Publication date: February 6, 2026
We have been very pleased to contribute to BioLawEurope comparative survey on Digital Therapeutics and its legal status across Europe. KG LEGAL Kiełtyka Gładkowski prepared the entry on Poland and its standing on DTx.
The results can be seen here:
https://www.biolaweurope.com/blog
Digital Therapeutics ( DTx ) is evidence-based clinical software that prevents, manages, or treats diseases through digital programs installed on smartphones, computers, or other devices. Unlike typical health apps, these apps must undergo clinical trials and often meet medical device criteria.
The State of Poland – Where We Are Now
In Poland, there is no dedicated regulation and reimbursement – there are no separate regulations yet that would allow for the full implementation of DTx in clinical practice, including reimbursement or therapeutic “pharmacy” use (e.g. prescription applications).
This means that currently:
– digital therapies can function mainly as commercial health solutions,
– are not covered by the National Health Fund reimbursement system,
– they cannot be officially prescribed like medicines or traditional medical services.
At the European level, DTx are treated as medical devices in accordance with the MDR ( Medical Device Regulation ), and in Poland this rule is in force – but there is no national implementation, approval and financing path yet.
Nevertheless, Poland already has solid digital foundations for digital health:
– central P1 platform, e-prescriptions, e-referrals, Online Patient Account – which facilitates the integration of new health solutions,
– government health digitalization strategy 2022–2027,
– high level of smartphone and internet penetration.
There are several Polish HealthTech startups operating on the market, also in the area of digital therapies (e.g. Prosoma as an example of a DTx-focused venture in the medical technology ecosystem).
Polish innovators plan to develop AI-based solutions and collaborate with pharmaceutical companies, which could accelerate the adoption of DTx in clinical practice.
The digital therapy market in Poland is still small, but forecasts show its dynamic growth – from a market worth ~$9.9 million in 2024 to over $30 million in 2032, with an average annual growth of approximately 20%.
Although Poland is still finalizing its regulations, digital therapies offer:
– treatment based on clinical evidence,
– 24/7 availability and ease of use on mobile devices,
– possibility of personalizing therapy,
– support for chronic conditions and mental health.
Health Application Portfolio (PAZ)
In Poland, certified health apps are primarily those that have received official recognition and assessment from the Ministry of Health and have been included in the Health Application Portfolio (PAZ). This program aims to provide patients with safe, relevant, and proven mobile tools that support health and preventative care.
What are MZ Certified Applications? These are applications that have passed the verification process of the Ministry of Health in terms of substantive quality, information security and usefulness for patients.
After a positive evaluation, they receive the title of “MZ Certified Application” and are published in the Health Application Portfolio (PAZ). The certificate is awarded for 24 months, and applications in the PAZ are available free of charge to all users through mobile stores (Google Play / AppStore ).
The goal is to more easily identify reliable tools that can support people in managing their health and implementing their doctors’ recommendations.
The certification process includes:
– Substantive and technological evaluation of the application.
– Checking data security and patient privacy.
– Verification of innovation and user usability.
PAZ applications support patients, among others:
– in self-monitoring of health,
– in preventive and educational services,
– in preparation for medical visits,
– in maintaining healthy habits and implementing recommendations.