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(1) The Federal Joint Committee in accordance with section 91 shall establish an academic Institute for Quality Assurance and Transparency in the Healthcare System, which shall be impartial. To this end, the Committee shall establish a foundation under private law which shall be the financing entity of the Institute.
(2) The Board of the Foundation shall appoint the management of the Institute, with the approval of the Federal Ministry of Health. The Federal Ministry of Health shall second a member to the Board of the Foundation.
(3) The Institute shall work on behalf of the Federal Joint Committee on quality assurance measures and in order to portray the quality of care in the healthcare system. It should in particular be commissioned
1. to measure and portray the quality of care where possible on a cross-sectoral basis to develop coordinated risk-adjusted indicators and tools, including modules for supplementary patient surveys,
2. to develop the necessary documentation for inter-institutional quality assurance, taking account of the principle of data minimisation,
3. to participate in the implementation of inter-institutional quality assurance, and in doing so, where necessary, to involve the further facilities in accordance with sentence 3,
4. to publish the results of the quality assurance measures in a suitable manner and in a form that is understandable for the public,
5. on the basis of suitable data which are published in the hospitals’ quality reports, to draw up, per facility, comparative risk-adjusted overviews of quality in relevant fields of in-patient care, and to publish them on the Internet in a form that is understandable for the public; results in accordance with No. 6 are to be included,
6. to portray, for the further development of quality assurance on selected benefits, the quality of out-patient and in-patient care additionally on the basis of suitable social data provided to the Institute by the health insurance funds in accordance with section 299 subsection (1a) on the basis of guidelines and resolutions of the Federal Joint Committee, as well as
7. to develop criteria on the evaluation of certificates and quality seals which are widespread in out-patient and in-patient care, and to use these criteria to provide information on the authoritativeness of these certificates and quality seals in a form that is understandable for the public.
In cases in which further facilities contribute towards the implementation of the mandatory quality assurance measures in accordance with section 137 subsection (1) sentence 1 No. 1, the latter must provide to the Institute in accordance with subsection (1), on the basis of the guidelines of the Federal Joint Committee on inter-institutional quality assurance, the data necessary to perform its tasks in accordance with sentence 2.
(4) The institutions forming the Federal Joint Committee, the non-partisan members of the Federal Joint Committee, the Federal Ministry of Health, and the organisations that are relevant at federal level for representing the interests of patients and the self-help of chronically-ill persons and persons with disabilities, may apply to the Federal Joint Committee for the Institute to be commissioned. The Federal Ministry of Health may directly commission the Institute to carry out examinations and recommendations for action on the tasks in accordance with subsection (3) for the Federal Joint Committee. The Institute may reject a commission from the Federal Ministry of Health unless the Federal Ministry of Health agrees to fund the performance of the commission. The Institute can also deal with tasks in accordance with subsection (3) without being commissioned; the Board of the Foundation shall be informed promptly thereof by the Institute’s management. Up to 10 percent of the budget funds which are available to the Institute may be used annually for the activity in accordance with sentence 4. The results of the work in accordance with sentence 4 shall be submitted to the Federal Joint Committee and to the Federal Ministry of Health prior to being published.
(5) The Institute shall guarantee that the tasks in accordance with subsection (3) are carried out on the basis of the relevant, internationally-recognised standards of the scientific disciplines. To this end, the Foundation’s statues shall provide for an academic advisory council made up of non-partisan experts, which shall advise the Institute on fundamental issues. The members of the academic advisory council shall be appointed by the board of the Foundation, in consultation with and at the proposal of the Institute’s management. The academic advisory council may make proposals to the Institute for addressing matters in accordance with subsection (4) sentence 4.
(6) In agreement with the Federal Joint Committee, the Institute may issue research and development commissions to external experts to carry out the tasks in accordance with subsection (3); section 299 shall apply where personal data are to be transmitted in so doing.
(7) The following shall be involved in the development of the contents in accordance with subsection (3):
1. the National Associations of Statutory Health Insurance Physicians,
2. the German Hospital Federation,
3. the National Association of Statutory Health Insurance Funds,
4. the Association of German Private Healthcare Insurers,
5. the German Medical Association, the German Dental Association and the Federal Chamber of Psychotherapists,
6. the professional organisations of the nursing professions,
7. the Scientific Medical Societies,
8. the German Network for Healthcare Research,
9. the organisations that are relevant at federal level for representing the interests of patients and the self-help of chronically-ill persons and persons with disabilities,
10. the Federal Government’s Commissioner for Patients’ Affairs,
11. two representatives to be determined by the Conference of Ministers of Health of the Länder, as well as
12. the higher federal authorities within the portfolio of the Federal Ministry of Health, where their task areas are affected.
(8) Section 139c shall apply mutatis mutandis to the funding of the Institute.
(9) In order to ensure the impartiality of the Institute, the Board of the Foundation shall ensure that conflicts of interest of employees of the Institute, as well as of all other persons and institutions involved in the performance of the tasks in accordance with subsection (3), are avoided.
(10) The Federal Joint Committee may commission the Institute or another agency that is involved in inter-institutional quality assurance to evaluate the data collected in the mandatory quality assurance measures in accordance with section 137 subsection (1) sentence 1 No. 1 on request by a third party for purposes of academic research and the further development of quality assurance. To this end, any natural or legal person may lodge a request with the Federal Joint Committee, or with an agency commissioned in accordance with sentence 1, to evaluate and transmit the result of the evaluation. After examining the justified interest, the Institute or other agency commissioned in accordance with sentence 1 shall transmit to the applicant the anonymised results of the evaluation if the latter has undertaken, when lodging the application, to assume the costs incurred. Taking into account requirements of data protection law, as well as the principle of data security, the Federal Joint Committee shall – in the rules of procedure for the evaluation of the data collected in accordance with section 137 subsection (1) sentence 1 No. 1 and the transmission of the results of the evaluation – regulate a transparent procedure as well as details on the procedure for assuming costs in accordance with sentence 3. The Federal Joint Committee shall have the data protection concept regularly examined and evaluated in order to improve data protection and data security for the performance of the tasks in accordance with sentences 1 and 3 by independent experts; the result of the examination shall be published.
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