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

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: Małgorzata Kiełtyka, Jakub Gładkowski 

 Law Firm / Organization:  KG LEGAL KIEŁTYKA GŁADKOWSKI 

 City / Country:  Warsaw, Poland                                                           

 Email:  mk@kg-legal.pl

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, there is no legal definition in the Polish legal system of DTx (digital therapeutics). The most important initiative in this area is the so-called "Health Application Portfolio (PAZ)", created to implement a project co-financed by the European Regional Development Fund. The project aims to award state medical universities grants to develop 10 mobile applications. The applications created will ultimately receive the title of "MZ Certified Application", which will signify that, among the numerous applications available on the market, there will be also those verified by the ministry for their content deemed safe. The title can also be awarded to other entities that submit an application. After receiving a positive assessment in the verification process and signing an agreement with the owner, the application will receive the title of MZ Certified Application. The list of certified applications constitutes the Health Application Portfolio. 

The idea behind the Health Application Portfolio (HAP) is to identify safe and reliably developed applications dedicated to patients. Currently, there are many health-related products (applications) available on the market. However, for potential users, choosing applications that, for example, securely store data or are based on applicable medical standards can be challenging. Therefore, the Ministry of Health (MH) has decided to work on creating a Health Application Portfolio, a catalog of applications that patients can use safely and free of charge. Using a given application by a patient can also help medical staff monitor their health and support them in implementing recommendations not only regarding medication but also regarding diet, exercise, and other aspects. 

The process of inclusion in the HPA applies to applications that are submitted by their owners for review. The title of "Application Included in the PAZ" will be awarded to an application that: 

• is a medical device - if it is an application that performs diagnostic or therapeutic processes and has the appropriate certificate; 

• supports well-being (wellness/wellbeing application) - if it is an application that does not perform diagnostic or therapeutic processes, medical device status is not required. 

Submissions will be verified in terms of form, content, and information security. The fundamental assumption is the transparency of the process and the impartiality of the assessment, which is why significant participation from expert and patient organizations has been assumed both during the preparation process and during the application evaluation stage. 

After receiving a positive evaluation in the verification process and signing an agreement with the owner, the application will receive the title of Application Included in the PAZ. 

Soft-law that is not generally applicable law but that is also relevant when awarding applications the title mentioned earlier include, in particular, the Regulations for awarding applications the "Ministry of Health Certified Application" title and for placing applications in the Health Application Portfolio (PAZ).  

The Regulations, the contract template, as well as annexes to the regulations and other documents related to PAZ can be found, for example, on the website of the Polish Ministry of Health for investment management, Investment Project Service Platform (POPI): https://e-inwestycje.mz.gov.pl/wybranykonkurs/054eb66d-7fc9-ed11-b597-000d3aaaee06 [online, accessed: 11/07/25] 

This document indicates that the title of digital therapeutic app will be available to applications whose software has been classified as a medical device, provided that it is a health application that performs diagnostic or therapeutic processes. For well-being apps that do not perform diagnostic or therapeutic processes, medical device status will not be required. The process of obtaining this designation consists of several phases: submission of the application proposal via the application form, verification of the application by a designated Ministry of Health team for formal application evaluation, information security assessment, substantive assessment (including by expert and patient organizations), consultation with the author, confirmation of compliance with all conditions, and signing of the agreement. In the agreement between the Minister of Health, as the authority granting the designation, and the application owner, the latter undertakes to provide the application free of charge for a period of 24 months. In addition to this obligation, the application owner is subject to numerous restrictions, such as the obligation not to include advertising or any promotional content in the application for the entire period of holding the "MZ Certified Application" designation. The certifying authority also declares in the agreement that the agreement will not result in any financial consequences for the application owner. 

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)?

The Health App should be considered a medical device, primarily based on Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (Medical Devices Regulation) which is main source of interpretation in this respect. 

Accordingly, digital therapeutics can be considered a medical device, but mainly if its intended use meets the definition of a medical device. Much depends on what the app is used for and what functions it offers. Generally speaking, an app is classified as a medical device when its primary purpose is: 

• diagnosing, preventing, monitoring, treating, or alleviating disease; 

• diagnosing, monitoring, treating, alleviating, or rehabilitating injuries or disabilities; 

• examining, altering, or replacing anatomical structures or physiological processes. 

  
  

In this respect examples of such digital therapeutics that may be considered medical devices are: 

• blood pressure monitoring apps that allow for data tracking and analysis, as well as sharing data with a doctor; 

• apps that help monitor blood glucose levels; 

• apps for remote diagnosis and monitoring of patient health. 

In turn, digital therapeutics may not be classified as a medical device if its functions are limited to storing, archiving, transmitting, or simply searching for data.   

3. What criteria determine whether a DTx is classified as a medical device or as a well-ness/lifestyle/other product? & 4. What are the regulatory requirements for market access (e.g., conformity assessment, CE marking, national registration)?

Importantly, a medical device is not a product (software) that does not meet the definitional requirements of the MDR Regulation. If software does not meet the purposes referred to in Article 2, it may not be qualified as a medical device. A health app that is also a medical device is a qualified form of a health app with a supportive purpose. A health app that is also a medical device must meet the appropriate requirements for medical devices being introduced to the market for the first time. The procedure depends on the class of the medical device. According to Rule 11 in Annex VIII to the MDR Regulation, software intended to provide information used in decision-making for diagnostic or therapeutic purposes is classified as Class IIa, except in cases where the consequences of such decisions may result in: death of the individual or an irreversible deterioration of their health, in which case the software is classified as Class III, or a serious deterioration of the individual's health or the need for surgical intervention, in which case the software is classified as Class IIb. Software intended for monitoring physiological processes is classified as class IIa, except when it is intended for monitoring vital physiological parameters where a change in these parameters may result in an immediate danger to the patient, in which case the software is classified as class IIb. Other software is classified as class I. The classification of a medical device into a specific class depends on the potential hazards of its use, its intended use, and the monitoring requirements. Recital 60 of the MDR Regulation states that, as a general rule, the procedure for obtaining market approval for a Class I device should be conducted under the sole responsibility of the manufacturer due to the low level of exposure associated with such devices. For Class IIa, Class IIb, and Class III devices, an appropriate level of involvement of a notified body should be mandatory. Under Polish law, the procedure is as follows: for Class I medical devices, the involvement of a notifying body is not required – the manufacturer declares, by affixing the CE marking, that the device being placed on the market meets the essential requirements, legal provisions, quality, and safety standards applicable to the device. For devices other than Class I, the involvement of a notifying body is required. The notifying body issues a certificate of conformity. Classification of a medical device as Class III requires clinical evaluation, which must be conducted with at least one participant. Furthermore, every manufacturer of a medical device is obligated to conduct a clinical evaluation based on clinical data confirming compliance with the requirements and the device's safety. Recital 19 of the MDR clarifies that: standalone software, if specifically intended by the manufacturer for at least one of the medical purposes specified in the definition of a medical device, qualifies as a medical device, whereas software for general use, even if used in healthcare, or software for lifestyle and well-being applications, is not a medical device. The classification of software – as a device or as accessory – is independent of the location of the software and the type of connection between the software and the device. 

A health app that is not a medical device is exempt from the above requirements, although it is also subject to evaluation (in terms of its content) according to the rules specified in the Regulations for awarding applications the "Ministry of Health Certified Application" title and for placing applications in the Health Application Portfolio (PAZ). Currently, the PAZ contains two applications, one of which is also a medical device. The Regulations also specify that the submitted application must not require additional devices, such as a scale or blood pressure monitor, to function. Moreover, only applications available in Polish may be submitted for evaluation, which is the same as the requirement arising from Article 12, Section 1 of the Medical Devices Act. The substantive criteria subject to evaluation by experts and medical specialists indicated in the Regulations are outlined as follows: 1) the relevance and importance of the clinical/public health problem addressed by the application, 2) substantive justification of the content provided in the application, 3) justification of the effectiveness of the proposed solution, 4) ensuring the patient’s health safety when using the application, 5 ) the usefulness of the application in terms of assistance in patient care. 

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

The level of interoperability, such as integration with digital solutions from the Ministry of Health, is not a concern for the Regulations and is not a criterion for substantive expert or patient assessment. However, the situation is different when it comes to cybersecurity and personal data protection. The Regulations specify seven elements that will be subject to assessment by the e-Health Center (CeZ) in Poland: 1) Results of security tests performed by an independent certified entity (including penetration tests) compliant with OWASP Mobile (MASVS) submitted by the application owner; 2) APK and IPA source file verification reports submitted by the application owner; 3) Terms of Use and system regulations; 4) Profiling mechanisms, if applicable; 5) Possible cooperation with other entities regarding user session activity or authentication and authorization; 6) Possible data sharing requests; 7) Information security requirements for all assets owned or held by the application owner. Additionally, the application developer must comply with all requirements arising from legal provisions, e.g. the previously mentioned MDR Regulation or the GDPR Regulation. 

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

Article 29 of the Medical Devices Act introduces a derogation from conformity assessment procedures. The President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) may, by way of an administrative decision, consent to the placing on the market of a device for which conformity assessment procedures have not been conducted, and whose use is in the interest of public health or patient safety or health. These solutions however have not yet been directly said to apply to DTx.  

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

At this time, the PAZ system is a pilot project of relatively minor importance. Therefore, there are no statutory regulations or ordinances that would create a legal definition of DTx and other digital solutions different from DTx. The only possible distinction is between health apps that are also medical devices and those that are not (those that are supporting). In the future, if the Health Application Portfolio expands to include a significant number of entities, and if a statutory definition of Health Applications ( DTx ) is created, it will potentially be possible to differentiate between certified and non-certified apps. However, such a distinction cannot be made at this time. 

D. Reimbursement According to your Jurisdiction

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

Currently, the Polish Ministry of Health did not prepare any regulations directly defining the reimbursement method or pathway for DTx, and at this stage there are only discussions in this respect. 

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

Reimbursement for DTx in Poland, within the National Health Fund (NFZ), is currently in development and not yet widespread. The reimbursement conditions for DTx are closely linked to the app's recognition as a medical device and completion of the certification process by the Ministry of Health. The app must be qualified as a medical device. The app must undergo a certification process, which assesses its usefulness for patients, its usefulness for medical professionals, and data security. Apps that obtain certification can be included in the "Health App Portfolio," which can in the future open the door to funding. Only after meeting the above conditions and being included in the "Health App Portfolio" will the DTx be able to be considered for reimbursement by payers such as the National Health Fund (NFZ) if such provisions are implemented in Poland.  

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

It is not possible to provide information in this respect due to the fact that so far no DTx has been qualified for reimbursement. 

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

A medical device is admitted to trading under the Medical Devices Act, but to a greater extent under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. More information on how, in accordance with rule 11 of Annex VIII to the MDR Regulation, medical devices that are also software are classified can be found in the answers to questions no. 3 and 4. Notified bodies are designated by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products by way of an administrative decision, who is the authority responsible for notified bodies (Art. 28, paragraph 5, point 1 and Art. 3, paragraph 1, point 2 of the Medical Devices Act). 

Currently, the notified bodies in Poland are: 

• Polish Centre for Testing and Certification SA (1434) 

• TÜV NORD Polska Sp. z o. o. (2274) 

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Under the said Regulations, currently the formal evaluation of the application is performed by at least two employees of the Ministry of Health (MZ team). The information security evaluation is performed by at least two employees of the e-Health Center (CeZ team). The substantive evaluation from the perspective of a medical expert is performed by three experts appointed by an organization (or several organizations) of medical professionals with knowledge and experience in the indicated field of medicine or public health. 

The substantive evaluation from the perspective of a patient is performed by two, or in the absence of consensus, three, representatives of patient organizations with knowledge and experience in the area covered in the application. 

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

As evidenced in the responses to other questions above, the legal status in Poland would potentially allow for the introduction of medical devices such as DTx into the reimbursement system. However, no such applications are currently included in this reimbursement system. What specific limitations this will entail in the future, if reimbursement is chosen as the financing system for DTx solutions, remains uncertain. However, it can be stated without any doubt that the Polish legal system lacks a legal and statutory definition of a Health Application as a subtype of medical device or even a separate category which may entail different interpretations. 

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

Only medical devices that have been placed on the market can be reimbursed (Article 10, Section 1 of the Act on the Reimbursement of Medicines, Foodstuffs for Particular Nutritional Uses, and Medical Devices), so there is no possibility of obtaining a "provisional" reimbursement. "Conditional reimbursement" in this context can only mean that the reimbursement is provided by the National Health Fund only in specific cases, e.g. for specific diseases, age groups or in certain clinical conditions. Moreover, reimbursement is made after an authorized entity issues an order, so products not approved for marketing cannot be reimbursed.  

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)?

It is impossible at this point to assess and pinpoint the practical problems, other than the fact that the Ministry of Health's offer to private entities interested in commercializing their product to cover the costs of its development, maintenance, updates, etc., is currently not very attractive to these entities. It is important that, according to the agreement between the app owner and the Minister of Health, the former undertakes to make the application available free of charge. There are at the same time certain benefits to receiving the "MZ Certified Application" designation. While this undoubtedly indicates that the application has been positively assessed for its merits, it also often means that such an entity had to undergo complex and lengthy procedures related to the possibility of releasing a medical device onto the market. This does not necessarily entail compensation, as the Ministry of Health's declaration regarding the future of the pilot program is ambiguous. There are at least several ways to finance new DTx solutions. 

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?

The Health Application Portfolio is, so far, the only initiative supporting the development of DTx. However, the Medical Chambers have recognized this trend and established the NIL IN initiative, a network of physician innovators who support the development of modern digital medicine.  

Important step has been made this year (2025), namely launching the programme aimed at awarding the "Application Included in the Health Application Portfolio" (PAZ) title to applications and inclusion in the "Health Application Portfolio" (PAZ) through POPI (Investment Project Management Platform). This is an initiative of the Ministry of Health aimed at recognizing and promoting healthcare-related mobile applications that meet specific technical requirements and ensure an appropriate level of security and privacy for patient data. 

As part of the initiative, application developers can submit applications for the "Application Included in the PAZ" title, thus including inclusion of their applications in the "Health Application Portfolio" (PAZ) through the Investment Project Service Platform (POPI). Applications that receive the title and are included in the PAZ will have the opportunity to reach a wider audience, including patients and medical staff. The applications will be assessed for, among other things, functionality, usability for patients and medical staff, ease of use, data security and privacy, and innovation. and development potential. 

Awarding the title of "Application Included in the PAZ" and being included in the PAZ will constitute an important distinction for application developers, which can contribute to increased user confidence and the development of their projects. 

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

Health Application Portfolio is currently the program that could potentially serve as a precursor to DTx reimbursement at a later stage. The level of stakeholder cooperation is currently under development. While medical experts and patient representatives participate in the substantive assessment, the process of developing Health Applications, which is just beginning in Poland, at this point lacks representation from application developers. A commendable initiative, however, is the announcement of the use of EU funds for grants to state medical universities to develop at least 10 Health Applications.