"Murgova & Partners" in search of the working legal mechanisms for digital healthcare in Bulgaria -

January 25, 20220

Petya Murgova is a lawyer with 30 years of experience and founder of Murgova & Partners. The reason she started her own business more than 15 years ago was the desire to bring together a highly efficient team of professionals. Thus, she surrounded herself with experts for whom raising the prestige of the legal profession and upholding the rule of law is a mission. According to Murgova & Partners, the law is not just a written principle, and the goal of the law firm is to help more and more companies improve their legal security from the very beginning of their development through its excellent knowledge and understanding of business.

“Murgova & Partners has over 12 years in the healthcare industry serving hospitals and businesses providing medical and consulting services in the areas of medicine, pharmacy, clinical trials and healthcare management. Driven by the desire to support the efficiency of the healthcare sector, Murgova & Partners is joining as a member of the Digital Health and Innovation Cluster Bulgaria (DHI Cluster Bulgaria) in 2019. The leading reason for the law firm to become part of the Bulgarian digital ecosystem is the opportunity to contribute to the digital transformation of healthcare, the dynamic technological innovations and the accompanying changes in the regulatory framework of the sector. This makes the firm an important player in the process of digitalization of healthcare in Bulgaria.

In 2020 Petya Murgova was awarded by the prestigious international legal publication The Legal 500 as a leading expert in the healthcare and pharmaceutical sector in Bulgaria. Her law firm was ranked at the top of the same ranking for another year in recognition of excellence in 5 areas. These also included construction and real estate, litigation, negotiation and out-of-court dispute resolution, commercial and corporate law.

Adv. Murgova, what are the problems in the healthcare sector that prevent the digitalization of the sector?

Healthcare is an area I have been following for years in terms of both my professional commitments and my personal interests. It is an area where the lack of a comprehensive strategy affects all our lives with particular intensity. A change in the status quo is needed, as the law is now beholden to and lagging behind technological progress.

In order to do this the only possibility is by introducing a holistic approach. The aim is to place the patient at the centre of this ecosystem and to view them through the prism of their humanity – emotions, energy and physical body. There is also a need to focus on its contemporary needs – easier access to healthcare services, prevention, diagnosis, personalised treatment, protection of sensitive data.

Therefore, with the introduction of an appropriate regulatory framework for digital solutions in the healthcare sector, all processes will be enabled to develop while the available solutions e will begin to function effectively and harmoniously.

The main case studies and challenges facing the new government in the healthcare sector in our view relate to:

  • Removing fragmented solutions in the sector, especially those related to digitalization / eHealth /
  • The lack of a comprehensive vision for healthcare
  • Lack of an adequate and functioning regulatory framework
  • The need to update the legal framework in line with modern technical developments

What are the best practices for public-private sector coordination that we can borrow from other economies?

Internationally, there is active discussion around health ecosystems and the role of businesses that have invested tremendous time and resources in creating digital and other technological capabilities to support the solutions that the government sector wants to establish as meaningful and workable for society.

According to global studies, the ideal structure of such an ecosystem starts with telemedicine and reaches online pharmaceutical services. They take time to form in terms of synchronisation and adaptation of existing formulas, but once established, these systems achieve their most important goal – convenience, accessibility and, above all, increased value of medical care for the patient. In Bulgaria, these steps have not yet been taken, and the results of this delay reflect not only on the health and lives of citizens, but also on the credibility of the competent authorities and institutions with the authorisations currently on offer.

In summary, it is important to share that the lack of an overall strategic vision and cooperation with professionals in different sectors that would contribute to the rapid and effective implementation of these ambitious projects has led to numerous imperfections and gaps that have in practice created an impossibility for the practical application of the solutions created, respectively for the achievement of the main objectives they set.

What are the necessary steps to overcome the current problems in healthcare?

Insofar as the National Health Information System includes the electronic health records of citizens (as required by the European Data Protection Regulation 2016/679 and the Health Act), these data should be protected. The type of information contained therein and the manner, conditions and procedure for its provision should be determined by a Regulation of the Minister of Health.

Medical and healthcare institutions shall submit information to the Ministry of Health in accordance with the legal framework for the creation and maintenance of citizens’ electronic health records. The Regulation should lay down the conditions and procedure for keeping the registers, information databases and systems included in the National Health Information System. At present, no such Regulation has yet been adopted. Therefore, there is currently no legal regulation guaranteeing the protection of the population’s data, as well as the procedure for accessing, maintaining and storing the databases.

The creation of the above-mentioned Regulation is of utmost importance, because this concrete action would be an expression of the responsibility assumed by the competent public authorities regarding the protection and storage of so-called ‘sensitive data’, such as health data. Such steps relate to general societal values and are necessary to restore citizens’ confidence in the foundations of the rule of law.

The European Commission is discussing the creation of a European health data area. What would this mean for Bulgaria?

Building a European data space is one of the Commission’s priorities for the period 2019-2025, including in the health sector. In this sense, the functioning of a common European Health Data Space will ensure better exchange and access to different types of health data (electronic health records, genomic data, patient registry data, etc.) not only to support healthcare delivery (so-called primary data use) but also for health research and policy development purposes (so-called secondary data use).

The whole data system will be built on transparent foundations that ensure full data protection of citizens and improve the portability of their health data as set out in Article 20 of the General Data Protection Regulation (GDPR).

The Commission, in cooperation with Member States, has started the preparatory work and the development of the European Health Data Space. Member States will be supported by a new “Joint Action on the European Health Data Space”, designed to help them and the Commission facilitate the exchange of health data for public health, treatment, research and innovation purposes in Europe.

The European Health Data Space will be built on 3 main pillars:

  • Robust data management system and data exchange rules
  • Data quality
  • Robust infrastructure and interoperability

Advances in science and modern technology enable treatment and aftercare for all patients with efficiency, speed and precision unmatched by that which only conventional methods can provide. It is for this reason that the EU institutions, particularly in the context of the adopted European Cancer Plan, also point to the need to introduce affordable innovative methods in the healthcare sector. Timely but thorough legislative action in this area is an urgent step that should be taken, with joint efforts and cooperation between the competent authorities, lawyers with a high level of expertise in the healthcare sector and digital companies in the sector, which will ensure the possibility of a better and healthier future for the population.

The biggest challenge we will face will be finding the balance between digitalisation and the old order. The technical feasibility of the system, the synchronisation between the different registers and how to legally stimulate the actual use of digital solutions (e-prescription, e-prescription, e-prescription booklet, etc.) should be examined very carefully. In addition, it is very important to consider and secure how this system will create the conditions for the development of digital solutions in the sector and stimulate businesses to develop high added value products and create innovation at regional level.

The transition to digitalisation is not only imperative, it is overdue. It must be smooth and unidirectional. I believe that digital healthcare has a future in Bulgaria, and the steps taken so far, and in these particularly short terms, have shown that our country is adaptable and can quickly catch up with other European countries. The delay could also prove positive for Bulgaria. It gives us the opportunity to learn from the mistakes of other countries and to benefit from the experience already available in the field.

The pandemic has forced us, in a short time, to go the long way towards digitalisation and virtualisation in areas that we have not even imagined so far. This is why I believe that digital healthcare is the next step towards which our efforts must be united. In its completed form, the NHIS will be of enormous benefit in speeding up healthcare processes and thus increasing their efficiency.

Is Bulgaria ready for such a transformation?

Such a legal framework would also encourage patients to monitor and control the information available on their health status. This would have an impact in preventing attempts at abuse, improving and refining implemented solutions.

In view of these circumstances the team of Murgova & Partners, in collaboration with the Digital Health and Innovation Cluster Bulgaria (DHI Cluster Bulgaria), referred to the competent institutions the currently existing gap in the regulatory framework and stated its readiness to participate with its expertise in the creation of a legal framework.

As a matter of urgency, the possibility of extending the ways citizens access NHIS, who can currently do that only with certified electronic signature, should also be discussed.

The joint efforts and declared will for real change should also be technically backed, which inevitably requires the support of the digital companies operating in the sector. Some of them have ready-made digital solutions that currently enjoy overwhelming support from other European countries. Thanks to the vast experience gained, in Bulgaria they would lead to a quick and cost-effective implementation of the proposals in the sector. The realisation of such a cooperation in terms of both the digital solutions implemented so far and their optimisation, as well as for the new modules to be upgraded would greatly support the entire ecosystem. I believe that the result of such a collaboration would be significant and visible for the whole society.

In addition to being an invariable companion in the implementation of modern healthcare solutions, innovation and digital technologies raise the question of deriving our own stable legal framework and introducing the concept of “telemedicine” into national legislation as an option for the provision of medical services at a distance. The need to take timely action to update and amend the legal framework at national level to reflect the state of the art in technology is also becoming increasingly apparent in the context of the pandemic caused by Covid-19. If we claim that our main priority is to protect and improve the quality of life of patients and their families, it is important to provide a real opportunity for facilitated access to healthcare, prevention and accompanying care, including from a distance, through modern means of communication and data processing. We are now two years into a pandemic that has limited access to a large volume of services. Since people’s health is a fundamental and most precious asset, healthcare should not be limited by this impossibility, but made even more accessible. Unfortunately, however, we are not seeing a change in this direction, as several countries in the European Union have done, in order to contain the virus on the one hand and, on the other, to cover the need for timely access to medical care and consultation.

The ultimate goal we must focus on is improving the quality of service for the patient and increasing patient satisfaction. This inevitably goes through a digital transformation of the sector – medical professionals to be supported by technology, the state to have predictability and control over all mechanisms, and patients to be placed at the centre of the system and made an active participant in the management of their health. And this should be the primary concern of the whole society!


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