184. Regulation of the Federal Minister of Health on electronic laboratory reports in the Register of Notifiable Diseases

On the basis of § 4 (15) of the Epidemiegesetz 1950, BGBl. No. 186/1950, as last amended by the Federal Law BGBl. I No 80/2013, shall be arranged:

§ 1. (1) laboratories within the meaning of this Regulation are bodies which directly or indirectly diagnose notifiable diseases in humans.

(2) Labors are obliged to fulfil their reporting obligations pursuant to § 3 paragraph 1 Z 1a of the Epidemiegesetz 1950, BGBl. No 186/1950, as amended, to be electronically entered in the Register of Notifiable Diseases.

(3) The message shall include the following types of data:

1.		Data for the identification of sufferers, deceased or excretions (name, gender, date of birth, social security number),
2.		the nature of the erratic,
3.		investigated material,
4.		the method of investigation and
5.		Details of the analysis result.

(4) In the event of a technical failure of the register, the notification shall be made within 24 hours in another appropriate manner (e.g. by telephone).

§ 2. (1) The electronic transmission has either online by entering the data in the register by means of the intended application software or via an interface for health provided by the Federal Ministry of Health for Laboratory information systems shall be carried out.

(2) Labors shall be obliged to use the respective valid version of the laboratory interface description provided by the Federal Ministry of Health for the transmission of the data.

§ 3. (1) In the form of a form provided on the homepage of the Federal Ministry of Health, laboratories shall provide the following information:

1.		the name or name,
2.		professional postal accessibility,
3.		an electronic contact address,
4.		the role according to Annex 1 of the 2012 Health Telematics Ordinance, BGBl. II No 483/2012, as amended, and
5.		the nature of the intended data transmission (Section 2 (1)).

(2) The laboratory shall then have access to the electronic access authorization in the district administrative authority where the activity is carried out in the course of which the laboratory is carried out.

(3) The district administrative authority shall, in particular, verify the completeness and accuracy of the information referred to in paragraph 1 and, where appropriate, the laboratory shall have the access data necessary for obtaining the certificate provided for authentication purposes. to be handed out.

(4) On the basis of the identity established in electronic form in accordance with paragraph 1, a comparison of these data with those in the eHealth directory service (§ 10 of the Health Telematics Act 2012 (GTelG 2012), BGBl. I n ° 111/2012, in the current version) for the purpose of checking the role (§ 5 GTelG 2012) of data stored by the district administration authority.

(5) The transfer of the certificate is not permitted. The loss of the certificate shall be immediately announced to the Federal Ministry of Health.

§ 4. (1) The obligation to make an electronic declaration shall be 1. Jänner 2014 in force.

(2) laboratories carrying out their activities according to the 1. January 2014 shall ensure that they are able to comply with the obligation of electronic reporting with the inclusion of their activities.

Stöger