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Article L1413-8 of the French Public Health Code

Where it proves necessary to prevent or control serious risks to human health : 1° Any natural person or legal entity is required, at the Agency’s request, to provide it with any information it holds relating to such risks; 2° Any public or private medical biology laboratory, as well as any laboratory approved or recognised in application of articles L. 202-1 to L. 202-3 of the Rural and Maritime Fishing…

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Article L1413-9 of the French Public Health Code

I.-The Agency is administered by a Board of Directors, made up of the following members in addition to its Chairman, appointed by decree: 1° Representatives of : a) The State ; b) Compulsory health insurance schemes ; c) Institutional partners of the Agency ; d) Health professionals ; e) Associations of users of the healthcare system approved in application of article L. 1114-1, approved associations active in the field of…

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Article L1413-10 of the French Public Health Code

The Agency is headed by a Director General, appointed by decree. The Director General issues opinions and recommendations falling within the remit of the Agency and, on behalf of the State, takes decisions at the request of the Minister for Health pursuant to article L. 1413-4. Subject to the powers of the Board of Directors, the Chief Executive Officer of the Agency exercises the powers referred to in articles L….

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Article L1413-11 of the French Public Health Code

A Scientific Advisory Board ensures the quality and consistency of the Agency’s scientific policy. An Ethics and Professional Conduct Committee, in conjunction with the compliance officer referred to in article L. 1451-4, ensures compliance with the ethical and professional conduct rules applicable to the Agency, the members of its bodies, its staff and its occasional collaborators. A Steering and Dialogue Committee contributes to the development of public debate and collective…

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Article L1413-12 of the French Public Health Code

The Agency shall be subject to an administrative, budgetary, financial and accounting system and to State control adapted to the specific nature of its mission and defined in this chapter. The Agency’s resources are made up of : 1° Subsidies from the State, local authorities, their public bodies, the European Union or international organisations; 2° A contribution from compulsory health insurance schemes, paid and distributed in accordance with conditions laid…

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Article L1413-12-2 of the French Public Health Code

I.-The rules of professional conduct applicable to members of the Agency’s Boards and Committees, its employees, health reservists and persons who occasionally provide assistance to the Agency or its bodies, and guaranteeing compliance with the obligations of confidentiality, professional secrecy and impartiality, are specified by the Board of Directors, after consulting the Ethics and Professional Conduct Committee, in compliance with the provisions of Articles L. 1451-1 to L. 1452-3. These…

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Article L1413-12-3 of the French Public Health Code

The terms and conditions for the application of this section shall be laid down by decree in the Conseil d’Etat, which shall specify in particular: 1° The conditions under which the National Public Health Agency or, where applicable, other members of the national public health network have access to information covered by medical confidentiality, professional confidentiality or business confidentiality. This decree specifies the conditions under which the confidentiality with regard…

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Article L1413-13 of the French Public Health Code

In the event of risks to public health or to the health of a person due to an abnormality arising during investigations, treatments or preventive actions, the administrative authority may give formal notice to the professionals, bodies or establishments which carried out these investigations, treatments or preventive actions to inform the persons concerned if it appears that this information was not provided in accordance with article L. 1111-2.

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Article L1413-14 of the French Public Health Code

Any healthcare professional, healthcare establishment or medico-social establishment or service having observed either a healthcare-associated infection, including a nosocomial infection, or any serious adverse event associated with healthcare, in the context of care provided during investigations, treatments, medical procedures, including cosmetic procedures, or preventive actions, shall report it to the Director General of the Regional Health Agency. The healthcare professionals concerned analyse the causes of these infections and undesirable events….

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