Biological decree
Regarding the exchange of biology exam reports, Decree no. 2016-46 of 26.01.2016 stipulates the following requirements:
- the medico-biological examination report must be structured in accordance with the Health Information Systems Interoperability Framework (CI-SIS) under the title “medico-biological examination report section”;
- the report on medical biological examinations is entered in the common medical record, as long as it contributes to the coordination of care;
- the medical biological test report is communicated to the physician electronically through secure electronic health messaging.
These requirements refer to reports on medico-biological examinations prepared by health institutions and city medico-biological laboratories.
Context
Historically, the city’s medico-biological laboratories send dematerialized reports of biological examinations to prescribing physicians in HPRIM doctor 3.0 format. In health care facilities, electronic biological examination reports are sent in HL7 V2 format.
The Biologics Regulation therefore requires healthcare professionals and health information systems teams to implement secure healthcare messaging and gradually transition to a CI-SIS format biologic screening report.
The support program is run by the Agency for Digital Health
At the beginning of 2017, the Agency for Digital Health defined the implementation path with publishers of Laboratory Management Systems (grouped within SFIL) and publishers of Practice Management Software (FEIMA) and an extensive support plan for these publishers, as well as the users involved: medical-biological laboratories , prescribers in cities or health institutions in the implementation of the regulation.
In order to accelerate the compliance of medical-biological laboratories with the regulatory framework of Regulation 2016-46, the Agency for Digital Health launched an extensive support program structured around 3 main axes:
- creating and maintaining specifications content of the section “report on medical biological examinations” intended for publishers Biomedical Laboratory Management System for city laboratories or healthcare facilities and publishers and publisher training in this specification;
- translation, maintenance, distribution and terminology training of users Logical observation identifier names and codes (LOINC) in partnership with AP-HP which enables the structuring of biological data in reports (www.bioloinc.fr);
- deployment safe health messages and a report on biological tests in accordance with CI-SIS in medical-biological laboratories in cities and health institutions. In 2018, the close relations established with 12 SIL publishers and the support of the Agency for Digital Health and regional stakeholders (ARS, GRADeS) from 33 laboratories distributed throughout the national territory made it possible to make 66% of the software on the market CDA R2 N3 compatible and to develop the use of MSSanté to send medical biological reports.
In order to enable mass digital transformation and wider spread of interoperability, the Agency for Digital Health is extending its support actions to all laboratories in the national territory.
To benefit from this support, learn more about MSSanté website.