National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by www.CaleaEuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the European opportunities for digitisation of the healthcare system in Romania, but also on the steps that our country needs to go through in the digital transition so that Romanian patients can benefit in the coming years from easy access to healthcare and telemedicine.

The main lessons learned by the European Union since the beginning of the pandemic and until now were discussed, as well as the need to accelerate the digital transition in the European Union’s health systems, but especially the importance for the Romanian authorities, regardless of political colour, to establish a unitary strategy for the digitisation of health, a strategy that coordinates the institutions in the field and is connected to European directives.

The digitisation of the Romanian health system must allow transparent access to reliable data which must be published in formats suitable for secondary use, for epidemiological or health policy analysis.

Topics of interest for Romania in the field of digitisation of health can be (non-exhaustive list): European Cancer Knowledge Database; European Cancer Imaging Initiative; Cancer Management Inequalities Registry in Member States; Connecting e-prescribing and electronic patient record systems between Member States; Connecting and exchanging information between reference centres for rare diseases; Participation in transnational registries in the field of chronic diseases; National/transnational remote medical consultations and second opinion in imaging or pathology; Evaluation of health apps for reimbursement, etc.

Develop a government project covering the key issues for digitisation in health, needed

Prof. Dr. Adrian Streinu-Cercel, President of the Health Committee of the Romanian Senate, calls for a government project covering the key aspects of digitisation in health: “To be an integrated system it has to start from one head, i.e. the Romanian Government. If we don’t decide what we want this digitisation to look like, it will be everyone with their own database, everyone with their own application.”

• We have the opportunity to do a very good job from the beginning and for that we all have to sit around the same table, regardless of political colours, and discuss how we want this national digitisation programme to look like and how to integrate with other countries, if we want that.

Romania needs to establish a National Contact Point to align our country with European directives

Ștefan Busnatu, advisor for digitisation to the Minister of Health, set up a digitisation strategy for the health system a year ago, which unfortunately has not been integrated into the NRDP.

• We need to establish a National Contact Point, which will deal with the whole digitisation component in order to be aligned with the Brussels directives and all the European reforms. The National Contact Point is a three million euro project, which theoretically has to be taken on by someone. At the moment the CNAS have sent the assumption from a coordination point of view. It is important to decide where it would be most coherent to create the National Contact Point in Romania for digitisation and digital transformation.

The time has come for telemedicine to offer patients a better quality of life, while giving doctors new tools

Adela Cojan, President of the National Health Insurance House, reviewed the latest national milestones for the digital transformation of Romania’s healthcare system. A Memorandum has been signed at governmental level for tripartite participation to access European funds for the development of the project “IT systems for connecting to the electronic health record the providers of paraclinical services, specialist outpatient, rehabilitation, home care, providers of clinical services, palliative, medical devices or emergency consultations at home”, being basically an extension of the electronic health record, which was initially designed only on family medicine and hospitals.

• The societal and economic benefits of the widespread use of telemedicine are practically enormous. At the moment we are far from being fully in the middle of their use, but I believe the time has come for telemedicine to offer patients a better quality of life, while giving doctors new tools. It is a challenge, there have been reservations, but now in the areas where we have introduced remote consultations they have been widely accepted, which is why we have also extended them in the regulations for next year.

Lack of interoperability of databases in the healthcare system, one of the critical issues

Adrian Hatos, Chairman of the Committee for Science, Innovation and Technology in the Romanian Senate, says that one of the critical problems facing the entire public system in Romania, not only the medical system, but also the administration and education, is the interoperability of databases or the interoperability of data in general in the medical system, which makes it impossible to access and use data: “We have the possibility of datafication, big data techniques and remote communication in education or medicine. The problem in Romania is primarily institutional and human rather than technical.”

• So far there have been public and European financial resources for digitisation. We need to look at the problem of working with so many database systems that cannot communicate with each other. We have the opportunity of RRF funding, but also the implementation of a governmental Cloud to force the creation or implementation of a data infrastructure that is unitary, standardised at national level, so that we can communicate in the various structures and take advantage of the opportunities that telemedicine offers.
• The digital transition must also include changing the attitude of doctors and patients towards technology.
• The Committee on Science, Innovation and Technology of the Romanian Senate can initiate legislation and support legislation in this area. It can initiate debates in the Senate on digitisation in health.

Patient registers, the most important thing today when it comes to digitising health

Felicia Ciulu Costinescu, Director, Medical Technologies Evaluation Directorate, National Agency for Medicines and Medical Devices of Romania (ANMDMR), says that digitisation of healthcare has become a necessity for facilitating the patient pathway in the healthcare system and has become more important in the context of the pandemic.

• ANMDMR experts are active and present in Brussels working groups of the European Medicines Agency (EMA) or the European Commission, including in task forces dedicated to digital transformation: “This concern comes from the need to provide EU patients with innovative solutions and emerging technologies. All this can only be achieved by transforming and optimising regulatory processes, improving centres of expertise, providing digital solutions and building an e-learning ecosystem. All of this requires investment over time, but the process has been started and will bring the benefits it was designed to deliver.
• The digitisation paradigm is a complex one. Patient registries are the most important thing at the moment when we talk about digitising health. The need for these registries is even greater as very high-cost personalised therapies are knocking at the door. These registries will be useful when we want to have access to some data. Interconnecting them with both national and existing European health platforms. The main aim is to develop a common dataset to support the reimbursement decision as well as to support technicians to have easy access to medical data.
• Digital technologies, intelligent data collection and integration are the present and the future for patient access to personalised, effective and safe treatments.

The leadership of the Romanian Digitisation Authority (ADR) gave details of the objectives of the RegInterMed project in its message to the expert meeting on 14 December. According to the ADR, in October the Ministry of Health put the specifications of the RegInterMed project out to public consultation.

• The project will implement 100 disease registers for 18 specialities. These will be established separately during the implementation period. In addition, 4 specific registers will be implemented for the INSP (Register “reporting biocidal substances”, Drinking water quality register (RECAP), National operational computerised register of occupational diseases, Register on the management of waste resulting from medical activity).
• It will have a working meeting on Wednesday 15 December with the new management delegated by the Ministry of Health for this project.

The European Commission is exploring the possibility of European patient registers, but the condition is that national registers exist in all EU countries

Cristian Bușoi MEP, Chair of the Industry and Research Committee of the European Parliament’s ITRE Committee, as the European Parliament’s rapporteur for the EU health programme, EU4Health, insisted that one of the priorities of this programme is digitisation in health at European level and the creation of the EU Health Data Space, which is an initiative of the European Commission that he supports.

• We also advocated that money from this programme should fund interoperability between different e-health systems at national level, such as electronic patient registers to be interconnected and prescription, which is an e-health solution found in most European countries and this needs to be interconnected.
• The European Commission is looking at the possibility of European patient registries, but the condition is that there should be national registries in all EU countries, at least for cancer and rare diseases where the number of patients is not so large, it would be easier to manage these patients. At European level, digitisation in health is an essential component. EU4Health can only give a general outline, just as the EU Health Data Space will create some rules for governance, for interoperability.
• Romania needs to prioritise these projects in order to be able to use European funding.

Romania has all the necessary tools to digitise its health system and to offer Romanian patients European and quality conditions in terms of health and telemedicine. It is essential that decision-makers and politicians have forward-looking projects adapted to European requirements so that Romanian patients can benefit from the opportunities of the digital transition.