Digital health apps and telemedicine in Czech Republic

1.1 Is it considered a “medical device” or a “product” to which liability can attach, and if so, under what regulations?

A software in the form of digital health apps can be classified as “medical device” if it falls within the definition of the medical device set out in Article 2 of the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (“MDR”).

Medical devices are primarily regulated by the MDR and Act No.: 89/2021 Coll., on Medical Devices, as amended.  In vitro diagnostic medical devices are primarily regulated by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 (“IVDR”) and Act No.: 268/2014 Coll., on In vitro Diagnostic Medical Devices, as amended.

1.2 If your response to Q1.1 is yes, please state whether there are any exclusions/exemptions applicable with regard to liability, and/or whether those are applicable only under certain circumstances (e.g., for in-hospital use)?

Commentary literature confirms that, in general, a software is considered a product in the meaning of the Czech Civil Code. Therefore, we are of the opinion that the rules of the civil law liability can apply in case of digital health apps / software as well.

1.3 If your response to (b) is yes, please state whether there are any exclusions/exemptions applicable with regard to liability, and/or whether those are applicable only under certain circumstances (e.g., for in-hospital use)?

There are no specific exclusions / exemptions for digital health apps / software. Therefore, the general liability rules set out in the Czech Civil Code will primarily apply.  

• Act No.: 268/2014 Coll., on in vitro Diagnostic Medical Devices, as amended, and relating decrees, such as Decree No.: 62/2015 Coll., as amended;
• Act No.: 89/2021 Coll., on Medical Devices, as amended;
• Act No.: 325/2021 Coll., on Digital Health Services, as amended;
• Act No.: 89/2012 Coll., the Civil Code, as amended;
• Act No.: 372/2011 Coll., on Provision of Healthcare Services, as amended;
• Act No.: 110/2019 Coll., on Processing of Personal Data, as amended, and GDPR;
• Act No. 408/2004 Coll., on Certain information society services, as amended, and Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002;
• Respective European legislation, in particular MDR and IVDR;
• Act No.: 634/1992 Coll., on Protection of Consumers, as amended;
• Act No. 40/1995 Coll., Advertising Act, as amended.

3.1 The users are residents using it within their jurisdiction and/or using it outside their jurisdiction.

Czech law does not differentiate between the use of software by patients using it either within their jurisdiction or outside their jurisdiction. However, there might be some legal consequences as a result of transfer of personal/sensitive data across jurisdictions. In addition, in case of cross jurisdiction cases it might be necessary to take into account the regulation of conflict of laws.

3.2 It is a “B2B” (business to business) rather than “B2C” (business to end consumer) service.

Both cases, i.e., B2B and B2C, can occur. B2C cases will cover all scenarios in which a patient is included (e.g., relationship between the manufacturer and a patient or a healthcare provider and a patient). In case of B2C cases, patients are usually considered a “weaker party”, and they are more protected.  B2B services can occur in relationship between, for example, a manufacturer and a healthcare provider.

No, Czech law does not currently set out any further specific restrictions, and the general rules will apply. The particular features would be primarily subject to the data protection rules.

In case a physician uses a faulty software, and a damage (injury) occurs as a result of such faulty software (i.e., not as a consequence of a physician’s error), a patient has a possibility to choose whether he/she will claim damages from the physician or directly from the author/distributor of the software depending on where the fault lies. Both scenarios are governed by different regimes with different liability rules.

In case of a regulatory non-compliance of the digital health apps/software (e.g., as regards notification/registration of the medical device, distribution and vigilance system), the law primarily sets out monetary fines which are enforced by the respective regulatory authorities. For example, a manufacturer can be fined up to CZK 30,000,000 (approx. EUR 1,217,000) if it fails to ensure that medical devices are designed and manufactured in accordance with the MDR. The Czech Institute for Drug Control is the respective regulatory authority. There are also rules regulating breach of data protection rules for which the law again sets out primarily monetary sanctions.

In addition, if the defective health app causes injury, a civil law claim can be brought against the manufacturer/supplier of the product and/or the healthcare professional/healthcare institution.

In extreme cases, criminal law liability may arise as well.

Currently, a proposal to amend the Consumer Protection Act and the Civil Code is being discussed in the legislative process, and these amendments will provide for new obligations in the area of consumer (patient) information, etc.

All physicians are obligatory members of the Czech Medicine Chamber (“CMC”). CMC is an independent, non-political autonomous professional organisation responsible for the interests, the professionalism, the ethics and the honour of the medical profession.

Provision of healthcare services is further supervised by the Czech Ministry of Health and the Czech State Institute for Drug Control.

Primarily, it is Act No.: 372/2011 Coll., on Provision of Health Services (the “Act”) and Decree No.: 98/2012 Coll., on Health Documentation (the “Decree”). With the effectiveness as of 1 January 2022 amendments to the Act have been adopted. In respect of telemedicine, the amendments newly set out that (i) consultation services can be provided outside the premises of healthcare institution and (ii) consultation services outside the healthcare institution can be provided by way of remote access.

In 2022, new Act No. 325/2021 Coll., on Digital Health Services (the “Digital Health Services Act”), or rather some of its provisions, came into force. The Digital Health Services Act introduces a general framework for e-health in the Czech Republic and, in particular, for safe and secured sharing of information, especially between providers of healthcare services. Three elementary registries will be created, (i) register of providers of healthcare services, (ii) register of healthcare professionals and (iii) register of patients. Healthcare professionals will be able to share the information in e-form and patients will be able to access information through a specific platform.

In relation to telemedicine, Act No. 378/2007 Coll., on Pharmaceuticals, as amended (the “Pharmaceuticals Act”) regulates electronic prescription (the so called “eRecept”) under which physician can provide patients with electronic prescription (e.g., via e-mail, text message, etc.).

Currently, there is no complex legislation regulating telemedicine. As set out above, there are only certain elements of telemedicine which are regulated. However, the government is preparing a legislation to specifically regulate the provision of telemedicine services.

As set out above, currently there is no complex regulation of telemedicine and only certain elements of telemedicine are regulated.

There was no specific, time limited, legal regulation of telemedicine during Sars-Cov – 2 pandemic. However, during the pandemic, sick funds (health insurance companies) started to reimburse remote consultation services provided by physicians from the public healthcare system as a specific medical service. As this was not regulated by law (sick funds regulated the consultations in accordance with their own rules), there are now discussions whether there should be a “permanent” legal regulation of teleconsultation services. 

As the current Czech law does not specifically regulate the use of telemedicine, there have not been any changes in the standards of care in the context of using telemedicine.

11.1 Are there legal requirements for physicians to give disclaimers or other types of notices to patients (as part of the consent process) before using telemedicine? If so, please indicate these.

According to the recommendations of the Czech Society of General Medicine ČLS JEP (which is not legally binding), before the start of the procedure, the physician should request the patient's consent to the treatment being performed by telemedicine and should inform the patient of possible limitations compared to an in-person medical examination.

11.2 Does the use of telemedicine increase the risk of liability (e.g., if a physician is asked to certify someone’s fitness to engage in a particular employment and does so virtually versus an in-person consultation)?

Czech law does not differentiate between telemedicine and in-person medical examinations in relation to liability of physicians. From the practical perspective, the risk is indeed higher in case of telemedicine since the diagnostic might be limited in this case (in comparison with in-person diagnostic). It is always up to the individual physician to decide on a case-by-case basis whether a telemedicine consultation is possible, or if an in-person examination is necessary.

In 2018, the ePrescription system was launched in the Czech Republic. A physician issues an electronic prescription (ePrescription) for the patient using the ePrescription system and on the basis of the ePrescription, the pharmacy dispenses the medicinal product. There are no specific restrictions on the type of medicine that can be prescribed through this system. 

As we set out above, for a limited period of time during Sars-Cov – 2 pandemic, sick funds reimbursed remote consultations (teleconsultations). Given that this was not regulated by law, each sick fund had its own rules, which were in general similar for all sick funds but there were some differences. For example, in order for the teleconsultation to be reimbursable:

• the patient had to already be registered in the physician’s registry;
• teleconsultation could have been provided once a day, twice a month maximum (each for maximum 15 minutes); and
• physicians must have been physically present in their office; etc.

It is now discussed that there should be a legal framework and clear rules specifically regulating reimbursement of teleconsultation.

As regards the reimbursement of the telemedicine services for patients (in particular through private telemedicine platforms/apps), these are not in general reimbursed from the public healthcare system. Therefore, patients need to pay for the use of such platforms. However, as a form of a benefit, some sick funds (there is in total 7 sick funds in the Czech patients Republic) reimburse the use of some platforms to their clients (patients).

There are no specific data protection rules covering telemedicine. The Digital Health Services Act includes some elementary principles in this respect. However, as stated above, the Digital Health Services Act does not regulate telemedicine itself.

The Czech government realises the importance of telemedicine. The Czech Ministry of Health is working on a legal regulation which should govern telemedicine, as a whole.