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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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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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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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The Convergence platform supports you in developing your business and defining your plan for compliance with regulations specific to the e-health sector.
To this end, the platform is organized around two tracks:
- digital health doctrine ;
- My health space.
Each of these paths is broken down into steps:
- doctrine is divided into 4 steps: Evaluation and projection socles , Teleconsultation, teleexpertise, telecare;
- My Health Space is divided into 2 steps: referencing without data exchange and referencing with data exchange.
The procedures include questionnaires which, once completed, will enable you to assess the maturity and/or compliance of your products with the digital health doctrine, or the assessments required for My Health Space registration.
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The first step in completing the platform is to identify a manager who will oversee the completion operations. This person can then make an inventory of the products to be included in the scope of data entry, and list the resources to be mobilized: product managers, technical and functional experts, etc. Despite efforts to contextualize the questions, knowledge of healthcare IS interoperability, security and the ambitions of the doctrine of digital health is a prerequisite.
The questionnaires can then be read in groups. Based on the completion of an initial product, the reading of the questionnaires enables the identification of subjects that have been mastered, as well as those that require further investigation.
The pilot can then propose regular meetings with all product managers to monitor the progress of data entry, guarantee the consistency of responses and share expert feedback.
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There are two main user profiles on the Convergence platform:
- Manager: this is either the Corporate Officer or a person authorized by the Corporate Officer; he/she is authorized to add new contributors, create products and grant rights to contributors from his/her company;
- Contributor: authorized to create accounts for other contributors, create products and complete questionnaires, within the limits of the rights assigned to him/her.
Contributors are given access rights to questionnaires for products already created within the platform, and to questionnaires relating to global strategy.
Contributors who do not have the right to validate questionnaires can only save drafts for questionnaires to which they have access.
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In order for your service to be referenced in the My Health Space database, it must comply with the eHealth doctrine.
The doctrine is re-edited each year and defines the base rules of good practice for security, interoperability, and ethics applicable to eHealth services.
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My Health Space includes the following health data:
- The medical profile entered by the patient, in an unstructured format (preconditions, allergies);
- Health measurements (weight, height, BMI, temperature, waist size, heart rate, blood pressure, glycemic index, level of pain) in FHIR format;
- Health documents (for example: test and diagnosis results, hospitalisation reports, medical treatments).
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