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.
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
§ 3 Grundelemente, Patientenorientierung einschließlich Patientensicherheit to Verantwortung und Führung
§ 4 Messen und Bewerten von Qualitätszielen
§ 4 Erhebung des Ist-Zustandes und Selbstbewertung
§ 4 Regelung von Verantwortlichkeiten und Zuständigkeiten
§ 4 Prozess- bzw. Ablaufbeschreibungen
§ 4 Teambesprechungen, Fortbildungs- und Schulungsmaßnahmen
§ 5 Dokumentation, Selbstbewertung für interne Zwecke
Teil B II § 2, umzusetzen innerhalb von drei Jahren nach Zulassung
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
§ 4 Risikomanagement
§ 4 Fehlermanagement und Fehlermeldesysteme
§ 4 Checklisten, OP-Checklisten bei Eingriffen mit zwei oder mehr Ärzten oder unter Sedierung
§ 4 Notfallmanagement
§ 4 Hygienemanagement
§ 4 Arzneimitteltherapiesicherheit
§ 4 Prävention von und Hilfe bei Missbrauch und Gewalt
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
§ 4 Patientenbefragungen
§ 4 Beschwerdemanagement
§ 4 Patienteninformation und -aufklärung
§ 630e BGB, Aufklärung mündlich, rechtzeitig und verständlich
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
§ 630f BGB, Dokumentation in unmittelbarem zeitlichem Zusammenhang
§ 630f BGB, Berichtigungen nur, wenn der ursprüngliche Inhalt erkennbar bleibt
§ 630f BGB, Aufbewahrung zehn Jahre nach Abschluss der Behandlung
§ 10 MBO-Ä, Dokumentationspflicht
§ 3 QM-RL, Informationssicherheit und Datenschutz
§ 22 BDSG, Protokollierung und Beschränkung des Zugangs
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
§ 6 QM-RL, Erhebung und Darlegung des Stands der Umsetzung
Anlage 1 Abschnitt I, Fragen zur Erhebung
Anlage 1 Abschnitt II, jährlich mindestens 2,5 % oder zweijährlich 4 %
Vorlage einer schriftlichen Dokumentation
Maßnahme nach § 75 Absatz 2 i.V.m. § 81 Absatz 5 SGB V
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
§ 2 und § 3 BÄO, Approbation
Meldeordnung der Ärztekammer, Anzeige innerhalb eines Monats in Berlin
§ 17 MBO-Ä, Niederlassung und Ausübung der Praxis
§ 21 MBO-Ä, Haftpflichtversicherung
§ 95 SGB V, Zulassung durch den Zulassungsausschuss
Anlage 1 of the QM-RL sets the questions, and the practice answers with written documentation.2
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.
02
Quality goals
Whether practice goals are defined regularly, measured in a self-assessment, and the result documented for internal use.
03
Responsibilities and processes
Organisation, responsibilities and key processes set out in writing, available to staff and reviewed at set intervals.
04
Risk and error management
A risk strategy, an error reporting and learning system open to everyone, and OP checklists where they apply.
05
Patients
Patient surveys, a complaints process patients know about, and reliable patient information.
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
ImplementedEvery method in place, reviewed, and developed further
In progressWithin three years of Zulassung, in any order the practice chooses
Feedback and supportTraining, advice or a QM-Kommission from the KV
RefusedA measure under § 75 Absatz 2 with § 81 Absatz 5 SGB V
3 years
is the time a practice has from its Zulassung to put every QM method and instrument in place and review it.2
90%+
of practices in the twelfth KV survey said they use quality instruments and methods systematically.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.
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.
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
Decided. On 2 September 2026 the G-BA commissioned the IQTIG to set up regular reporting on QM in hospitals.
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
Fehlermeldesystem, the error reporting and learning system.
Approbation, the licence to practise as a doctor.
Landesärztekammer, the doctors' chamber of each Land, and its Berufsordnung.
Behandlungsakte, the patient file under § 630f BGB.
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.
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.
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.
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.