The ANS publishes the technical doctrine of digital health

February 18, 2020

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This doctrine, initially planned for late January by the government roadmap on digital health, has been progressively submitted for consultation since the end of September, we recall.

The ANS reported having received more than 250 contributions.

The document "describes the technical framework and the urbanization framework in which digital health data exchange and sharing services will have to fit" and will be updated annually, she said.

It is made up of "a summary, a macro-planning, a target architecture diagram and 26 chapters classified according to the guidelines of the digital health roadmap on foundations and baseline frameworks, basic digital services, digital health platforms and support for actors and innovation ".

The target audiences are "the bearers of digital health services, whether they ensure project management (regional support groups for the development of e-health, health establishments, etc.) and / or project management. (solution publishers, integrators, etc.) and the users of these digital services (health and medico-social professionals or users of digital health services in the broad sense) ".

The doctrine "is applicable to all digital services handling health data and used on French territory", it is recalled.

It takes up the principle of "platform state" dear to Dominique Pon and Laura Létourneau, respectively ministerial responsible and ministerial delegate for digital health.

"Technical doctrine has no regulatory value," it said. "On the other hand, the major part of the principles which are developed there are intended to be declined in regulatory reference frames. The conformity of the digital services with the doctrine will be the object of a control and a national publicity."

Certification of generalized information systems in 2022

A chapter of the technical doctrine is devoted to the certification of information systems, which will be implemented on January 1, 2021, as announced last December by the Directorate General for Health Care (DGOS).

The first version of this reference system "will be constructed from indicators from:

  • of the Hop’EN program

  • the auditability of information systems within the framework of the account certification process (ISAE 3402, for example)

  • certification requirements for hosting personal health data

  • interoperability requirements

  • the SSI security action plan (security of information systems), in particular for OSE establishments

  • the information system component of the certification procedure for health establishments by the French National Authority for Health (HAS)

  • of the SI's compliance with the technical digital health doctrine (taking into account the system of compliance and convergence with the technical doctrine presented in chapter V – 4.1)

  • and a number of regulatory requirements for which it would appear desirable to assess a level of compliance, such as all the accreditation and certification systems required in certain fields of activity of health establishments. "

The generalization of this certification should begin in 2021 and end in 2022. A call for applications from pilot establishments will be launched in June 2020.

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