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For Vertragsarztpraxen, MVZ and private clinics in Germany, G-BA, KV and the Länder

QM-Richtlinie software for German practices, built to help you achieve a QM system that stands up to the KV Stichprobe.

Every practice in statutory care must run the internal quality management the G-BA sets in its QM-Richtlinie, and the Kassenärztliche Vereinigungen check it by random sample every year or two. wai runs booking, signed clinical notes, patient messaging in German or any language, payments and an audit trail on one record, so the evidence a QM system needs is kept as the work is done.

Updated . Every QM-RL fact is checked against g-ba.de and the other official pages cited below.

A woman in a long robe holding a cup on a high terrace above Berlin at dusk, a glass-walled room behind her

For

Vertragsarztpraxen, MVZ and Berufsausübungsgemeinschaften, private clinics and hospitals

Regulators

Gemeinsamer Bundesausschuss, the Kassenärztliche Vereinigungen, the Land authorities and the Landesärztekammern

Framework

QM-Richtlinie in force since 20 August 2026, § 135a SGB V, §§ 630e to 630g BGB, the Berufsordnung

Records

Hosted in each clinic's own country, under that country's rules

What the KV finds with wai

A German practice on wai answers every enquiry in the language the patient wrote in, closes each consultation with a note the doctor has signed, and can show who read or changed any record, to the minute. When the KV letter arrives, the written QM documentation draws on records the team already keeps.

What does German law ask of a practice in 2026?

Six areas, from the G-BA's QM-Richtlinie to the Land licence.

Six areas German law and the G-BA regulate, from the QM system to the Land licence. Open one for the rules behind it.1

01Das QM-SystemQuality management is a leadership task. The practice sets quality goals, measures them, assigns responsibilities in writing, describes its key processes, holds team meetings and reviews itself regularly, within three years of Zulassung.8 requirements
  1. § 3 Grundelemente, Patientenorientierung einschließlich Patientensicherheit to Verantwortung und Führung
  2. § 4 Messen und Bewerten von Qualitätszielen
  3. § 4 Erhebung des Ist-Zustandes und Selbstbewertung
  4. § 4 Regelung von Verantwortlichkeiten und Zuständigkeiten
  5. § 4 Prozess- bzw. Ablaufbeschreibungen
  6. § 4 Teambesprechungen, Fortbildungs- und Schulungsmaßnahmen
  7. § 5 Dokumentation, Selbstbewertung für interne Zwecke
  8. Teil B II § 2, umzusetzen innerhalb von drei Jahren nach Zulassung

Das QM-System on g-ba.de

02Risiko- und FehlermanagementMinimum standards no practice may waive. Risks are identified and managed, errors are reported and learned from, and procedures with two or more doctors or under sedation use an OP checklist. Emergencies, hygiene, medication safety and protection from abuse and violence are regulated too.7 requirements
  1. § 4 Risikomanagement
  2. § 4 Fehlermanagement und Fehlermeldesysteme
  3. § 4 Checklisten, OP-Checklisten bei Eingriffen mit zwei oder mehr Ärzten oder unter Sedierung
  4. § 4 Notfallmanagement
  5. § 4 Hygienemanagement
  6. § 4 Arzneimitteltherapiesicherheit
  7. § 4 Prävention von und Hilfe bei Missbrauch und Gewalt

Risiko- und Fehlermanagement on g-ba.de

03Patienten, Information und BeschwerdenThe practice asks patients for feedback, runs a complaints process patients know about, keeps reliable patient information to hand, and explains every treatment orally, in time and in words the patient understands.5 requirements
  1. § 4 Patientenbefragungen
  2. § 4 Beschwerdemanagement
  3. § 4 Patienteninformation und -aufklärung
  4. § 630e BGB, Aufklärung mündlich, rechtzeitig und verständlich
  5. § 630g BGB, Einsichtnahme in die Patientenakte

Patienten, Information und Beschwerden on g-ba.de

04Patientenakte und DatenschutzThe treatment is documented at the time it happens, a correction never hides what was there before, and the file is kept ten years after treatment ends. Health data needs logging, access limits and, from 20 people, a data protection officer.7 rules
  1. § 630f BGB, Dokumentation in unmittelbarem zeitlichem Zusammenhang
  2. § 630f BGB, Berichtigungen nur, wenn der ursprüngliche Inhalt erkennbar bleibt
  3. § 630f BGB, Aufbewahrung zehn Jahre nach Abschluss der Behandlung
  4. § 10 MBO-Ä, Dokumentationspflicht
  5. § 3 QM-RL, Informationssicherheit und Datenschutz
  6. § 22 BDSG, Protokollierung und Beschränkung des Zugangs
  7. § 38 BDSG, Datenschutzbeauftragter ab 20 Personen

Patientenakte und Datenschutz on gesetze-im-internet.de

05Die KV-StichprobeEach KV asks a random sample of practices for written QM documentation, at least 2.5% every year or 4% every two years, gives feedback and support, and reports through the KBV to the G-BA. A practice that refuses after repeated requests faces a measure under the SGB V.5 requirements
  1. § 6 QM-RL, Erhebung und Darlegung des Stands der Umsetzung
  2. Anlage 1 Abschnitt I, Fragen zur Erhebung
  3. Anlage 1 Abschnitt II, jährlich mindestens 2,5 % oder zweijährlich 4 %
  4. Vorlage einer schriftlichen Dokumentation
  5. Maßnahme nach § 75 Absatz 2 i.V.m. § 81 Absatz 5 SGB V

Die KV-Stichprobe on g-ba.de

06Approbation, Kammer, Zulassung und KonzessionA doctor practises in Germany with an Approbation from a Land authority, reports to the Landesärztekammer and follows its Berufsordnung. Statutory care needs a Zulassung from the Zulassungsausschuss, and a private clinic with inpatient care needs a Konzession under § 30 GewO.6 requirements
  1. § 2 und § 3 BÄO, Approbation
  2. Meldeordnung der Ärztekammer, Anzeige innerhalb eines Monats in Berlin
  3. § 17 MBO-Ä, Niederlassung und Ausübung der Praxis
  4. § 21 MBO-Ä, Haftpflichtversicherung
  5. § 95 SGB V, Zulassung durch den Zulassungsausschuss
  6. § 30 GewO, Konzession für Privatkrankenanstalten

Approbation, Kammer, Zulassung und Konzession on gesetze-im-internet.de

What does the KV ask a sampled practice?

Anlage 1 of the QM-RL sets the questions, and the practice answers with written documentation.2

  1. 01

    Practice profile

    Whether the practice operates with two or more doctors or under sedation, employs staff, sees patients in person and prescribes, and whether it has existed for more than three years.

  2. 02

    Quality goals

    Whether practice goals are defined regularly, measured in a self-assessment, and the result documented for internal use.

  3. 03

    Responsibilities and processes

    Organisation, responsibilities and key processes set out in writing, available to staff and reviewed at set intervals.

  4. 04

    Risk and error management

    A risk strategy, an error reporting and learning system open to everyone, and OP checklists where they apply.

  5. 05

    Patients

    Patient surveys, a complaints process patients know about, and reliable patient information.

  6. 06

    Application areas

    Emergencies, hygiene, medication safety, pain, falls, and the prevention of abuse and violence, with a Schutzkonzept where children are treated.

How does a KV QM check end?

There is no grade and no public rating. The KV assesses the documentation, gives feedback and support, and reports the results through the KBV to the G-BA.3

  1. ImplementedEvery method in place, reviewed, and developed further
  2. In progressWithin three years of Zulassung, in any order the practice chooses
  3. Feedback and supportTraining, advice or a QM-Kommission from the KV
  4. RefusedA measure under § 75 Absatz 2 with § 81 Absatz 5 SGB V
  1. 3 years

    is the time a practice has from its Zulassung to put every QM method and instrument in place and review it.2

  2. 90%+

    of practices in the twelfth KV survey said they use quality instruments and methods systematically.3

  3. 10 years

    is how long § 630f BGB requires the Behandlungsakte to be kept after treatment ends.4

  • The KVs ask either at least 2.5% of practices every year or 4% every two years, drawn at random by Betriebsstätten-Nummer, and the KBV sets the mode for all of them.
  • A practice drawn once is taken out of the next draw.
  • Risk management, error management and error reporting, and OP checklists where they apply, may never be waived, even in a small practice.
  • The KBV reports to the G-BA every two years by 31 July of the following year, and the G-BA publishes the reports.

What changed for German practices in 2026?

Four changes a practice should know in October 2026, each marked as in force or decided.

  1. In force. The G-BA amended Teil A and Teil B of the QM-RL on 18 June 2026, published in the Bundesanzeiger on 19 August 2026, and the new text has applied since 20 August 2026.
  2. In force. The survey of hospitals now runs through the structured Qualitätsbericht, with the first report due in 2028 on 2026 data, while practices stay on the KV sample.5
  3. Decided. On 2 September 2026 the G-BA commissioned the IQTIG to set up regular reporting on QM in hospitals.
  4. Adopted. The 130th Deutscher Ärztetag amended the (Muster-)Berufsordnung on 13 May 2026, and it binds a doctor once their Landesärztekammer adopts it as a Satzung.

The Länder, body by body

The Land licenses the doctor and the clinic. Four Länder, as their own pages set it out.6

LandBodyWhat it decides
BerlinLandesamt für Gesundheit und Soziales, Landesprüfungsamt für GesundheitsberufeThe Approbation for doctors examined in Berlin, at a fee of 139 euros
BerlinÄrztekammer BerlinEvery doctor working or living in Berlin reports to it within one month
BayernRegierung von Oberbayern or Regierung von UnterfrankenThe Approbation by place of study, at 200 euros, valid across Germany without time limit
HamburgLandesprüfungsamt für Heilberufe, SozialbehördeThe Approbation for doctors trained in the EU, at 350 to 600 euros
HessenRegierungspräsidium DarmstadtThe Konzession for a Privatkrankenanstalt under § 30 GewO

The German names

The official names behind this page, as German law and the bodies write them.

  1. Gemeinsamer Bundesausschuss, the G-BA, which sets the QM-Richtlinie.1
  2. Kassenärztliche Vereinigung, the KV, one per region, and the Kassenärztliche Bundesvereinigung, the KBV.
  3. Einrichtungsinternes Qualitätsmanagement, internal quality management.
  4. Fehlermeldesystem, the error reporting and learning system.
  5. Approbation, the licence to practise as a doctor.
  6. Landesärztekammer, the doctors' chamber of each Land, and its Berufsordnung.
  7. Behandlungsakte, the patient file under § 630f BGB.
  8. Konzession, the licence for a Privatkrankenanstalt under § 30 GewO.

What should practice software in Germany actually run?

Each module runs part of the practice 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 Patienten, Information und BeschwerdenApprobation, Kammer, Zulassung und Konzession

    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 Patienten, Information und Beschwerden

    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 Patientenakte und DatenschutzDas QM-System

    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 Patienten, Information und Beschwerden

    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 Risiko- und FehlermanagementPatientenakte und Datenschutz

    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 Das QM-SystemPatientenakte und DatenschutzApprobation, Kammer, Zulassung und Konzession

    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 Die KV-StichprobeDas QM-SystemRisiko- und Fehlermanagement

    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 man in a dark suit at a floor-to-ceiling window high above Munich at sunset

How does wai evidence each QM requirement?

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

Das QM-System

Responsibilities and processes that match the system the team uses.

  • Named accounts for every person, with role-based access
  • Reports on response times, the front desk and takings for any period
  • Every booking, reminder and change, with a time and a name
  • Signed notes and letters on one record per patient

On request. Show who holds which role and how a visit runs, from booking to signed letter, on live records.

For patients
A practice where every step has an owner.
For the business
Quality goals measured on live data, without a separate collection exercise.

Risiko- und Fehlermanagement

The audit trail a risk review starts from.

  • Who saw what, who changed what, and when, to the minute
  • Patient flags for controlled drugs and safeguarding notes
  • Signed, timed notes for every visit
  • Reports for any period, produced on the day

On request. Rebuild the timeline behind a critical event from the record, with times and names.

For patients
Problems found and fixed, with the reason recorded.
For the business
Error reviews that take an hour, from a record nobody rewrote.

Patienten, Information und Beschwerden

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 the whole conversation with a patient, who replied and how fast.

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

Patientenakte und Datenschutz

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

  • Notes drafted from the consultation, read, edited and signed by the doctor
  • 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 file when they ask for it.
For the business
Less time writing notes after clinic, and a file that meets § 630f.

Die KV-Stichprobe

Written QM documentation drawn from live records.

  • Reports for any period, produced on the day they are asked for
  • Named accounts and roles, matched to the organigram
  • An audit trail of every read and change
  • Response times on every patient enquiry

On request. Answer the Anlage 1 questions with records the practice already keeps, the day the letter arrives.

For patients
A practice that measures how it treats them.
For the business
A sample check answered in days, with no binder written for the occasion.

Approbation, Kammer, Zulassung und Konzession

Systems running before the first patient arrives.

  • Online booking, reminders and waitlist offers from the first day
  • Named accounts for every person, with role-based access
  • 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 and access controls a Konzession file or a Kammer enquiry describes, running on real patients.

For patients
A practice that works properly from the first appointment.
For the business
An opening date held, with the record system already in use.

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.7

  2. 30%

    Clinicians using an ambient scribe did 30% less work after hours.8

  3. 23%

    Patients sent a notification before their visit were 23% more likely to attend.9

How does wai surface QM evidence on request?

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

  1. The BehandlungsakteThe patient record, beside the transcriptOpen the consultation to see the note, its author, signature and time together.
  2. Corrections to an entryThe audit trailWho changed the note, when, and the signed version that stands.
  3. Access to health dataEvery recordWho read it, under which account, to the minute, as § 22 BDSG asks.
  4. ResponsibilitiesAccounts and rolesWho holds which role, matched to the organigram in the QM documentation.
  5. Aufklärung and consentThe booking and the noteThe recording notice the patient saw at booking, and the consent discussion in the signed note.
  6. Complaints and enquiriesThe patient's threadEvery message, in German or any language, with response times.
  7. Fees and policiesPaymentsWhat was charged, against which visit, and the policy the patient saw.
  8. Quality goalsReportsResponse, front desk and takings reports for any period, on the day.

How do you prepare a practice for the KV's QM check?

A readiness checklist in four parts.

01The QM system

  • Quality goals written down, measured and reviewed at least once a year.
  • An organigram or table of responsibilities, with every safety-relevant process owned.
  • Key processes described and available to every member of staff.
  • The self-assessment documented for internal use, with its date.

02Risk and safety

  • A risk strategy, and an error reporting system open to all staff, anonymous and without sanction.
  • OP checklists for any procedure with two or more doctors or under sedation.
  • Emergency equipment and training current, and the hygiene rules written down.
  • A Schutzkonzept where children and young people are treated.

03The patient file

  • Every entry made at the time, and no correction that hides the original.
  • Files kept ten years after treatment ends.
  • A patient's request to see the file answered without delay.
  • Access to health data logged and limited by role.

04Licences and people

  • Every doctor's Approbation and Kammer registration on file.
  • The start of practice and every change reported to the Ärztekammer.
  • Professional liability insurance in place for every doctor.
  • For a clinic with beds, the § 30 GewO Konzession current.

What will the KV or the Land authority ask you?

Questions that follow from the QM-RL's Anlage 1 and the Land rules, what to show, and where wai holds the answer.

01Do you set practice quality goals and check how far you reach them?

What to show

Written goals, the measure for each, and the last self-assessment with its date.

Where wai has it ready

Reports on response times, the front desk and takings run for any period, on the day.

02Who is responsible for what in this practice?

What to show

An organigram or table, with a named lead for every safety-relevant process.

Where wai has it ready

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

03How do staff report errors and near misses, and what happens next?

What to show

A low-threshold, anonymous reporting route and the actions taken on recent reports.

Where wai has it ready

The audit trail and the signed note give each review its timeline, to the minute.

04How is a correction to the patient file made?

What to show

A file where every change shows the original and its date, as § 630f asks.

Where wai has it ready

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

05How is the patient informed before treatment?

What to show

The oral explanation recorded, in time, with copies of anything the patient signed.

Where wai has it ready

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

06Who can see health data here?

What to show

Roles, access limits and a log of who read what, as § 22 BDSG lists.

Where wai has it ready

Role-based access enforced in the database, every read logged, records hosted in the clinic's own country.

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 doctor signs the note, and a person approves every message.

What is at stake in German QM and licensing?

Any practice in statutory care can be drawn in the next sample, and the profession it serves is large and growing.

  1. 4%

    of practices are drawn at random for the KV's QM survey every two years, or at least 2.5% every year.2

  2. 4,519

    Vertragsärzte and psychotherapists were written to in the twelfth survey, and 96% took part.3

  3. 446,000

    doctors were working in Germany at the end of 2025, and 39% of doctors in ambulatory care were employed in practices or MVZ.10

Questions

What is the best practice software for the QM-Richtlinie?

The best software for QM is the system the practice already runs on, so the evidence is kept as the work is done. Look for a record that shows the author and time of every entry, notes signed by the doctor, messaging in German and English, named accounts with role-based access and a full audit trail. wai is built that way, to help you achieve a QM system that stands up to the KV Stichprobe.

Is there G-BA or KV approved practice software?

The Gemeinsamer Bundesausschuss sets the QM-Richtlinie, the Kassenärztliche Vereinigungen check practices against it, and the Land authorities license doctors and private clinics. It does not approve, certify or endorse software, wai included, and software cannot earn a QM check result on a provider's behalf. wai keeps the records your team uses to show your KV how care is delivered, and your KV decides the QM check result.

Does a practice need QM certification?

No. The KBV says there is no duty to certify a practice's QM. A practice may build its own system or use an existing model such as QEP, which the KBV and the KVs developed for practices.

Does the QM-Richtlinie apply to a purely private practice?

The QM-RL binds every provider taking part in vertragsärztliche Versorgung. Every doctor, private or not, also answers to the Berufsordnung, whose model text obliges doctors to take part in the Ärztekammer's quality measures.

How long must a German practice keep patient files?

Ten years after treatment ends, under § 630f BGB and § 10 of the model Berufsordnung, unless another rule sets a longer period.

Does a private clinic need a Konzession under § 30 GewO?

Only when it provides inpatient treatment with accommodation and meals. The Regierungspräsidium Darmstadt states that a facility treating only outpatients needs no § 30 GewO licence.

Can AI write notes in a German practice?

§ 630f BGB asks that entries are made at the time and that every correction leaves the original visible. A note drafted by AI meets that when the doctor reviews it, edits it and signs it under their own name, and every change stays 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 German or English, on your own practice's records. Built to help you achieve a QM system that stands up to the KV Stichprobe. 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