Key legal aspects of implementing digital therapeutics (DTx) in Czech Republic

The use of medical devices in the Czech Republic is primarily regulated by MDR and further elaborated in Act No. 375/2022 Coll., on Medical Devices, as amended, and Act No. 268/2014 Coll., on In-Vitro Diagnostic Medical Devices, as amended.  

Czech law does not provide for its own definition of a medical device and refers to the definition set out in the MDR. Therefore, if the product falls under the definitions of the medical device under EU law, it would be considered a medical device in the Czech Republic.  

In principle, whether a software is considered a medical device or, for example, a lifestyle app depends on its medical benefit – if it is used to treat, monitor health or compensate for a disease then it would be considered a medical device. If it is designed, for example, for weight loss or fitness maintenance, it does not qualify as a medical device. 

In case a manufacturer is not sure whether or not the product qualifies as a medical device, it is possible to have formal consultations with the respective regulatory authority (the Czech State Institute for Drug Control).

Czech law does not set out detailed rules concerning telemedicine, including use of software for remote provision of healthcare services. However, telemedicine is currently a hot topic in the Czech Republic and there are draft laws in very early stages of the legislative process. Therefore, it can be expected that new laws and regulations will come into force in rather near future.  

In principle, healthcare services can be provided only by (i) physicians or another licensed healthcare professional (ii) in the premises of a healthcare institution. Only consultation services can be provided outside the healthcare institution by way of remote access. This, however, requires nevertheless that the services are provided by HCPs.  

Therefore, DTx including healthcare services cannot be provided by the DTx only. Rather, HCPs need to be involved in the process. 

There are various telemedicine platforms active in the Czech Republic providing medical advice (e.g. an app through which a virtual nurse guides a patient and helps to describe the health problem. A physician then contacts the patient and advises on how to proceed further). There are discussions whether these platforms are required to meet the criteria and be registered as a medical device or not.   

The forthcoming new legal regulations should enable and specify in more detail the prerequisites for the provision of healthcare services through information technology with regard to the technical requirements for the quality and security of communication. 

Given the lack of explicit regulation of telemedicine services, Czech law does not currently regulate technical requirements for the provision of telehealth services. As regards the data protection, general rules under GDPR will apply.   

However, new legal regulations should regulate the question of technical security in more detail. Stricter regulation will concern the conditions for keeping medical records in electronic form and achieving the greatest possible protection of personal data.  

Currently, Czech law does not specifically regulate a medical software / DTx and it is a grey area to some extent. There are, however, ongoing discussions and new legislation in early stage of legislative process. As regards the qualification of a software/DTX as a medical device, MDR applies. As regards processing of personal data, GDPR needs to be followed.  

Advertising, including advertising of medical devices, is primarily regulated by the Czech Advertising Act. If the product qualifies as a medical device, advertising rules under MDR will also apply. 

In principle, if the product is a medical device which meets requirements of MDR for placing on the market, it can be advertised towards HCPs as well as towards laypersons (general public), unless pursuant to the instruction for use, the product can be used solely by HCPs.  

As basic rules, with regards to advertising towards laypersons (general public), the advertising must not: 

• give the impression that a medical consultation, intervention or treatment is not necessary, especially by offering a diagnosis or offering remote treatment; 
• be aimed exclusively at persons under 15 years of age; 
• recommend the medical device with reference to recommendations of scientists, medical professionals or persons who are not such professionals but who, by virtue of their actual or presumed social status, could support the use of the product. 

As regards advertising towards HCPs, information may be disseminated only through means of communication intended primarily for such persons, in particular in professional publications, the professional press, professional audiovisual programs or by direct communication with such persons, and must contain sufficient, demonstrable and objective information to enable them to form their own opinion on the clinical benefit, safety and efficacy of a particular medical device and in vitro diagnostic medical device. 

The Advertising Act expressly sets out that it is prohibited to offer, promise or provide gifts or other benefits to HCPs in connection with the advertising of medical device unless they are of negligible value and related to their professional activity.  

In addition, provision of benefits to HCPs can also create issues under the professional code of doctors and even the criminal code. According to these rules, providing material and immaterial benefits to HCPs might be problematic, in particular if such benefit is provided in order to make the HCPs prefer the respective product in an undue manner.  

As regards provision of incentives and benefits towards laypersons, Czech law is silent on this. It is a rather common practice that sellers of medical device run various promotional activities towards customers, e.g. for one package of a medical device, a customer gets the second package for free, or that if a customer buys a medical device, they get a small gift for free.  

We see several possible distribution channels for DTx: 

• Users (both patients and HCPs) can individually download the software; 
• Provision of DTx to employers for use as a form of an employee benefit; 
• Distribution via cooperation partners, such as pharma / medtech companies, distributors, advertising agencies, etc; 
• Provision of DTx to healthcare organizations for use by their patients; 
• Provision of DTx to insurance companies for use by their clients.  

In the Czech Republic, cooperation in the distribution and promotion of medical software is not yet a common practice. Nevertheless, we can imagine various types of cooperation with different parties, such as hospitals, pharma/medtech companies, etc. (please see above). 

There are two possible options of monetization of DTx – private route and public route through the reimbursement from the public healthcare system (see below). 

The private route is the least regulated option since customers (patients, HCPs, etc.) pay directly to the seller (manufacturer) for DTx. This gives some flexibility to the seller as regards setting-up pricing conditions. On the other hand, the manufacturer (seller) needs to follow the rules on Consumer Protection since customers will be considered consumers in the vast majority of cases. 

So that the customers do not have to pay for the medical device the full price, (i) the medical device needs to be reimbursable in the public healthcare system and (ii) an HCP needs to prescribe such medical device to a patient.  The reimbursement process is rather complex which is initiated by a manufacturer by way of filing a formal application.  

Once the medical device is reimbursable in the public healthcare system, the price of the product (as well as business margin) is regulated by the Ministry of Health.  

To our knowledge, currently there is no medical software / DTx that would be reimbursed by the public healthcare system.