106. Ordinance of the Federal Minister of Health for the Implementation and Development of ELGA (ELGA-Ordinance 2015-ELGA-VO 2015)

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 to implement and further develop 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 (§ § 14 and 16),
b)			the interaction-relevant, non-prescription-only medicinal product (§ 15),
c)			the minimum requirements for the content of an exception for ELGA health service providers (§ 18),
d)			the access rules for ELGA for unenduring minors (§ 19) and
e)			The operator of the authorization and logging system (§ 20).

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 standard (Z 1) according to § 16 (1).
b)			"EIS Structured" means the ELGA interoperability stage where the headboard is structured and coded in accordance with the standard (Z 1) in accordance with § 16 (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 in which both the header 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 § 16 (1).
d)			"EIS Full Support" means the ELGA interoperability level in which both the head part and the main part of ELGA's health data are structured according to standard (Z 1) and the information contained in the main body is also structured according to § 16 (1) are fully encoded.
3.		"compliance criterion" means the information contained in the implementation guides as to whether fields must be used, may be used or prohibited, with the following:
a)			"conformity criterion [M]" shall mean those fields for which:
aa)				the actual values must be specified, and
bb)				reasons why no actual values can be specified,
cc)				nor are fictitious values to be given,
b)			"conformity criterion [NP]" means those fields which must not be used, i.e.
aa)				no actual values,
bb)				the reasons why no actual values can be given,
cc)				nor fictitious values
			may be indicated,
c)			"conformity criterion [R]" means those fields for which:
aa)				the actual values must be specified, and
bb)				it should not be possible to specify the reasons why no actual values can be specified, but
cc)				the fictitious values cannot be specified;
d)			"Conformity criteria [R2]" means those fields for which
aa)				the indication of actual values is recommended and
bb)				reasons why no actual values can be specified,
cc)				nor are fictitious values to be given,
e)			"Conformity criteria [O]" shall mean those fields for which:
aa)				actual values, or
bb)				Reasons why no actual values can be specified
			may be indicated,
f)			"Conformity criteria [C]" means those fields whose permissible use is dependent on further conditions specified in the following sequence.
4.		"Terminology": a collection of subject expressions and permitted values of a subject area in a form that can be used for automation support.
5.		"Opt-out" (opt-out) : Statement of intent pursuant to § 15 (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 No 83/2013, irrespective of whether or not
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).
6.		"Withdrawal": declaration of intent pursuant to § 15 para. 4 GTelG 2012, with which a contradiction (§ 2 Z 5) is reversed.

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 Office shall be taken over by § 31d 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 in relation to contradictions and/or Revoke,
5.		electronic processing of the contradictions or Revocation for the access portal (§ 23 GTelG 2012),
6.		Documentation and electronic archiving of the contradictions or Revocation,
7.		Support the ELGA system partners in improving the appeals process and
8.		Questions that do not fall within the scope of the appeal body to the right place in accordance with Section 6 (1) of the General Administrative Procedure Act 1991 (AVG), BGBl. I No 51/1991, as amended by the Administrative Jurisdictions-Adaptation Law-Home Affairs, BGBl. I No 161/2013.

Form of contradictions and revocation

§ 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. The Federal Minister of Health can also make this form available at www.gesundheit.gv.at.

(2) In the event of an objection, please state:

1.		name and any academic degree of the declaratory,
2.		Sex, date of birth and place 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, the representative/representative shall, in addition to the information referred to in paragraph 2, make the following information on his/her own person:

1.		Name and any academic degree from the representative,
2.		Gender, date of birth and place 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 authorities or by the representative of the representative. According to § 33 (1) ZustG, if the representative is in conflict with the citizen card (§ 2 Z 10 of the eGovernment Act [E-GovG], BGBl. I n ° 10/2004, in the version of the DSG-Novelle 2014, BGBl. I n ° 83/2013), 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 hand.

(5) In the case of representation,

1.		proof of the representation of the representative authority or the property as professional party representative/professional party representative shall be settled on the appeal form, which shall be sent by post to the appeal body,
2.		for the clear identification of the representative, a copy of his/his official photo ID shall be enclosed, and
3.		The declaration of intent will be signed by the representative of the representative.

(6) A declaration of intent, which is electronically without a qualified signature according to § 2 Z 3a of the Signature Act, BGBl. I n ° 190/1999, in the version of the Federal Law BGBl. I No 75/2010, shall not be capable of providing evidence of a clear identity.

(7) In the case of doubt about the identity of an ELGA participant/an ELGA participant, or The representative of the representative/representative shall be subject to the provisions of the General Administrative Procedure Act of 1991, in particular Article 13 thereof. In accordance with § 17 of the E-GovG, the information to be used for checking the identity shall be the information provided in accordance with the rules of administrative assistance (Art. 22 B-VG) are included in the available registers.

Identification of employees/in/n of the appeal body

§ 5. (1) Employees of the appeal body may only take action if their unique identity (§ 2 Z 2 E-GovG) has been established.

(2) Employees of the Opposition Office may not require ELGA health data made available by ELGA in accordance with Section 14, Section 3, Z 1 GTelG 2012, nor access it or use it.

(3) The main association of the Austrian social insurance institutions shall have organisational measures to ensure that the access of the employees of the opposition body to ELGA health data is excluded.

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. This obligation shall also exist after the termination of its activity at the point of appeal. In particular, it is necessary to comply with the data usage principles in accordance with § 6 of the Data Protection Act 2000 (DSG 2000), BGBl. I n ° 165/1999, in the version of the DSG-Novelle 2014, BGBl. I No 83/2013, as well as the data security measures pursuant to § 14 DSG 2000.

(2) The staff of the appeal body must be informed about their obligations under the internal data protection regulations, including the data security regulations. The employees are verifiably informed about the obligation to comply with the obligation to comply with their duties.

(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.

Art and treatment of Willenserdeclarations

§ 7. (1) In the case of the acceptance of contradictions or Revoked ("Willenserclarification") the opposition body must, in particular, ensure that the clear identity (§ 2 Z 2 E-GovG) of the declaring is ensured, otherwise the opposition body has a corresponding demand in accordance with § 3 paragraph 2 Z 4 with the declaring person ,

(2) Depending on the nature of the declarations of intent, a distinction is made between:

1.		Declarations of intent electronically introduced via the access portal;
2.		Declarations of intent made in writing at the point of appeal.

(3) Full contradictions introduced in the access portal; Revocation pursuant to paragraph 2 Z 1 shall become legally effective immediately upon registration. The declarant receives a corresponding confirmation in the access portal immediately after entering her/his declaration of intent. Appeals made in writing at the appeal body Revocation pursuant to paragraph 2 Z 2 shall be legally effective upon registration by the Opposition Office. In this case, the appeal body shall confirm the registration in writing with respect to the declaring in accordance with Section 3 (2) (3) (3) (3).

(4) Not complete contradictions or Rejections which have been made in writing shall not be legally effective until after the necessary additions have been received and the electronic registration has been completed.

(5) The main association of the Austrian social insurance institutions shall decide by means of information on entries which are not being complied with.

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 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 responding to technical questions related to ELGA for ELGA participants,
4.		Receipt of technical questions in connection with ELGA for ELGA health service providers or its service providers, the limitation of technical problems and, where appropriate, the electronic transmission of a fault ticket to the competent operator;
5.		Advice to ELGA participants in the delivery of contradictions, in particular with regard to the possible legal consequences in accordance with § § 15 (3) and (4) and 16 (3) GTelG 2012,
6.		Advice on revocation options,
7.		Send the form to explain a contradiction or revocation of the objection,
8.		Exchange of information on the processing status of the declaration of intent as well as
9.		Requests that do not fall within the scope of the service line should be referred to the right place within the meaning of Section 6 (1) of the AVG.

(3) Employees of the Service Group may not require or access any ELGA health data made available by ELGA in accordance with Section 14 (3) (1) of the GTelG 2012. 0

(4) The main association of Austrian social insurance institutions has to ensure that the access of the employees of the service line to ELGA health data is excluded.

Special requirements for the employees of the service line

§ 9. (1) The employees of the service are obliged to secrecy about all facts entrusted to them in the exercise of their profession or become aware of the facts. This obligation also exists at the end of their duties at the service level. In particular, compliance with the data usage principles in accordance with § 6 DSG 2000 as well as the data security measures pursuant to § 14 DSG 2000 must be ensured.

(2) The employees of the service line shall be informed of their obligations under the internal data protection regulations, including the data security regulations. The employees are verifiably informed about the obligation to comply with the obligation to comply with their duties.

(3) The employees of the service line shall sign a document prior to commenting their duties, confirming their compliance with the obligation laid down in paragraph 1 and having received the information provided for in paragraph 2.

Section 3

ELGA ombudsman

ELGA ombudsman and its tasks

§ 10. (1) The Federal Minister for Health operates the ELGA Ombudsman. In so far as the Federal Minister of Health does not carry out this task on his own, it may, within the meaning of Article 7 of the Agreement according to Art. 15a B-VG, on the organisation and financing of the health care system, BGBl. I n ° 105/2008, as amended by the agreement, BGBl. I No 199/2013, and after the conclusion of a corresponding agreement (Art. 17 B-VG), exclusively the bodies responsible for the tasks of the patient representation in the countries according to § 11e of the Federal Act on hospitals and courting institutions (KAKuG), BGBl. No. 1/1957, as a service provider according to § 4 Z 5 DSG 2000. An assignment of third parties is inadmissible.

(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 GTelG 2012 in connection with § 17 para. 2 GTelG 2012 are in particular:

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 for the ELGA participants,
4.		Support of the ELGA system partners in the further development of the participants/interior/rights and data protection as well as
5.		Questions that do not fall within the remit of the ELGA ombudsman are to be referred to the right place within the meaning of Section 6 (1) of the AVG.

(4) The ELGA ombudsman shall, in due time, start to operate in such a timely manner that the tasks referred to in paragraph 3 can be fulfilled as soon as ELGA health data are available in ELGA. In accordance with § 21 (1) to (3), there may be different regional commissioning activities.

Coordinating body

§ 11. (1) For the staff of the ELGA ombudsman, a coordinating body is set up in the Federal Ministry of Health.

(2) The tasks of the coordinating body shall be in particular:

1.		Contact for the matters of the ELGA ombudsman and
2.		Creation of an annual activity report for the previous calendar year.

Special requirements for the staff of the ELGA ombudsman

§ 12. (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. The ELGA ombudsman also has an obligation to do so after the end of her duties. In particular, compliance with the data usage principles in accordance with § 6 DSG 2000 as well as the data security measures pursuant to § 14 DSG 2000 must be ensured.

(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 employees are verifiably informed about the obligation to comply with the obligation to comply with their duties.

(4) The staff of the ELGA ombudsman have to sign a document before commenting their duties, in which they confirm that they are required to comply with the obligation laid down in paragraph 2 and to have received the information provided for in paragraph 3.

(5) 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, commissioned their representatives to act for a specific case; and
3.		a verification of identity in accordance with § 13.

(6) The access to ELGA health data by employees of the ELGA ombudsman is to be 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

§ 13. (1) The unique identity of ELGA participant/inn/n or The ELGA ombudsman is to be shown to their representative:

1.		by means of the personal interview of the ELGA participants and presenting an official photo ID or
2.		by means of personal presentation of representatives and evidence
a)			of their own unique identity by means of official photo-ID,
b)			the power of representation granted to them by the submission of appropriate documents; and
c)			the clear identity of the representative by means of a copy of an official photograph of the representative, or
3.		in writing by way of an ELGA participant's post
a)			the name and the general academic degree of the ELGA participant,
b)			of the gender and date of birth of the ELGA participant/participant,
c)			the address of the ELGA subscriber to the ELGA subscriber for the delivery of documents by the postal service, and
d)			the telephone number, address or e-mail address of the ELGA participant/ELGA participant for queries or
4.		In writing by post of representatives
a)			by proof of their own unique identity by means of a copy of an official photo-ID and a personal signature,
b)			by proof of the power of representation granted to them by the submission of appropriate documents,
c)			by proof of the unique identity of the representative by means of a copy of an official photo ID of the representative and
d)			by stating your telephone number, address or e-mail address for further questions.

(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 is requested pursuant to paragraphs 1, Z 3 and 4, may only be granted if the ELGA ombudsman-as far as possible organisationally possible-while respecting a Four-eyes principle convinced of the unique identity of the requesting ELGA participant/the requesting ELGA participant. If less than two persons are regularly active in the ELGA Ombudsman, the ELGA ombudsman has, by means of an adequate internal organisation and written control mechanism, carried out the implementation of the identity findings in accordance with (1) and to ensure. The ELGA ombudsman has written records on the identification of identity and on the implementation of an inter-organisational control mechanism. The Federal Minister of Health has to ensure that regular risk-based checks are carried out.

Section 4

Structure, format and standards for ELGA health data

Structure and format for medication data

§ 14. (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 unique, 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) Instead of the collection of trade names or The active substance referred to in paragraph 1 (1) (3) shall also be authorised to collect the medicinal product on the basis of a clear order of order if it allows a unique and unmistakable designation of the medicinal product, its mode of action and its size, such as the pharmaceutical central number or other non-proprietary nomenclatures. In the interests of interoperability, it is also possible, where 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

§ 15. (1) The Federal Minister for Health has to publish a list of medicinal products not subject to medical prescription at www.gesundheit.gv.at, which because of their relevance for interactions as medication data in the sense 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, the Federal Chamber of Industry and Industry in their Property as a legal representation of manufacturers as well as of Austrian social insurance.

(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 no later than six months after their publication, they must be used.

Implementation guides

§ 16. (1) The content, structure, format and encoding of ELGA health data (§ 2 Z 9 lit. a and b GTelG 2012) are defined in the following implementation guides:

1.		Common CDA Implementation Guide (version 2.05),
2.		Guidelines for the discharge of a medical certificate (version 2.05),
3.		Implementation guide for dismissal letter care (version 2.05),
4.		Implementation guide for Laborbefund (version 2.05),
5.		Implementation guide findings for diagnostic imaging (version 2.05),
6.		Implementation guide XDS metadata (version 2.05) and
7.		Implementation guide E-Medication (version 2.05).

(2) The implementation guidelines according to paragraph 1, their checksums as well as their unique identifiers (OID according to § 10 paragraph 5 GTelG 2012) are to 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 and medication data shall contain all the fields referred to in the implementation guides with the conformity criteria "Mandatory" (M) "Required" (R). The ELGA interoperability level shall be obtained from the actual use of fields referred to in the implementation guides with the compliance criteria "Mandatory" (M) and "Required" (R).

(4) Updates to the implementation guidelines, including their new version designations, shall be published by the Federal Minister of Health in accordance with 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.

Terminologies

§ 17. (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 § 14 or § 16 (3), the terminology required for this purpose must also be used in a binding manner.

Section 5

Other business

Take out the participants/inner/right

§ 18. (1) ELGA health service providers according to § 2 Z 10 GTelG 2012 have in the areas in which patient/inn/en logged in or , in the form of an understandable, clearly visible and easily accessible hangout, to be informed about the participants/rights granted in accordance with § 16 GTelG 2012. The date on which ELGA health service providers have to make the information accessible is based on the provisions of § 27 GTelG 2012 in conjunction with § 21.

(2) The caption shall contain the heading "Patient Information" and the ELGA logo. Both the headline and the ELGA logo must be designed in the spelling, font size and presentation usual for other attacks in the ELGA health service provider, in order to be easily visible even from some distance. The height and width of the hanger shall not be less than the height and width specified by the DIN A4 format. Adaptations to the respective external appearance ("corporate design") of the ELGA health service provider are permitted.

(3) The slope shall be informed of the provisions of § 16 para. 1 to 3 GTelG 2012. This shall include in particular information on:

1.		Provide information on the ELGA health and historical data concerning the access portal or through the ELGA ombudsman,
2.		possibility of setting individual access rights via the access portal or through the ELGA ombudsman office,
3.		Option to set up an ELGA health service provider of trust, and
4.		the inclusion of ELGA health data in relation to the respectively treating or the ELGA health service provider is in a position to contradict the situation in a specific situation, whereby the situational contradiction must also be explained in the context of the excercise.

(4) In accordance with Section 16 (4) of the German Telemedia Act (GTelG 2012), the legal advocacy groups for health professionals who exercise their profession as a health service provider have a comprehensible, easily accessible and easily accessible service. To make available to the respective ELGA health service providers within the scope of their transferred scope of action, the minimum contents according to paragraph 3 being to be complied with in any case. This notice shall be ready and available at the time defined in § 27 para. 3 GTelG 2012.

(5) The Federal Minister for Health has to provide the ELGA health service providers with samples for a hang-out.

Access to ELGA for unmutable minors

§ 19. The ELGA of their children may be entitled to care until the completion of the 14. Use of healthcare as well as the perception of the participants/inner/rights in accordance with Section 14 (2) of the GTelG 2012.

Operator definitions

§ 20. The authorization system (§ 21 GTelG 2012) as well as the logging system (§ 22 GTelG 2012) are to be operated by the Bundesrechenzentrum Gesellschaft mit beschränkter Haftung within the meaning of § 28 paragraph 2 Z 11 GTelG 2012.

Transitional provisions

§ 21. (1) Starting on 1 December 2015, pursuant to Article 27 (2) of the GTelG 2012 in conjunction with Section 13 (3) of the GTelG 2012, hospitals pursuant to § 3 paragraph 2b of the KAKuG, which are to be deducted from the State Health Fund, have the Allgemeine Unfallversicherungsanstalt (Allgemeine Unfallversicherungsanstalt) to the extent that: it operates pursuant to section 24 (2) of the ASVG Hospital, as well as institutions of care pursuant to § 2 Z 10 lit. e GTelG 2012 ELGA to the extent that the use of the ELGA components (§ 24 GTelG 2012) is technically possible for the use of ELGA health data.

(2) The beginning of the use of ELGA in accordance with paragraph 1 can be carried out regionally and in time, insofar as the use of the ELGA components (§ 24 GTelG 2012) for the use of ELGA health data is technically possible. According to the rules of ELGA, ELGA-health service providers according to paragraph 1 may test regionally regionally (test phases) before ELGA is used in real-life operation.

(3) Para. 1 and 2 apply only to inpatient institutions of care (Annex 1, Part 2, Z 10 of the Health Telematics Ordinance 2013 [GTelV 2013], BGBl. II No 506/2013). § 27 para. 2 GTelG 2012 in conjunction with § 13 para. 3 GTelG 2012 is not applicable until the beginning of the use of ELGA for mobile care.

(4) As soon as ELGA is tested in a region or In accordance with § 10, the ELGA ombudsman has also started its operations in this region.

(5) As of 1 December 2015, the date of birth and place of birth according to § 4 para. 2 Z 2 or Section 3 Z 2 to be used for unequivocal identification.

(6) According to § 28 (2) (1) (1) lit. a to c GTelG 2012 will be published for dismissal letters (§ 2 Z 9 lit. a sublit. aa GTelG 2012), laboratory findings (§ 2 Z 9 lit. a sublit. bb GTelG 2012) as well as findings of imaging diagnostics, including all-time image data (§ 2 Z 9 lit. a sublit. cc GTelG 2012) the following ELGA interoperability levels are defined as minimum standards:

1.		EIS Structured from 1 December 2015,
2.		EIS Enhanced from 1. Jänner 2017 and
3.		EIS Full Support from 1. Jänner 2018.

(7) According to § 28 (2) (1) (1) lit. d GTelG 2012 will be used for medication data (§ 2 Z 9 lit. b GTelG 2012) the ELGA interoperability level EIS Full Support is established as a standard from 1 December 2015.

6.

Final provisions

In-and out-of-power

§ 22. (1) This Regulation shall enter into force on 15 May 2015.

(2) The ELGA Regulation (ELGA-VO), BGBl. II No 505/2013, shall not enter into force on 14 May 2015.

Notification of notification

§ 23. This Regulation has been adopted in compliance with the provisions of Directive 98 /34/EC laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services, OJ L 206, 22.7.1998, p. No. OJ L 204 of 21.07.1998 p. 37, as last amended by Directive 2006 /96/EC, OJ L 327, 30.12.2006, p. No. 81, of the European Commission, under the notification number 2014 /629/A, notified to the Commission.

Oberhauser