From feasibility
to active protocol.
Every Coopo engagement follows the same three-phase architecture. Each phase has a defined deliverable, a defined timeline, and a defined regulatory layer. Nothing is skipped. Every act is traceable. The methodology is the same whether the engagement is for a private practice or a university hospital and its 1,000 healthcare professionals.
A cooperation protocol is a regulated instrument. It must meet the specific quality and safety criteria defined by the HAS (French National Authority for Health), and must be able to withstand any legal scrutiny at every stage of its implementation. Coopo's methodology is built in accordance with these two requirements from day one of the structuring work — and is not adapted a posteriori during filing. This section documents the regulatory foundation of each of Coopo's commitments.
1
Protocol Title
The official name of the cooperation protocol — precise, unambiguous, and aligned with the clinical scope of the delegation.
2
HAS recommendations and regulatory texts on which the protocol is based
The HAS professional guidelines, the recommendations of the relevant learned societies, recognized foreign guidelines, the regulatory texts governing the activity of the facility and the delegated professional, and any additional bibliographic references — French or international — on which the protocol is based.
3
General overview of the protocol and its implementation context
The implementation objectives, the patients and pathologies concerned, the qualifications and specialties of the delegating and delegated professionals, the required professional experience of the delegates, and the place of implementation — healthcare facility, medico-social structure, or outpatient care structure.
4
Patient inclusion criteria
The precise definition of all criteria determining a patient's eligibility for the protocol — including criteria related to age, clinical history, and the stage of the pathology. No criterion is left implicit.
5
Patient exclusion criteria
The criteria that exclude a patient from the protocol — generally related to complications of the pathology concerned, comorbidities, or other clinical factors that require management outside the delegated scope.
6
Synthetic description of patient inclusion and pathway — by algorithm
The complete patient journey under the protocol, presented as a decision-making algorithm — covering eligibility verification, patient information and consent, the delegate's intervention, escalation to the delegating professional, and emergency procedures. Written patient consent is not mandatory as long as oral agreement is documented in the medical record.
7
List of all planned derogations
The exhaustive list of deeds and activities that deviate from the professional scope of practice decrees for delegated professionals — in chronological order. Each deviation has its own dedicated appendix containing the decision tree, pre-established prescriptions, patient information sheets, and the specific training program if the training is segmented deviation by deviation.
8
Complementary theoretical and practical training for delegated professionals
The training program required for delegates to exercise the new delegated skills — theoretical training validated if possible by the relevant National Professional Councils, practical training with defined validation terms, and skill maintenance conditions including the minimum number of procedures to be performed. The program must be validated by the delegate prior to the implementation of the protocol.
9
Team organization for protocol implementation
The methods for collecting, tracing, and sharing health data between delegating and delegated professionals; the procedures for accessing eligibility grids, decision trees, and appendices; the protocols for transmitting the care report to the delegating physician, the primary care physician, and other professionals; the availability and conditions of intervention of the delegating professional; and the management of scheduled and unscheduled absences — including substitute delegators and emergency protocols.
10
Main risks related to the implementation of the protocol, analysis of risk management practices and procedures
The list of potential adverse events related to the implementation of the protocol — including interpretation errors of criteria, clinical signs, tests, and prescriptions — with the corresponding preventive measures, the methods for collecting and analyzing adverse events, and the frequency of coordination and practice analysis meetings between delegates and delegating professionals. Team organization is prioritized.
11
Monitoring indicators
Five indicators are mandatory under Articles D. 4011-4-1 and D. 4011-4-2 of the Public Health Code: the number of patients cared for under the protocol, the rate of resumption of care by the delegator, the rate of reported adverse events, the rate of reported serious adverse events (suspension of the protocol if >0), and the satisfaction rate of healthcare professionals. Optional indicators may be added depending on the protocol's context — typically the protocol adherence rate and the impact on the organization of care.
Legal validation
Each Coopo file is reviewed and validated by a health law specialist. Her role is structural rather than advisory. She intervenes from the very first version of the protocol, verifying the legal soundness of the cooperation model, the liability framework between delegating and delegated professionals, patient consent documents, and institutional liability agreements. When a Coopo file is submitted, it has therefore already undergone a legal review. This is not an additional service, but an integral component of the methodology.
Most draft cooperation protocols fail or get bogged down because the regulatory and legal review occurs too late in the process, once the methodology has already been developed. When legal vulnerabilities are identified, the structural work must be completely redone. Coopo's methodology integrates legal validation right from the first phase, thereby ensuring that the submitted file is compliant and legally secure from its very inception.
Make cooperation scalable.
The implementation of a cooperation protocol involves monitoring 5 mandatory HAS (French National Authority for Health) indicators, reporting to the ARS (Regional Health Agency) according to a defined schedule, maintaining an immutable audit trail for each delegated act, and managing the operational coordination of the healthcare team throughout the duration of the protocol. Coopo's digital solution was specifically designed for this purpose, rather than being adapted from a generic clinical tool. It serves as the operational foundation for Coopo's methodology, developed to sustain cooperation protocols on a large scale.
8 key features
Registration of the deed
Each delegated act is recorded using a guided four-step form. Each act is timestamped, electronically signed by the performing professional, and becomes immutable upon validation. No patient data is collected — each act is identified by a unique act identifier. The act constitutes legal proof of execution within the framework of the protocol.
Real-time monitoring
of the 5 mandatory HAS indicators
The five regulatory indicators are automatically calculated as the acts are recorded. No manual reporting is required, no spreadsheet management is necessary, and no thresholds are missed. The institution thus constantly knows its situation regarding regulatory requirements.
Proactive alert system
Alerts on protocol expiration at D-30, D-15, and D-7. Alerts for protocol volume thresholds at 80% and 100% of the authorized scope. Alerts on ARS report deadlines 15 days before the due date. Nothing can be overlooked.
Regulatory declarations
and ARS exports
Server-signed PDF exports in the format required by the ARS (Regional Health Agency). Excel exports configured in accordance with regulatory specifications. The next report intended for the ARS is generated automatically; it is not a document to be produced manually every quarter.
Initialization of the protocol
Authorized Referents can initiate a new cooperation protocol directly from the platform. Coopo reviews and validates this initiation before its activation. The methodology remains under the control of experts, while the platform ensures the structural management of the workflow.
Care team management
Role-based access control for all professionals involved in the protocol — delegating professional, delegated professional, Referent, institutional administrator. One session, one user, one role. Access isolation is strict by establishment and by protocol.
Training
and skills monitoring
The training framework for delegates is documented within the platform. Initial certifications, practical training phases, as well as competence maintenance thresholds are tracked for each professional as part of their activity under the protocol.
Continuous monitoring and quarterly review preparation
The quarterly review cycle required by the HAS is prepared within the platform. The data is structured, the indicators are pre-calculated, and the documentation is ready. The review thus becomes a validation step, rather than a reconstruction effort.
Certified
HDS
OVH HDS, France. HDS certified, qualified SecNumCloud by ANSSI. Data hosted exclusively in France.
Multi-factor authentication required
Mandatory TOTP multi-factor authentication for all roles. Strict isolation of access by establishment and by role.
Natively GDPR compliant
AES-256 encryption at rest, TLS 1.3 in transit. No patient data. Limited retention, documented erasing.