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. 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?
    5. 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)? 
    6. 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?
    7. 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. 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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Bulgaria
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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?

The software within a digital health app is classified as a “medical device”, as per the definition in § 1, it. 21 of the Supplementary provisions of the Medical Devices Act. The software within a digital health app shall qualify as a medical device, when the software (app) is intended to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
  2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
  3. investigation, replacement or correction of an anatomical part or of a physiological process; or
  4. control of conception,

and does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The standalone software is deemed to be an active medical device.

For devices that incorporate software or for software that represents medical device in itself, the software must be validated according to the development of the state of the art taking into account the principles of development life cycle, risk management, verification and validation.

According to Art. 39a of Ordinance on the essential requirements and the procedures for assessment of the conformity with the essential requirements of the medical devices under Art. 2, para. 1, item 3 of the Medical Devices Act, the manufacturer is liable for the placing on the market and putting into service of the medical device. No specific exception is available for the software in the form of digital health apps. The general regulation of liability under the Bulgarian Contracts and Obligations Act shall apply.

The digital health software, related to processing of personal data will be also regulated by the Bulgarian Personal Data Protection Act and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

Such personal data are information that allows, directly or indirectly, the identification of a natural person (i.e., by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person).

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). 

General Data Protection Regulation territorial scope provides that the Regulation applies to the data processing “in the context of the activities of an establishment of a controller or a processor in the Union, regardless of whether the processing takes place in the Union or not” (Art. 3, para. 1). The GDPR also applies to the processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union, where the processing activities are related to: (a) the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union; or (b) the monitoring of their behaviour as far as their behaviour takes place within the Union.

Article 9 of the GDPR Processing of special categories of personal data shall apply in cases of processing data concerning health, as defined in Article 4, paragraph 15 of the GDPR (“data concerning health” means personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about his or her health status”).

As per Article 51 of the Bulgarian Personal Data Protection Act the processing of personal data concerning health shall be allowed where this is strictly necessary, where there are appropriate safeguards for the rights and freedoms of the data subject, and where this is provided for in European Union law or in the Bulgarian legislation. Specific grounds for data processing of personal data concerning health are provided in the Bulgarian Personal Data Protection Act, Article 51, para. 2 where this is strictly necessary, there are appropriate safeguards for the rights and freedoms of the data subject, and: (i) processing is necessary to protect the vital interests of the data subject or of another natural person, or (ii) if processing relates to data which are manifestly made public by the data subject. In addition, suitable measures for non-discrimination must be taken in cases of processing of personal data concerning health.

There is a principal set forth in the Bulgarian Constitution that tracking of any individual requires his/her consent. Bulgarian Electronic Communications Act (“ECA”) ensures the confidentiality of communications by prohibiting any taping, recording, storage or other kinds of interception or surveillance of communications and the related traffic data by persons other than users, without the consent of the users concerned. 

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 manufacturer is liable for the placing on the market and putting into service of the medical device. The manufacturer is liable in particular for the design, construction and manufacturing of the medical device (containing software) and is obliged to ensure the safe installation and maintenance of the medical device.

The physicians are obliged to carry out their activity in strict compliance with the medical standards of good clinical practice.

In case the patient has suffered damages due to the malfunctioning of the medical device, the manufacturer (producer) will be liable. If the damages are caused due to physician’s misuse of the medical device, then the physician will be liable for the damages. The allocation of liability depends on the facts.

Bulgarian Drug Agency exercises control over the medical devices. The administrative sanctions in the event of breach of the requirements for the medical devices are set out in the Medical Devices Act. As an example, the fine for placing on the market and/or putting into service of a medical device without conformity assessment in accordance with the requirements is in the range of approximately EUR 5,000 to EUR 10,000.

The Commission for Personal Data Protection (“CPDP”) is the supervisory body that implements the data protection provisions in Bulgaria.

A breach of the Electronic Communications Act (“ECA”) may qualify for cybercrime and may be subject to penal proceedings under the Bulgarian Penal Code (e.g., using software for obtaining information or copying computer data without the required permission could be qualified as cybercrime).

Currently there is no draft Law on amendment and supplement of the Medical Devices Act or other relevant legislation which governs this topic.

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 professional organisation of physicians in Bulgaria is the Bulgarian Medical Association (BMA). All physicians must be members of the BMA in order to practice medicine.

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

Physicians must carry out their activity in compliance with the medical standards of good clinical practice that are approved by ordinances of the Minister of Health. Such relevant ordinance is Ordinance No. 3 of 06.10.2017 for approval of the medical standard “Emergency Medicine”, based on the Medical Establishments Act (“Ordinance on Emergency Medicine”).

Ordinance No. 16 of 30.07.2014 on the terms and conditions for registration of rare diseases and on the expert centres and reference networks for rare diseases (“Ordinance on rare diseases”).  

Ordinance No. 4 of 04.03.2009 on the conditions and procedure for prescribing and dispensing of medicinal products.

Directive 2011/24/EU of the European Parliament and of March 9, 2011 for exercising patients' rights in cross-border healthcare.

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

There are no general provisions for applying telemedicine in Bulgaria. There are specific provisions that are included in the Ordinance on Emergency Medicine and in the Ordinance on rare diseases. As per the Ordinance on Emergency Medicine telemedicine may be offered in the context of emergency aid.

According to the Ordinance on rare diseases the expert centres for rare diseases maintain opportunities for cooperation with other centres and with reference networks at national and international level, including, if possible, for conducting telemedicine.

Following amendment of 2022 of Ordinance No. 4 of 04.03.2009 on the conditions and procedure for prescribing and dispensing of medicinal products, the physicians are entitled to prescribe medicine by electronic prescriptions through the website of the National Health Fund. However, there is still a requirement for physical presence for a medical examination.

A draft Law on the amendment and supplement of the Health Act which includes a new chapter “Telemedicine” and relevant requirements was proposed by members of the parliament but  was not adopted by the Bulgarian parliament.

10.1 What are the requirements?

There are still no general provisions on the requirements for telemedicine in Bulgaria.

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

As per Article 14c of the Ordinance on implementing the right of access to medical assistance (a new provision adopted in December 2020), in case of a declared state of emergency or a declared emergency epidemic situation due to the spread of a contagious disease under Art. 61, para. 1 of the Health Act, physicians may issue medical referrals to carry out medical-diagnostic tests to establish the infectious disease in a patient without performing an examination of the patient, but after conducting a telephone consultation to discuss his complaints and take an anamnesis. In these cases, the outpatient list issued by the physician must explicitly state that the physical examination was not carried out and the reasons for issuing the referral.

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

Currently, there are no general provisions regulating telemedicine.

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

N/A

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

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.

N/A

Currently there is no pending legislative procedure for amendment of the relevant legislation.