The app on prescription – “DiGA” in Austria?

The political mandate

Digitalization, as we know, does not – and especially not – stop in the healthcare sector. Since Germany introduced the “app on prescription,” the possibility of prescribing and reimbursing health apps – referred to as “digital health applications” – has also been widely discussed in Austria.

A first step, which shows the political will to establish this, was taken in 2023 with the “Digital Austrian Act.” Section 7 of this document (accessible here) includes a separate section on “Digital Healthcare.” A central component of this subsection is “digital health applications.” It was already established in 2023 that their prescription should be made possible in cooperation with social insurance providers and that they should complement telemedical care.

This clear political will to establish digital health applications is also reflected in the Austrian e-Health Strategy (accessible here), which was presented in July 2024. The strategy includes an initial attempt at a definition but also highlights the existing legal uncertainty. In addition to a variety of other measures that are intended to contribute to the digitalization of the healthcare system, it also states that healthcare providers should “make decisions together with patients about suitable digital health applications, such as a health app that supports therapy.” But how far is the road to this goal – isn’t the reimbursement of such applications already possible through social insurance?

Current legal framework

While the classification of “DiGAs” (Digital Health Applications) under medical device law appears relatively straightforward at first glance, an examination of social insurance law, specifically the Austrian General Social Security Act (ASVG), reveals that – despite the very clear political expressions of intent – explicit provisions for digital products are absent. 

However, an analysis of existing literature and case law shows that “DiGAs” could, under certain circumstances, be classified as “other means” under section 136 ASVG and, in any case, as “other necessary medical aids” under section 137 ASVG. Therefore, patients could already request reimbursement under certain conditions if they pay for a medically prescribed health app, even though the legal framework for in-kind benefits is not yet in place. In any case, the requirements of section 133 para. 2 ASVG must be met, meaning that the “DiGA” must be necessary and appropriate without exceeding the scope of what is necessary. (For more details, see Ernst/Gabauer, “Digital Health Applications in Austria,” RdM 2023). Current practice among social insurance providers seems to involve rejecting such applications. One thing is clear: In order to ensure that in-kind benefits are granted – i.e., that the app is reimbursed directly by social insurance upon prescription – several clarifications and additions to the legal framework are still needed.

The app on prescription ante portas?

Despite political advances, the app on prescription is not yet reality. Even though the necessary adjustments to the current legal framework might be minor, it would be desirable for it to be enshrined in law so that there is legal certainty for patients, product providers and social insurance providers.

However, as part of a pilot project currently underway, the relevant stakeholders have already agreed on some important cornerstones. For example, the Austrian Agency for Health and Food Safety (AGES) is expected to take on central responsibilities, along with other entities such as social insurance providers, the Central Association of Austrian Social Insurance Authorities, and the Gesundheit Österreich GmbH. The various “assessment domains” of the process to be established are set to include, for example, the examination of data protection, security, interoperability and medical benefits. Additionally, a pre-evaluation phase is planned to enable early assessment of DiGA reimbursement. This will be followed by a comprehensive evaluation process. The concept is expected to be finalized by February 2025, with the first DiGAs to be reimbursed starting in 2026.

It therefore remains to be seen whether these steps can be implemented as planned and whether the next government will honor the outcomes of the pilot project and remain committed to the Digital Austrian Act and the Austria e-Health strategy. A legal anchoring of the process is essential in order to ensure legal certainty for all parties involved.

Our health law experts are happy to keep you updated on these developments and are available to answer any questions and

provide practical support. For more information on Gisela Ernst‘s lecture on the topic, visit: 6th Praevenire Digital Health Symposium – Digital Health Applications in Focus | DigitalDoctor (medmedia.at).

Another update awaits you at the pharmaKon 2024.

Disclaimer

This article is for general information only and does not replace legal advice. Haslinger / Nagele Rechtsanwälte GmbH assumes no liability for the content and correctness of this article.

 

14. November 2024

 

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