Objective no. 1  consists in an evaluation study of the existing monitoring and recording methods of radiation doses cumulated by patients as a result of medical investigations by radiological andscintigraphic imaging methods. Focus will be placed on the following:

·         Elaboration of a detailed comparative study of the current medical practice in Romania versus the national legislation in this field.

·         Elaboration of a comparative study of the current medical practice in Romania versus the European medical practice and European regulations regarding safety of patients investigated by radiological imaging methods.

Thus, we focus on studying the patients  flow in radiation and scintigraphic investigation services in terms of how the ionized doses of radiation are recorded in the monitoring sheet. In this respect, a study evaluates the real number of patients that hand/present the monitoring sheet at the investigations and also the number of the new released sheets and the amount of information received from the doctors before the investigation. The research is undertaken within the X-ray, computer tomograpgy and scintigrafic services of the Central Military Hospital (SUUMC) as an open prospective study that will include the patients referred for investigations by the attending physicians. 

Considering the particularities of these results, we identify the differences between the real life medical practice and the “ideal” stipulated by legal regulatory authorities. A series of parameters are taken into account, such as: cumulative dose, radioprotection security, data protection, ease of use of the actual system etc, as well as their recognition by the international standards with direct impact on international interoperability.

Objective no. 2  focuses on the design and development of a system dedicated to record and manage the radiation doses cumulated by the patients in order to ensure the their radiological safety and security. Based on the results of the studies realized in the first phase of the project, the consortium :

· Identifies the requirements that have to be implemented by the proposed SRSPIRIM system. There are taken into consideration the needs of the patients, the needs of the national health system and, of course, the national and European legislation regarding prevention and radioprotection. Another important aspect taken into consideration is the flexibility and scalability of the system, in order to be able to easily extend the system with new features and integrate other domains of activity with risks to radiation exposure, like nuclear industry.

· Elaborates the technical project of the proposed SRSPIRIM system. The project must include all the hardware and software elements of the system including the architecture and the dependencies between the major parts of it, the role of the human interactions and such as laboratory personnel or patients. The technical projects also include the chosen security solution based on PKI infrastructure.

·         Elaborate the project technical specifications of the proposed SRSPIRIM system. In this way will be defined the system architecture and the operational workflows. The components and needed applications of the system will be also identified and designed. As we already described in the first part of the section, the proposed system needs a distributed data storage model containing medical centers specific databases, a central database and individual on-card information storage. Their structure and the technologies that we intend to use will be defined. The security mechanisms regarding protection of on-card data read/write access, application access and authentication roles are also addressed. Establishing the smartcard technology that will be used is also an important decision. We have to decide between a dedicated and close smartcard technology or using an open (likeJavacard or .NET) multiapplication technology. The multiapplication technology could be an option that allows the developed patient cards to be used later for other medical related applications extending in this way the proposed system.

Objective no. 3 is to develop and implement a pilot system containing all needed software components to be ready to use. The implementation of the pilot system is intended to prove the feasibility of such advanced solution in the current medical practice at hospital level (radiology and scintigraphy departments). The system implementation involves development of the:

·         back-office type central applications

· local medical center related off-card applications

·         on-card applications that will be loaded and used on the patient cards

·         all other needed components like security mechanisms, reporting tools, data replication and backup of the system.

The proposed system will include the following components:

·         Smart cards dedicated to patients: Citizen Radiation Safety Card – CRSC  and

·         Professional Radiation Safety Card – PRSC – intended to medical and investigation laboratories personnel.

·         Smart card readers in order to record and retrieve the information about the type of investigations and the specific emitted doses

·         A data base that will record all the necessary information in order to replicate a lost or destroyed card but also this database will provide the possibility of collecting data about the patients on several criteria, it will provide the possibility of  create standard or customized  reports.

· The security solutions such as PKI infrastructure in order to achieve a high level of security of recording and retrieving data 

The pilot system tests the hidden aspects medical practice in radiological imaging investigations including patient and laboratories personnel behavior and communication.

The pilot system reveals technical problems that can be diagnosed and solved in the future in a national or international system.

Objective no. 4  focus on the development of a prospective comparative study lasting one year, with the main purpose the head to head comparison of the cumulative doses expressed in mSv/year in patients monitored through classic means, through the monitoring data sheed versus the new SPRSPIRIM system. The study will include two categories of patients:

· The informed patients, that a specialized doctor will provide all the information regarding the exploration and the ionized radiation risks.

· The “uninformed” patients from the real-world medicine that request these services.

At the end of the study d a set of cross-comparative analysis will be developed among all the categories of patients included monitored through classic means ( through the monitoring sheet), or through the SRSPIRIM system. The gathered results are presented in workshops, scientific communications and/or International specialized publications.  

Objective no. 5 consists in a proposal of standardization in terms of the format of the data stored on cards, in view of interoperability at European level of the cards (we called them Citizen Radiation Safety Card in the idea that they will also be used in other activities with risk of radiation exposure) and eventual integration into the electronic health cards. Based on the obtained data, proposals will be made to modify the related legislation in force.

Objective no. 6 consists in obtaining a patent for the solution. The innovative nature of the project consists in the fact that the proposed centralized and distributed model for the management of radiation exposure to patients' history could prevent of unnecessary radiation exposure of the patients regardless of technological capabilities of the medical investigation centers. The proposed system could be a solution for unitary and cumulative treatment of every type of investigations with radiologic effects on the patients (radiology, computer tomography, scintigraphy).

The project will allow:

·         Highlighting the new problem of storing information about the radiation cumulative doses received by the patients during the increasing numbers of imagistic investigations

·         Finding the electronic recording solution of the emitted dose by the medical equipment and received by the patient in the radiological services during imagistic investigations, using smart cards. These cards can replace the current records based on paper and give the possibility of easily transform, cumulate, calculate and indicate the maximum safe dose. The cards is in fact a distributed database tracking each patient

·         The new idea of create a central database storing all the information about a patient history of radiological investigations. This central database that can replicate the cards and give the possibility to create standard or customized reports

·         proposing the usage of a security solution in data manipulation based on PKI infrastructure that ensures logical security regarding authentication, digital signature, confidentiality

·         Developing a comparative prospective study for head to head comparison of cumulate doses for classical monitorised patients  versus the new SRSPIRIM system

·         Developing comparative study of the current medical practice in Romania versus European medical practice and European regulations

Thus, it can be ascertained that this project meets a stringent necessity of the economic environment, in terms of both execution and use of secure application that can improve the storing and retrieving data about the history of a patient closely linked with human radioprotection, health and a better life. The new electronic system is a modern solution regarding the ecological and economic environment.

The project will help lifting the technological and operational barrier between current medical practice in Romania versus European medical practice and European regulations regarding the cumulative radiation dose of the patients investigated in radiological services. It also will improve the storing and retrieving the information about the patients and will keep the security of the personal data.

Expected impact

The project results consist in a pilot system used in SUUMC and three studies developed during the project.

A future national implementation of the project will have a major impact on the investigated patients but also on economic environment. The pilot system only announce these major changes:

a)     25% decrease of expenses for the health insurance system, according to statistics from countries implementing a similar system

b)    the improvement of eHealth services, and an increase of Government interest in such smart cards

c)     a simple administrative way to investigate and receive information on patients

d)    a simple way for repayment and refund of medical services;

e)     a cost reduction by implement a national wide system with smart cards and PKI

f)     integrated Health platforms and softwares in European Unit

g)    a easy tracking of patients across European Union

Electronic cards and electronic data storage are ways to use electronic media that reduce office paper waste with ecological impact of the environment.

The pilot system is a modern way designed to replace in the future the classical paper where there are written the doses of the imagistic investigation for each patient according to existing laws.

At national, European and international level, the project will be developed in several years. The benefits to patients can be quantified in future studies. The patient safe dose of radiation will be always monitored and no more diseases will be developed caused by overdoses. The costs of treatments and medicine are huge in such cases.

The economic impact can also be studied because the number of imagistic analyses will be tracked and maybe the doctors will think twice before asking a CT scan.

Large scale reports on CT scans and other X-rays investigations will be easily performed all over the world.

The social impact of the project is directly focused on citizen:

a)      It will allow the implementation of a lifesaving system, allowing a close monitoring of the potential health threatening effects of medical investigations

b)      Identifying the optimum technologies of interoperability among the European Union States

c)      Young students can be involved in project developing

d)     The system users will be convinced by the security of the information system with multiple resources

The social impact on patients will be huge. Every patient will be conscious of the importance of the cumulative doses. Each patient will carry information on its personal card, information replicated also in a central database.

If the system will be implemented all over the world, even the patients that are travelling in many countries will have their cumulative dose always accurate monitored.

The importance of a distributed database together with a global database is also huge. Searching information will be performed in a easy way and it doesn’t imply a large number of hired people.

Dissemination and/or exploitation of project results, and management of intellectual property rights

The dissemination of the project results will be realized within the academic environment, the public health systems and governmental agencies responsible with radiation prevention and protection like CNCAN. Each member of the project will disseminate the results among its peers and they will join their efforts in order to promote and lobby for the utilization of the result by the national public health system.

Articles will be published in ISI recognized publications and the results of the project will be presented at international conferences. The consortium is experienced to realize such dissemination activities, in 2011 CERTSIGN being invited to participate at 2 international conferences in order to present the results of its work in information security.

More specifically, the results achieved by the project will be disseminated by the following means:

· Web Site: The project will have a dedicated web site, which will comprise elements such as the project description, objectives of the project, partner profiles and expertise, regular information on the project’s progress and achievements.

· Academic courses: Research and academic members of UPB and SUUMC will disseminate project results in academic laboratories at universities, universitary hospitals and in other scientific seminars and tutorials.

• Participation in conferences: Partners of the SRSPIRIM project will target the following conferences for publishing and disseminating the project outcomes: International Conference or prestigious congresses such as European Congress of Radiology (ECR) and American Congress of Radiology. The consortium will allocate mobility funds and will pay fees for international conferences such as E-Health across Europe, Int. Conf. of The European Federation for Medical Informatics, Medinfo
• Papers in the scientific literature: Academic and research project partners will publish their work in related academic journals.
• Workshop: The project will consider organizing 4 workshops on the SRSPIRIM research topics for the international research community and potential interested parties (including health industry representatives and investors). In these workshops we will give an overview of the project, discuss solutions and future challenges, and present the SRSPIRIM results, challenges and the next steps to the medical and academic community.

These conferences and journals are focused on the research issues addressed in SRSPIRIM, therefore acceptance of papers implies originality of the work and enables fruitful discussions with a focused research community. Moreover, presenting SRSPIRIM at such venues guarantees a wide visibility ofthe project results.