Digital health apps and telemedicine in Slovakia

Software within digital health apps (the “DHA Software”) can be considered as a medical device.

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

DHA Software can be classified as a computer program, which under certain circumstances falls within the definition of a medical device according to the Slovak Act on Medicinal Products and Medical Devices (the “Act”). The Act implemented Directive 93/42/EEC. In addition to the Act, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the “EU Regulations”) should be also taken into account. 

The manufacturer shall assess whether the DHA Software it created falls under the regime of the EU Regulations. The EU Commission provides numerous non-binding guidance documents (e.g., Manual on borderline and classification in the community regulatory framework for medical devices) for this purpose, which are intended to assist manufacturers in determining whether their DHA Software falls within the definition of a medical device. 

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)?

There is no specific legal regime governing the DHA Software. The claims related to DHA Software considered to be a medical device shall be analysed on case by case basis, taking into account general liability regimes provided for in the Slovak Civil Code. It is necessary to distinguish between damage caused by the DHA Software manufacturer and damage caused by a health care practitioner using the DHA Software. The health care practitioner using the DHA Software could fall under a strict liability regime. This means that the practitioner cannot benefit from liability exemptions. The practitioner is held liable even if he or she proves that he or she did not cause damage to a patient by his or her misconduct or omission. On the other hand, the liability of the DHA Software manufacturer may not be strict liability. The DHA Software manufacturer may fall under the liability regime which allows for exemptions if it can prove that it is not culpable (i.e., did not breach its duty).

Furthermore, there is a risk of liability for violation of rights to protection of personality if there is a casual link between the caused damage and the DHA Software used. No liability exemptions apply in this case.

Besides the above-mentioned Slovak and EU regulations, the DHA Software in general can be also regulated under other Slovak acts, such as the following:

• Health Care and Health Care Services Act;
• Act on Personal Data Protection;
• Act on Electronic Communications;
• National Health Information System Act; and
• Copyright Act.

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

Claims for damage caused to residents outside their jurisdiction will likely invoke application of rules on conflict of laws. These rules differ in EU member states and in third countries. Therefore, it is necessary to assess each claim individually depending on applicable legal regime.

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

Certain cases can be considered as B2B while the others as B2C. Each of them has a different liability regime. Liability of the manufacturer towards the patient will be assessed in the B2C regime. B2C applies strict liability regime which does not allow for exemptions. For details please refer to Question 1 above. 

The liability of the manufacturer could be assessed towards the health care practitioner in B2B regime because the health care practitioner can be involved in such a relationship within his profession.

Further additional consents, regulatory approvals and/or other restrictions beyond the general ones mentioned in Question 1 or Question 2 are for example as follows:

1. business licences;
2. conformity consents (i.e., all medical devices must bear a mark of conformity issued by the State Institute for Drug Control certifying that a medical device poses no health risk);
3. consents according to the Act on Personal Data Protection;
4. consents according to the Act on Electronic Communications.

Please see Question 1 for more details regarding limitations of liability. 

In numerous Slovak cases, the health care practitioners are likely to be held liable. According to the Health Care Act and the Health Care Services Act and therein attached Code of Ethics, the health care practitioners are obliged to always act lege artis (i.e., in accordance with the most current medical knowledge) and in a such way, that no patient would suffer any damages. Such strict liability cannot be transferred or exempted. Thus, the health care practitioners shall not rely on Producer’s liability for a defective DHA Software.

From the perspective of a patient who suffered damage, potential enforcement mechanisms are for example as follows:

1. a court claim for pecuniary damages or non-pecuniary damages; 
2. fillings to the Health Care Surveillance Authority, the Office for the Personal Data Protection of the Slovak Republic, or to the Regulatory Authority for Electronic Communications and Postal Services; and
3. disciplinary proceedings held by the Slovak Medical Chamber.

Legal consequences for non-compliance depend on the type of a breach and its seriousness and are as follows:

1. administrative fines issued by health care authorities;
2. prohibition of provision of health care services;
3. indemnities;
4. disciplinary penalties (disciplinary reprimands, fines, expulsion from the Slovak Medical Chamber); 
5. contractual penalties (depending on contract in place, e.g., between hospital and patient, hospital and insurance company); and
6. imprisonment (in case of a criminal liability).

Currently, there is no new legislation planned on digital health apps or software in the near future. Digitalisation of the health care industry is a step ahead of the relevant legislative updates. Some of the legal issues which still need to be addressed by Slovak legislators are the specific legal definition of the DHA Software and the specific regulation and liability regimes applicable to usage of DHA Software.

The Slovak regulators are as follows:

• Slovak Medical Chamber, an independent, self-governing professional organisation, which plays major role in overseeing and licensing of health care professionals and internal disciplinary proceedings. Membership within the Chamber is compulsory;
• Health Care Surveillance Authority, which performs surveillance over all relevant aspects of health service system; and
• The Public Health Authority, which controls and coordinates the activities carried out by regional public health offices. The Public Health Authority also prepares proposals for directions and priorities of the state health policy in the field of public health, which may have an impact on the day-to-day services provided by physicians.

Please see Question 1 and Question 2 (laws and regulations mentioned therein shall also apply to physicians in general).
There is no legal definition of telemedicine in Slovak law. Similarly, as in some other EU member states, telemedicine is not regulated by a specific act. However, Slovakia has a regulatory framework of acts governing the provision of health care in Slovakia, which in general also applies to physicians active in telemedicine (i.e., the Act on Health care Providers, Health Care Workers and Professional Organisations in Healthcare, the National Health Information System Act, etc.). 

Currently, there are no planned legal updates on telemedicine.

In Slovakia, there is currently no legislation which explicitly recognises usage of telemedicine by physicians as a manner of provision of the health care. 

Even though no law was adopted to specifically regulate the telemedicine in Slovakia, there has been widespread use of the telemedicine during lockdown period in the spring of 2020 due to Covid-19 pandemic (e.g., physicians conducted online consultations and examinations of patients with chronic illnesses). However, such ad hoc developments in health care have not yet been followed by changes in the Slovak legal environment. 

No. There are no specific requirements applicable to physicians 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.

Not applicable.

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)?

Slovak law does not distinguish between physicians’ liability in case of provision of health care using telemedicine and liability in case of provision standard health care.

Slovakia has no specific regulation governing telemedicine. Thus, there are no statutory restrictions on the type of medicine that can be prescribed via telemedicine. 

However, we can draw some practical guidance from practitioners in the healthcare sector. In case of long-term drugs for chronic patients, medicine is often prescribed without the patient being present on site. If the patient is yet to be treated with a new medicine, it is usually necessary for patient to personally visit a health care professional.

Telemedicine is not explicitly recognised as a service reimbursable under the state’s medical insurance.

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? 

Not applicable.

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

Not applicable.

No, there are no specific rules. General rules according to, e.g., the GDPR, the Slovak Act on Personal Data Protection, and the Act on Electronic Communications would apply.

Currently, there are no planned legal updates related to telemedicine. However, there is a growing trend of introducing explicit regulation on telemedicine in neighbouring countries. For instance, the Czech Ministry of Health started works on a legislative framework for telemedicine. The officials from the Czech Ministry of Health indicated, that their inspiration comes from Germany, where legislation regulating telemedicine has already been adopted. 

Based on the above, we believe that there will be similar developments in Slovakia soon. Moreover, the increased need for telemedicine during Covid-19 pandemic may expedite this process.