Elga Regulation Elga-Vo

Original Language Title: ELGA-Verordnung – ELGA-VO

Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2013_II_505/BGBLA_2013_II_505.html

505th regulation of the Federal Minister of health to implement by ELGA (ELGA regulation ELGA-VO)

On the basis of § 28 para 2 of the Gesundheitstelematikgesetzes 2012 (GTelG 2012), Federal Law Gazette I no. 111/2012, as amended by the amendment to the DSG 2014, Federal Law Gazette I is no. 83/2013, prescribed the following:

1 section

General terms and conditions

Subject

§ 1 subject matter of this regulation is the implementation of the electronic health record (ELGA), how in particular through: 1 the establishment of a) a contradiction and a helpline (section 2), b) an ELGA ombuds office (section 3), 2. setting a) of structure, format, and standards by ELGA health data (§§ 12, 14) and b) the interaction between relevant, non-prescription medicines (article 13).

Definitions

§ 2. Within the meaning of this regulation means: 1 "CDA": clinical document architecture, an international XML-based standard for the storage and disclosure of health data.

2. "ELGA inter interoperability level": the degree of standardisation and unification by ELGA health data, and with a) "ice basic" those ELGA inter interoperability level is known in the head part of ELGA-health data standards compliant (No. 1) in accordance with structured article 14, paragraph 1 and is encoded, b) "Ice structured" those ELGA inter interoperability level is known, at the head of standard-compliant (No. 1) in accordance with structured article 14, paragraph 1 and is encoded and the ELGA health data that is embedded in the body of a uniform structure of the content , with the requirements of "Ice-enhanced" or "ice full support" matches, c) "Ice enhanced" those ELGA inter interoperability level is known in both head and body by ELGA health data standards (Z 1) are structured, the body but not or not fully stamp is encoded according to section 14, paragraph 1, and d) "ice full support" those ELGA inter interoperability level is known in both head and body by ELGA health data are structured and information contained in the body in accordance with article 14, paragraph 1 is fully coded.

3. "Terminology": a collection of terms and permissible values of a field in a form that can be used automatically.

4. "contradiction" ("opt-out"): opposition pursuant to § 15 para 2 Gesundheitstelematikgesetz 2012 [GTelG 2012], Federal Law Gazette I no. 111/2012, regardless of whether he a) was submitted in writing before the opposition site or electronically through of the access portal and b) on all or some types of ELGA-health data (§ 2 Z 9 GTelG 2012) refers to.

2. section

Opposition Centre and helpline

Contradiction body and their tasks

§ 3 (1) in accordance with § 28 para. 2 Z 7 GTelG 2012 is set, that the main Association of Austrian social insurance institutions to ensure the perception of participants / rights under sections 15 and 16 in connection with section 23 paragraph 2 Z 2 GTelG 2012 the function of the contradiction point way 31d para 3 ASVG takes over.

(2) the tasks of the opposition Centre are: 1. receipt and processing of written contradictions ("opt-out"), 2 reception and processing of written revocation pursuant to § 15 para 4 GTelG 2012 ("opt out of the opt-out"), 3. sending to an acknowledgement that the opposition or the revocation of the opt-out was validly registered, 4. demand for ambiguities relating to ELGA participants-seekers, which contradict an ELGA participation or the opposition withdraw , 5. secure the electronic processing of contradictions or cancellations via the access portal (§ 23 GTelG 2012), 6 documentation and filing of oppositions and cancellations and 7 support the ELGA system partner in improving of the opposition proceedings.

Form of contradictions

4. (1) contradictions can access portal pursuant to § 23 para 2 Z 2 GTelG 2012 issued. For contradictions, which are submitted in writing, a form of ServiceLine (§ 8) can be requested in writing or by telephone. This is also the Federal Minister for health under www.gesundheit.gv.at to make.

(2) when an objection is to specify: 1 name and academic degrees, or label the / of the explanatory, 2. gender and date of birth of / of the explanatory, 3. social security number / of the explanatory, if any, 4. address / of the accounting for the service of documents on by post, 5 telephone number or E-mail address / of the explanatory for questions relating to its Declaration of intent as well as 6 whether this contradiction on all types by ELGA health data pursuant to section 2 (General opt-out") or single ("partial opt-out") Z 9 GTelG 2012 must relate.

(3) in the case of representation one ELGA participant of ELGA participant has this / r in addition to the indications referred to in his own personal information to make par. 2. These data include: 1 name, academic degrees or name of representative of the representative, 2. gender and date of birth of the agent / representative, 3. social insurance number representative of the representative, if any, 4. address of representative / representative for the service of documents by post and 5 telephone number or email address of representative / representative for questions relating to the Declaration of intention / of the represented.

(4) a copy of an official photo ID must be accompanied to uniquely identify the / of the explanatory the opposition form, that mail is delivered to the contradiction point. The Declaration must be signed in, by hand.

(5) in the case of representation, a proof of the power of Attorney must be included with the opposition form, that mail is delivered to the contradiction point. In addition, a copy of an official photo ID to uniquely identify the representative / representative must enclosed and the Declaration of intent by hand by the representative / signed by the representative.

(6) a declaration of intention, the electronically without advanced signature according to § 2 No. 3 signature Act, Federal Law Gazette I no. 190/1999, in the currently valid version is issued, is not a proof of unique identity.

Identification of employees-seekers of the opposition site

§ 5 (1) employees of the contradiction point may be only active, if their unique identity (§ 2 No. 2 of the E-Government Act [E-GovG], Federal Law Gazette I no. 10/2004), has been established in its current version.

(2) employees of the contradiction point may by ELGA ELGA health data exposed neither require nor access nor use this.

(3) the operator of the opposition site has technically to ensure that the staff of the opposition point to ELGA health data is excluded.

Special requirements for the staff of the opposition site

Section 6 (1) the opposition Office staff are sworn to secrecy about all entrusted to them in the exercise of their profession or known facts.

(2) the staff of the opposition point must be taught about their obligations after the intra-organisational data protection rules, including the data safety.

(3) the employees of the contradiction point have prior to its establishment, to sign a document in which they confirm to comply with the obligation referred to in paragraph 1 and to have received the information referred to in paragraph 2.

Proceedings before the opposition site

Has to pay attention to the contradiction point in particular, section 7 (1) at the acceptance of contradictions or revoke that the unique identity (§ 2 Z 1 E-GovG) of explanatory ensure, otherwise is making a demand pursuant to section 3 para 2 Z 4 the accounting person on the part of the opposition body.

(2) a complete declaration of intent, which is released into the access portal, takes effect immediately. A full declaration of intent, which will be submitted in writing, will be effective with their receipt at the point of contradiction. This is to confirm the opposition point to the explanatory in writing pursuant to section 3 para 2 No. 3. An incomplete declaration of intent, which will be submitted in writing, will only be effective after deposit of the necessary additions.

(3) are not met a contradiction or a withdrawal, has the main Association of Austrian social insurance institutions by means of notification to decide.

ServiceLine

Section 8 (1) in accordance with § 28 para. 2 Z 9 GTelG 2012 is set, that the main Association of Austrian social insurance institutions to ensure the perception of participants / rights under sections 15 and 16 in connection with section 23 paragraph 2 Z 2 GTelG 2012 the function of the ServiceLine ("Service Center") in the ways of 31d para 3 ASVG takes over.

(2) the tasks of the service line are: 1. receiving and responding to General questions to ELGA, both by telephone, as well as in writing, in particular to the participants / right (§ 16 GTelG 2012), 2 receiving and responding to General questions to ELGA, by phone as well as writing for health service providers, 3.

Receiving and answering technical questions related to ELGA, both ELGA participants as well as ELGA health service providers or their service providers, 4. advice by ELGA participants-seekers distribution of contradictions, in particular with regard to the possible consequences in accordance with § 15 par. 3 and 4, as well as 16 para 3 GTelG 2012, 5. advice on withdrawal options, as well as 6 to the form to explain an objection or withdrawal of objection.

(3) staff the helpline may by ELGA ELGA health data exposed not require nor access nor use them.

(4) the operator of the service line has technically to ensure that the access of staff the helpline to ELGA health data is excluded.

3. section

ELGA ombuds office

ELGA Ombudsman's Office and its duties

§ 9 (1) the Federal Minister of Health operates the ELGA ombuds office at remote locations.

(2) the ELGA Ombudsman's Office is a health service provider within the meaning of article 2 subpara 2 lit. e GTelG 2012. Therefore, in particular, the provisions of the 2nd section of the Gesundheitstelematikgesetzes apply to them 2012.

(3) the tasks of the Ombudsman's Office of ELGA according to § 16 para 1 in conjunction with § 17 para 2 2012 are GTelG: 1 legal advice of the ELGA participants relating to legal issues to their personal ELGA or the ELGA of a person they represent in a specific case, and in matters of data protection, 2. identification of the ELGA health service provider responsible for the processing of health data ELGA, 3. support the ELGA system partner in the further development of the participants / rights and data protection, as well as 4 requests , which affect the task pane of the ServiceLine (§ 8) or the opposition agent (section 3) to point to the right place.

(4) the ELGA ombuds office has no later than their activity to include 1 January 2015.

Special requirements for the staff of the ELGA Ombudsman's Office

Employees of the ELGA Ombudsman must have relevant knowledge of the law § 10 (1), with a degree of in law is not a prerequisite.

(2) the staff of the ELGA Ombudsman's Office are obliged to maintain confidentiality of all entrusted to them in the exercise of their profession or known facts.

(3) the employees of the ELGA Ombudsman's Office must be taught about their obligations after intra-organisational data protection rules, including the data safety. The ELGA Ombudsman's Office staff have prior to its establishment, to sign a document in which they confirm to comply with the obligation referred to in paragraph 2 and to have received the instruction.

(4) employees the ELGA Ombudsman's Office may be only active if: 1 your unique identity (§ 2 Z 2 E-GovG) was found, 2. they were commissioned by ELGA participants or their representatives to be, 3. a verification of identity in accordance with § 11 worked for a concrete case and 4 written questions in accordance with article 11, paragraph 1 was the four-eyes principle pursuant to § 11 par. 3 No. 3.

(5) the access to ELGA health data by staff of the ELGA Ombudsman's Office collected 2012 GTelG of the logging system in accordance with article 22, paragraph 2.

Verification of identity by ELGA participants-seekers or their Deputy Wu

§ 11 (1) is the unique identity of ELGA participants-seekers or their representative Wu to prove: 1. attending the ELGA participants and presentation of an official photo ID or 2. by attending by representatives of Wu, the a) their own unique identity with an official photo identification, b) them granted authority by submission of the relevant documents and c) the unique identity / of the represented by means of copy of an official photo ID of the representative / of the represented or 3rd in writing on the post by ELGA participants-seekers by: a) name, as well as academic degrees the ELGA participant of ELGA participant, b) gender and date of birth the ELGA participant of ELGA participant, c) social security number the ELGA participant of ELGA participant, if any, d) address the ELGA participant of ELGA participant for the service of documents by post, as well as e) phone number or E-mail address the ELGA participant of ELGA participant for feedback, accompanied of a copy of an official photo ID and handwritten signature or 4. electronically by ELGA participants-seekers with an advanced electronic signature according to § 2 Z 3 of the signature act under following information by: a) name, as well as academic degrees the ELGA participant of ELGA participant, b) gender and date of birth the ELGA participant of ELGA participant, c) social insurance number the ELGA participant of ELGA participant, if any, d) address the ELGA participant of ELGA participant for the service of documents by post, as well as e) phone number or E-mail address the ELGA participant of ELGA participant for questions.

(2) on the findings of identity in accordance with paragraph 1, the ELGA ombuds office has written records to lead. These are to undergo regular risk-based controls by the Federal Ministry of health.

(3) information on the ELGA health data and log data in accordance with § 22 GTelG 2012, which will be requested pursuant to paragraph 1 No. 3 may be granted only if the ELGA Ombudsman's Office generally is satisfied the requesting ELGA participant of requesting ELGA participant respecting a four-eyes-principle of the unique identity.

4 section

Structure, format, and standards for health data ELGA

Structure and format for medication data

12. (1) the records to prescription and dispensing of medicinal products in accordance with § 2 all no. 9 lit. b GTelG 2012 have to contain: 1 the medicines prescribed the ELGA participants, to the identity or issued is, through the use of unique identifiers of the patient index according to § 18 GTelG 2012, 2. unique identifiers of the health service provider index in accordance with § identity actually prescribing or issuing ELGA health service provider by using corresponding 19 GTelG 2012, 3. the trade name or the active ingredient, 4. the draft regulation ID as the unique , mechanically identified and machine readable identifier of regulation, as well as 5 the tax ID as the unique, mechanically forensic identifier of the levy.

(2) for the purpose of completeness and uniqueness of interaction information for medicinal products, specifying the trade name, if strength and dosage form with collected, is sufficient. Otherwise, all active substances 1. for medicinal products with the ATC-code (anatomical therapeutic chemical classification system of the World Health Organization) and 2nd at highways are preparations with their label in addition to the trade name to capture.

(3) the trade name or active ingredient referred to in paragraph 1 Z 3 equivalent is also the registration of the medicinal product on the basis of a unique concept of order, which allows a unique and distinctive designation of the medicinal product, its effectiveness and its packaging, such as the Pharmazentralnummer or other, non-proprietary nomenclatures, usable identifiers to be used are in terms of interoperability possible also in other Member States of the European Union. The main Association of Austrian social security institutions has the appropriate capture option to offer.

(4) records concerning the regulation of medicinal products in accordance with § 2 No. 9 lit. b GTelG 2012 may contain paragraph 1 also: 1. information concerning the period of validity and tax repetition of regulation, 2. the revenue rules at the time of the regulation, 3. the prescribed Pack number and 4 according to the type of the respective drug prescription required, communicated to the patient / patient information.

(5) records to the dispensing of medicinal pursuant to § 2 No. 9 lit. b GTelG 2012 may contain paragraph 1 also: 1 the revenue rules at the time of submission, 2. the specified Pack number and 3 required according to the type of the respective drug delivery, communicated to the patient / patient information.

Interaction-related, non-prescription medicines

Section 13 (1) the Federal Minister of health has to publish a list of non-prescription medicines, which because of its relevance to interactions as medication data within the meaning of section 2 No. 9 lit under www.gesundheit.gv.at. 2012 to see b GTelG are.

(2) the Federal Minister for health can serve to establish the list referred to in paragraph 1 of the Austrian Agency for health and food safety (AGES). An Advisory Board has the AGES to set up, in particular representatives of the Austrian Medical Chamber, the Austrian Chamber of dentists, the Austrian Chamber of pharmacists and the Austrian Federal Chamber of commerce include in their capacity as the legal representative of the manufacturer.


(3) the list referred to in paragraph 1 is for applications that serve dispensing this drug store (§ 13 para 3 Z 5 GTelG 2012), to provide the ELGA health service providers. The dates for the storage obligation of this data in accordance with sec. 27 paragraph 2 to 6 2012, GTelG remain unaffected.

(4) updates the list of non-prescription medicines are to publish under www.gesundheit.gv.at of the Federal Minister of health. Updated lists are allowed from the day of its publication, no later than one year after their release they must be used.

Implementierungsleitfaeden

Section 14 (1) content, structure, format and encoding of medical documents (§ 2 Z 9 lit. a GTelG 2012) are laid down in the following Implementierungsleitfäden: 1 General CDA implementation guidance (version 2.02), 2. implementation guideline medical Entlassung letter (version 2.02), 3. implementation guidance Entlassung letter care (version 2.02), 4 implementation guidance laboratory findings (version 2.02), 5 implementation guidance finding Imaging Diagnostics (version 2.02) and 6 implementation guidance XDS metadata (version 2.02).

(2) the Implementierungsleitfäden referred to in paragraph 1, their checksums, as well as their unique identifiers (OID in accordance with § 10 paragraph 5 GTelG 2012) are to release under www.gesundheit.gv.at of the Federal Minister of health. The time of publication, as well as updating the health portal are to publish in the Official Gazette of the Wiener Zeitung.

(3) medical documents must contain all fields that are referred to in the Implementierungsleitfäden with the conformance criteria [M] and [R]. The compliance level of ELGA inter interoperability arises from the actual use of fields that are referred to in the Implementierungsleitfäden with the conformance criteria [M] and [R].

(4) updates the Implementierungsleitfäden are including their new version labels to publish by the Federal Minister of health pursuant to par. 2 of the beginning or the middle of a calendar year. Updated Implementierungsleitfäden may be used from the day of its publication, not later than 18 months after their release they must be used, unless this is required in accordance with paragraph 3.

(5) in accordance with the in § 27 para 7 to 9 GTelG 2012 defined times the ELGA inter interoperability level "Ice structured" applies from 1 January 2015 1 dismissal letters in accordance with § 2 Z 9 lit. a sublit aa GTelG 2012, 2 laboratory findings in accordance with § 2 No. 9 lit. a sublit. BB GTelG 2012, 3. findings of imaging Diagnostics including any image data according to § 2 Z 9 lit. a sublit. CC GTelG 2012 as recommended and from 1 July 2015 as mandatory.

Terminology

Section 15 (1) terminology, as well as their unique identifiers (OID in accordance with § 10 paragraph 5 GTelG 2012) are published under www.gesundheit.gv.at as controlled vocabularies in electronic form by the Federal Minister of health.

(2) updated terms and concepts are to publish by the Federal Minister of health referred to in paragraph 1.

(3) If an obligation on the use of data within the meaning of article 12 or article 14, para. 3, also the necessary terminology are mandatory to use.

5. section

Miscellaneous

Operator definitions

§ 16. The permission system in accordance with § 21 GTelG 2012 is operated limited company as a service provider by the Federal Computing Centre.

6 article

Final provisions

Entry into force

§ 17. This Regulation shall enter into force 1 January 2014.

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