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 |
BGBl. II Nr. 106/2015 |
|
ELGA Ordinance Amendment 2019 - ELGA-VO-Nov 2019 |
BGBl. II Nr. 54/2019 |
|
eHealth Regulation - eHealthV |
BGBl. II Nr. 449/2020 |
|
eHealth Regulation Amendment HPV |
BGBl. II Nr. 53/2023 |
|
Data protection adaptation act 2018 |
BGBl. I Nr. 62/2016 |
|
Signature and Confidential Service Ordinance - SVV |
BGBl. II Nr. 208/2016 |
|
Telematic health regulations 2013 - GTelV 2013 |
BGBl. II Nr. 506/2013 |
|
Changes of the agreement in accordance with Article 15a B-VG on the organization and financing of the health care system |
BGBl. I Nr. 199/2013 |
|
Changes of the signature regulation 2008 |
BGBl. II Nr. 401/2010 |
|
Changes to the E-Government Act - E-GovG-amendment-2007 |
BGBl. I Nr. 7/2008 |
|
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 |
BGBl. I Nr. 101/2007 |
|
Information security act, InfoSiG |
idF BGBl. I |
|
Signature and Confidential Services Act and amendment of the eGovernment Act, etc. |
idF BGBl. I |
|
Professional right- amending law for notaries, lawyers and civil engineers 2006 - BRÄG 2006 |
BGBl. I Nr. 164/2005 |
|
Supplementary register regulation - ERegV |
BGBl. II Nr. 241/2005 |
|
Delivery service regulation - ZustDV |
BGBl. II Nr. 233/2005 |
|
Address register regulation - AdrRegV |
BGBl. II Nr. 218/2005 |
|
Amendment to the Data Protection Act 2000 - DSG 2000 Link to the Federal Chancellery Austria |
BGBl. I Nr. 13/2005 |
|
Register of ordinances regulation 2009 – StZRegBehV 2009 |
BGBl. II Nr. 330/2009 |
|
Health reform act 2005 |
BGBl. I Nr. 179/2004 |
|
E-Government Area Segregation Regulation - E-Gov-BerAbgrV |
BGBl. II |
|
E-Government act - E-GovG |
BGBl. I Nr. 10/2004 |
|
583. Regulation: Determination of the requirements for an invoice transmitted by electronic means |
BGBl. II Nr. 583/2003 |
|
Information security regulation, InfoSiV |
BGBl. II |
|
Commission implementing Decision laying down standards for the security evaluation of qualified signature and seal creation devices... |
(EU) 2016/650 |
25.04.2016 |
EU Directive - requirements for accounting |
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 |
BGBl. II Nr. 31/2000 |
|
EU Regulation on electronic identification and trust services for electronic transactions
|
Nr. 910/2014 |
17.9.2014 |
Judgment of the Supreme Court on the obligation to provide documentation |
OGH 8 Ob 134/01s |
|
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.