Establishment and Utilization of Electronic Health Records in Iran: A Review of the Policy Documents of the Past Four Decades

1. Background

It is difficult to manage health systems based on traditional and paper-based processes. Due to the development of technology, electronic systems have come to the aid of health systems. Thus, many advantages have been created for service recipients, such as transparency, reduction of unnecessary services, reduced medical errors, and helping health research (1, 2).

According to the definition provided by Iran's Ministry of Health and Medical Education (MoHME), the electronic health record is the collection of information related to citizens' health events from before birth (from the fetal period and in vitro fertilization) to after death (autopsy, burial place, etc.), which is continuously stored electronically over time. This information is exclusively possessed by the owner of the file and will be given to authorized persons only with the owner's permission and in compliance with the rules of confidentiality and privacy. This file will also be a platform for providing various managed electronic health services (3).

According to the roadmap of the MoHME regarding electronic health, there are three key goals: (1) connecting all health service providers to the health information exchange center; (2) launching the electronic health record for citizens to access their health records; and (3) deploying the electronic health service on the platform of electronic health records (3). For the realization of the first goal, it is necessary to have about 172,000 centers, including hospitals, clinics, laboratories, pharmacies, offices, emergency rooms, blood transfusion centers, and food and medicine centers in various governmental and nongovernmental sectors. Besides, health insurance organizations, health centers, health and treatment departments of the MoHME, and the medical system organization should be connected to each other. The second goal is to develop the electronic health record, whose components are the electronic record, information exchange portal, information systems of centers, the Sepas, SIAM, and Maxa systems, and an electronic file viewer. The third goal, which involves launching electronic health services for citizens based on the electronic health record, aims to use the files through the systems and provide services based on the files, process electronic documents, prescription and hard copies, eligibility assessment, and elimination of overlaps and referrals.

Over the past two decades, various laws regarding the establishment of electronic health records and the provision of health services via a platform have been approved in Iran. However, the extent of their enforcement is uncertain. Although Iranian health authorities have announced that the electronic health infrastructure is ready (3), our observation show that we are far from the complete and flawless enforcement of the provisions of the laws.

2. Objectives

We set out the current study to present a picture of the tasks set for the main institutions and stakeholders in the establishment and implementation of electronic health records in Iran and to examine the fulfillment of these tasks based on the documents.

3. Methods

The present qualitative study involved document analysis. All the documents, laws, policies of establishment, and uses of electronic health records in Iran were examined. The process and steps of the documentary research method include choosing the topic, determining the research goals and questions, performing exploratory investigations, collecting and selecting the documents, analyzing the documents, and presenting a report (4). Therefore, the research population comprised all the reports made by the MoHME and other institutions and the approved high-level documents, including laws, policies, programs, and relevant national guidelines. We continued sampling of the documents related to the selected subject purposively with maximum variation until we did not find any other relevant document. All the documents were studied until the end of March 2022.

We used a data extraction form to collect and extract the data to create a logical routine, unify the received information, and prevent the loss of relevant data. Moreover, we eliminated the possible shortcomings of the data extraction form based on experts' opinions and guidance. The form designed for data collection included the title, type, and general characteristics of the document, time and place of publication, related organizations, and items related to the content of the document. Since not all sources have the same scientific and content value, we selected high-quality sources according to the four criteria introduced by Scott (i.e., originality, credibility, visibility, and meaningfulness) (4). We ensured the authenticity of the author(s) of the documents by receiving the documents from reliable sources. By means of the visibility criterion, we determined that the document was representative of the data it introduced. The comprehensibility and transparency of the documents were checked with the criterion of significance. Based on the validity criteria, we checked the absence of errors and deviations in the documents (4). Meanwhile, we used descriptive analysis to analyze the data (5).

4. Results

The tasks related to the establishment of electronic health records have been approved over time and through different laws. Therefore, currently, some of the provisions contained in the fourth and fifth development plans or the notes approved in the annual budget laws of the past years have expired. Some of these tasks have been approved in the law of the sixth development plan. In addition, there are direct and indirect provisions in this regard within the high-level documents. Besides the emphasis on the use of advanced human sciences and techniques and efforts to advance them, the history of electronic health in the laws approved by the Islamic Council dates back to the law of the fourth development plan. Therefore, we think that this issue has been clearly included in Iranian laws since 2003. Of course, the use of technology in providing governmental services is generally mentioned in the laws of the previous development plans and other high-level documents. Table 1 lists the main provisions related to the establishment of electronic health records contained in the high-level documents and laws.

The findings showed an increase of about 2.5 times in electronic health record approvals since 2016. Although the approvals in this area have a history of more than 4 decades, the electronic health project was selected as a high-priority project. Regarding the law enforcement status, despite the passage of a relatively long period (about 17 years) since the approval of the legal decrees related to electronic health (e-health), the enforcement has not been in accordance with the assigned tasks and has not been approved by the supervisors. Table 2 presents the law enforcement status based on the documents.

According to the documents, 56% of the laws have been enforced; on the other hand, the execution of 22% of the orders was not in accordance with the assigned tasks, and 22% of the orders were ambiguous in their implementation or were incompletely executed. Furthermore, the review of the enforcement status of the approvals showed that the status of tasks since 2018 has ended with a positive result. According to all the provisions contained in the high-level laws and documents, as well as the annual budget laws mentioned in the previous section, there are various players in the field of electronic health records. Table 3 shows the players and stakeholders mentioned above, along with the summary of each role and the status of law enforcement.

5. Discussion

Based on the results of this study, in 2004, the concept of a comprehensive health information system was introduced to the legal literature of Iran. Besides, the concept of an electronic health record was introduced for the first time in 2007. Until 2022, this concept (the creation of a comprehensive and integrated health information system) was still included in the legal provisions and other approvals.

Until 2007, the rules and tasks related to the establishment of electronic health records were limited to infrastructures only. However, as mentioned in the documents, the information platforms, including the integrated portal for the exchange of health information, have not had the necessary stability to determine the main path of receiving and exchanging information; for example, other insurance systems are slow during peak service times, as also mentioned by other studies (7-9).

Funds related to the establishment and operation of the electronic health record were not properly allocated and were often spent on the costs of unrelated systems. Studies also emphasize that, compared to other countries, the situation and mechanism for financing the electronic health system in Iran is unclear, and the budget deficit is the most important factor (8, 10-12). Therefore, as the present study showed, financing of electronic health records has been specifically addressed by policymakers in annual budgets since 2016. Some of these issues are related to electronic health, and some are included in the annual budget laws to fulfill the provisions contained in the law of the sixth development plan, such as the enforcing the establishment of an online information database for the insured people, and the use of electronic tools instead of paper booklets that have been included in the budget laws since 2017. Some were approved to compensate for the backlogs of the assignments in the development plan laws, such as being obliged to establish the electronic health record in the sixth development plan due to its non-fulfillment in the fifth development plan, as well as the approval of the implementation of the electronic health record system in an integrated manner by the MoHME, which was not realized in previous years. Some notes have also been included in the budget laws to accelerate the actions and processes of e-health implementation; for example, the Supreme Council of Health Insurance was obliged to design an electronic prescription because, in 2019, basic treatment insurance organizations were required to accept only electronic prescriptions.

The results also revealed that since 2020, approvals related to the execution and operation of electronic health records were observed in the Iranian laws, but we still observed general and repeated approvals. Of course, actions in this regard have been accelerated in the last 2 years. Currently, additional measures have been taken (both by the legislature and the executive branch) to accelerate the work and compensate for the previous shortcomings and delays.

In addition to the approval of detailed laws, a positive step in this field has been the acceleration of the enforcement and approval of binding laws regarding the establishment and operation of electronic health records in the last 4 years. These approvals include the following: Extension and issuance of the license of centers should be subjected to sending the files to the electronic health record system; monitoring and supervision of pharmaceutical items and consumables are done only through electronic prescription; controlling and monitoring of the identity and authenticity of doctors and their electronic signatures, prohibition of purchasing services outside the electronic health cycle, and a lack of binding laws in Iran for the faster development of e-health are quite noticeable compared to other countries (8, 13, 14).

However, we are far from the desired outcome. A mandatory rule is the inability to connect most of the service centers with the exchange center in Iran. In fact, less than 30,000 centers are connected to the health information exchange centers, which is mentioned in the present research and other studies (15).

Refusal of doctors to register electronic prescriptions and nonfulfillment of doctors' digital signatures are other legal requirements that are still far from the desired level and need more legal requirements. However, the final implementation of this plan was given more serious attention due to the legal requirement from the beginning of December 2020; despite the request to stop it, even with the approval of the president, governmental hospitals and clinics also joined this project. Studies also confirm that the resistance of healthcare workers and their lack of understanding and awareness of the advantages of e-health, especially among doctors, are still the most serious obstacles to the widespread implementation of health information systems, especially electronic healthcare records (3, 16-18). In this regard, the findings of another research indicated that professional and social norms influence the acceptance of electronic health records by doctors (16, 19, 20). In addition, proper training and direct or indirect incentives can improve the participation of doctors (14, 18).

Based on the results of the present study, like other studies, the monitoring and supervision of pharmaceutical items and consumable equipment has been done only through electronic prescriptions since 2020, which clarifies and creates a suitable platform for gathering information for decision-making, supply chain monitoring, and management of drug and medical equipment shortages; meanwhile, the most important result is the elimination of corruption paths (21, 22).

One of the results of the review of the enforcement status was the electronic prescription coding problems. For example, each of the main basic insurance companies has set up its own systems to carry out their tasks separately; if it were to be extended to all 19 basic medical insurance funds in the country, it would create many problems. Besides the problems related to data collection and the lack of communication between systems, the approaches are also different; for instance, prescriptions for people in the Social Security Organization are based on the national code, but in the Iran Health Insurance Organization, a tracking code is assigned separately to each service (15).

The lack of optimal security of the electronic prescription systems is another result of the present study and other studies, which has been emphasized even in the current approvals under the general policies of social security organizations (22, 23). In fact, ethical-legal barriers are very important in electronic health, and the most important of them are security and privacy issues caused by the vast accessibility of electronic data (24-26).

Another finding of the current study in relation to enforcement status is the lack of reliable reports, poor quality of electronic health record systems, and the wide discrepancies in the statistics of patients' hospitalization records. Moreover, the laws related to the use of electronic health records from the sixth development plan in 2016 were introduced into the legal literature of Iran, with the legal provision of establishing a database on the line of medical insurance. Studies show that in countries such as Canada, England, and Australia, the private sector has participated along with the public sector in the design and creation of electronic health records and making appropriate investments in this field. In fact, to advance the related measures faster, various duties have been approved for some of the main players in recent years; moreover, various measures have been taken to execute the aforementioned legal duties that have not been fully implemented yet. In addition, studies indicate that multiple players and the lack of a comprehensive plan are among the problems of the establishment of electronic health records in Iran. The division of tasks and project execution stages are also crucial and can appear as obstacles or facilitators (18). In this regard, the experience of other countries indicates the gradual and phased implementation of electronic health (8). In other words, the lack of a plan and macro-architecture agreed upon by the players is one of the main reasons for the scattered, parallel, and isolated actions of the electronic health record project. Studies also highlight that the information technology infrastructure in Iran is vague and complex; as a result, the custodians, policymakers, implementers, and users of the country's information technology are not exactly known, and different institutions claim to be in charge of the country's information technology and approve the related documents separately (3, 8).

5.1. Limitations

This study was limited by the lack of similar studies on the establishment and utilization of electronic health records in Iran.

5.2. Conclusions

One of the findings of the current study was an increase of about 2.5 times in electronic health record approvals since 2016. Besides, although the approvals in this area have a history of more than 4 decades, the electronic health project was selected as a high-priority project only in 2017. Similar results were obtained regarding the enforcement status of the approvals. As the results showed, the actions since 2018 have ended with a positive outcome.

The findings revealed that although many efforts have been made to implement electronic health in Iran, the electronic health strategy is rather general and has not been fully implemented due to the lack of stability and the existing obstacles. Seriousness and follow-ups in the coming months will lead to full implementation, which in many ways is considered a success for the promotion of Iran's health system in the region and the world. The timely emphasis of the 2020 budget law and the President's emphasis on law enforcement have also been effective in the progress of this plan.

Note that electronic prescription writing and filing are only parts of the electronic health project, and by implementing them only, one cannot claim that the electronic health record project has been executed. The measures related to electronic prescriptions are also conducted in an isolated manner. Although the measures seem to respond to insurance processes despite the challenges, they need to be integrated with other electronic health components to serve the electronic health system. Given the role of different stakeholders in the execution of e-health and various considerations (e.g., training of role-players, culture-building in society, defense considerations, issues related to confidentiality and security of systems and information, and legal considerations), it is necessary to establish e-health based on a macro-architecture (trusted by the main players), including project execution stages and accurate distribution of the roles of each stakeholder to address the above-mentioned considerations.