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. 2. Are there any other legal regimes that may govern digital health software? (e.g. data protection/ privacy) If yes, please indicate these.
    3. 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). 
    4. 3.1 The users are residents using it within their jurisdiction and/or using it outside their jurisdiction.
    5. 3.2 It is a “B2B” (business to business) rather than “B2C” (business to end consumer) service.
    6. 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?
    7. 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)? 
    8. 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?
    9. 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. 10.1 What are the requirements?
    5. 10.2 Were there any new (time-limited) regulation regarding the Sars-CoV-2 pandemic?
    6. 11. Do the standards of care applicable to physicians change in the context of using telemedicine?
    7. 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.
    8. 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)?
    9. 12. Are there any restrictions on the type of medicine that can be prescribed through telemedicine?
    10. 13. Are telemedicine services reimbursable under the state’s medical insurance / subsidy / coverage? 
    11. 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.
    12. 15. Are you aware of any future legal developments in your jurisdiction with regard to telemedicine?

jurisdiction

Serbia
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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?

Medical devices for human use are regulated by the Law on Medical Devices (Official Gazette of the Republic of Serbia, no. 105/2017).

The Law on Medicines and Medical Devices (Official Gazette of the Republic of Serbia, no. 30/2010, 107/2012, 113/2017, and 105/2017) regulates medical devices for veterinary use and may apply if the product combines the medicine and medical device for human use. 

General medical device for human use is defined as any instrument, apparatus, appliance, software, implant, reagent, material and other product used alone or in combination, including software provided by the manufacturer for diagnostic or therapeutic purposes which provides a software support necessary for the proper use in human beings, and is used for:

  1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  2. diagnosis, monitoring, treatment, alleviation or compensation of injury or disability,
  3. investigation, replacement or modification of the anatomy or physiological or pathological process and state,
  4. providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
  5. control or support of conception, 6) products intended for cleaning, disinfection or sterilization of medical devices. In vitro diagnostic medical devices and active implantable medical devices are defined separately. 

The law does not specifically address the issue of the software within digital health apps, and the practice on the matter is yet to be established. 

Medicines and Medical Devices Agency (“ALIMS”) is authorised to determine whether a certain product is a medical device or not. Hence, they will decide on the matter in each particular case. 

If the product is determined to be a medical device, it will have to be approved by ALIMS and entered into the appropriate registry, and the provisions of the Law on Medical Devices regulating liability will apply.

If the product is not determined to be a medical device, standard liability would apply in line with the Law on General Safety of Products (41/2009 and 77/2019), Law on Consumer Protection (Official Gazette of the Republic of Serbia, no. 62/2014, 6/2016, and 44/2018) and the general provisions of the Law on Obligations (Official Gazette of SFRY no. 29/78, 39/85, 45/89, and 57/89, Official Gazette of SRY, no. 31/93, Official Gazette of SCG, no. 1/2003 and Official Gazette of the Republic of Serbia, no. 18/2020)

All software falls into the same category regarding data protection and privacy, and there is no special regime which governs only this type of software.

Depending on the exact software and application, and the information that may be processed, the compliance with both the Law on Personal Data Protection (Official Gazette of the Republic of Serbia no. 87/2018) and the Law on Patient’s Rights (Official Gazette of the Republic of Serbia no. 45/2013 and 25/2019).

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.

This may be relevant in the case of transfer of personal data out of Serbia, as there are certain restrictions and/or additional requirements related to such transfer. 

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

Regardless of whether it is B2B or B2C service, if the personal data is processed, this has to be done in accordance with the Law on Personal Data Protection. 

Under the Law on Personal Data Protection and the Law on Electronic Communications (Official Gazette of the Republic of Serbia, no. 4/2010, 60/2013, 62/2014, and 95/2018), location tracking and monitoring real-time information requires explicit consent from the person whose data is being processed.

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)? 

The physician is liable to the patient for any wrongdoing on his part. 

When a fault or inaccuracy with the software occurs, which leads to damage or injury of the patient, the producer will be liable for the faulty product. Depending on the specific circumstances (whether the faulty product solely or directly caused the injury or damage or the improper use by the physician contributed to it, whether or not there was a physician’s error in diagnostics or implementation of the product, etc.), the liability of the physician and producer can be joint and several or individual. 

If software is considered as a medical device, the compliance is monitored by the Ministry of Health and ALIMS. Non-compliance with the Law on Medical Devices may result in commercial offence proceedings where fines ranging from approx. EUR 12,700 to EUR 25,500 may be imposed on the legal entity. Objects used or intended for committing commercial offence shall be confiscated, and a protective measure prohibiting the legal entity from performing a certain business activity may be imposed in the period from three to ten years. Additional legal consequences may arise in the form of damage claims. 

If the software is not considered a medical device, but rather a product, it has to comply with the requirements for general safety of the product, and also standard consumer rights would apply. In case of non-compliance, a fine may be imposed on the manufacturer in the amount of approx. EUR 2,500 to EUR 25,500. Additional legal consequences may arise in the form of damage claims.

Regardless of the nature of the software, incompliance with the Law on Personal Data Protection may result in a fine approx. EUR 450-17,000. Additional legal consequences may arise in the form of damage claims.

Currently there are no draft laws or regulations related to the telemedicine in the procedure. 

Any future legal developments are likely to follow the ones of the EU. 

Telemedicine

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

Both Ministry of Health of the Republic of Serbia and Serbian Medical Chamber have competences over physicians (the latter being in charge of their licensing).

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

Telemedicine is not regulated in Serbian legislation. Therefore, law regulating healthcare in general would apply, i.e., Law on Health Care (Official Gazette of the Republic of Serbia, no. 25/2019).

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

No.

10.1 What are the requirements?

The Law on Health Care neither recognises, nor regulates telemedicine; therefore, specific requirements for providing telemedicine services are not provided in the law.

10.2 Were there any new (time-limited) regulation regarding the Sars-CoV-2 pandemic?

There are no Sars-CoV-2 pandemic specific regulations regarding telemedicine. However, Ministry of Health did provide a new portal E-health which was introduced as preparation for the introduction of telemedicine in Serbia. For the time being, the portal allows patients to fill out the symptom self-assessment questionnaire, after which they receive guidelines on how to proceed based on the answers. If they leave a phone number and if their answers indicate a suspicion of COVID-19, their physician will invite them for an examination at the Health Centre Institution.

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

No.

Bearing in mind that telemedicine is not separately regulated, physicians are not required under the law to give any additional disclaimers or other types of notices to patients, apart from the ones they provide in case of in person 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)?

Considering that telemedicine is not regulated in Serbian jurisdiction, increased liability could be expected if a physician practises distance diagnosis or treatment. However, no specific regulations nor practice has been introduced in this regard.

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

As telemedicine is not regulated, there are no instructions related to the prescription of medicines through telemedicine. General rules related to the prescription of medicines would apply.

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

At this point there are no regulations regarding telemedicine services, and they are not separately listed as reimbursable under the state’s medical insurance/subsidy/coverage. 

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 covering telemedicine except for general regulation provided in the Serbian Law on Personal Data Protection. 

Law on Personal Data Protection provides that processing of health data is allowed only if it is necessary for the purpose of preventive medicine or occupational medicine, to assess the working capacity of employees, medical diagnostics, provision of health or social care services, or management of health or social systems, by law or by contract with a health worker, if processing is performed by or under the supervision of a healthcare professional or another person who has the obligation to maintain professional secrecy prescribed by law or professional rule.

Currently there are no draft laws or regulations related to the telemedicine in the procedure. Any future legal developments are likely to follow the ones of the EU.

Ministry of health and physicians are slowly preparing the platform with available tools under the current legal framework, so we could be expecting further developments in this field.