, to cover the entire processes and encourage new eHealth initiatives to improve care for newborn patients. First in line: a high demand for software solutions to manage processes, from prescription to administration, in paediatric reanimation.

The ANS aims to optimise the safety regulations in neonatology, but several factors make this a delicate process. As an industrial, these challenges concern you. Our mission is to help you: 

  • Adapt prescription assistance software: designed for adult patients, these solutions are often inadequate for neonatology;
  • Standardise current practices, to encourage the development of a common service offer;
  • Smooth out management issues, for example in the prescription functions of hospitals;
  • Define a new referential for mandatory certification of hospital software;
  • Target a niche market with fewer than 100 units in France.

Discover and use the neonatology referential

The neonatology referential enables health structures to define their needs for digital solutions. These functionalities will be integrated into the Hospital Information System (SIH).

There’s also a plan to build a national thesaurus to reference drug prescription in the neonatology sector. The project is spearheaded by the ANS, commissioned by the Ministry of Health’s General Direction of Care Offer (DGOS).

Rendering of the processes covered in the neonatology toolkit

Neonatalogy in numbers

75 neonatology units in France (as of 2015) - a developing niche market

41 Recommendations from the Social Affairs General Inspection (IGAS) in order to improve security in the neonatology and paediatric reanimation sectors

139 requirements to comply with the minimal security level needed to integrate a module into the Hospital Information System

Key service dates

December 2015

A report is conducted in the neonatalogy sector: it recommends to develop digital services for prescription and administration

July 2016

A first draft of the neonatology referential is issued

June 2017

The current version (v2) of the referential is published. It includes advice from experts consulted during the previous elaboration phases.

Frequently Asked Questions

The ANS answers the most common questions about the neonatalogy referential

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There are several levels of requirements for a module’s integration into the Hospital Information System. 

The main requirements set out by the referential are: 

  • Interfacing, control, security guidelines; 
  • Prescription process requirements; 
  • National prescription thesaurus integration requirements; 
  • Requirements regarding medico-economic and decision processes; 
  • Guidelines for ergonomics, functions, and notification alerts; 
  • Settings function requirements. 

In total, 139 requirements are used to reach the minimal level of security needed for a solution’s integration into the hospital information system.

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[ Date de mise à jour : ]

The current referential (2017) was written with industry experts. It introduces the particular context of this mission and the goals to reach in order to improve safety measures in neonatology and paediatric reanimation. The referential walks you through the fundamental concepts you need to grasp to understand the several requirements and protocols involved with software development for this sector.

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[ Date de mise à jour : ]

Neonatology is a high-risk practice for two main reasons:

  • The patients are extremely fragile (premature babies) 
  • 50% of the drugs used in the sector have yet to receive a marketing authorisation.

A survey conducted in 2014 evidenced a risk in the prescription process across the sector. The digitalisation of prescription is among the 41 recommendations that the report issued in order to increase safety levels.

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