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Table of Contents

• Introduction
• Flow Chart
• Written Explanation of Flow Chart
  1. Study Initiation
  2. Operational Execution (Phases I, II and III)
     • Phases I
     • Phases II
     • Phases III
  3. Data Management
  4. Monitoring
  5. Data Analysis
  6. Study Termination & Post-Marketing
  7. Surveillance and Approval
• Bibliography

Introduction

This study discusses various aspects associated with the clinical flow chart for medical apparatus & Electronic Medical Record development and approval process in Canada. Figure 1, 2 and 3 illlustrates about the overview of Canadaian national healthcare system to analyze and approve a prospective medical device and software based utility (Jamshidi et. al, 2014).

Flow Chart

Figure 1a – Clinical Flow Chart – Development and Approval of Electronic Medical Record Software for Canada’s Healthcare Industry (Shelton, 2018)

 

Figure 3 – Rules and Guidelines set by the Canadian Healthcare Agencies (Minister of Health, 2018)

 

Written Explanation of Flow Chart

The rapid development in digital technology contribute a lot to make it possible for the technologists to devise and make certain software based tools to assist the healthcare professionals in their practice. The Electronic Medical Record is one of the useful tool which can be installed on the handheld device of the practitioner in order to provide adequate Technology specific assistance in its practice. In 2006, 20% of the canadian practitioners in Medical Science and healthcare department who were using the electronic medical record based software applications. In 2013, 63% of the Canadian Healthcare practitioners are utilizing the electronic medical record software to streamline and optimize their medical practice (Figure 4). By looking at this trend of adaptability of electronic medical record software among the Healthcare practitioners in Canada, it can be a useful practice to developer clinical trial flowchart concerning the development and approval of our national electronic medical record software for Canada (Raymond et. al, 2015).

Figure 4 – Adapabability of EMR by the Canadian physician

1. Study Initiation

The first step to initiate the study is by conducting the research process for the development and approval of electronic medical record software prototype from the Canadian Healthcare authorities (Figure 1). Figure 3 specifically illustrates certain aspects for the approval of active therapeutic devices and software which can assist in the management of the healthcare based operations. The proposed National EMR software can be subjected to follow the rule number 9 and its subclasses at first place. The initial part of the development process associated with the electronic medical record software for Canada is to consider all the guidelines provided in pertaining to rule number 9 during the development of the software.

2. Operational Execution (Phases I, II and III)

Off today research and development phase concerning the development and approval process of electronic medical record software, the next step is to perform adequate operational execution of the software. This will involve three phases:

Phases I

In the first phase, the electronic medical record software can be developed and operated in the laboratory-specific healthcare oriented atmosphere. It is important for the developers of the software to integrate it with all the guidelines provided by the national Healthcare government agencies related regulation of medication specific devices and software. It is most important part of the development and approval process of the software as it will include the technical as well as the legal part satisfaction and adherence (Chang & Gupta, 2015).

Phases II

In the second phase, the electronic medical record can be integrated with a particular healthcare facility as per testing requirements. The necessary legal process and permission taking procedures from the concerned Healthcare authority can be performed by the development agency of the software. Application of the software in a real Healthcare facility can help the development team to check the effectiveness of the software pertaining to real-time healthcare specific operations’ management (Jamshidi et. al, 2014).

Phases III

In 3rd phase, the electronic medical record can be submitted to the concerned Healthcare administration agencies of Canada in order to review it and provide their feedback for any further modification. The feedback provided by the agency pertaining to Healthcare services from national level can be forwarded to the development team of the software to consider and integrate into the next version of the electronic medical record software (Raymond et. al, 2015).

3. Data Management

It is important for the concerned agency or entity which is trying to develop and get approval pertaining to the Electronic medical software from the Canadian Healthcare agencies to understand the nature and requirement of data flow related to the Healthcare industry in Canada. Once the software is approved from the Canadian Healthcare agencies and accreditation departments it is important for the developer agency of the electronic medical software to integrate the real-time data management properties in the electronic medical record software in order to make it feasible to use for the Healthcare practitioners and staff in Canada (Chang & Gupta, 2015).

4. Monitoring

It is also important for the development agency involved in the approval process of the electronic medical record software from the Canadian National agencies to monitor and evaluate the functioning of the electronic medical record software pertaining to the data flow of the Canadian national healthcare industry. The electronic medical record should not we crashed or encounter with any technical problem concerning the management of lodge for huge data set of the country (Shelton, 2018).

5. Data Analysis

The electronic medical record software developed to be used in Canada by the Healthcare practitioners must be standardized and it’s data needs to be analyzed for checking any potential errors. The standardization and data analysis of electronic medical record can help in streamlining and optimizing the use of electronic medical records software in the country for increasing the efficiency of medical practice and performance of Healthcare Practitioners (Raymond et. al, 2015).

6. Study Termination & Post-Marketing

Once electronic medical record software is developed in accordance with the rules set by the Canadian Healthcare authority’s and it can handle the real-time data set pertaining to be Canadian Healthcare agency it launched for use of the Canadian Healthcare practitioners. There are many options which can be adapted to market its use and the adequate business-oriented model developed in consultation with the Canadian Healthcare authorities to facilitate the people and community of Canada to the best (Chang & Gupta, 2015).

7. Surveillance and Approval

Once the electronic medical record software is launched successfully for use in real time by the Healthcare practitioners of Canada it to conduct post launch civilians based operations in order to improve the quality of the electronic medical record software. Once there are many recommendations or corrective measures needed pertaining to the development of a new version of the electronic medical records software, the development agency can seek approval from the Canadian health Care Agencies to develop the new version of the software which can address the latest challenges pertaining to the Canadian Healthcare industry (Jamshidi et. al, 2014).

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