Legal Tasks of DIMDI

Legal Tasks of DIMDI

Page Overview

• Survey
• Legal Basis of DIMDI's Tasks
• Publication of Official Classifications
• Implementation and Operation of an Information System of Medical Devices
• Implementation and Operation of an Information System on Drugs
• Implementation and Operation of an Information System on Health Technology Assessment and Evidence Based Medicine

Survey

The tasks of DIMDI mainly cover the following subjects:

• giving access to information on medicine and related fields according to the decree of DIMDI's foundation of 1 September 1969 (text: see Appendix);
• implementation and operation of database-supported information systems on drugs and medical devices and publication of official classifications based on German or European Health Law or Directives
• setting up of documentations and implementation of an information system for health technology assessment and evidence based medicine.

More than 70 medical databases with more than 100 mio. documents have been implemented. This database pool is the basis for the work concerning health legislation, which has become more and more important for DIMDI. The following list shows the relevant laws and administrative regulations.

Legal Basis of DIMDI's Tasks

• Decree of Foundation of DIMDI, dated 1 September 1969
• Health Care Reform Act of 21 December 1992 (GSG) and Notifications of 17 June 1993, 27 July 1995, 14 October 1994, 19 September 1995 and 20 February 1996
• Cancer Register Act of 4 November 1994
• Medical Devices Act of 2 August 1994
• German Drug Law (AMG) (8th Amendment Act of 7. September 1998) 
• Second Law on the Reorganization of the Statutory Health Insurance of 23 June 1997

(Excerpts of the a.m. laws, regulations and decrees are to be found in the Appendix.)

Publication of Official Classifications

The Health Care Reform Act of 1992 (GSG) has become effective as of 1 Januar 1993. Besides other aspects this law prescribes the coding of diagnoses and medical procedures using international medical classifications issued by DIMDI as ordered by the Federal Ministry of Health. The classifications published according to the a.m. laws are the recent versions of the International Classification of Diseases (ICD) and the Operation Code persuant to section 301 SCV (OPS-301), which is based on the International Classification of Procedures in Medicine.

The excerpts of the laws and the corresponding notifications being issued for the implementation of the Law so far are to be found in the Appendix.

A comparable regulation in the Cancer Register Act (KRG) of 4 November 1994 requires the publication of a classification for the coding of tumor diagnoses; the corresponding excerpt of the law is given in the Appendix.

Implementation and Operation of an Information System of Medical Devices

The Medical Devices Act (MPG) prescribes in section 33 the implementation of an information system on medical devices.

In order to support the execution of the a.m. law, DIMDI has the task to implement and offer databases as follows:

• Databases for Competent Authorities with information derived from data collections according to sections 18, 20, 24, 25, 29, 30 and 33 (MPG), viz:
  • Notifications on the first placing of medical devices on the market
  • Informations relating to certifications 
  • Reports from incidents with medical devices
  • Notifications on safety officers responsible for medical devices
  • Notifications on clinical investigations/performance evaluations of medical devices
• Access to databases for Competent Authorities of other Member States and institutions of the European Communities and the other states party to the Agreement on the European Economic Area
• Implementation of databases generally available on medical devices, standards etc.

To facilitate these tasks, DIMDI publishes a German version of the Universal Medical Device Nomenclature System ( UMDNS)

Implementation and Operation of an Information System on Drugs

§ 67a of the German Drug Law (AMG) (8th Amendment Act of 7. September 1998) prescribes the implementation of a drug information system in cooperation with the Federal German drug regulatory authorities (Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Paul-Ehrlich-Institute (PEI) and Federal Institute for Health Protection of Consumers and Veterinary Medicine (Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, BgVV).

The information system "AMIS - Bundesländer" containing data from the above mentioned Federal Institutes is offered to the Competent Authorities of the German Länder online via DIMDI .

The database "AMIS - Medizinischer Dienst" contains selected parts of the system m.a. and is offered to the Head Associations and Medical Services of the German Statutory Health Insurance System.

A third system "AMIS - Öffentlicher Teil" containing a defined set of basic information according to § 34 of the German Drug Law is offered to the public.

Implementation and Operation of an Information System on Health Technology Assessment and Evidence Based Medicine

Collection, evaluation and active dissemination of information on health technology assessment and evidence based medicine become more and more important. In most of the developed countries organizations exist which are active in this field. No corresponding organization existed in Germany up to now, although it was widely accepted that the medical and economic efficiency of diagnostic, preventive and therapeutic procedures must be evaluated.

Based on the Second Law on the Reorganization of the Statutory Health Insurance of 23 June 1997 (see German Appendix) the Federal Ministry of Health therefore ordered DIMDI to implement and operate an information system on Health Technology Assessment and Evidence Based Medicine. The information system shall provide scientific research material as a basis for decisions in health policy, especially for the purposes of the Statutory Health Insurance System.