Betrieb einer Röntgeneinrichtung oder wesentliche Änderung des Betriebs Erteilung zur Teleradiologie

§ 14 paragraph 2 Radiation Protection Act (StrlSchG)
§ 123 Radiation Protection Ordinance (StrlSchV)

If you want to use an X-ray device for teleradiology, you need a permit.
If you want to make changes to an X-ray facility for teleradiology, you also need approval.

To operate an X-ray facility for the purpose of teleradiology, you require approval from the responsible authority.
If you want to make significant changes to the facility, you will also need permission.

Examples of other significant changes include:

• a change of room
• a change of the image receiver
• structural changes to the room

Any changes to the radiation protection officer’s personnel must also be reported again.

• Written application for approval signed by the radiation protection officer
• Description of the X-ray equipment and, if applicable, expert test report
• Appointments of the required number of radiation protection officers
• Proof of the required expertise of teleradiologists and radiation protection officers
• Proof of the knowledge of local doctors
• Proof of the technical expertise of the persons carrying out the work
• Overall concept for teleradiology operations
• Acceptance of the teleradiology line and components

• They have the necessary reliability and expertise in radiation protection.
• The necessary number of radiation protection officers have been appointed and the necessary powers granted.
• Other persons working there have the necessary knowledge and skills with regard to the possible radiation hazards and the protective measures to be applied.
• The necessary personnel is available.
• They have the necessary equipment and have taken the necessary measures.
• It is a justified type of activity according to a legal regulation or there are no significant doubts as to the justification of the type of activity.
• There are no other public law provisions to the contrary.
• You or the person responsible for radiation protection are permitted to practice medicine or dentistry.
• You may involve a medical physics expert to closely collaborate in your treatment.
• The necessary equipment is available and the necessary measures have been taken to ensure that the quality required for the application is achieved.
• The availability of the teleradiologist during the examination is guaranteed.
• The technical implementation is carried out by a person with the necessary expertise in radiation protection and the authorization to technically carry out the examination in teleradiology.
• A doctor with the necessary knowledge of radiation protection is present at the technical implementation site.
• An overall concept for teleradiology operations is available, which
  • ensures the required availability of the teleradiology system.
  • enables the teleradiologist to be personally present at the location of the technical implementation within a period of time necessary for emergency care; in justified cases, another doctor who has the necessary expertise in radiation protection can also be personally present.
  • Regular and close integration of the teleradiologist into the clinical operations of the radiation protection officer is ensured.

The granting or refusal of the permit is subject to a fee. The fees are calculated according to the time spent in accordance with Section 2 of the Hamburg Fee Schedule.

• You submit an application for approval or an application for a significant change to an existing approval.
• You add all necessary documents.
• If the documents or information required for processing are incomplete, you will be contacted by the processing department.
• If the requirements for approval are met, you will receive approval.
• The approval will be sent to you by post.
• You will receive the fee notice by separate mail.

If all documents are available, processing normally takes 4 weeks.

You need the permit before you start carrying out the activity.
The permit is limited to a maximum of 5 years.

Authorisation to operate an X-ray facility for teleradiology is limited to night, weekend and holiday service. It may be granted for longer than night, weekend and holiday service if there is a need for patient care.

Objection within one month of receipt of the decision

• Apply for approval of an X-ray facility for teleradiology
• Authorisation to operate a facility/equipment/X-ray facility for the purpose of teleradiology
• Approval for significant modification of the system/facility/X-ray facility for the purpose of teleradiology
• Significant changes include
  • Change of room
  • Changing the image receiver
  • structural changes to the room
• Changes in the personnel of the radiation protection officers must also be reported again.

Justice and Consumer Protection Authority