1. Digital Health Apps/Software
    1. 1. How is the software in the form of digital health apps classified in your jurisdiction, and what regulation(s) apply?
    2. 1.1 Is it considered a “medical device,” and if so, under what regulations?
    3. 1.2 Is it considered a “product” to which civil liability can attach, and if so, under what regulations?
    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 (i.e., standalone software), whether for in-person or telemedicine consultations, are there circumstances where the physicians’ liability can be limited or transferred to the developer of the app software, or the producer 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 digital health apps. What are the legal consequences for non-compliance?
    12. 7. Are you aware of any expected 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. 10.1 What are the requirements?
    5. 11. Do the standards of care applicable to physicians change in the context of using telemedicine?
    6. 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.
    7. 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)?
    8. 12. Are there any restrictions on the type of medicine that can be prescribed through telemedicine?
    9. 13. Are telemedicine services reimbursable under the state’s medical insurance/subsidy/coverage?
    10. 13.1 If so, are there any special provisions about the reimbursement/coverage of costs regarding the use of mobile apps that can combine digital health and telemedicine?
    11. 13.2 And further, if yes, who is covering the costs for apps that are mostly used by healthcare professionals and by patients?
    12. 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.
    13. 15. Are you aware of any future legal developments in your jurisdiction with regard to telemedicine?

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Ukraine
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Digital Health Apps/Software

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

1.1 Is it considered a “medical device,” and if so, under what regulations?

Generally, the software within digital health apps may be qualified as a “medical device”, if it is intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

The definition of a medical device covers both standalone software and software that is used in combination with a device and is established by Technical Regulation No. 753 on Medical Devices.

All standalone and embedded software is currently regulated by Technical Regulation No. 753 on Medical Devices, save for in vitro diagnostics software, covered by Technical Regulation No. 754 on in vitro diagnostics Medical Devices, and any implantable devices software, covered by Technical Regulation No. 755 on active implantable Medical Devices.

1.2 Is it considered a “product” to which civil liability can attach, and if so, under what regulations?

Manifold definitions of “product” (including “an item of movable property, including electricity” in the product liability law, and “any substance, preparation or other product produced in the course of production activity” in the product safety, and conformity assessment laws), as well very little court practice of its application in general, and no known to us court practice of its application to software in particular, makes it currently unclear whether software within digital health apps alone would be qualified as a product.

In case of embedded software (used in combination with a device), the device along with software contained in it would be covered by general product liability rules.

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)?

No specific exceptions or exemptions to liability are provided for medical devices or software contained in such devices either by the relevant Technical Regulation or product liability legislation.

Yes. Digital health software may be subject to regulation by data protection/privacy, intellectual property, consumer protection, e-commerce, competition laws and advertising law requirements, as well as other regulations depending on the use and nature of the software at issue.

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.

Generally, yes. The application of the laws in most cases is limited to the territory of Ukraine. For example, jurisdictional application of data protection regulations is not explicitly defined. However, current regulations are interpreted in such a way that they (i) apply to all personal data processed in the territory of Ukraine and (ii) have extraterritorial application with respect to data being transferred to and from Ukraine

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

Generally, no. In certain cases, some specific laws may apply to B2C relations only, such as consumer protection regulations.

The legal regime of such features as location tracking or monitoring real time information is fully covered by those already mentioned in answers to Q1 and Q2. However, it should be separately noted that health related data and location tracking data are sensitive data under personal data legislation, and such data may only be processed under specific circumstances. Moreover, such data may only be processed under explicit consent of a data subject. 

Additionally, processing of sensitive personal data requires:

  • notification to the Ukrainian data protection authority (Ukrainian Parliament Commissioner for Human Rights, Ombudsman) of such processing (as well as of any changes in the submitted information, and of cessation of processing) by the data controller, and
  • appointment of a data protection officer/department at a data controller or processor and notification of the data protection authority of such appointment.

5. In the context of physicians relying on digital health apps (i.e., standalone software), whether for in-person or telemedicine consultations, are there circumstances where the physicians’ liability can be limited or transferred to the developer of the app software, or the producer 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?  

Yes.

Generally, healthcare providers (institutions and individual healthcare professionals) may bear civil, administrative or criminal liability only in case of violation of the established legal procedures (addressed to such providers).

Even if we assume the physician could still be liable under the general legislation applicable to medical professionals, such liability would require causation and fault by the physician, which may both be lacking if the inaccuracy is due to a fault of the software rather than the physician's error.

Where the software constitutes a medical device, the producer (if a resident of Ukraine), or its authorized representative in Ukraine (if producer is a non-resident) will generally bear liability for putting an unsafe device on the Ukrainian market.

More specific distribution of liability will depend on facts of a particular case.

Q1. If the software within digital health apps is qualified as a “medical device,” non-compliance with the requirements of the Technical Regulation on Medical Devices, including labelling requirements, generally eliminates the possibility to put such software into circulation in the territory of Ukraine, or, in the event it ceases to comply with the mentioned requirements, such non-compliance causes its removal from circulation in the territory of Ukraine by the responsible state authority (State Service of Ukraine on Medicines and Drugs Control or customs authorities). There may be some derogations to this rule in exceptional situations (such as the martial law regime).

Q2 and Q4. Ukrainian data protection legislation provides for several levels of liability for breach of data protection rules, including administrative, civil and criminal liability.

Q2. Advertising legislation. If the software within digital health apps is qualified as a medical device, persons violating the legislation regulating advertising may be subject to civil and administrative liability. Generally, persons ordering advertising would be the ones responsible for the content of the advertising.

The enforcement mechanism as well as legal consequences of non-compliance with other regulations mentioned in Q2 above need to be analysed on a case-by-case basis depending on the specific use of the digital health software.

For several years now Ukraine has been undergoing massive transformation and development in the spheres of e-governance and e-health, where the use of digital health apps and software is becoming a daily practice.

This was mainly triggered by the COVID-19 pandemic which led to the launch of the governmental COVID-19 related app DII VDOMA for monitoring person’s self-isolation status.

The declaration of martial law following the full-scale invasion of Ukraine by the Russian Federation has introduced some adjustments to the process, but overall has only made it even more relevant, as many Ukrainians who were forced to leave their homes still need to have contact with their primary physicians and as many Ukrainians still need to have access to medical assistance in poorly-accessible areas due to combat actions.

Additionally, the emerging Ukrainian e-health system (even now, under the constraints of the martial law regime) provides room for engaging software developers and medical system users into the health digitalization process through their use of apps aimed at supporting of healthcare system.

There is a special legal regime in Ukraine called “Diia City,” stimulating the development of the digital economy in the country. This regime provides its residents with tax benefits, the ability to use flexible employment models, as well as other advantages.  In August 2024, the Diia City regime became available for companies involved in bionic prosthetics, including the development and production of prostheses and orthoses that allow computer control of the product and programming of its parameters. In February 2025, the coverage of the Diia City regime was further extended, and the regime became available for companies engaged in R&D activities, excluding the fields of social and humanitarian sciences. As a result, Life Sciences & Healthcare companies, including HealthTech, involved in the above activities can benefit from the advantages of the regime.

Additional changes are expected to be introduced within the medical device legislation. In July 2022, a draft law “On medical devices” (No. 7585) was registered in the Parliament of Ukraine. The first draft of the law does not contain substantial changes to Digital Healthcare regulation, however, this may change as (if) the draft proceeds further.

Telemedicine

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

The physicians’ activities are regulated by the Ministry of Health of Ukraine.

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

  • Law of Ukraine “Fundamentals of Legislation of Ukraine on Healthcare”;
  • Law of Ukraine “On Increase of Availability and Quality of Medical Service in Rural Area”;
  • Law of Ukraine “On Rehabilitation in the Sphere of Healthcare”;
  • Order of the Ministry of Health of Ukraine No. 681, dated 19.05.2015, “On approval of regulatory documents regarding the application of telemedicine in the sphere of healthcare”;
  • Methodological Recommendations for diagnostics and treatment of certain diseases using telemedicine by Ministry of Health of Ukraine (2019);
  • Order of the Ministry of Health of Ukraine No. 504, dated 19.03.2018, “On approval of the procedure for providing primary care”;
  • Order of the Ministry of Health of Ukraine No. 383, dated 26.02.2022, “On the involvement of foreign medical workers to the providing medical care to the injured during martial law” (valid only during martial law);
  • Order of the Ministry of Health of Ukraine No.1695, dated 17.09.2022, “On approval of the procedure for providing medical and/or rehabilitation care using telemedicine for the period of martial in Ukraine or its individual localities” (valid only during martial law).

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

10.1 What are the requirements?

Generally, Ukrainian legislation does not limit circumstances under which physicians can or shall use telemedicine. At the same time, the secondary legislation or methodological recommendations define areas (like primary care), or diseases (like coronavirus (COVID-19), where telemedicine can be applied. For example, in case of the primary care physician may provide certain services by using telecommunications. Moreover, there is no direct prohibition to use telemedicine in other cases (areas/diseases), where relevant, even if the secondary legislation contains no specific permission to use telemedicine in this regard.

As a general rule, there are certain formal administrative requirements to providing medical care via telemedicine (such as setting up a special telemedicine cabinet, requirement to fill out certain documents for a physician, etc.). These requirements have been waived for treatment of certain war-related injuries and conditions according to the list of injuries approved by the Ministry of Health of Ukraine during martial law for healthcare institutions and physicians appointed for this purpose.

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

There are no specific legal requirements for physicians to give disclaimers or other types of notices to patients before using telemedicine. At the same time, according to the Methodological Recommendations for diagnostics and treatment of certain diseases via telemedicine by Ministry of Health of Ukraine (2019), before starting a real-time teleconsultation, a physician is obliged to explain the procedure of teleconsultation to the patient and obtain his/her consent.

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)?

No. Simultaneously, some requests, namely certification of someone’s fitness to engage in a particular employment, require an in-person consultation and cannot be carried out through telemedicine.

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

Yes, there are certain restrictions for the prescription of medicines through telemedicine.By way of background, Ukrainian legislation enables prescriptions to be issued electronically. Moreover, according to effective Ukrainian legislation, e-prescriptions should be normally used by physicians as the default option, except for certain exemptions when the issuance of paper prescriptions is allowed.

In the context of telemedicine, changes introduced by the MOH’s Order No. 1333, dated 21 July 2023, starting from October 2023, significantly expanded physicians’ ability to issue e-prescriptions remotely (without conducting an in-person examination).  If a patient approaches a physician using technical means of electronic communications, the physician has the right to issue an e-prescription without an in-person examination based on the results of remote interaction with the patient, relying on the data received from the patient about the current state of their health and complaints, and information from primary medical records the physician has access to, except for cases of substitution maintenance therapy and where an in-person examination is required by the industry standards approved by the MOH. 

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

Yes, telemedicine services may be covered by the state to the extent stipulated by the Programme of the state guarantees of the provision of healthcare services to patients. For example, for primary care, usage of telemedicine is indicated as an alternative way of providing the care under certain circumstances, and thus is covered under the general rule.

13.1 If so, are there any special provisions about the reimbursement/coverage of costs regarding the use of mobile apps that can combine digital health and telemedicine?

There are no specific provisions or guidelines about the reimbursement/coverage of costs regarding the use of mobile apps combining digital health and telemedicine yet.

13.2 And further, if yes, who is covering the costs for apps that are mostly used by healthcare professionals and by patients?

N/A.

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 regulations governing telemedicine services. Nonetheless, the provision of healthcare services through telemedicine shall conform to the personal data protection regulations, including requirements on processing sensitive personal data regarding health.

As an exemption from the general rule that the transborder transfer of personal data is possible only if the state where the receiving party is located ensures adequate protection of personal data—the list of such states includes members of the EEA and some others—effective Ukrainian personal data protection laws directly allow the transborder transfer of personal data specifically for the purposes of providing medical or rehabilitation сare using telemedicine to other states as well, on the condition that the protection of personal data is ensured according to the legislation of the state where the relevant healthcare/rehabilitation professional or healthcare institution providing medical/rehabilitation care is allowed to carry out medical practice. This exemption applies during the period of martial law in Ukraine and six months after its termination or cancellation and is not applicable if the receiving party is a citizen of the Russian Federation or the Republic of Belarus.

The coronavirus pandemic and the introduction of the martial law regime in Ukraine on 24 February 2022 following full-scale invasion of Ukraine by the Russian Federation are major drivers behind digitalization of healthcare in Ukraine. We therefore expect continuation of the significant developments with regards to telemedicine in the next future.

The development of e-health, i.e., expanding e-prescription, extensive use of e-referral (from primary care to specialised care provider), implementation of the e-medical records system, will lead to the further growth of the telemedicine segment.

On 29 July 2022, Ukrainian Parliament adopted the law No. 2494-IX, under which it is expressly stated that during martial law foreign physicians may be engaged in medical assistance in Ukraine, including via telemedicine, upon compliance with certain administrative conditions, which are nonetheless much simpler than those applicable under normal circumstances (such as a complicated process of recognition of a foreign diploma / medical practice license, etc.). The law provided a reliable legal ground and more clarity around engaging foreign healthcare professionals into helping Ukrainians during these unprecedented times.

In July 2023, the Cabinet of Ministers of Ukraine approved the Telemedicine Development Strategy, outlining key strategic objectives in this area and an operational plan containing concrete steps to achieve these objectives for the period of 2023-2025.  The strategic objectives, among others, include the expansion of telemedicine via different organizational and technical means, the improvement of the legislative basis for the application of telemedicine, and informational campaigns promoting its use.  It is expected that the further development of telemedicine will remain among the top priorities of the national healthcare system for the foreseeable future.