Elga Regulation Elga-Vo

Original Language Title: ELGA-Verordnung – ELGA-VO

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.

505. Ordinance of the Federal Minister of Health for the Implementation of ELGA (ELGA-Regulation-ELGA-VO)

On the basis of § 28 (2) of the German Health Telematics Act 2012 (GTelG 2012), BGBl. I n ° 111/2012, in the version of the DSG-Novelle 2014, BGBl. I n ° 83/2013, the following shall be prescribed:

Section 1

General provisions

Subject matter

§ 1. The purpose of this Regulation is the implementation of the Electronic Health Act (ELGA), in particular by:

1.

the institution

a)

an objection site and a service line (2) Section),

b)

an ELGA ombudsman (3. Section),

2.

the definition of

a)

the structure, format and standards of ELGA health data (§ § 12, 14) and

b)

the interaction-relevant, non-prescription-only medicinal product (§ 13).

Definitions

§ 2. For the purposes of this Regulation:

1.

"CDA": Clinical Document Architecture, an international, XML-based standard for the storage and transfer of health data.

2.

"ELGA interoperability level" means the level of standardisation and harmonisation of ELGA health data, with

a)

"EIS Basic" means the ELGA interoperability level in which the head part of ELGA health data is structured and coded in accordance with the standard (Z 1) in accordance with § 14 para. 1,

b)

"EIS Structured" means the ELGA interoperability stage where the headboard is structured and coded in line with the standard (Z 1) in accordance with Article 14 (1), and the ELGA health data included in the main body is a uniform structure of the Have content that matches the EIS Enhanced or EIS Full Support preferences,

c)

"EIS Enhanced" means the ELGA interoperability level where both the head part and the body of ELGA health data are standard-compliant (Z 1), but the body is not or is not fully encoded in accordance with Section 14 (1) and

d)

"EIS Full Support" means the ELGA interoperability level in which both the head part and the body of ELGA health data are structured and the information contained in the body is fully encoded in accordance with § 14 paragraph 1.

3.

"Terminology": a collection of subject expressions and permitted values of a subject area in a form that can be used for automation support.

4.

"Opt-out" (opt-out) : Contradiction according to § 15 paragraph 2 of the German Health Telematics Act 2012 [GTelG 2012], BGBl. I No 111/2012, irrespective of whether it is

a)

has been submitted in writing before the appeal or electronically by the access port; and

b)

is related to all or some types of ELGA health data (§ 2 Z 9 GTelG 2012).

Section 2

Opposition and Service Line

Opposition and its tasks

§ 3. (1) According to § 28 paragraph 2 Z 7 GTelG 2012, it is stipulated that the main association of Austrian social insurance institutions in order to ensure the perception of the participants/rights in accordance with § § 15 and 16 in connection with § 23 para. 2 Z 2 GTelG 2012 The function of the Opposition Unit shall take over the function of Section 31d (3) of the ASVG.

(2) The tasks of the Opposition Unit shall be:

1.

Receipt and processing of written contradictions ("Opt-Out"),

2.

Acceptance and processing of written revocation pursuant to § 15 para. 4 GTelG 2012 ("Revocation of opt-out"),

3.

To send a confirmation that the objection or the revocation of the opt-out has been legally registered,

4.

Demand for ambiguities associated with ELGA participants, which are contrary to ELGA participation, or revoke the appeal,

5.

To ensure the electronic processing of the contradictions and/or Revocation over the access portal (§ 23 GTelG 2012),

6.

Documentation and filing of the contradictions and/or Revocation and

7.

Support of the ELGA system partners in improving the appeal procedure.

Form of contradictions

§ 4. (1) Appeals can be submitted via the access portal pursuant to § 23 paragraph 2 Z 2 GTelG 2012. A form can be requested in writing or by telephone on the service line (§ 8) for contradictions which are made in writing. This is also to be made available by the Federal Minister of Health at www.gesundheit.gv.at.

(2) In the event of an objection, the following shall be stated:

1.

the name and the academic degree or designation of the declaring,

2.

sex and date of birth of the declaring,

3.

Social security number of the declaring, where available,

4.

Address of the declaring person for the delivery of documents by the postal service,

5.

Telephone number or e-mail address of the declaring person for questions related to her/his declaration of intent, as well as

6.

whether this contradiction is to all ("general opt-out") or individual ("partial opt-out") Types of ELGA health data in accordance with § 2 Z 9 GTelG 2012.

(3) In the case of the representation of an ELGA participant/an ELGA participant, this participant must provide his/her own personal information in addition to the information provided in paragraph 2. These data include:

1.

Name and academic grade or name of the representative,

2.

Gender and date of birth of the representative,

3.

Social security number of the representative (s), if any,

4.

Address of the representative for the delivery of documents by the postal service, and

5.

Telephone number or e-mail address of the representative for questions relating to the declaration of intent by the representative.

(4) A copy of an official photo ID must be attached to the appeal form, which is sent by post to the appeal body, for the purpose of unequivocal identification of the declaring person. In addition, the declaration of intent must be signed on its own.

(5) In the case of representation, a proof of the representative authority must be resolved to the opposition form, which is sent by post to the appeal body. In addition, a copy of an official photo ID must be enclosed with a clear identification of the representative and the declaration of intent must be signed by the representative of the representative/representative.

(6) A declaration of intent which is electronically without an advanced signature in accordance with § 2 Z 3 Signature Act, BGBl. I n ° 190/1999, as amended, does not correspond to proof of a clear identity.

Identification of employees/in/n of the appeal body

§ 5. (1) Employees of the appeal body may only act if their unique identity (§ 2 Z 2 of the eGovernment Act [E-GovG], BGBl. I n ° 10/2004), as amended, respectively.

(2) Employees of the Appeal Office may not require or access any ELGA health data made available by ELGA or use it.

(3) The operator of the appeal body shall have the technical means to ensure that the access of the employees to the appeal body is excluded from the ELGA health data.

Special requirements for the employees of the appeals office

§ 6. (1) The employees of the opposition body are obliged to secrecy about all facts entrusted to them in the exercise of their profession or become aware of them.

(2) The staff of the appeal body must be informed about their obligations under the internal data protection regulations, including the data security regulations.

(3) Before taking up their duties, the staff of the Opposition Office shall sign a document confirming that they have fulfilled the obligation laid down in paragraph 1 and have received the instruction provided for in paragraph 2.

Proceedings before the appeal

§ 7. (1) In the case of the acceptance of contradictions or In particular, the appeal body must be revoked in order to ensure that the clear identity (§ 2 Z 1 E-GovG) of the explanatory statements is ensured; otherwise, in accordance with Section 3 (2) (4) (4), the declaring person shall be a member of the declarant. to meet demand.

(2) A complete declaration of intent, which will be issued in the access portal, will take effect immediately. A complete declaration of intent, which will be made in writing, will be legally effective at the appeal body. This has to be confirmed in writing in accordance with Section 3 (2) (3) (3) (3) (3) of the German Opposition Office (appeal A non-complete declaration of intent, which is made in writing, will only be legally effective after the necessary additions have been made.

(3) Where a contradiction or the main association of the Austrian social insurance institutions has to decide by means of a decision.

Service line

§ 8. (1) According to § 28 paragraph 2 Z 9 GTelG 2012, it is stipulated that the main association of Austrian social insurance institutions in order to ensure the perception of the participants/rights in accordance with § § 15 and 16 in connection with § 23 para. 2 Z 2 GTelG 2012 the function of the service center ("service center") in accordance with § 31d paragraph 3 of the ASVG.

(2) The tasks of the service line are:

1.

Receiving and answering general questions about ELGA, both by telephone and in writing, in particular to the participants/internal rights (§ 16 GTelG 2012),

2.

Receiving and answering general questions on ELGA, both by telephone and in writing for health service providers,

3.

Receiving and answering technical questions in connection with ELGA, both for ELGA participants and ELGA health service providers. their service providers,

4.

Advice to ELGA participants in the delivery of contradictions, in particular with regard to the possible consequences according to § § 15 (3) and (4) and 16 (3) GTelG 2012,

5.

Advice on revocation options as well as

6.

Send the form to explain a contradiction or Revocation of the appeal.

(3) Employees of the Service Group may not require or access any ELGA health data made available by ELGA.

(4) The operator of the service line shall have the technical means to ensure that the access of the employees of the service line to the ELGA health data is excluded.

Section 3

ELGA ombudsman

ELGA ombudsman and its tasks

§ 9. (1) The Federal Minister of Health runs the ELGA ombudsman office at decentralised locations.

(2) The ELGA ombudsman is a health service provider within the meaning of § 2 Z 2 lit. e GTelG 2012. For this reason, the provisions of the second section of the 2012 Health Telematics Act are in particular valid.

(3) The tasks of the ELGA ombudsman pursuant to § 16 para. 1 in connection with § 17 paragraph 2 GTelG 2012 are:

1.

legal advice to ELGA participants in connection with legal issues relating to their personal ELGA or the ELGA of a person represented by them in a specific event and in matters of data protection,

2.

Designation of the ELGA health service provider responsible for the processing of ELGA health data,

3.

Support of the ELGA system partners in the further development of the participants/interior/rights and data protection as well as

4.

Questions concerning the role of the appeal body (§ 3) or the service line (§ 8) should be referred to the correct position in each case.

(4) The ELGA ombudsman shall have its activities at the latest by 1. Jänner 2015.

Special requirements for the staff of the ELGA ombudsman

§ 10. (1) Employees of the ELGA ombudsman must have relevant legal knowledge, with the completion of a study of the legal sciences being not a prerequisite.

(2) The staff of the ELGA ombudsman are obliged to secrecy about all the facts entrusted to them in the exercise of their profession or become aware of the facts.

(3) The staff of the ELGA ombudsman must be informed about their obligations under the internal data protection regulations, including the data security regulations. The staff of the ELGA ombudsman have to sign a document before commenting their duties, confirming that they are required to comply with the obligation laid down in paragraph 2 and to have received the instruction.

(4) Employees of the ELGA ombudsman may only take action if:

1.

its unique identity (§ 2 Z 2 E-GovG) has been established,

2.

they are carried out by ELGA participants, Their representatives were instructed to take action in a specific case,

3.

a verification of identity in accordance with § 11 and

4.

in the case of written questions pursuant to § 11 paragraph 1 Z 3, the four-eye principle according to § 11 para. 3

took place.

(5) The access to ELGA health data by employees of the ELGA ombudsman office is recorded by the logging system in accordance with § 22 para. 2 GTelG 2012.

Verification of the identity of ELGA participant/inn/n or your deputy/inn/n

§ 11. (1) The unique identity of ELGA participant/inn/n or Their representative is to be proved:

1.

by means of the personal interview of the ELGA participants and presenting an official photo ID or

2.

by means of a personal interview of representatives who:

a)

their own unique identity by means of an official photo ID,

b)

the power of representation granted to them by the presentation of the relevant documents; and

c)

the unique identity of the representative by means of a copy of an official photograph of the representative/representative

or

3.

in writing by ELGA participant/in/n:

a)

Name and academic grade of the ELGA participant/participant,

b)

Gender and date of birth of the ELGA participant/participant,

c)

Social security number of the ELGA participant/ELGA participant, where available,

d)

Address of the ELGA participant/ELGA participant for the delivery of documents by the postal service, and

e)

Telephone number or e-mail address of the ELGA participant/ELGA participant for questions

in the case of a copy of an official photo ID and a personal signature, or

4.

electronically supplied by ELGA participant/s with an advanced electronic signature in accordance with § 2 Z 3 of the Signature Act, under the following information:

a)

Name and academic grade of the ELGA participant/participant,

b)

Gender and date of birth of the ELGA participant/participant,

c)

Social security number of the ELGA participant/ELGA participant, where available,

d)

Address of the ELGA participant/ELGA participant for the delivery of documents by the postal service, and

e)

Telephone number or e-mail address of the ELGA participant/ELGA participant for inquiries.

(2) The ELGA ombudsman shall have written records of the determination of the identity referred to in paragraph 1. These are subject to regular risk-based controls by the Federal Ministry of Health.

(3) Information on ELGA health data as well as log data according to § 22 GTelG 2012, which are requested in accordance with paragraph 1 Z 3, may only be granted if the ELGA ombudsman is in principle informed by the The unique identity of the requesting ELGA participant has convinced the requesting ELGA participant.

Section 4

Structure, format and standards for ELGA health data

Structure and format for medication data

§ 12. (1) Data sets for the regulation and delivery of medicinal products according to § 2 Z 9 lit. b GTelG 2012 have to contain:

1.

the identity of the ELGA participants to which the medicinal product is assigned or , by using the appropriate unique identifiers of the patient index in accordance with § 18 GTelG 2012,

2.

the identity of the actual or Issuing ELGA health service providers through the use of appropriate unique identifiers of the health service provider index in accordance with § 19 GTelG 2012,

3.

the trade name or the active substance,

4.

the Regulation ID as a clear, machine-readable and machine-readable identifier of the Regulation; and

5.

the delivery ID as a clear, machine-determined identifier of the levy.

(2) For the purpose of completeness and uniqueness of the information relevant to the interaction of proprietary medicinal products, the indication of the trade name shall be sufficient if the strength and pharmaceutical form are included in the information. Otherwise, in addition to the trade name, all active substances

1.

in the case of proprietary medicinal products with their ATC code (anatomical and therapeutic chemical classification system of the World Health Organisation), and

2.

in the case of magistral preparations with their name

shall be recorded.

(3) The trade name or The active substance referred to in paragraph 1 (3) is also equivalent to the detection of the medicinal product on the basis of a clear order of order which allows a unique and unmistakable designation of the medicinal product, its mode of action and its pack size, such as: such as the pharmaceutical central number or other non-proprietary nomenclatures, where, in the sense of interoperability, it is also possible to use identifiers which can be used in other Member States of the European Union. The main association of Austrian social insurance institutions has to offer the appropriate coverage.

(4) Data sets for the regulation of medicinal products according to § 2 Z 9 lit. b GTelG 2012 may also contain the following paragraph 1:

1.

information on the duration of the validity and resubmission of the Regulation;

2.

the adoption rules at the time of the Regulation,

3.

the prescribed number of packers, and

4.

additional information required by the patient in accordance with the provisions of the relevant pharmaceutical regulation.

(5) Records for the delivery of medicinal products according to § 2 Z 9 lit. b GTelG 2012 may also contain the following paragraph 1:

1.

the rules of entry at the time of the levy;

2.

the number of packages delivered, and

3.

additional information required by the patient in accordance with the type of delivery of the medicinal product concerned.

Interaction-relevant, non-prescription medicines

§ 13. (1) The Federal Minister of Health shall publish a list of medicinal products not subject to medical prescription at www.gesundheit.gv.at, which is due to their relevance for interactions as medication data within the meaning of § 2 Z 9 lit. b GTelG 2012 are to be considered.

(2) The Federal Minister of Health may use the list in accordance with paragraph 1 of the Austrian Agency for Health and Food Safety (AGES). The AGES has set up a consultative body, in particular representatives of the Austrian Medical Association, the Austrian Dentists ' Chamber, the Austrian Pharmacists Chamber and the Federal Chamber of Industry and Industry in their Property as a legal representation of manufacturers.

(3) The list in accordance with paragraph 1 is to be made available to the ELGA health service providers for applications that serve to store the release of these medicinal products (§ 13 paragraph 3 Z 5 GTelG 2012). The dates for the storage obligation of these data in accordance with § 27 para. 2 to 6 GTelG 2012 remain unaffected.

(4) Updates to the list of non-prescription medicines are to be published by the Federal Minister of Health at www.gesundheit.gv.at. Updated lists may be used from the date of their publication, and must be used no later than one year after their publication.

Implementation guides

§ 14. (1) Content, structure, format and coding of medical documents (§ 2 Z 9 lit. a GTelG 2012) are defined in the following implementation guides:

1.

Common CDA Implementation Guide (version 2.02),

2.

Implementation Guide Dismissal Letter Medically (version 2.02),

3.

Implementation guide for dismissal letter care (version 2.02),

4.

Implementation guide for Laborbefund (version 2.02),

5.

Implementation guide findings of diagnostic imaging (version 2.02) and

6.

Implementation guide XDS metadata (version 2.02).

(2) The implementation guidelines referred to in paragraph 1, their checksums as well as their unique identifiers (OID according to § 10 paragraph 5 GTelG 2012) shall be published by the Federal Minister of Health at www.gesundheit.gv.at. The date of publication and the update in the health portal are to be published in the official journal of the Wiener Zeitung.

(3) Medical documents shall contain all the fields referred to in the implementation guides with the conformity criteria "[M]" and "[R]". The ELGA interoperability level shall be obtained from the actual use of fields referred to in the implementation guides with the compliance criteria "[M]" and "[R]".

(4) Updates to the implementation guidelines, including their new version designations, shall be published by the Federal Minister of Health pursuant to paragraph 2 in each case at the beginning or the middle of a calendar year. Updated implementation guides may be used from the date of their publication, and no later than 18 months after their publication, they shall be used, provided that this is necessary in accordance with paragraph 3.

(5) In accordance with the dates defined in § 27 para. 7 to 9 GTelG 2012, the following shall apply from 1. Jänner 2015 the ELGA interoperability level "EIS Structured" for

1.

Letters of dismissal according to § 2 Z 9 lit. a sublit aa GTelG 2012,

2.

Laboratory findings according to § 2 Z 9 lit. a sublit. bb GTelG 2012,

3.

Findings of imaging diagnostics, including any image data in accordance with § 2 Z 9 lit. a sublit. cc GTelG 2012

as recommended and as mandatory from 1 July 2015.

Terminologies

§ 15. (1) Terminologies as well as their unique identifiers (OID according to § 10 paragraph 5 GTelG 2012) are published as controlled vocabularies in electronic form by the Federal Minister of Health at www.gesundheit.gv.at.

(2) Updated terminologies shall be published by the Federal Minister of Health pursuant to paragraph 1.

(3) If there is a duty to use data within the meaning of § 12 or § 14 (3), the terminology required for this purpose must also be used in a binding manner.

Section 5

Other business

Operator definitions

§ 16. The authorization system in accordance with § 21 GTelG 2012 is operated by the Bundesrechenzentrum Gesellschaft mit beschränkter Haftung as a service provider.

6.

Final provisions

entry into force

§ 17. This Regulation shall enter into force 1. Jänner 2014 in force.

Stöger