The regulations and measures related to electronic health were compiled by the Ministry of Health and its draft review was included in the agenda of the meeting of the digital economy working group of the Ministry of Communications and Information Technology
According to the Iran digital economy annotation, Reza Bagheri Asl, Deputy Chairman of the Digital Economy Steering Committee, said: The agenda of the digital economy working group meeting is the regulations and measures related to e-health, health operators and drug distribution system.
He added: Also, facilitating the processes by which companies enter the stock market and the requirements that devices have for investing in the digital economy are among the orders that we hope will be reviewed and approved by the digital economy working group.
Bagheri Assal emphasized that any matter that is finalized in the commission will be included in the agenda of the meeting of the digital economy working group. The special working group for digital economy is formed every once in a while and the steering committee for the country’s digital economy is formed continuously.
You can read parts of the draft text of the “Executive Regulations, Rules and Principles Governing Intelligent Operators in the Field of Electronic Health” which was compiled in order to develop online and intelligent services and to distribute more access and improve services:
Duties of the Digital Health Regulatory Working Group
– Compilation and notification of process standards in the system of providing health services and managing the flow of services based on the capabilities of information and communication technology
-Establishing the place of supervision, policymaking and supervision of the general governance and distancing from unnecessary business affairs in the electronic health sector (to be mentioned as a goal in the introduction)
– Guiding the maintenance and development of the electronic health record or the national health information database and the development of related inquiry services
– Guiding the establishment and development of governance infrastructure in the electronic health sector and creating stability and security for the production, exchange and storage of sensitive health data
– Providing suggestions on how to process health data, including information access management, analysis management, analysis and representation of health data to the Interactivity Working Group
-Setting online rules and online monitoring of operators and service providers and implementing information security rules
Facilitating the presence of the non-governmental sector and encouraging it to participate as much as possible in the treatment and health management affairs and monitoring the chain of services provided by the platforms.
– Support the development of integrated systems of health operations in the government sector in order to protect national interests and people’s rights and maintain healthy competition among e-health activists
– Approving technical and executive rules and requirements of public and private sector digital health systems
– Creating and completing the structure of the electronic health record
– Completing and updating and presenting on line the standards, rules and executive procedures, reference models of the country’s e-health sector and the national coding unit system in order to integrate the operations of different players in all application areas related to this sector.
– Communicating competition rules and not adopting discriminatory procedures in the activities of businesses active on the platform
– Communicating the rules for providing smart and electronic online services instead of physical services
Duties of the carver
-Creating a digital health platform in compliance with the rules of the health regulator to develop the market for providing online, stable and smart health services to the people
– Execution of documents related to process and data standards required for the implementation of e-health services and the development of related application software from the e-health regulatory body
– Establishing and guaranteeing the quality of providing electronic health services to people and businesses
– Helping to develop the country’s health infrastructure, helping to develop social welfare and health, and helping to have fair access to health-oriented facilities, services and products throughout the country.
-Implementation of the rules announced by the regulator with the aim of reducing violations in the health sector, creating transparency for patients and service centers
– Creation and use of electronic prescription infrastructure and production and exchange of health data to complete the electronic health record
-Providing smart chain services for the distribution of drugs and other health-oriented products to end users and helping to monitor online the service chain provided by platforms in the field of drugs and medical equipment.
-Sharing of hardware and software infrastructures to provide electronic health services by the non-governmental sector
– Complying with competition rules and not adopting discriminatory procedures in the activities of businesses active on the platform
-Monitoring and supervising the performance, digital health services and data exchange of all persons active in the platform, including the infrastructure systems of the following platforms in accordance with the instructions issued by the electronic health regulatory body
– Creating the necessary capabilities to manage electronic transactions, income and expenses of active persons on the platform in accordance with the rules announced by the regulator.
Specialized requirements
1- Authentication for citizens to enter the platforms is done only through authentication microservices of the national window of smart government services.
2- All services provided to natural persons in the employment layer and in the field of treatment must be done through interaction with the entitlement assessment system based on the country’s national health insurance database.
3- In order to ensure the stability and accessibility of electronic health services, before providing services, an agreement on the minimum acceptable level of services should be presented in accordance with the frameworks approved by the Regulatory Commission.
4- All the information of the patient’s health measures and treatment, which contains the data elements of the people’s electronic health record, must be sent online and in real time to the Ministry of Health, Medicine and Medical Education, and Carver and its platforms and systems are allowed to be stored and deposited, operated and Unauthorized exchange (outside the provisions of the National Data and Information Management Law) does not have this data.
5- Carver is obliged to provide its services through web browsers and mobile platforms in order to make it easier for people to use, and in accordance with user-friendly principles.
6- Each of the carvers are responsible and accountable for their electronic services, and in case of disruption or interruption of these services, they are responsible for paying fines and compensation according to the provisions of the agreement on the minimum acceptable level of services approved by the digital health regulator.
7- The carver is obliged to apply the coding system, standards and rules issued by the Ministry of Health, Treatment and Medical Education to provide its services and ensure that they are up-to-date.
8- In order to reduce the traffic load of information exchange in the executive bodies of the health sector, if there are governmental and inter-agency electronic services, these services should be provided through the country’s national information exchange center.
9- Respecting the privacy of health service recipients in the operational layer is mandatory for license holders of all types of electronic health services; In this regard, the identity information, the health and treatment measures taken, the health and illness status of the person, and the patient’s insurance information are exclusively in the possession of the owner of the file and only if the person gives his permission, with his permission and in compliance with the rules of secrecy, confidentiality and privacy. private, will be available to authorized persons or institutions.
10- Within the framework of compliance with the above, Carver is the intermediary provider of all health system services, to large and small businesses and helps innovators in this field as well; Obtaining certificates of continuity of activity of service delivery platforms to provide services in an intermediary form according to the official regulations and laws of the country and regulation of the health sector.
11- Carver cannot provide services directly where the type of data and service is not governmental and there is at least one online service provider in the non-governmental sector with a quality level approved by the regulator.
Note: In case of disagreement regarding the quality of the services, the decision will be made by the regulatory body in interaction with the Radio Communications Regulatory Commission.
12- Carver is obliged to share the information of the citizens’ health portal (health record display) which is created through the electronic health record data services by the Ministry of Health, Treatment and Medical Education in order to provide people with online access to their health information and enable them to take care of their health. View or manage from different views to create and update online.
13- Carver is obliged to control and supervise the platforms and service systems of its subcategories in terms of observing all the laws and regulations notified by the Ministry of Health, Treatment and Medical Education as a regulator of this field, including observing the data structure and standards and coding used and Compliance with the content-technical evaluation documents of the systems/services. The diagnosis and registration of this can be done through authorized laboratories under the Carver group and approved by the regulatory body.
Obligations of regulatory bodies
1- The Regulation Commission in cooperation with the Ministry of Health, Treatment and Medical Education, the Ministry of Communications and Information Technology and the Ministry of Labor Cooperation and Social Welfare are responsible for reviewing and issuing licenses for smart service providers in the country, regarding the services that the regulatory body provides for their services. There is, the commission is empowered to assign this task to a committee consisting of the regulatory body and interested organizations to issue a license in interaction with that body.
2- The regulatory body / bodies responsible or beneficiary of brokerage services are obliged to monitor the activity of the broker, and in case of violation of general / specialized / commercial and financial conditions, they are obliged to submit the documents of the relevant violations along with the proposed fine for consideration by the regulatory commission. provide
Obligations of the smart media service of electronic health services:
A- Legal obligations
1- In providing services, the operator is obliged to operate in accordance with the laws of the Islamic Republic of Iran and within the limits of the criteria set for e-health operators and in the specialized area of his license.
2- After obtaining the service license, the carver must start providing his services within a maximum period of 6 months, and in case of delay, he will be subject to a fine determined by the regulatory organization.
3- The carver does not have the right to stop his services during the period of the issued license, in which case he will be fined or license revoked according to the rules set by the regulatory organization.
4- Carver does not have the right to assign or outsource all or part of the services mentioned in his license to companies or parties outside the scope of his company or consortium without written permission from the Regulatory Organization / Information Technology Organization.
1- The final authority for approving the tariff for smart service providers is the Regulation Commission, which is based on the proposal of the data weighting factor of messages and corresponding services of these services by the Ministry of Health, Medical Education and the annual lump sum except for health information technology announced by this commission. and approves the tariff.
Terms of license issuance, cancellation and renewal
1- The Regulatory Commission as one of the regulatory executive bodies in coordination with the Ministry of Health, Medical Education, the Ministry of Communications and Information Technology, and the Ministry of Labor Cooperation and Social Welfare regarding the review of the issuance of a license to set up, establish and supervise smart brokers of electronic health services. , and the outsourcing of services is carried out in compliance with the law on the implementation of the general policies of the forty-fourth (44) of the Constitution approved in 2007.
2- The regulatory commission is obliged to complete and expand the application management system, license renewal and cancellation, register and update the information of license holders and smart brokers (operators) of electronic health services within three months from the date of notification of this approval.
3-P The licenses issued are valid for 10 years and brokers are allowed to operate based on that, and after that they need to be renewed in 10-year time periods, and in case the broker withdraws or the license holder is found to be ineligible by the issuing institution, according to The daily price of the equipment, systems and the value of the license can be assigned to the new qualified applicant.
Observance of principles, protection of privacy, crimes
1- Whenever it is determined that part of the information declared by the applicant’s carver is not correct or the conditions are incorrect, the regulatory commission can, after receiving the opinion of the license supervisor, while mentioning the examples of fines or revocation of the license and introducing the violator to the authorities in accordance with the approvals of the regulatory commission take legal action
2- Whenever it is determined that the carver has deviated from the conditions mentioned in the license, the supervisor of the license can take a fine or revoke the license and refer the violator to the judicial authorities by citing the examples.
3- The licensee is obliged to solve the possible problems in establishing the service of the users in the least possible time. In the event of a dispute between the licensee and the users and applicants, or if any of the parties do not fulfill their obligations, in the first stage, the two parties will resolve the dispute through negotiation, and if the agreement is not reached, the regulatory commission/organization will take action. and works according to the condition announced in the license conditions.
4- The use of users’ information after obtaining permission is only limited to the services of Carver’s field of activity and in accordance with the provisions of this regulation, and Carver is responsible for any possible leakage or misuse of this information, and for this purpose, the necessary security approvals must be obtained. obtain from the Information Technology Organization (AFTA certificates) regarding the way of providing services and infrastructure systems.
Competition principles:
1- The possibility of receiving services by recipients and service providers, in an optional form, and the possibility of changing the receipt of services between different providers is considered as the most important condition and principle of competitiveness between smart electronic health service providers and must be observed.
2- In case there are not many brokers in a department or exclusive provision of some services by one broker (as determined by the regulatory commission), the regulatory organization is obliged to monitor the principles and methods of providing services, the possible increase of tariffs and changes in the timing of receiving services.
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