Regulation on the implementation of the rules on data transparency (Data transparency regulation-DaTraV)

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DaTraV

Date of completion: 10.09.2012

Full quote:

" Data Saving Ordinance of 10 September 2012 (BGBl. I p. 1895) "

Footnote

(+ + + Text certificate: 18.9.2012 + + +) 

  

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Input formula

Pursuant to § 303a (1) sentence 2, paragraph 2, and 3 sentence 2 of the Fifth Book of the Social Code-statutory health insurance-which is defined by Article 1 (83) of the Law of 22 December 2011 (BGBl. I p. 2983), the Federal Ministry of Health is responsible for: Unofficial table of contents

§ 1 Scope

The regulation regulates the details of the exercise, implementation and financing of the tasks of data transparency in accordance with § § 303a to 303e of the Fifth Book of Social Law. Unofficial table of contents

§ 2 Task perception

(1) The tasks of the trust body according to § 303c of the Fifth Book of the Social Code shall be carried out by the German Institute for Medical Documentation and Information (DIMDI). (2) The tasks of the data processing unit according to § 303d of the Fifth Book The Social Code is responsible for DIMDI. (3) It is necessary to ensure that the place of trust and the data processing site are conducted independently of each other in terms of space, organization and personnel. The spatial independence is ensured by a strict separation of the rooms and the data processing structures, in particular the systems used for data processing. The personal autonomy is ensured by:

1.

Employees may only be employed for the job of the trust or the data processing unit,

2.

employees who are or have been active in the place of trust may not be employed in the data processing unit for the whole duration of their employment relationship,

3.

Employees who are or have been active in the data processing unit shall not be able to work at the place of trust for the entire duration of their employment relationship; and

4.

Employees of the trust office during their work alone are subject to the technical instructions of the Data Protection Officer of DIMDI.

The organisational autonomy shall be ensured by establishing the tasks referred to in paragraphs 1 and 2 in different organisational units. Unofficial table of contents

§ 3 Procedure and extent of the data transfer by the Federal Insurance Office

(1) The Federal Insurance Office shall transmit to the data processing office annually after the implementation of the corrected annual compensation the following in accordance with § 268, paragraph 3, sentence 14 in conjunction with sentence 1 number 1 to 7 of the fifth book Social Code Data collected and checked for completeness and plausibility without the pseudonyms transmitted by the sickness funds for the purpose provided for in § 303d paragraph 1 sentence 1 of the Fifth Book of Social Code. (2) The Federal Insurance Office shall be transmitted the Office of Trust each year following the implementation of the corrected annual compensation and after completion of the examination for completeness and plausibility of the data, a list of the pseudonyms belonging to the data referred to in paragraph 1 by the sickness funds for the pseudonyms in § 303c (1) of the Fifth Book of the Social Code (3) The details of the transfers referred to in paragraphs 1 and 2 shall be agreed by the data processing office, the trust office and the Federal Insurance Office; the Federal Commissioner shall be responsible for questions of data protection and data security. for data protection and information freedom and the Federal Office for Security in the Information technology. Unofficial table of contents

§ 4 Procedure at the point of trust

(1) The trust authority transfers the list of temporary pseudonyms to permanent pseudonyms sent to it by the Federal Insurance Office. The procedure to be used for the transfer of the pseudonyms is determined by agreement with the Federal Office for Information Security. In this case, a key-dependent method is to be provided for the formation of the permanent pseudonyms, which makes possible a nationwide, unambiguous, cross-accrual relationship of the data to a insured person for all the power ranges. In order to transfer the pseudonyms, the trust office uses the key that has been developed for the procedure in § 30 (3) sentence 2 of the Risk Structure Compensation Ordinance. (2) The trust office checks whether the transfer to permanent Pseudonyms have been error-free and the data processing unit shall transmit the list of permanent pseudonyms as referred to in paragraph 1. After that, the lists with the temporary and permanent pseudonyms are to be deleted at the trust point. Unofficial table of contents

§ 5 Data provision by the data processing unit

(1) The data processing site links the list of permanent pseudonyms sent to it by the trust authority with the data transmitted to it by the Federal Insurance Office and prepares them for the data provided in § 303e (2) of the Fifth Book. (2) For applications to the data processing unit for data processing and data use, a form to be provided by the data processing unit is to be used. It shall also indicate the purpose of the data use by the applicant and whether the data requested should be combined with each other or with external data. (3) The data processing unit shall examine if any requests are made to:

1.

the applicant is entitled to process and use the Social Code according to § 303e (1) of the Fifth Book of the Book of Social Law (authorised use),

2.

the specified purpose of data processing and data use (purpose of use) corresponds to the catalogue in accordance with § 303e (2) of the Fifth Book of the Social Code,

3.

the scope and structure of the data available to it are sufficient for this purpose;

4.

the scope and structure of the requested data are necessary for this purpose; and

5.

not to be able to re-identify the insured persons concerned by bringing together in accordance with the second sentence of paragraph 2.

(4) The data processing site shall, in principle, provide the authorized user with the data for which an entitlement is granted anonymized and summarised to the necessary extent. The provision of the anonymized and aggregated data may be made by the data processing site

1.

provides fictitious structure data sets by means of which the user authorized evaluators can create evaluation programs; with these evaluation programs the data processing unit evaluates the original data and transmits the data to the data processing unit. Entitled to use the results,

2.

Evaluations shall be drawn up and the persons entitled to use the results shall be forwarded or

3.

makes use of standardized data sets available to the user.

The provision can be made in electronic or written form. (5) The data processing unit provides the data processing authorities with the data in an exceptional manner as individual data sets, if the specified and pursuant to § 303e (2) (2) of the Fifth Book of the Social Code cannot be achieved through the processing of anonymized data. Such a provision shall ensure that the insured persons concerned cannot be re-identified. The pseudonymized individual data sets are provided in the rooms of the data processing site. (6) A health insurance-related evaluation is only permitted with the consent of the respective health insurance company. The consent shall be submitted by the user with his/her application. It should be ruled out that health insurance-related evaluations in combination with further evaluations can be used to obtain information about health insurance companies which have not given consent to an evaluation. (7) The The data processing centre shall decide on the application in writing or electronically by administrative act. The administrative act may, in particular, be accompanied by the obligation to refrain from merging the requested data with one another or with external data holdings. The decision on the specific form of delivery in individual cases shall be taken by the data processing unit at the discretion of the authorities. The application referred to in paragraph 2 shall be decided within a period of three months from the receipt of the documents. The data processing unit may extend the time limit by one month, if this is necessary because of the difficulty of the examination or on the grounds of the applicant's reasons. The extension of the time limit shall be justified on the basis of the applicant. Unofficial table of contents

§ 6 reimbursements and advance payments

(1) The Confederation of Health Insurance Funds shall reimburse DIMDI the costs (physical and personnel costs) to be borne by the health insurance funds pursuant to section 303a (3) sentence 1 of the Fifth Book of Social Code, which costs the data processing unit and the Create trust through the performance of the tasks of data transparency. These costs are reimbursed by the health insurance companies according to the number of their members. (2) For the reimbursement of the costs of physical and personnel costs, the staff costs and the flat-rate flat rates of a fee are paid. Workplace in the Federal Administration for Cost Calculations And Economic Analyses of the Federal Ministry of Finance in the current version. In addition, the additional costs of up to EUR 140 000 arising from the special tasks of the data processing unit and the trust office shall be reimbursed annually. (3) The reimbursement of expenses as referred to in paragraph 2 by the Association of the Federal Government the health insurance funds are made in quarterly rates up to the third working day of the quarter as an advance to DIMDI. The advance payment shall be made in each case under the second sentence of Article 303e (2), second sentence, of the Fifth Book of the Social Code without interest, but the costs incurred as a result of the collection of user fees by third parties, (4) The DIMDI has the actual costs incurred in accordance with paragraphs 1 and 2 in relation to the Confederation of Health Insurance Funds (Confederation of Health Insurance Funds). The actual staffing level shall be decisive for the proof of the material and personnel costs referred to in the first sentence of paragraph 2. The additional material costs referred to in the second sentence of paragraph 2 shall be proved by individual evidence. Overpayments are to be added to the advances referred to in paragraph 3 without interest. (5) The DIMDI and the Association of the Federal Government of the Health Insurance Funds agree on the implementation of paragraphs 3 and 4. Unofficial table of contents

§ 7 Transitional arrangements

(1) By way of derogation from § 3 (1), the Federal Insurance Office shall transmit the book for the implementation of the annual compensation for the compensation years 2009 and 2010 in accordance with § 268 (3) sentence 14 in conjunction with the first sentence of the fifth sentence of 1 to 7 of the Fifth Book Social code collected and checked for completeness and plausibility without the pseudonyms transmitted by the health insurance companies to the data processing site until 1 February 2013. (2) By 1 February 2013, the Federal Insurance Office shall send a list of the pseudonyms belonging to the data referred to in the first sentence of paragraph 1 of the Fifth Book in accordance with Section 303c (1) of the fifth book. Purpose of the Social Code to the place of trust. § 3 Paragraph 3 applies accordingly. (3) The Federal Government of the Health Insurance Funds shall pay the DIMDI EUR 120 000 a month after the entry into force of this Regulation and a further EUR 120 000 for investment costs at the request of the DIMDI on 1 December 2012 as well as physical and personnel costs. The first sentence of Article 6 (2) shall apply accordingly. The DIMDI has the actual costs incurred in accordance with the first sentence in relation to the Confederation of Health Insurance Funds. The actual staffing costs are decisive for the proof of the costs of personnel and personnel. The investment costs must be proven with individual receipts. Overpayments are to be calculated on the payments under paragraph 4 without interest. (4) The top association of the health insurance funds will pay the DIMDI to the DIMDI in 2013 on its concrete demand investment costs of up to EUR 1 000 000. less the investment costs of 2012, as proven in the fifth sentence of paragraph 3. The DIMDI has the amount actually required in accordance with the first sentence of the Federal Government of the Health Insurance Funds. Overpayments are to be added to the advances in accordance with § 6 (3) without interest. (5) DIMDI and the Association of the Federal Government of the Health Insurance Funds agree on the implementation of paragraphs 3 and 4. Unofficial table of contents

§ 8 Evaluation

DIMDI reports to the Federal Ministry of Health on 31 December 2015 in writing about the experiences it has had with the performance of the tasks of data transparency. In order to compile this report, DIMDI is allowed to store and use the applications and the resulting evaluations. Unofficial table of contents

Section 9 Entry into force

This Regulation shall enter into force on the day following the date of delivery.