Under § 30 GewO, the operator of a private hospital, private maternity clinic or private psychiatric clinic needs a Konzession from the competent authority. The Regierungspräsidium Darmstadt states that only facilities for inpatient treatment with accommodation and meals need it, so a clinic treating only outpatients does not.
Who needs it, and when it is refused
§ 30 GewO requires a Konzession for operators of Privatkrankenanstalten, Privatentbindungsanstalten and Privatnervenkliniken.1 It is refused only if facts show the operator is unreliable, if adequate medical and nursing care does not appear assured, if the building and technical installations fail health requirements, or on two grounds about neighbours and other residents of the building.1
The Regierungspräsidium Darmstadt states that, following the case law, only facilities designed for inpatient treatment including accommodation and meals fall under § 30, and that a facility doing only outpatient treatment needs no § 30 licence.2 It adds that the Konzession never replaces the building permit or the duties under the Berufsordnung, the Infektionsschutzgesetz and Hessen's hygiene rules.2
What the file contains in Hessen
The application is informal, and Darmstadt lists what goes with it, a Gewerbezentralregister extract and a Führungszeugnis for the operator and its managers, a tax certificate, the commercial register extract, the trade registration, the contract with the responsible doctor and a named deputy, the hospital hygienist, the data protection officer and the patient safety officer.2 Plans, room uses and bed numbers come in triplicate, with the building permit for use as a hospital and a description of operations, emergency equipment and the on-call service.2
- Confirm it applies. Inpatient treatment with accommodation and meals needs it. Outpatient care alone does not.
- Secure the building permit first. Use as a hospital must be approved in building law, which the Konzession never replaces.
- Collect the probity documents. Registers, Führungszeugnis, tax certificate and CV for the operator and every manager.
- Name the responsible people. The responsible doctor and deputy, hygienist, data protection officer and patient safety officer.
- Describe the operation. Rooms, beds, emergency equipment, on-call service, meals and alarms.
- File the complete set. With the competent authority, and keep the record of every change after the grant.
- Operator ______ Legal form ______
- Building permit for hospital use dated ______
- Responsible doctor ______ Deputy ______
- Hospital hygienist ______ Data protection officer ______
- Patient safety officer ______
- Beds ______ On-call service described ______
- Filed with ______ On ______
The rules that run beside it
Every doctor in the clinic stays bound by the Berufsordnung, which keeps outpatient work outside licensed clinics tied to a Praxissitz.3 A day clinic or a facility for ambulatory surgery keeps hygiene plans under § 23 IfSG.4 A data protection officer is named once, as a rule, at least 20 people constantly process personal data by automated means.5
Questions
Does a day surgery centre need a § 30 Konzession?
Darmstadt says § 30 covers facilities for inpatient treatment with accommodation and meals, so a purely outpatient centre does not. It still keeps hygiene plans under § 23 IfSG.
Who grants the Konzession?
The competent authority of the Land. In Hessen, the Regierungspräsidium Darmstadt publishes the procedure.
Can a Konzession be refused for staffing?
Yes, if facts suggest adequate medical and nursing care of patients does not appear assured.
Does the Konzession replace the building permit?
No. Darmstadt states that the trade licence never replaces the building permit or other duties.
Sources
- 1Bundesministerium der Justiz, Gesetze im Internet, 2026§ 30 GewO, PrivatkrankenanstaltenRead source
- 2Regierungspräsidium Darmstadt, Land Hessen, 2026Antragsverfahren nach § 30 Gewerbeordnung, PrivatkrankenanstaltenRead source
- 3Bundesärztekammer, 2026(Muster-)Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte, MBO-Ä 1997, in der Fassung des 130. Deutschen Ärztetages vom 13. Mai 2026Read source
- 4Bundesministerium der Justiz, Gesetze im Internet, 2026§ 23 IfSG, Nosokomiale Infektionen, ResistenzenRead source
- 5Bundesministerium der Justiz, Gesetze im Internet, 2026§ 38 BDSG, Datenschutzbeauftragte nichtöffentlicher StellenRead source
Written by the wai team from Gemeinsamer Bundesausschuss, the Kassenärztliche Vereinigungen and the Länder guidance, checked on 16 October 2026. This is guidance, not legal advice. Neither the G-BA, any KV nor any Land authority endorses wai or any software.

