Legal frameworks

For archiving and distributing medical data exists a legal set of rules, that precisely specifies the requirements. marc fulfills the current requirements and also commits to meet future standards.

Titel	Desig./ Nr.	Date of issue
ELGA Ordinance 2015 - ELGA-VO 2015 Ordinance of the Federal Minister of Health on the Implementation and Further Development of ELGA (ELGA Ordinance 2015 - ELGA-VO 2015) Link to the Federal Chancellery Austria	BGBl. II Nr. 106/2015	12.05.2015
ELGA Ordinance Amendment 2019 - ELGA-VO-Nov 2019 Ordinance of the Federal Minister of Labor, Social Affairs, Health and Consumer Protection amending the ELGA Ordinance 2015 (ELGA Ordinance Amendment 2019 - ELGA-VO-Nov 2019) Link to the Federal Chancellery Austria	BGBl. II Nr. 54/2019	26.02.2019
eHealth Regulation - eHealthV Ordinance of the Federal Minister for Social Affairs, Health, Care and Consumer Protection, laying down more detailed regulations on the eHealth application Electronic Vaccination Certificate (eHealth Ordinance - eHealthV) Link to the Federal Chancellery Austria	BGBl. II Nr. 449/2020	16.10.2020
eHealth Regulation Amendment HPV Ordinance of the Federal Minister for Social Affairs, Health, Care and Consumer Protection, amending the eHealth Ordinance (eHealth Ordinance Amendment HPV) Link to the Federal Chancellery Austria	BGBl. II Nr. 53/2023	24.02.2023
Data protection adaptation act 2018 The Data protection basic regulation become effective on 25 May 2018. The DSGVO will replace the Data Protection Directive 95/46/EG with the aim to harmonize European data protection law. Link to the Federal Chancellery Austria	BGBl. I Nr. 62/2016	12.05.2017
Signature and Confidential Service Ordinance - SVV Ordinance of the Federal Chancellor on the suitability of certification bodie Link to the Federal Chancellery Austria	BGBl. II Nr. 208/2016	01.08.2016
Telematic health regulations 2013 - GTelV 2013 The regulation of the BMG came into force on January 1, 2014 and replaced the previous health care regulations (BGBl II 2012/483 and BGBl II 2008/451). Link to the Federal Chancellery Austria	BGBl. II Nr. 506/2013	16.11.2022
Changes of the agreement in accordance with Article 15a B-VG on the organization and financing of the health care system Link to the Federal Chancellery Austria	BGBl. I Nr. 199/2013	15.10.2013
Changes of the signature regulation 2008 Link to the Federal Chancellery Austria	BGBl. II Nr. 401/2010	09.12.2010
Changes to the E-Government Act - E-GovG-amendment-2007 Link to the Federal Chancellery Austria	BGBl. I Nr. 7/2008	07.01.2008
Federal law on Adapting legislation to the agreement according to Art. 15a of the organization and financing of health care for the years 2008 to 2013 Link to the Federal Chancellery Austria	BGBl. I Nr. 101/2007	28.12.2007
Information security act, InfoSiG (incl. changes) Link to the Federal Chancellery Austria	idF BGBl. I Nr. 23/2002 Nr. 129/2003 Nr. 10/2006 Nr. 32/2018	15.01.2002 30.12.2003 13.01.2006 17.05.2018
Signature and Confidential Services Act and amendment of the eGovernment Act, etc. Link to the Federal Chancellery Austria	idF BGBl. I Nr. 50/2016	08.07.2016
Professional right- amending law for notaries, lawyers and civil engineers 2006 - BRÄG 2006 Link to the Federal Chancellery Austria	BGBl. I Nr. 164/2005	30.12.2005
Supplementary register regulation - ERegV Regulation of the Federal Chancellor on the supplementary register according to the E-Government act. Link to the Federal Chancellery Austria	BGBl. II Nr. 241/2005	01.08.2005
Delivery service regulation - ZustDV Regulation of the Federal Chancellor on admission as an electronic delivery service Link to the Federal Chancellery Austria	BGBl. II Nr. 233/2005	28.07.2005
Address register regulation - AdrRegV Regulation of the Federal Minister of Economics and Labor on the content and structure of the address register Link to the Federal Chancellery Austria	BGBl. II Nr. 218/2005	20.07.2005
Amendment to the Data Protection Act 2000 - DSG 2000 Link to the Federal Chancellery Austria	BGBl. I Nr. 13/2005	31.03.2005
Register of ordinances regulation 2009 – StZRegBehV 2009 Link to the Federal Chancellery Austria	BGBl. II Nr. 330/2009	12.10.2009
Health reform act 2005 The Federal Law on Hospitals and Spas, the General Social Insurance Act, the Industrial Social Insurance Act, the Farmers' Social Insurance Act, the Civil Servants' Health and Accident Insurance Act, the Social Insurance Supplement Act, the Physicians' Act 1998 and the Federal Act on Documentation in Health Care, and enacting a Federal Act on the Quality of Health Care Services and a Federal Act on Telematics in Health Care (Health Care Reform Act 2005). Link to the Federal Chancellery Austria	BGBl. I Nr. 179/2004	30.12.2004
E-Government Area Segregation Regulation - E-Gov-BerAbgrV Regulation of the Federal Chancellor, which defines the scope of state activities for identification purposes in E-Government communications (incl. changes) Link to the Federal Chancellery Austria	BGBl. II Nr. 289/2004 Nr. 213/2013	15.07.2004 15.11.2022
E-Government act - E-GovG Enactment of an e-government law Link to the Federal Chancellery Austria	BGBl. I Nr. 10/2004	27.02.2004
583. Regulation: Determination of the requirements for an invoice transmitted by electronic means Regulation of the Federal Minister of Finance, which determines the requirements for an invoice sent by electronic means Link to the Federal Chancellery Austria	BGBl. II Nr. 583/2003	23.12.2003
Information security regulation, InfoSiV Regulation of the Federal Government on information security (incl. amendment) Link to the Federal Chancellery Austria	BGBl. II Nr. 548/2003 Nr. 67/2012 Nr. 131/2018 Nr. 268/2022	28.11.2003 14.03.2012 20.06.2018 06.07.2022
Commission implementing Decision laying down standards for the security evaluation of qualified signature and seal creation devices... Link to EUR-Lex	(EU) 2016/650	25.04.2016
EU Directive - requirements for accounting Link to EUR-Lex	2006/112/EG	01.07.2022
31. Regulation: Determination of the suitability of the association "Zentrum für sichere Informationstechnologie - Austria (A-SIT)" as confirmation body Link to the Federal Chancellery Austria	BGBl. II Nr. 31/2000	02.02.2000
EU Regulation on electronic identification and trust services for electronic transactions Link to EUR-Lex	Nr. 910/2014	17.9.2014
Judgment of the Supreme Court on the obligation to provide documentation Link to the Federal Chancellery Austria	OGH 8 Ob 134/01s	16.08.2001

Storage of x-ray images

The Federal Ministry for Social Security and Generations has informed the Austrian Medical Association about the legal regulations for the storage of radiographs:

Question 1: „Do X-rays fall under the ten-year retention period of Section 51 (3) of the Doctors' Act 1998 or are they to be kept for thirty years?“
X-ray images are in accordance with § 51 Abs. 3 Ärztegesetz 1998. BGBl. I No. 169, other, the documentation in the sense of § 51 Abs. 1 leg.cit. relevant documents and therefore in accordance with § 51 Abs. 3 leg.cit. ten years from the end of treatment.
Question 2: „Can a physician take radiographs to patients or other physicians, or does he have to keep them by himself and can only pass copies?“
In principle, it must be stated that the ultimate goal of this problem solution is to safeguard the patient's health. Therefore, everything must be done to avoid unnecessary health hazards and, under certain circumstances, even dangers resulting from multiple radiographs, etc., which could result in non-availability of radiographs. As a result of an interpretation of the legal interests or interests between the physician's obligation to keep the patient and the patient's health, the obligation to retain the right to rescind has to be withdrawn.
In concrete terms, the answer to the question depends on who can be regarded as the owner of radiographs.
On the basis of the opinion obtained, and on the basis of relevant literature and jurisprudence, the health resort has a differentiated view. The content of the treatment contract is decisive.
If, according to findings, the production of radiographs is agreed upon, as is customary in medical radiology diagnostics, the patient becomes the owner of the x-ray image because of the treatment contract which is largely to be qualified as a work contract must be handed over.
If, on the other hand, the production of an x-ray image is merely ancillary to a treatment contract, the doctor or health care provider remains the owner of the X-ray image. It is to be considered, for example, to the X-ray image of dentists.
In the last-mentioned constellation, the patient's right of access, which is deduced from the nature of the treatment contract as a secondary obligation, and which is also anchored in hospital and physician rights.
It also includes at least the patient's authority to request copies of his / her documentation. The cost of these copies is borne by the patient. In the absence of the necessary technical possibilities, however, the physician is obliged to surrender the above legal goods or interests.
Question 3: „Is a so-called" takeover "declaration necessary or is it sufficient with this retention obligation?“
Since there are no special formal requirements, there is no need for a separate declaration of acceptance, even though this can certainly be useful for the purpose of proof-of-preservation. However, a corresponding note must be made in the patient's medical history.
Question 4: „What doctor must keep the X-ray image when several physicians are involved?“
There are no explicit legal provisions, even if it would be sensible that every physician treating a radiograph had a radiograph. However, this will be virtually impossible, since copies will incur additional costs and will not be available in any case.
For this reason, it is recommended that the doctor in charge of the last treatment keep the X-ray image, and the other doctors in the patient's health record where the radiograph is.