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For clinics, centres and hospitals authorised in Madrid and Cataluña

Spanish clinic authorisation software, built to help you achieve an autorización sanitaria de funcionamiento.

In Spain every health centre needs an autorización sanitaria from its comunidad autónoma before it sees a patient, under Real Decreto 1277/2003, and Ley 41/2002 sets what the historia clínica and consent must show. wai runs booking, signed clinical notes, patient messaging in Spanish, Catalan, English or any language, payments and an audit trail on one record, so the evidence the Consejería or the Departament reads is kept as the work is done.

Updated . Every Spanish autorización sanitaria fact is checked against boe.es and the other official pages cited below.

A clinician at ease in a vast, light-filled private clinic in Madrid, the city beyond the glass

For

Consultas médicas, polyclinics, dental and aesthetic clinics, day surgery, hospitals and health systems

Regulators

Comunidad de Madrid's Consejería de Sanidad, and the Generalitat de Catalunya's Departament de Salut, with REGCESS at the Ministerio de Sanidad

Framework

Ley 14/1986, Real Decreto 1277/2003 as amended by Real Decreto 239/2026, Decreto 51/2006 in Madrid, Decret 151/2017 in Cataluña, and Ley 41/2002

Records

Kept in each clinic's own country, under its rules

What a Spanish health authority finds with wai

A Madrid or Barcelona clinic on wai answers every enquiry in the language the patient wrote in, closes each consultation with a note the clinician has signed, and can show who wrote and who read any entry when the inspección asks. The renewal, the staff list and the historia clínica draw on the same records.

What do Madrid and Cataluña ask of a clinic in 2026?

Five areas the national bases and the two comunidades regulate, from the authorisation to the patient's consent.

Five areas Madrid and Cataluña regulate, from the autorización sanitaria to consent. Open one for the rules behind it.1

01La autorización sanitariaEvery health centre, whatever its size or owner, needs prior authorisation from its comunidad autónoma to install, to operate, to change and to close. Madrid renews it every eight years, and Cataluña grants it before activity starts.5 requirements
  1. Ley 14/1986 artículo 29, autorización administrativa previa para la instalación y el funcionamiento
  2. RD 1277/2003 artículo 3, autorización de funcionamiento, de modificación, de instalación y de cierre
  3. Decreto 51/2006 artículo 13, renovación cada ocho años en la Comunidad de Madrid
  4. Decret 151/2017, autorització abans de l'inici d'activitat a Catalunya
  5. RD 1277/2003 anexo I, la clasificación común de centros y unidades asistenciales

La autorización sanitaria on boe.es

02El registro de centrosEvery authorisation is entered in the comunidad's own register, and the comunidades send it on to REGCESS, the Ministerio de Sanidad's public national register of authorised centres.5 rules
  1. RD 1277/2003 artículo 5, el Registro general de centros, servicios y establecimientos sanitarios
  2. Orden SCO/3866/2007, contenido y estructura del REGCESS
  3. Registro de Centros, Servicios y Establecimientos Sanitarios de la Comunidad de Madrid
  4. Centres, serveis i establiments sanitaris autoritzats, the Departament de Salut's search tool
  5. The authorisation document on display, with type, address, date and register number

El registro de centros on sanidad.gob.es

03Profesionales and the staff fileSince 1 July 2026 every centre must keep current information on all its health staff and a personal file showing each professional's official degree. Madrid asks for a signed staff list and notice of every change, and Cataluña names a responsable assistencial and a referent de seguretat del pacient.5 requirements
  1. RD 1277/2003 artículo 7, garantías de atención sanitaria, added by RD 239/2026
  2. Expediente personal actualizado with each professional's titulación oficial
  3. Decreto 51/2006 artículo 10, the plantilla signed by the Director Técnico Asistencial
  4. Comunicación de variación de plantilla sanitaria in the Comunidad de Madrid
  5. Responsable assistencial and referent de seguretat del pacient in Cataluña

Profesionales and the staff file on boe.es

04La historia clínicaLey 41/2002 requires a historia clínica for every patient that identifies the professionals who took part, kept at least five years from each discharge, with the patient's right to see it and receive a copy. Cataluña keeps the key documents 15 years and logs every change with its author.6 rules
  1. Ley 41/2002 artículo 14, the historia clínica identifies the professionals who took part
  2. Ley 41/2002 artículo 15, the contenido mínimo of the historia clínica
  3. Ley 41/2002 artículo 17, kept at least five years from the alta of each proceso asistencial
  4. Ley 41/2002 artículo 18, the patient's access and a copy of their data
  5. Ley 21/2000 de Cataluña artículo 9, every change recorded with the professional identified
  6. Ley 21/2000 de Cataluña artículo 12, key documents kept at least 15 years from the alta

La historia clínica on boe.es

05Información and consentimiento informadoLey 41/2002 makes information and consent verbal as a rule, recorded in the historia clínica, and written for surgery, invasive procedures and procedures with notable risks. The patient can revoke consent in writing at any time.5 rules
  1. Ley 41/2002 artículo 4, información asistencial, verbal as a rule and recorded in the historia clínica
  2. Ley 41/2002 artículo 8, consentimiento written for surgery, invasive procedures and notable risks
  3. Ley 41/2002 artículo 10, the información básica before written consent
  4. Ley 41/2002 artículo 8.5, consent revocable in writing at any time
  5. Ley 21/2000 de Cataluña artículo 6, written consent, revocable at any time

Información and consentimiento informado on boe.es

What does a Spanish health authority look at?

Six areas the Madrid and Catalan authorisation files name.2

  1. 01

    The care offer

    Madrid authorises each centre and every service in its oferta asistencial, and Cataluña asks for a plan funcional describing services, techniques and procedures.

  2. 02

    People and roles

    A staff list signed by the Director Técnico Asistencial in Madrid, and in Cataluña an organigram naming the responsable assistencial and the patient safety referent.

  3. 03

    Qualifications

    Each professional's degree, colegiación where it applies and professional liability insurance, with a personal file for each under RD 1277/2003 artículo 7.

  4. 04

    Premises and equipment

    A technical project or scaled plans, the equipment list, and the X-ray register entry where X-ray equipment is installed.

  5. 05

    Patient records

    A historia clínica under Ley 41/2002 that identifies every professional, and in Cataluña a log of every change.

  6. 06

    Display and complaints

    The authorisation document and staff list on display in Madrid, and complaint forms in every private Madrid centre.

How does an autorización sanitaria decision end?

The decision is an authorisation, which the comunidad grants, modifies, renews or refuses, and its conditions run for as long as the centre operates.3

  1. GrantedBefore any activity starts, entered in the register
  2. RenewedEvery eight years in Madrid, by declaración responsable for consultas
  3. ModifiedFor a new owner, a new service or a new address
  4. Refused or lapsedSilence after three months means no on a first application
  1. 3 months

    is the longest the Comunidad de Madrid takes to decide a first operating authorisation, and silence after it means the application is refused.3

  2. 213.35 euros

    is Cataluña's fixed fee for authorising a consulta mèdica to start operating.4

  3. 5 years

    is the minimum Ley 41/2002 sets for keeping clinical documentation from the alta of each proceso asistencial.5

  • In Madrid, a first operating authorisation is decided within three months and silence is a refusal, while a renewal, a modificación or a closure left unanswered for three months is treated as granted.
  • In Madrid, a renewal not requested at least three months before the eight years end lapses, and the centre must apply again from the start.
  • In Cataluña, the application must be filed before activity starts, and an application unanswered after three months is refused by silence.
  • Under Ley 14/1986, inspectors may enter any health centre at any time without notice, and the authority may suspend activity or close a centre.

What has changed for Spanish clinics?

Three things a clinic should know in October 2026, each marked as in force or proposed.

  1. In force. Real Decreto 239/2026 added artículo 7 to RD 1277/2003 from 1 July 2026, requiring current information on all health staff and a personal file for each, and gives centres six months to bring their staff information up to date.
  2. In force. Since Decreto 205/2023 the Comunidad de Madrid renews an operating authorisation every eight years instead of five, by declaración responsable for consultas and similar centres without fixed electromedical equipment.6
  3. Proposed. A draft Catalan decree reviewed by the CTESC on 1 June 2026 would repeal Decret 151/2017, set a renewal every 10 years and move most closures to a declaració responsable. It is not in force.

Madrid and Cataluña side by side

The same national bases, run by two comunidades under their own rules.7

Comunidad de MadridCataluña
AuthorityConsejería de Sanidad, Dirección General de Inspección y Ordenación SanitariaDepartament de Salut
Regional ruleDecreto 51/2006, amended by Decreto 205/2023, and Orden 1158/2018Decret 151/2017, with a draft replacement under review
Time to decide3 months, silence is a refusal3 months, silence is a refusal
Fee for a consulta96.21 euros without X-ray213.35 euros for a consulta mèdica
Validity8 years, 4 for assisted reproductionNo renewal period on the tràmit page, 10 years in the draft
Responsible personA Director Técnico Asistencial, qualified, registered and insuredA responsable assistencial, with a patient safety referent
Patient recordsLey 41/2002, at least 5 years from dischargeLey 41/2002 and Ley 21/2000, 15 years for key documents
RegisterRegistro de Centros, Servicios y Establecimientos SanitariosCentres, serveis i establiments sanitaris autoritzats

The Spanish and Catalan names

The official names behind this page, in the language each authority uses.

  1. Autorización sanitaria de funcionamiento, the operating authorisation for a centre.1
  2. Autorización de instalación, required before works for centres with fixed equipment.
  3. Declaración responsable, a signed statement of compliance that replaces an application in some cases.
  4. REGCESS, the Registro General de centros, servicios y establecimientos sanitarios at the Ministerio de Sanidad.
  5. Oferta asistencial, the services and units a centre is authorised to provide.
  6. Director Técnico Asistencial, the professional accountable for care at a Madrid centre.
  7. Responsable assistencial, the person accountable for care at a Catalan centre.
  8. Historia clínica, the patient record under Ley 41/2002.

What should clinic software in Madrid and Cataluña run?

Each module runs part of the clinic and records the evidence for the requirements listed beside it.

  1. 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.

    Evidences La autorización sanitariaEl registro de centros

    For patients
    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.
  2. 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.

    Evidences El registro de centrosInformación and consentimiento informado

    For patients
    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.
  3. 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.

    Evidences La historia clínicaInformación and consentimiento informado

    For patients
    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.
  4. 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.

    Evidences Información and consentimiento informado

    For patients
    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.
  5. 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.

    Evidences La historia clínicaInformación and consentimiento informado

    For patients
    Flags and checks in the record at the point of care.
    For the business
    Incident reviews that start from the audit trail, with times and names.
    On the record
    Who saw what, who changed what, and when, to the minute.
  6. 06

    Staff access and accountability

    Named accounts for every person, and role-based access enforced in the database, so every action sits under a name.

    Evidences Profesionales and the staff fileLa historia clínica

    For patients
    Their record seen only by staff whose role allows it.
    For the business
    Access and actions tied to named people, in the same system as the record.
    On the record
    Who holds which role, and every action taken under it.
  7. 07

    Reporting

    Takings, front desk and website reports, response targets, and the patient's own record exportable on request.

    Evidences El registro de centrosLa autorización sanitaria

    For patients
    A copy of their record when they ask for it.
    For the business
    Weekly reports for leaders on response times, the front desk and takings.
    On the record
    Reports for any period, produced on the day they are asked for.

Prices for clinics, groups and hospitals are published on the wai pricing page, and you can request a demo of the full platform.

A clinician at ease in a vast, light-filled private clinic in Barcelona, the city beyond the glass

How does wai evidence each authorisation requirement?

For each requirement, the records wai keeps, how you produce them, and what changes for patients and the business.

La autorización sanitaria

Systems running before the authorisation is granted.

  • Named accounts for every person, with role-based access
  • Online booking, reminders and waitlist offers from the first day
  • Signed, timed notes on one record per patient
  • Records hosted in the clinic's own country, set up with you before go-live

On request. Show the record system the plan funcional or the authorisation file describes, running on real patients.

For patients
A clinic that works properly from the first appointment.
For the business
An authorisation granted inside the three months, with no time lost to an incomplete file.

El registro de centros

Activity that matches the oferta asistencial on the register.

  • Every booking recorded with the clinician and the visit
  • Reports for any period, by clinician and by service
  • Named accounts showing who delivers care at each centre
  • Takings reconciled against visits, with an export for your accountant

On request. Show what the centre actually did in any period, by clinician, against the services it is authorised for.

For patients
Care from a centre that is what the public register says it is.
For the business
Changes to the oferta asistencial spotted early, before they need a modificación.

Profesionales and the staff file

Every action under a named, qualified person.

  • A named account for every clinician and every member of staff
  • Role-based access enforced in the database
  • The signing clinician recorded on every note and letter
  • Every read and change of a record logged against the account

On request. Show who holds which role, and every action taken under it, to the minute.

For patients
Their record seen only by the people whose role allows it.
For the business
A staff list and an access log that match, ready for the Consejería or the Departament.

La historia clínica

A record where every entry has an author and a time.

  • Notes drafted from the consultation, read, edited and signed by the clinician
  • The transcript beside the note, so the source of each entry stays visible
  • Every read and change logged against a named account
  • The patient's own record exportable on request

On request. Open any consultation to see the note, its author, its signature and its time together.

For patients
A copy of their historia clínica when they ask for it.
For the business
Less time writing notes after clinic, and a record that meets Ley 41/2002.

Información and consentimiento informado

Every patient conversation on one record, in their language.

  • WhatsApp, email and calls on one thread per patient, with response times
  • Replies drafted in the patient's language for your team to approve
  • Recording consent taken at booking, and the consent discussion in the note
  • The price and cancellation policy shown before the patient commits

On request. Show what the patient was told, when they agreed, and where it is written.

For patients
Clear answers in Spanish, Catalan, English or the language they wrote in.
For the business
More enquiries answered within the hour, when they are most likely to become appointments.

What do patients and the business gain?

Published research on response times, ambient scribes and appointment reminders.

  1. 7x

    An enquiry answered within the hour is nearly seven times as likely to become a real conversation.8

  2. 30%

    Clinicians using an ambient scribe did 30% less work after hours.9

  3. 23%

    Patients sent a notification before their visit were 23% more likely to attend.10

How does wai surface authorisation evidence on request?

What may be asked for, where it is kept in wai, and how it is produced.

  1. The historia clínicaThe patient record, beside the transcriptOpen the consultation to see the note, its author, signature and time together.
  2. Changes to an entryThe audit trailWho changed the note, when, and the signed version that stands.
  3. Access to recordsEvery recordWho read it, under which account, to the minute.
  4. Staff and rolesAccounts and rolesWho holds which role, matched to the plantilla the comunidad holds.
  5. ConsentThe booking and the noteThe recording notice the patient saw at booking, and the consent discussion in the note.
  6. Patient communicationThe patient's threadEvery message, in Spanish, Catalan or any language, with response times.
  7. Fees and policiesPaymentsWhat was charged, against which visit, and the policy the patient saw.
  8. Activity by serviceReportsBookings and visits by clinician for any period, on the day.

How do you prepare a Spanish clinic for its autorización sanitaria?

A readiness checklist in four parts, for Madrid and Cataluña.

01The authorisation

  • Classify the centre and every unit against anexo I of RD 1277/2003.
  • File before opening, and never treat a patient before the authorisation is granted.
  • In Madrid, diary the renewal at least three months before the eight years run out.
  • Ask for a modificación before a new owner, service or address.

02People

  • A Director Técnico Asistencial in Madrid, or a responsable assistencial in Cataluña, named and qualified.
  • A personal file for every health professional, with the official degree, under artículo 7.
  • Colegiación and professional liability insurance on file where they apply.
  • Every arrival and departure notified to the Consejería in Madrid.

03Records

  • Every historia clínica identifies the professionals who took part.
  • Records kept at least five years from discharge, and 15 years for key documents in Cataluña.
  • Patients can see their record and receive a copy.
  • Every change to an entry is recorded with its author.

04Consent and display

  • Written consent for surgery, invasive procedures and notable risks.
  • The información básica given before written consent, and recorded.
  • The authorisation document and the staff list on display in Madrid.
  • Complaint forms available in every private Madrid centre.

What will the inspección ask you?

Questions that follow from what the law lets the inspección see, what to show, and where wai holds the answer.

01Who is responsible for care at this centre?

What to show

The Director Técnico Asistencial or the responsable assistencial, qualified, registered and named in the file.

Where wai has it ready

Named accounts and roles show who holds the lead role, and every action taken under it.

02Which professionals work here, and what are their degrees?

What to show

A current staff list and a personal file for each professional, with the official degree.

Where wai has it ready

Every person has a named account, so the staff list and the access log match.

03Does the care you deliver match your authorisation?

What to show

The authorised oferta asistencial, and what the centre actually does.

Where wai has it ready

Bookings and visits by clinician for any period, produced on the day.

04Show me a historia clínica.

What to show

A record that identifies every professional, with the consent and the reports in it.

Where wai has it ready

Notes are signed and timed by the clinician, and every change is logged against a named account.

05Where is the written consent for this procedure?

What to show

The signed consent, and the información básica the patient received before it.

Where wai has it ready

Recording consent is taken at booking, and the consent discussion is in the signed note.

06Can a patient obtain a copy of their record?

What to show

How a request is handled, and how fast.

Where wai has it ready

The patient's record can be exported on request.

07How do you use AI in care?

What to show

Where AI is used, and who decides.

Where wai has it ready

AI drafts the note and the reply. The clinician signs the note, and a person approves every message.

What is at stake in a Spanish autorización sanitaria?

No centre may see a patient before its authorisation is granted, and the market it opens is large.

  1. 601,012.10 euros

    is the highest fine Ley 14/1986 sets for a very serious health infraction, beside temporary closure for up to five years.11

  2. 8 years

    is how long a Madrid operating authorisation runs before it must be renewed, four for assisted reproduction.12

  3. 3,497,277

    people lived in the city of Madrid on 1 January 2026, 30.5% of them born abroad.13

Questions

What is the best clinic software for a Spanish autorización sanitaria?

The best software for a Madrid or Barcelona clinic is the system the clinic already runs on, so the evidence is kept as the work is done. Look for a historia clínica that identifies the author and time of every entry, notes signed by the clinician, messaging in Spanish, Catalan and English, named accounts with role-based access and a full audit trail. wai is built that way, to help you achieve an autorización sanitaria de funcionamiento.

Is there government approved clinic software in Spain?

Each comunidad autónoma's health authority, the Consejería de Sanidad in Madrid and the Departament de Salut in Cataluña, authorises health centres, services and establishments. It does not approve, certify or endorse software, wai included, and software cannot earn an autorización on a provider's behalf. wai keeps the records your team uses to show the comunidad autónoma how care is delivered, and the comunidad autónoma decides the autorización.

Does a doctor's own consulta need an autorización sanitaria?

Yes, Ley 14/1986 requires prior authorisation for every health centre whatever its size, and RD 1277/2003 classifies a consulta médica as a centre. Madrid's page says any centre needs one however limited its offer, and Cataluña runs its own procedure for consultes mèdiques.

How long does a Madrid authorisation last?

Eight years, or four for assisted reproduction. Consultas and similar centres without fixed electromedical equipment renew by declaración responsable, filed at least three months before the end.

How long must a Spanish clinic keep the historia clínica?

At least five years from the alta of each proceso asistencial under Ley 41/2002. In Cataluña, consent forms, discharge reports, surgical and anaesthesia records and test reports are kept at least 15 years.

Can AI write notes in a Spanish clinic?

Ley 41/2002 asks that the historia clínica identifies the professionals who took part, and Cataluña's law asks that every change records who made it. A note drafted by AI meets that when the clinician reviews it, edits it and signs it under their own name, with every change kept in the audit trail.

Where does wai keep our records?

In each clinic's own country, under that country's rules, encrypted, with a full audit log. We set this up with you before go-live.

See wai on your own diary, notes and inbox.

Fifteen minutes on video, in Spanish or English, on your own clinic's records. Built to help you achieve an autorización sanitaria de funcionamiento. wai hosts each clinic's records in its own country, under that country's rules. We set this up with you before go-live.

team@wellnessa-i.com

Sources

  1. 1Boletín Oficial del Estado, 2026Real Decreto 1277/2003, de 10 de octubre, por el que se establecen las bases generales sobre autorización de centros, servicios y establecimientos sanitarios, texto consolidadoRead source
  2. 2Comunidad de Madrid, Consejería de Sanidad, 2026Autorización de centros y servicios sanitariosRead source
  3. 3Comunidad de Madrid, Consejería de Sanidad, 2026Autorización de centros, servicios y establecimientos sanitarios, sede electrónicaRead source
  4. 4Generalitat de Catalunya, Departament de Salut, 2026Autorització de consultes mèdiques, inici de funcionamentRead source
  5. 5Boletín Oficial del Estado, 2023Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica, texto consolidadoRead source
  6. 6Boletín Oficial del Estado, 2026Real Decreto 239/2026, de 25 de marzo, por el que se modifica el Real Decreto 1277/2003Read source
  7. 7Generalitat de Catalunya, Departament de Salut, 2026Autorització de centres o serveis sanitaris, iniciar l'activitatRead source
  8. 8Harvard Business Review, 2011The Short Life of Online Sales LeadsRead source
  9. 9JAMA Network Open, 2025Clinician Experiences With Ambient Scribe Technology to Assist With Documentation Burden and EfficiencyRead source
  10. 10BMJ Open, 2016Using digital notifications to improve attendance in clinic, systematic review and meta-analysisRead source
  11. 11Boletín Oficial del Estado, 2023Ley 14/1986, de 25 de abril, General de Sanidad, texto consolidadoRead source
  12. 12Boletín Oficial de la Comunidad de Madrid, 2023Decreto 205/2023, de 19 de julio, por el que se modifica el Decreto 51/2006, de autorización y registro de centros, servicios y establecimientos sanitarios, BOCM 175 of 25 July 2023Read source
  13. 13Ayuntamiento de Madrid, Estadística, 2026Padrón Municipal de Habitantes, primeros resultados a 1 de enero de 2026Read source