The ANS publishes the “probative force” reference system on the secure storage of health documents

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As part of the care of people, a large number of documents containing personal health data are produced, shared and exchanged by health and medico-social actors.

These documents, whether in paper or digital format, must often be kept securely for a long period of time, fixed by law in some cases.

As a reminder, an order published on January 12, 2017 in the Official Journal set out to regulate the methods of destruction of medical files once digitized and the conditions allowing to guarantee a probative value to the data and digitized health documents.

This ordinance specified in particular the conditions making it possible to guarantee probative value to health data and documents produced in digital form.

It created a new section in the Public Health Code, entitled “conditions for recognizing the probative value of documents containing personal health data created or reproduced in digital form and for the destruction of documents kept in a form other than digital “, allowing certain provisions of the Civil Code on electronic writing to be applied to medical files.

Articles L1111-25 to 31 of the Public Health Code – resulting from the ordinance of January 12, 2017 – set the conditions for recognizing the probative value of the following health documents: digital copies; documents natively created in digital format and natively digital documents materialized in paper format.

“The first work began at the end of 2018 around a working group to draft this reference document. In particular, several entities from the Ministry of Solidarity and Health, health insurance, the High Authority for Health were called upon. (HAS), to CIOs [directions des systèmes d’information] and archivists working in health structures, biologists, etc. “, said the ANS in a statement released on March 22.

“On the basis of these exchanges, a first version of the documents making up the evidentiary framework for health documents was drafted and then presented to a wider circle of stakeholders (interministerial service of the archives of France, Cnom [Conseil national de l’ordre des médecins], Cnop [Conseil national de l’ordre des pharmaciens], hospital federations, industrial federations, etc.). “

A repository made up of six appendices

The documents were proposed in internal consultation with the ministry “in the summer of 2019”, before being “adjusted”, “published and submitted for consultation” on the dedicated platform managed by the ANS: participez.esante.gouv.com , from November 2019 to mid-January 2020.

In total, the ministerial agency counted 16 contributors, 20 proposals made, 15 comments on these proposals added and 56 votes cast.

In details, the “probative force” standard is composed of an introductory document and six appendices dealing with the various health documents and their specific security mechanisms.

Thus, annex n ° 1 recalls the “common base of technical and organizational principles”, annex n ° 2 covers the security mechanisms to be implemented in the context of digitization, annex n ° 3 is , it, devoted to the security mechanisms to be implemented within the framework of the production of natively digital documents, appendix n ° 4 focuses on the security mechanisms to be adopted within the framework of the materialization of health documents, l he appendix n ° 5 provides a reminder on the management of metadata and, finally, the last appendix is ​​devoted to the classification of health documents.

To go further and explain this “probative” reference system, the ANS is organizing an online conference on Wednesday April 7 at 2 pm.

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