For établissements de santé in France, Haute Autorité de santé and ARS
HAS certification software, built to help you achieve the Haute qualité des soins mention.
HAS certifies every French health establishment every four years against 12 objectives, and the ARS authorises its activities, inspects it and receives its EIGS declarations. wai runs booking, notes, patient messaging and payments for clinics, centres and hospitals, and keeps each as evidence a patient traceur can follow, built to help you achieve HAS certification with the Haute qualité des soins mention.
What does HAS certification ask of a health establishment in 2026?
Three chapters and 12 objectives from HAS, and two ARS duties that run beside them.
Three chapters and 12 objectives in the référentiel 2025, and two ARS duties beside them. Open one for what sits under it.1
01Chapitre 1, Le patientThe result for the patient. Rights respected, information given, the patient engaged in the care plan, and patients and their representatives involved in the life of the establishment.4 objectives
1.1 Le respect des droits du patient
1.2 L'information du patient
1.3 L'engagement du patient dans son projet de soins
1.4 L'implication des patients et de leurs représentants dans la vie de l'établissement
02Chapitre 2, Les équipes de soinsTeams that coordinate around the patient, control the risks of their practice, work safely in high risk sectors and question the relevance of what they do.4 objectives
2.1 La coordination des équipes pour la prise en charge du patient
2.2 La maîtrise des risques liés aux pratiques
2.3 La sécurité dans les secteurs à risques majeurs
2.4 La culture de la pertinence et de l'évaluation
03Chapitre 3, L'établissementGovernance that drives quality and safety, manages its people and skills, works with its territory and adopts digital tools, AI included, under control.4 objectives
3.1 Le management global par la qualité et la sécurité des soins
3.2 La maîtrise des ressources professionnelles et des compétences
3.3 Le positionnement territorial
3.4 L'adaptation à des soins éco-responsables et aux innovations numériques
04ARS authorisationThe ARS director general authorises the creation of any health establishment, each activité de soins and each heavy equipment, for seven years from the declaration that it has started.4 requirements
Article L.6122-1 of the Code de la santé publique
24 activities and heavy equipment, set by articles R.6122-25 and R.6122-26
Applications only in windows, at least two a year per activity
A declaration of start, and a possible conformity visit within six months
05EIGS and inspectionEvery serious adverse event associated with care is declared to the ARS without delay, and its analysis within three months. The ARS inspects on a programme or on a signal, announced or unannounced.4 requirements
Articles L.1413-14 and R.1413-68 of the Code de la santé publique
Volet 1 sans délai, volet 2 within three months, on the national portal
How do HAS experts-visiteurs evaluate an establishment?
Five methods, each run in the wards and services, never from a binder alone.2
01
Patient traceur
A doctor expert-visiteur meets a patient, with their consent, then the team that cared for them, and reads the record.
02
Parcours traceur
Follows a patient's path across services to test coordination, continuity and team culture.
03
Traceur ciblé
Starts on the ground from a process such as the medication circuit or adverse event management, and works back up.
04
Audit système
Starts from governance and the process on paper, then checks how it runs in the services.
05
Observations
Points seen directly throughout the visit, such as dignity, accessibility and infection control.
06
Fiche anomalie
Written whenever an element of an impératif criterion is answered No, and weighed by the Commission de certification.
How does an HAS certification decision end?
Four levels, published on Qualiscope, with the macaron displayed at every reception point.3
Haute qualité des soinsCertified with the mention, next visit in 4 years
Qualité des soins confirméeCertified, valid 4 years
Qualité des soins à améliorerCertified under conditions, new visit within 2 years
Qualité des soins insuffisanteNot certified, new visit within 2 years
23.8%
of establishments held the Haute qualité des soins mention at the end of the 5th cycle, after 2,144 decisions.3
90.5%
had their quality of care confirmed, while 5.7% were certified under conditions and 3.7% were not certified.3
26%
of establishments in the first 72 decisions of the 6th cycle missed the impératif criterion on declaring adverse events.3
Each element is answered Oui, Non, NA or RI. Scores are averaged by criterion, objective and chapter into a global score against a target of 100%.
A No on any element of an impératif criterion opens a fiche anomalie, and HAS may refuse certification on it.
The visit report arrives 15 days after the visit, the establishment has one month for observations, then two months for a recours gracieux.
The certification report is published on Qualiscope and sent to the ARS, and no result may be announced before HAS publishes it.
What changes for French establishments on 1 January 2027?
The référentiel 2027 is adopted and applies to visits from 1 January 2027. The référentiel 2025 applies until 31 December 2026.
HAS adopted the référentiel 2027 by decision 2026.0116/DC/SCES of 25 June 2026. It holds 101 criteria, of which 22 are impératifs, against 118 and 21 in the 2025 version, and keeps most of the old numbering.
New criteria include 1.2-07, the patient is informed of any adverse event associated with their care, and 3.2-12 on preventing sexist and sexual violence between professionals. Criterion 3.1-04 on declaring adverse events moves into 1.2-07, 2.4-01 and 3.1-03.4
The first 72 decisions of the 6th cycle scored slightly below the 5th, six points lower on the patient chapter, and HAS names adverse event declaration, vital emergencies and isolation in psychiatry as the impératifs most often missed.
Who HAS certification applies to
Certification is for health establishments. Other providers answer to the ARS on other terms.
Monaco authorises medical practice by its own ministerial order.
A doctor in Monaco practises under an arrêté ministériel, issued after opinions from the Conseil de l'Ordre des Médecins and the Direction de l'Action Sanitaire and a deliberation of the Conseil de Gouvernement.5
The order names the doctor and the specialty, and says whether practice is liberal or within a named establishment.
Événement indésirable grave associé aux soins, the EIGS.
Commission des usagers, the CDU, in every health establishment.
What should clinic software in France actually run?
Each module runs part of the establishment and records the evidence for the chapters and duties beside it.
01
Appointments and booking
Online booking from your own website, every clinician's diary read from their calendar, reminders, rebooking after a missed visit and waitlist offers when a slot opens.
Online booking at any hour, with a reminder before the visit.
For the business
Fewer missed appointments, and cancelled slots offered to the waitlist.
On the record
Every booking, reminder and change, with a time and a name.
02
Billing and payments
Card payments into your own Stripe account, the cancellation policy shown at booking, invoices, statements and reconciliation, with an export for your accountant.
A clear price and policy before they commit, and an invoice in their app.
For the business
Payments reconciled against visits, with an export for your accountant.
On the record
What was charged, when, against which visit, and the policy the patient saw.
03
AI scribe and clinical notes
The note, letters and referrals written from the consultation, cited to published clinical guidelines, with the transcript beside the note, for the clinician to read, edit and sign.
The clinician's attention stays on them during the consultation.
For the business
Less time spent writing notes after clinic.
On the record
A contemporaneous note, signed, with the time, the signature and the source it cites.
04
Follow-ups and patient messaging
WhatsApp, email and calls in one thread per patient, replies drafted in the patient's own language for your team to approve, a response clock on every new enquiry, and recalls a clinician approves.
A reply in the language they wrote in, approved by your team.
For the business
More enquiries answered within the hour, when they are most likely to book.
On the record
The whole conversation on one record, with response times.
05
Referrals, consent and audit trails
Recording consent taken at booking, referrals written from the visit, patient flags for controlled drugs and safeguarding notes, and every read of a record logged against a named account.
The best HAS certification software is the system your establishment already runs on, so the evidence is a by-product of the care. Look for one record behind booking, notes, patient messaging, payments and access, a full audit trail, AI output that a person signs, and records hosted under your country's rules. wai is built that way, to help you achieve HAS certification with the Haute qualité des soins mention.
Is there HAS approved software?
The Haute Autorité de santé certifies health establishments, and the ARS authorises and inspects them. It does not approve, certify or endorse software, wai included, and software cannot earn a certification decision on a provider's behalf. wai keeps the records your team uses to show HAS how care is delivered, and HAS decides the certification decision.
Which providers must be certified by HAS?
Every French health establishment, public and private, under articles L.6113-3 and following of the Code de la santé publique. Autonomous cosmetic surgery installations are certified too, on an adapted référentiel. Medico-social activity is outside it, even inside a hospital.
Does HAS certification apply to a centre de santé or a private practice?
No. A centre de santé opens on ARS terms, with an agrément for ophthalmology and dental centres and a projet de santé with an engagement de conformité for the others. A doctor's own practice is not a health establishment. Both still declare any serious adverse event to the ARS.
How often does HAS visit?
Every four years after a certification with or without the mention. After certification under conditions or no certification, a full new visit comes within two years.
What is the difference between HAS and the ARS?
HAS is the independent authority that certifies the quality of care. The ARS is the regional state agency that authorises establishments and their activities, inspects them and receives EIGS declarations, and HAS sends it every certification report.
Does wai work in French?
Yes. wai drafts replies in the language the patient writes in, French, English or any other, for your team to approve.
Where does wai keep our records?
In its own country, under that country's rules, encrypted, with a full audit log. We set this up with you before go-live.
Fifteen minutes on video, walking one patient traceur through your own records. Built to help you achieve HAS certification with the Haute qualité des soins mention. wai hosts each clinic's records in its own country, under that country's rules. We set this up with you before go-live.
