E-Prescription and Digitalizing Health Care Law Firm in Bosnia and Herzegovina

1. Introduction

Before examining the regulation of e-prescriptions within the healthcare system in Bosnia and Herzegovina (“BiH”), it is important to mention that the legal and administrative structure of BiH is extremely complex, which directly impacts the legislation and policies regulating and supervising the healthcare sector in the country. Namely, BiH consists of two separate and distinct administrative entities, i.e., the Federation of Bosnia and Herzegovina (“FBiH”) and Republika Srpska (“RS”), as well as Brčko District (“BD”) as a separate administrative unit. In addition, the entity of FBiH consists of ten (10) cantons and each has its own governmental structure as well as legislation, regulations and policies. Due to this situation, healthcare is regulated at multiple levels and is subject to legislative provisions adopted at the level of BiH, entities level, i.e., FBiH and RS, level of BD, as well as cantonal level in FBiH (application of which depends where healthcare is provided).  

2. Key-features of the BiH E-Prescription

Federation of Bosnia and Herzegovina

E-prescriptions in FBiH are regulated mainly by the FBiH Law on Health Records from 2012. According to Art. 6 of the FbiH Law on Health Records, medical records need to be stored in a written and electronic form for reporting and supervision purposes. In other words, each prescription must be made both in electronic and in written (printed) form. 

Some efforts have been made to change the aforesaid provision to reflect the overall objective to digitalize the healthcare sector in Bosnia and Herzegovina. For example, according to the Draft Law on Health Records from 2021, records need to be stored in a written or electronic form. The proposed amendment to Art. 6 and the introduction of an „or“ option was intended to give healthcare professionals the option to enter data in either of the two ways, i.e. in writing or electronically, and thus positively impact the digitalization process while simplifying prescription issuance and use. The choice option, according to the drafters, was intended to represent gradual transition from printed/written to electronic prescriptions. However, the proposal was assessed as premature, bearing in mind that the basic conditions for the application of the electronic system had not been met. Even though FBiH still does not have unified legal regulations covering e-prescriptions, in some cantons in FBiH, digitalization projects supporting the use of e-prescriptions are underway. 

Sarajevo Canton, for example, started a project of digitalization by introducing the Integral Information System of Institute for Health Insurance of Sarajevo Canton. The pilot-project aimed to digitalize the issuance of prescriptions was introduced in 2015. E-prescriptions could therefore  be used in any pharmacy which has a contractual relationship with the Institute of Health Insurance of Sarajevo Canton. 

Tuzla Canton was the second and the last to introduce an e-prescription system in August 2022. Like the one introduced earlier in the Sarajevo Canton, it aims to cover all health insurance users in the Tuzla Canton. Other cantons' healthcare systems are still mostly operating on the basis of written prescriptions.

Republika Srpska

Unlike FBiH, regulation of e-prescriptions in RS is significantly better. Regulation of electronic documents, including electronic prescriptions came into force in 2022, with the amendment to the RS Law on Health Documentation and Records in the Field of Healthcare. The amendment included the option of choice between issuing and using electronic and written healthcare forms, which, among other things, include prescriptions. E-prescriptions have been in official use since April 2022 and were introduced as part of the "Integrated health information system” project. E-prescriptions can be used in pharmacies that are in a contractual relationship with the RS Health Insurance Fund. According to recent information (January 2023), a total of 4 million e-prescriptions have been issued in RS to date.

3. Addressing Risks Linked to E-Prescriptions

The e-prescription system is not yet a rule in the entire BiH healthcare system and key risks and limitations of its potential use could be recognized. One of the main obstacles lies in an undefined (and inconsistent) legal framework regulating electronic documents and signature.  Even though the basic legal framework exists at state level, i.e., the Law on Electronic Signature and the Law on Electronic Legal and Business Transactions, the required (implementing) secondary legislation is missing. 

Additionally, regulations between entities concerning e-signatures are not harmonized, which prevents inter-entity recognition of electronically signed documents. Also, application of the e-signature regulations implies the establishment of appropriate hardware and software solutions that ensure the protection of signatures and the documents on which they are used. 

An additional consideration to take into account is protection of personal data, which is governed under the state level Law on Protection of Personal Data; however it is argued that this piece of legislation should be amended to specifically address the sensitivity of health-related data found in documents such as e-prescriptions. Therefore, the adoption of further specific regulations covering storage and special measures of technical protection of personal data can be expected to ensure a safe e-prescription system.

4. Status Review

Considering the above, although some progress has been made, the e-prescription system is not yet fully integrated into the healthcare framework in BiH. The initiative exists, but important prerequisites are still missing which should be resolved in the upcoming period. Republika Srpska and Sarajevo and Tuzla Cantons, where the system of e-prescriptions is already in use represent positive examples in the proposition of implementing these systems, although the legislative framework is subject of further improvements and amendments.