1. Digital Health Apps/Software
    1. 1. How is the software within digital health apps classified in your jurisdiction, and what regulation(s) apply?
    2. 1.1 Is it considered a “medical device” or a “product” to which liability can attach, and if so, under what regulations?
    3. 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)?
    4. 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)?
    5. 2. Are there any other legal regimes that may govern digital health software? (e.g. data protection/ privacy) If yes, please indicate these.
    6. 3. If your response to Q2 is yes, please state whether it matters if, the users are residents using it within their jurisdiction and/or using it outside their jurisdiction; and/or it is a “B2B” (business to business) rather than “B2C” (business to end consumer) service. In each case, please summarise any implications (if applicable). 
    7. 3.1 The users are residents using it within their jurisdiction and/or using it outside their jurisdiction.
    8. 3.2 It is a “B2B” (business to business) rather than “B2C” (business to end consumer) service.
    9. 4. Do any particular features, such as location tracking, or monitoring real-time information, trigger any additional consent requirement, regulatory approval, and/or other restrictions beyond the general ones applicable to Q1/Q2?
    10. 5. In the context of physicians relying on digital health apps (containing software), whether for in-person or via telemedicine consultations, are there circumstances where the physicians’ liability can be limited or transferred to the producer of the software contained in the app, or of the final product/app itself, when a fault or inaccuracy with the software (rather than the physicians’ error) occurs, leading to damage (or injury)? 
    11. 6. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1, Q2, and/or Q4 in your jurisdiction with regard to the software contained in digital health apps. What are the legal consequences for non-compliance?
    12. 7. Are you aware of any future legal developments in your jurisdiction with regard to digital health apps/software?
  2. Telemedicine
    1. 8. How are physicians regulated in your jurisdiction (i.e., who is their Regulator; e.g., the General Medical Council in the UK)?
    2. 9. What laws and/or regulations apply to physicians regarding telemedicine?
    3. 10. Does the law in your jurisdiction regulate under what circumstances physicians can use telemedicine in order to treat patients?
    4. 11. Do the standards of care applicable to physicians change in the context of using telemedicine?
    5. 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.
    6. 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)?
    7. 12. Are there any restrictions on the type of medicine that can be prescribed through telemedicine?
    8. 13. Are telemedicine services reimbursable under the state’s medical insurance / subsidy / coverage? 
    9. 14. Are there specific data protection regulations covering telemedicine (outside the context of using a digital health app) in your jurisdiction? If so, please summarise what they are.
    10. 15. Are you aware of any future legal developments in your jurisdiction with regard to telemedicine?

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Czech Republic
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Digital Health Apps/Software

1. How is the software within digital health apps classified in your jurisdiction, and what regulation(s) apply?

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

Software in the form of digital health apps can be classified as a “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.: 375/2022 Coll., on Medical Devices and In vitro Diagnostic 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 the same Act No.: 375/2022 Coll., on Medical Devices and 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 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.: 375/2022 Coll., on Medical Devices and In vitro Diagnostic Medical Devices, as amended, and relating decrees, such as Decree No.: 377/2022 Coll.;
  • 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, including Decree No.: 30/2025 Coll., on telemedicine health services;
  • Act No.: 110/2019 Coll., on Processing of Personal Data, as amended, and GDPR;
  • Act No. 480/2004 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. If your response to Q2 is yes, please state whether it matters if, the users are residents using it within their jurisdiction and/or using it outside their jurisdiction; and/or it is a “B2B” (business to business) rather than “B2C” (business to end consumer) service. In each case, please summarise any implications (if applicable). 

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 B2B and B2C scenarios are possible. B2C cases include any situation involving a patient, such as the relationship between a 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.

5. In the context of physicians relying on digital health apps (containing software), whether for in-person or via telemedicine consultations, are there circumstances where the physicians’ liability can be limited or transferred to the producer of the software contained in the app, or of the final product/app itself, when a fault or inaccuracy with the software (rather than the physicians’ error) occurs, leading to damage (or injury)? 

If a physician uses faulty software and this results in harm (i.e., not as a consequence of a physician’s error), the patient may choose to claim damages either from the physician or directly from the author/distributor of the software depending on

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.

Recently, the new Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products was introduced and the EU member states, including the Czech Republic, are obliged to implement its provisions into their national laws by 9 December 2026. The new EU Product Liability Directive broadens the scope of product liability law to include AI and digital products, and among other things, enhances consumer rights, and introduces new compensable harm and financial claim thresholds. It is expected that current Czech law on product liability will be amended and thus affect product liability related to digital health apps/software.

Recently, the new Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (the AI Act) was introduced. As the provisions of the new EU AI Act gradually come into force, it is expected that digital health apps/software which use artificial intelligence will become subject to certain restrictions and obligations under the AI Act.

Telemedicine

8. How are physicians regulated in your jurisdiction (i.e., who is their Regulator; e.g., the General Medical Council in the UK)?

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.

9. What laws and/or regulations apply to physicians regarding telemedicine?

Primarily, it is Act No.: 372/2011 Coll., on Provision of Health Services, as amended (the “Act”), Decree No.: 444/2024 Coll., on Health Documentation (the “Decree on Health Documentation”) and Decree No.: 30/2025 Coll., on Telemedicine Health Services (the “Decree on Telemedicine Health Services”). With the effectiveness as of 1 October 2024, amendments to the Act have been adopted. In respect of telemedicine, the amendments newly set out (i) conditions for the provision of telemedicine health services; 

and (ii) rules and methods of keeping electronic medical records.  The Act defines telemedicine health services as health services that are provided remotely using information and telecommunication technologies or a medical device. Telemedicine health services can only be provided by healthcare providers authorised to provide healthcare services.  The Act together with the Decree on Telemedicine Health Services sets general conditions for provision of telemedicine services, in particular the requirements for security and quality of communication, method of proving identity and method of expressing and recording the patient's consent, or lack of consent, to recording the communication.

The Act No. 325/2021 Coll., on Digital Health Services, as amended (the “Digital Health Services Act”) provides 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. There are three elementary registries: (i) register of providers of healthcare services, (ii) register of healthcare professionals, and (iii) register of patients.  Digitalisation of health services is progressing over time and it is expected that in the upcoming years that healthcare professionals will be able to share the information in e-form and patients will be able to access information through specific digital platforms.  For these purposes, new digital platforms have been introduced, such as “eZkarta” (mobile app designed to enable patients to access their medical documentation) or “eŽádanka” (designed to enable healthcare provides to electronically request medical examinations and patients to access these information). Currently “eZkarta” only stores vaccination records and “eŽádanka” is not yet available.

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.).

10. Does the law in your jurisdiction regulate under what circumstances physicians can use telemedicine in order to treat patients?

The Act on Provision of Health Services defines telemedicine health services as health services that are provided remotely using information and telecommunication technologies or a medical device.  According to the Act, telemedicine health services can only be provided by healthcare providers authorised to provide healthcare services.

The Act provides that telemedicine health services can only be provided if the technical requirements for the quality and security of the communication are met, the communication channel is encrypted and the identity of the communicating parties is assured.  The communication may only be recorded by the healthcare service provider with the consent of the patient. More detailed conditions on the provision of telemedicine services are set out in the Decree on Telemedicine Health Services, in particular the requirements for security and quality of communication, method of proving identity and method of expressing and recording the patient's consent, or lack of consent, to recording the communication.

11. Do the standards of care applicable to physicians change in the context of using telemedicine?

In general, the standards of care applicable to physicians in the context of using telemedicine do not change, provided that all of the technical requirements for the quality and security of the communication are met, the communication channel is encrypted and the identity of the communicating parties is assured, as specified in the Act and Decree on Telemedicine Health Services.

According to the Act, a physician may only provide telemedicine healthcare services outside a healthcare facility in the following cases:  (i) provision of telemedicine healthcare services without the presence of the patient consists solely of the use of information and telecommunications technologies, including, where appropriate, by means of remote access or a medical device (e.g., teleradiology or telepathology); or (ii) provision of telemedicine healthcare services consists only in gathering medical information being obtained remotely or by means of a medical device and automatically transmitted to the physician (e.g., telemonitoring).

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, as telemedicine is not a separate form or type of healthcare service, but rather a way of providing a healthcare service that the physician is authorised to provide. From a practical perspective, the risk is indeed higher in the case of telemedicine since the diagnosis might be limited in this case (in comparison with a diagnosis made in person). It is always up to the individual physician to decide on a case-by-case basis whether a telemedicine healthcare service is possible, or if an in-person examination is necessary.

12. Are there any restrictions on the type of medicine that can be prescribed through telemedicine?

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

13. Are telemedicine services reimbursable under the state’s medical insurance / subsidy / coverage? 

Prior to the novelisation of the Act on Provision of Health Services in October 2024, physicians were able to provide telemedicine only in the form of remote consultations (teleconsultation). For a limited period of time during SARS-CoV–2 pandemic, health insurance funds in the Czech Republic reimbursed remote consultations (teleconsultations). Given that this was not regulated by law, each sick fund had its own rules, which were generally 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 a maximum of 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 telemedicine.

As regards the reimbursement of the telemedicine services for patients (in particular through private telemedicine platforms/apps), these are not generally 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 are a total of 7 sick funds in the Czech Republic) reimburse the use of some platforms to their clients (patients).

14. Are there specific data protection regulations covering telemedicine (outside the context of using a digital health app) in your jurisdiction? If so, please summarise what they are.

There are no specific data protection rules covering telemedicine, as the Digital Health Services Act only provides some elementary principles in this respect.  The Decree on Telemedicine Health Services sets out the technical requirements for the quality and security of the communication, including requirements for encryption of the communication channel and the method of expressing and recording the patient's consent, or lack of consent, to recording the communication.

In the Czech Republic there are still ongoing discussions on the legal framework and clear rules specifically regulating reimbursement of telemedicine.

Digitalisation of health services in the Czech Republic is progressing over time and some developments are expected in the area of digitalisation of information sharing between healthcare professionals and patients, as well as the ability of patients to access their medical records through specific digital platforms.