Q&A: REGULATION AND REIMBURSEMENT OF DIGITAL THERAPEUTICS (DTX) / Austria

To enable a consistent comparison of the legal frameworks surrounding digital therapeutics (DTx) across different jurisdictions, we have developed this Q&A template. It serves as the basis for a blog series on the BLE website that explores how various countries regulate, clas- sify, and reimburse digital health applications. By answering the following questions, you con- tribute to an international understanding of how DTx are integrated into national healthcare systems. We appreciate your time and expertise in supporting this cross-border digital health initiative.

A. Contributor Information 

Name:  Sonja Hebenstreit

 Law Firm / Organization:  Herbst Kinsky Rechtsanwälte GmbH     

 City / Country:  Vienna, Austria                                                             

 Email:  sonja.hebenstreit@herbstkinsky.at 

B. Introduction – Status and Definition of DTx

1. Does your country have any uniform or established regulations for digital therapeutics (DTx) which provides for a legal definition of DTx? If not, are there any soft law instruments, guidance documents, or working definitions used by authorities or HTA bodies?

Currently, no uniform regulation nor a definition exist in Austria so far, although a legal framework has been discussed over the last couple of years. Nevertheless, as the topic of DTx is discussed within the concerned parties and in the media, DTx are typically referred to as "Digitale Gesundheitsanwendungen" (DIGAs; " Digital Health Applications") which is the term that has been introduced in German law.

The Austrian eHealth-strategy (of June 2024) uses the following definition of such DIGAs[1]: "Digital health applications are software applications (web applications and apps) that are approved as medical devices within the meaning of the European Medical Devices Regulation (Regulation (EU) 2017/745) (and accordingly bear a CE mark) and can support patients in the treatment of diseases or the compensation of impairments."

C. Legal Classification of DTx in your Country

2. Under which legal framework do DTx fall in your country (e.g., medical devices, pharmaceuticals, others)?

According to the definition used in the Austrian eHealth-strategy, DTx would, as their intended use is for medical purposes^[2], qualify as medical devices and must accordingly comply with the legal requirements laid down in the legal framework applicable to medical devices, in particular the Medical Device Regulation. DTx must be distinguished from wellness and lifestyle products, which do not constitute medical devices.^[3]

3. What criteria determine whether a DTx is classified as a medical device or as a well-ness/lifestyle/other product?

Medical devices are tools (including software) to be used for human beings for specific medical purposes[4], whose intended primary effect on or in the human body is not achieved by pharmacological, immunological, or metabolic means, although their mode of action may be supported by such means. Their use does not primarily involve direct interaction with the patient’s organism or metabolism, nor does it directly affect the immune system. Nevertheless, by definition, medical devices are aimed at preventing, curing or alleviating diseases.

4. What are the regulatory requirements for market access (e.g., conformity assessment, CE marking, national registration)?

 According to Article 5(1) MDR, medical devices may only be placed on the market if they comply with the requirements of the MDR. Medical devices are subject to a certification process. Certification of a medical device with the CE marking takes place upon completion of the conformity assessment procedure. When products are sold online, the CE marking and any legally required warnings must be displayed on the website and visible before the end user completes the purchase.

Manufacturers of products in risk class IIa or higher must also demonstrate that an appropriate Quality Management System (QMS) is in place. Manufacturers of such products are subject to a conformity assessment including an assessment of the technical Documentation.  The manufacturer of a medical device must also plan, establish, document, implement, maintain an update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. As medical devices, DTx are subject to certain advertising restrictions, particularly arising from the Austrian Medical Devices Act (Medizinproduktegesetz).[5]

5. Are there specific cybersecurity, interoperability, or data protection requirements that apply to DTx?

The General Data Protection Regulation (GDPR) is applicable, as it is across all EU member states. This regulation governs the processing of personal data and requires that data be handled securely and confidentially. As DTx will in moste cases process health data, which are considered special categories of personal data, increased security measures will be needed. The processing of electronic health data and genetic data by a healthcare provider (Gesundheitsdiensteanbieter, ‘GDA’) pursuant to Section 2(2) of the Austrian Health Telematic Act 2012 (Gesundheitstelematikgesetz 2012, "GTelG 2012") is further governed by the mentioned GTelG 2012. In accordance with Section 4(1) and Section 4(4) of the GTelG 2012, the identity of both the patient and the GDA must be established or verified. In addition, the confidentiality and integrity of the processed health data and genetic data must be ensured. These obligations apply likewise to the manufacturer of the medical device who qualifies as GDA according to the GTelG.

While there is no specific cybersecurity law exclusively for DTx, the Network and Information Security (NIS) Directives provide legal measures to boost the overall level of cybersecurity in the EU. The NIS 2 Directive significantly expands the scope of application compared to the NIS Directive, as it now includes medium-sized companies from the list of critical and highly critical sectors. For the healthcare sector, this means broad applicability to healthcare providers, pharmaceutical and medical device companies, as well as companies (only) engaged in drug research, such as start-ups, provided that the size requirements are met. Subject to further examination of the specific DTx, the NIS 2 Directive (and any future Austrian implementing act in) may provide for cyber security requirements. Additionally, the Medical Device Regulation (MDR) includes provisions related to the security of medical devices, which would likewise apply.

6. Is there a specific regulatory pathway or fast-track available for digital health products or DTx (e.g., expedited review, sandbox programs)?

In the absence of specific legislation a particular regulatory pathway or fast-track for digital health products or DTx does not exist.

7. How is the legal distinction between DTx and other digital health applications handled (if any) in your jurisdiction?

Not applicable, as under Austrian (although not laid down in the law so far) terminology only software applications (web applications and apps) that are approved as medical devices   would qualify as DTx.

D. Reimbursement According to your Jurisdiction

8. Is there a legal basis for the reimbursement of DTx in your healthcare system?

Austrian law provides for a system of compulsory health insurance. The legal basis for the reimbursement of medical treatment of insured persons is laid down in the Austrian General Social Insurance Act ("ASVG"). Currently, there is no explicit provision in place that governs the reimbursement of DTx. DTx would therefore be reimbursed in accordance with the existing rules laid down in the ASVG.

9. Under what conditions can DTx be eligible for reimbursement (e.g., prescription require- ment, evidence of efficacy, medical benefit)?

According to Section 133 (1) ASVG, medical treatment which must be provided to the insured needing such treatment includes (i) medical assistance ("ärztliche Hilfe"), (ii) medicinal remedies ("Heilmittel") and (iii) medical aids ("Heilbehelfe").

Medical assistance is defined as consultation by a physician, therefore the reimbursement of DTx can in any case not be requested under this aspect. Medicinal remedies include medicinal products, but also remedies by other means which serve to eliminate or alleviate the disease or to ensure the success of the cure. The latter could, when carrying out a strict word interpretation, easily cover DTx. However, it is unclear whether DTx could qualify as such other means, as according to Austrian case law these must also unfold a certain effect on the body. 

According to Section 137 (1) ASVG, glasses, orthopaedic insoles, hernia bands and other necessary medical aids, which serve to cure, alleviate or prevent exacerbations of the disease are to be given to the insured. All medical aids therefore must be suitable to cure, alleviate or prevent the worsening of an illness.  As medical aids are not exhaustively listed in Section 137  ASVG, also DTx could potentially qualify as such aids.

Irrespective of whether DTx – as long as no specific legal framework dealing with DTx is implemented – would be qualified as medicinal remedies or medical aids, they need to be prescribed by a doctor in order to in principle qualify for reimbursement. Further, it should be noted, that in accordance with Section 133 (2) ASVG the medical treatment must be sufficient and appropriate, but must not exceed what is necessary. Any DTx on the market would therefore need to adhere to the principles of sufficiency, appropriateness and necessity in order to be reimbursable.

10. How is reimbursement of DTx practically  carried out – through catalogs, individual agreements, or direct claims to insurers?

While the reimbursement of medicinal products (qualifying as "medicinal remedies" in the terminology of the ASVG) is based on the reimbursement code ("Erstattungskodex"), listing all medicinal products that are (in principle) reimbursed by the Austrian social insurance, no such "list" is in place for medical aids. The making available of such aids to the insured is factually based e.g on overall contracts concluded between the social insurance and the pharmacies and/or other stakeholders who are typically dispensing such products to the patients. However, as the patient's legal entitlement to be provided with medical aids in accordance with Section 133 ASVG cannot be made contingent on the existence of such contracts, the patient could in such case claim direct reimbursement from the social insurance.

11. What role do health technology assessment (HTA) bodies or evidence evaluation procedures play in this process?

These bodies or processes are currently of no relevance, as such evaluation is currently only used to assess the application of selected high-priced and specialised medicinal products in the intramural sector or at the interface between the extra- and intramural sectors.

12. What limitations or uncertainties currently exist regarding the reimbursement of DTx in your country (e.g., missing lists, lack of contracts, definitional issues)?

Since there is no legal definition of digital therapeutics (DTx) in place in Austria, uncertainty remains regarding their classification and reimbursement. Accordingly, Austria currently lacks centralized procedures or dedicated platforms for the evaluation and reimbursement of DTx, which creates barriers to their integration into the public healthcare system.

13. Is temporary or conditional reimbursement (e.g., while real-world evidence is collected) possible in your jurisdiction?

Temporary or conditional reimbursement is not foreseen under Austrian law. However, it is theoretically possible through individual agreements or within the framework of pilot projects in cooperation with social insurance institutions.

E. Practical barriers

14. Have manufacturers of DTx in your country faced specific practical barriers (e.g., delays in evaluations, inconsistent insurer decisions, lack of digital infrastructure)?

The practical barrier would rather be the lack of a specific legal framework, no other specific entry barriers are known.

F. Perspectives – Future Outlook

15. Are there any ongoing initiatives or legislative efforts in your country to further develop or reform the legal and reimbursement framework for DTx?

In its current version, the Austrian e-health strategy of 4 June 2024 proposes specific measures within a timeframe until 2030, listing short-term (2024-2026), medium-term (2026-2028) and long-term (2028-) measures.[6] However, given Austria's tight budgetary situation, it is likely that at least some of these plans will be delayed.

16. Do these efforts include stakeholder consultations or pilot programs that manufacturers can engage with?

The current ehealth strategy foresees the development of pilot programs in the short term 2024-2026. There is no public information about the specific projects. The inclusion of mostly public stakeholders is for example implemented in the Viennese ehealth strategy board.[7]

[1] https://www.sozialministerium.gv.at/dam/jcr:d83aba44-320a-4f60-877a-4a8ecc9aaf4c/240204-eHealth-EN_bf.pdf  .

[2] According to the DIGA definition as referred to in section B 1, DIGAs "support patients in the treatment of diseases or the compensation of impairments"

[3] Cf. Recital 19 MDR.

[4] as defined in Article 2 para 1 of Medical Devices Regulation 2017/45.

[5]  Austrian Medical Devices Act, Federal Law Gazette I 2024/102.

[6]https://www.sozialministerium.gv.at/dam/jcr:d83aba44-320a-4f60-877a-4a8ecc9aaf4c/240204-eHealth-EN_bf.pdf, page 34.

[7] https://www.wien.gv.at/gesundheit/einrichtungen/planung/ehealth/strategieboard.html.