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Developing an EMR System Implementation Plan (DRAFT) Acknowledgments
ACKNOWLEDGMENTS
The workshop organizers, CDC Zambia, and the President's Emergency Plan for AIDS Relief
(PEPFAR) Health Management Information Systems Technical Working Group would like to
thank all of the participants and cooperating partners who were involved in planning and
carrying out the Strategies for Building National-Scale Longitudinal Patient Monitoring Systems
for HIV Treatment and Care in PEPFAR Countries Workshop from October 2 to 5, 2007, in
Lusaka, Zambia. The workshop organizers would especially like to thank the Zambia Ministry of
Health and the National AIDS Council of Zambia for their support.
The knowledge and experience shared by the representatives from the 15 countries who
attended the workshoptogether with U.S Government in-country mission staff members,
PEPFAR implementing partners, host country government staff members, and experts from
industry, academia, and multilateral organizationshave helped to greatly improve this
document from the working draft that was provided to workshop participants and used in small
group discussions and exercises.
This document has benefited from previous work in the field of electronic medical record
systems, particularly the World Health Organization documents Electronic Health Records: A
Manual for Developing Countries and Developing Health Management Information Systems: A
Practical Guide for Developing Countries, and the Joint United Nations Programme onHIV/AIDS document, Guidelines on Protecting the Confidentiality and Security of HIV
Information: Proceedings From a Workshop. In addition, the authors would like to gratefully
acknowledge the workshop participants who generously shared protocols, reports, and tools
from the development, piloting, and rollout of the SmartCare system in Zambia, the National
Electronic Data System for Antiretroviral Therapy Monitoring and Evaluation in Malawi, and the
Botswana HIV/AIDS Response Information Management System District Informatics
Assessment.
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Developing an EMR System Implementation Plan (DRAFT) Table of Contents | i
TABLE OF CONTENTS
INTRODUCTION ............................................................................ 1
How to Use This Document ...................................................................... 1
DEVELOPING AN EMRSYSTEM IMPLEMENTATION PLAN:GUIDELINES ... 3
A. Budgeting and Governance .............................................................. 3
1.0 Budgeting ........................................................................................................ 31.1 Building or Buying a System ................................................................ 41.2 Open Source or Proprietary Software .................................................. 4
2.0 Policy and Governance ................................................................................... 52.1 Executive and Steering Committees .................................................... 62.2 Barriers to Success .............................................................................. 82.3 Type of Implementation: Full vs. Phased ............................................. 92.4 Stakeholder Analysis and Consultation ............................................... 92.5 Integration and Retention of Existing Data ........................................ 102.6 Coexistence of Paper and Electronic Record Systems ..................... 102.7 Establishment of Project Teams/Working Groups ............................. 11
B. Pre-Implementation: Analysis, Requirements/ Specification,Design, and Testing ......................................................................... 16
3.0 Existing Systems Assessment ....................................................................... 183.1 Inventory of Existing Health Information Systems ............................. 183.2 Determining the Maturity of the Data Management Process ............. 193.3 Data Standards .................................................................................. 213.4 Unique IDs ......................................................................................... 233.5 Documenting Health Data Policies .................................................... 23
4.0 Health Management Information System (HMIS) User Assessment ............. 244.1 Engaging Users ................................................................................. 244.2 Determining User Needs ................................................................... 244.3 Follow-Up Assessments of Users ...................................................... 24
5.0 Risk Assessment/Management Strategy ....................................................... 255.1 Safeguards ........................................................................................ 26
6.0 Infrastructure Assessment ............................................................................. 286.1 Software Requirements ..................................................................... 29
7.0 Confidentiality and Security ........................................................................... 308.0 Requirements/Use of Data Assessment ........................................................ 33
8.1 Reporting on EMR System Implementation ....................................... 338.2 Other Data Use Requirements .......................................................... 35
9.0 Data Entry ...................................................................................................... 35
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TABLE OF CONTENTS (CONT.)
10.0 Design ........................................................................................................... 36
10.1 Database Design ............................................................................... 3610.2 Interface Design ................................................................................. 3610.3 Functional Design .............................................................................. 37
11.0 Testing ........................................................................................................... 3811.1 Systems Testing ................................................................................ 3811.2 Test Scripts ........................................................................................ 3911.3 End-to-End System Testing ............................................................... 4011.4 User Acceptance Testing ................................................................... 4011.5 Data Requirements ............................................................................ 40
C. Implementation ................................................................................ 41
12.0 Roll-Out and Scale-Up ................................................................................... 41
12.1 Roll-Out and Scale-Up Timeframes ................................................... 4112.2 Site Selection ..................................................................................... 4212.3 Assessing Site Readiness ................................................................. 4312.4 Operations Analysis ........................................................................... 4312.5 Baseline Assessment ........................................................................ 4512.6 Training .............................................................................................. 4512.7 Security and Confidentiality ............................................................... 4812.8 Backlog Data Entry ............................................................................ 4912.9 Post Implementation Review ............................................................. 4912.10 Maintenance and Support .................................................................. 50
13.0 Monitoring and Evaluation (M&E) .................................................................. 5113.1 M&E of EMR System Implementation ............................................... 51
13.2 The Role of EMR Systems in National M&E ...................................... 60
APPENDICES
Appendix AGlossaryAppendix BBibliography of EMR System ImplementationAppendix CDeveloping an EMR System Implementation Plan: Template
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DEVELOPING AN EMRSYSTEM IMPLEMENTATION
PLAN:GUIDELINES
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Developing an EMR System Implementation Plan (DRAFT) Guidelines | 1
INTRODUCTION
The Strategies for Building National-Scale Longitudinal Patient Monitoring Systems for HIV
Treatment and Care in PEPFAR Countries Workshop was held October 25, 2007 in Lusaka,Zambia. The purpose of the workshop was to enable participants to learn from each other, from
country case studies, and from academic and industry experts about best practices in developing
strategies for building national-scale, longitudinal, and patient-level patient monitoring systems for
HIV treatment and care in the President's Emergency Plan for AIDS Relief (PEPFAR) countries. A
working draft of this document was provided to workshop participants and used in small group
discussions and exercises. The draft served to guide discussions and to provide a framework that
participants could use to develop and document electronic medical record (EMR) system
implementation strategies tailored to suit their particular countrys circumstances and technical
infrastructure.
How to Use This Document
The purpose of this document is to guide the reader through the process of developing an EMR
system implementation plan. A template is provided in Appendix C that will allow readers to begin
developing an EMR implementation plan for their own country or program. This document is not
intended to be a set of definitive rules applicable in every situation, as each country or program
will have different needs and requirements, but a resource to help ensure that key activities and
issues are considered and addressed before proceeding with the task of developing andimplementing an EMR system. This document is intended to be used in conjunction with the
hyperlinked Bibliography of EMR System Implementation (Appendix B) which was also initially
developed for the Lusaka workshop, with the presentations from the workshop and other
reference materials, all of which are posted to the Lusaka workshop Web site
(http://globalhivevaluation.org/zambia-epms2007.aspx) and, where relevant, hyperlinked to this
document. The content and links to additional resources will be valuable to reference during all
stages of EMR system planning and implementation.
NOTE: Throughout this document, the bullet () is used to indicate a relevant document orpresentation that readers may find useful in preparing their own EMR implementation plans. If you
are using this document in an electronic form, a hyperlink is provided that will allow you to
download the materials. If you are using this document as a hard copy, the Web address where
you can find the materials is also provided. If you have any difficulty in accessing the links
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provided, please go to the Lusaka workshop Web site (http://globalhivevaluation.org/zambia-
epms2007.aspx) where you will be able to find the materials.
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DEVELOPING AN EMRSYSTEM IMPLEMENTATION PLAN:
GUIDELINES
A. Budgeting and Governance
1.0 Budget ing
Implementation of EMR systems is a complex and challenging task. One obstacle to successful
implementation can be the cost of converting to an electronic system when insufficient health care
funding has been budgeted. It is essential that stakeholders and personnel involved in planning
for EMR implementation understand what funding is available and develop a timeframe for
funding in conjunction with timetables for implementation.
The high cost of computers and computer systems means that the initial costs associated with the
introduction of an EMR are significant, both in terms of time and finance. However, the ongoing
costs of running an EMR as well as longer-term issues of maintenance and support are significant
as well. As discussed below in the Maintenance and
Support Section (Section 12.10), once an EMR system
has been implemented, both the hardware and the
software will undergo changes after delivery in order to
fix bugs, add new functionality, port the software to new
platforms, or adapt the software to new technologies.
Although it may seem that the system will be finished
after delivery, this is far from true. Maintaining and
enhancing software to cope with newly discovered
problems or new requirements can take more time than
the initial development of the software, and so must be budgeted for accordingly.
Table 1 lists some of the costs that should be considered when budgeting for EMR system
implementation. Note that many costs (whether for hardware, software, training, etc.) may have to
be budgeted for the national level as well as for district, regional, and facility levels.
Recommendations
Ensure adequate funding isavailable to provide systemsoftware, hardwareinfrastructure, and
implementation resources.
Ensure that a financialmanagement plan is in place toincorporate initial costs, ongoingneeds, and long-termmaintenance and support.
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Table 1: Costs to Consider in EMR System Implementation
Initial Costs Hardware
Software (development, debugging, testing, etc.)
Training
Consultants
Pilot testing
Ongoing Costs Enhancements
Coordination/collaboration with other sectors (integration of HIV/antiretroviral
therapy [ART] EMR systems with non-HIV Health Information Systems, with
financial data, etc.)
Technical assistance
Outward migration/training of replacement staff members
Evaluations
Maintenance
and Support
Costs
Equipment maintenance: Care of equipment (computers, touch screens,
keyboards, card readers, etc.)
Corrective maintenance: Fixing bugs in code Adaptive maintenance: Adapting the software to new environments
Perfective maintenance: Updating the software according to changes in user
requirements
Preventive maintenance: Updating documentation and making the software more
maintainable.
1.1 Building or Buying a System
It is not always necessary for countries or institutions to develop their own EMR systems. If
possible, an estimate should be obtained as to the possible cost of conversion from a manual
system that incorporates different options, including having a system designed specifically for a
country or purchasing a system already developed and implemented elsewhere. These options
have different costs, advantages, and disadvantages associated with them which should be
considered when making decisions. Ideally, a thorough cost-benefit analysis should be conducted
to compare the options and the costs of proposed systems against the perceived benefits, so as
to determine the value of the systems to an institution/government.
1.2 Open Source or Proprietary Software
Countries and institutions will also have to decide whether to budget for the purchase ofproprietary software or to use open source software. There are advantages and disadvantages to
each option. It should be noted that open source software is not truly free as it will still be
necessary to budget for programmers, training, adaptation, upgrades, etc. In some cases where
human and technical capacity are limited, there can be reasons to use proprietary software that
come with access to support. If countries do decide to use proprietary software, it is advisable to
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seek outside advice from experts to review contracts before signing, in order to ensure that the
contract will provide all the services that are needed. It is important to note that open source and
proprietary systems can be used in the same health system, as long as they are mutually
compatible. This issue is discussed further in Section 3.3.
Further Reading
Issues relating to the use of open source software for an EMR system were discussed in the
presentation Integrated System for HIV/AIDS and TB Data Management in South Africa
(http://www.globalhivevaluation.org/meetings/zambia2007/PresentationMaterials.aspx?id=1_1440
_1530).
2.0 Pol icy and Governan ce
The responsibility for all stages of the development, implementation, and maintenance of an EMR
system must be agreed upon in advance. All major partners and stakeholders should be in
agreement as to who will assume responsibility for funding and carrying out tasks, and who will
have the authority to make decisions if differences of opinion should arise. Establishing roles and
responsibilities is an important part of planning for EMR implementation, and can be carried out in
conjunction with the process for identifying and engaging stakeholders. Some important elements
of preparation for an EMR system implementation which should be agreed on by all stakeholders
include the following:
Who will be responsible for managing and carrying out the EMR implementation process?
Are resources, a budget, and authority available to carry out these tasks?
Who will take part in the executive and steering committees and working groups (i.e.,
composition and areas of expertise)? (See Section 2.1)
It is equally important to determine whether existing policies will support the development of a
new EMR system. Policies relating to medical record practice should be reviewed to identify areas
which will require updating to cover electronic medical records. Consider the following:
Does the country have a record retention policy? If so, is it being applied? Will it require
revision?
Does the country have a policy on the release of information from personal health records?
Does it need revision?
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What is the policy on patient access to their health care information? If there is no policy, is it
envisaged that patients will have access to their health information in the future?
If policies need to be developed or changed, who has the authority to make and enforce these
changes?
Does the government system facilitate the process for acquiring needed technologies?
Example
An analysis of health information systems (HIS) implemented in Tanzania and Mozambique
concluded that one of the key reasons that the systems were ultimately unsustainable was, in
both cases, the unbalanced relationship between the Ministry of Health and donors. Additionally,
weak institutional and technical capacity within the ministries, along with contracts that gave them
insufficient control over consultants, also contributed to unsustainable systems. These examples
highlight the importance of governance in EMR implementation.
Analyzing the Problem of Unsustainable Health Information Systems in Less Developed
Economies: Case Studies From Tanzania and Mozambique, by Kimaro and Nhampossa
(http://media.shs.net/globalaids/pdf/Article%202g%20-
%20Kimaro_Analyzing%20the%20Problem%20of%20Unsustainable%20HIS.pdf).
2.1 Executive and Steering Committees
It is suggested that an executive committee charged with
introducing the EMR be formed. The purpose of the
committee is to provide high-level oversight and provide a
conduit between the project team, government health
officials, and other stakeholders. The executive
committee will be comprised of a champion or visionary
for the initiative, sponsors, and other stakeholders. The
executive committee should be supported by a steering
committee that will be responsible for undertaking the planning and development of the proposedEMR system. This committee should consist of members of the administration, health information
management staff members, potential users from the medical and nursing services,
representatives from financial and information technology (IT) services, and any other individuals
identified as important to include. The steering committee should seek to ensure that there is early
input from medical and nursing
Recommendations
Establish an executivecommittee to oversee thedevelopment of the EMRsystem.
Establish a steering committeeto coordinate the implementationof the EMR system.
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staff members, and other key personnel within the institution. This involvement will help garner
support from the anticipated users of the system who need to be involved from the onset of
discussions.
The degree of formality of the executive and the steering committee will depend on the size of theEMR system being implemented. For example, if a system is only being implemented at a single
facility, a steering committee may not be necessary. For implementing a national system, a more
formal committee structure may be preferable.
Once the extent to which automation may be achieved has been determined, the executive and
steering committees need to develop outcome goals for the EMR system that will encompass the
perceived benefits and meet the needs of both users and consumers. They should be clearly
stated, realistic, and achievable.
If the executive or steering committee members feel that they do not have an adequate technical
background to make decisions, they should consider employing a consultant. The consultant
should have a strong background in health information management, health informatics, and EMR
implementation in the developing world. HMIS experts at the Centers for Disease Control and
Sample Outcome Goals for an EMR System
Ensure that all health care data is comprehensive, timely, accurate, and readilyavailable at all times for patient care
Improve communication between health care providers at both data entry level anddata retrieval level
Provide better access to an individuals health care information and improve healthcare delivery by sharing their data between attending practitioners
Enable individuals to access their personal health information
Provide timely and accurate information for medico-legal purposes
Provide timely and accurate information for the collection of morbidity and mortalitystatistics, for clinical research, and teaching
Support the administration in their policy decision-making and public health reporting
Provide a better link between primary care centers, between primary care andsecondary care (hospitals), and between hospitals
Source: World Health Organization (2006). Electronic Health RecordsManual for Developing
Countries.
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Prevention (CDC) and the U.S. Agency for International Development (USAID) can help the
executive committee identify appropriate consultants.
Some of the action items that the committee(s) will need to discuss include:
Project driverbusiness-related forces. For example, the purpose of a system is a project
driver, as are all of the stakeholders, each for different reasons.
Project constraintsidentify how the eventual system must integrate into a countrys IT
environment. For example, the system might have to interface with or use some existing
hardware, software, or business practice, or it might have to fit within a defined budget or due
date.
Functional requirementsthe fundamental subject matter of the system. These can be
measured by concrete means like data values, decision-making logic, and algorithms.
Non-functional requirementsthe behavioral properties that the specified functions must
have, such as performance, usability, etc. Non-functional requirements can be assigned a
specific measurement.
Mechanisms for managing project issuesthe conditions under which implementation of a
national-scale EMR system will be conducted.
2.2 Barriers to Success
An initial assessment will identify barriers that might hinder successful implementation. Forexample, countries may have no existing health information systems or infrastructure that can be
leveraged. Staff members with limited or no computer skills may be resistant to changes
introduced by an EMR system. Even if an initial assessment finds that the technical environment
will support an EMR system, resistance to its adoption by doctors and caregivers could prove a
major hurdle. Identified barriers should be documented and strategies to breach these barriers
and/or address resistance should be developed. Identified barriers will also inform the risk
assessment task described later in this document (Section 5.0).
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2.3 Type of Implementation: Full vs. Phased
It is recommended that countries opt for a phased
implementation rather than a big bang approach of
attempting to implement a national system throughout an
entire country all at once. A big bang approach would
likely be overwhelming to the health system and would
allow very little latitude to react to unforeseen challenges
that may be encountered. A phased approach would limit any complications of implementing a
new system to just the institution(s) participating in a given phase. An evaluation of each phase
will allow lessons learned to be applied to subsequent phases. As the implementation proceeds,
the plan will be continually fine tuned to inform the later stages of the implementation plan.
2.4 Stakeholder Analysis and ConsultationBecause the success of the EMR system depends upon access to records and data collected in
multiple clinics throughout the country, a high level of cooperation and buy-in are required from
multiple institutions and from stakeholders. The introduction of an EMR system is most successful
when stakeholders are involved in all phases of development and implementation. Stakeholders
can be included in the process through an initial consensus-building meeting to identify the priority
needs regarding the EMR system, through the establishment of a regularly meeting taskforce, and
through ad hoc consultation.
A rigorous multidisciplinary process involving a range of
stakeholders is required to select the most appropriate EMR
system. Regular meetings of stakeholders should be scheduled
in order to secure and maintain buy-in and support for the EMR
implementation. Negotiations may include discussion of different
stakeholders needs that the EMR will attempt to satisfy and the
value of satisfying those needs.
In summary, an essential requirement for the successful
implementation of an EMR system is the cooperation and
commitment of all stakeholders, including administration, medical and nursing staff members,
other health care professionals, and computer and clerical staff members.
Recommendation
Countries should adopt a phased
implementation approach andevaluate each phase beforeadvancing to the next phase ofimplementation.
Stakeholder
A stakeholder is any personor organization who has avested interest in theresponse to the HIV/AIDSepidemic, the roll-out of ARTand EMR systems, themonitoring of patients thatare initiating ART, thedirection of the study, and
the use of data.
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2.5 Integration and Retention of Existing Data
It is extremely important to make plans for how data from the existing system will be integrated
and retained in the new EMR system. Consider the following:
Will all old records be entered into the electronic record when the patient arrives for care afterthe new system is introduced?
Will old records be entered, kept in a secondary storage device, and brought into the new
system when needed?
Will summary information about a patient, rather than old records, be entered into the EMR
when the patient accesses care for the first time after the new system is in place?
Will old records that have been entered remain in manual storage for a prescribed time before
being destroyed?
Each option for integrating and retaining past data involves different levels of resources that must
be budgeted and planned for.
2.6 Coexistence of Paper and Electronic Record Systems
An EMR is not a simple replacement of the paper record. In almost every case, there will be a
long, perhaps indefinite, period of time when paper and electronic medical records will coexist. In
many systems, patient monitoring data will eventually be entered, analyzed, and transmitted
electronically. Systems vary as to when the paper to electronic transition occurs. It may occurduring initial ART scale-up, with an evolution toward earlier electronic entry over time. There may
also be differences between what can be done routinely at all sites and supported as a national
system, and what can be supported at facilities with special funding or research projects.
EMR systems are currently being developed to interface with paper-based systems at different
levels of data collection and analysis. Regardless of the data collection method, it is important that
the definitions of essential data elements be standardized so that each system, whether paper or
electronic, reports these data in a uniform way. Definitions of many data elements will already
exist (e.g., UNGASS indicators)1. There are also data definitions of national-level indicators in
countries M&E plans (e.g., PEPFAR indicators). Countries are encouraged to integrate the
1The UNGASS document, Monitoring the Declaration of Commitment on HIV/AIDS Guidelines on
Construction of Core Indicators [July 2005], contains detailed specifications of global indicators for nationalHIV/AIDS programs, the information required to measure them, and guidance on their interpretation(http://data.unaids.org/publications/irc-pub06/jc1126-constrcoreindic-ungass_en.pdf).
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existing data definitions into their EMR systems. These indicators are designed to help countries
assess the current state of their national response while simultaneously contributing to a better
understanding of the global response to the HIV/AIDS pandemic. The use of shared indicator
definitions, data, and reports in a nonconnected environment helps provide a more unified
monitoring system in the absence of a high level of connectivity. Staff members involved in the
design and implementation of EMR systems should interact with their national M&E team
counterparts throughout the process of designing and rolling out the EMR system. This is
discussed further in Section 13.2.
Table 2 shows the range of ways a paper-based system can link with district-level electronic
reporting, from a minimal system of electronic entry of reports by the district or regional
coordinator to a fully electronic system using an EMR.
Table 2. Paper-Based and Electronic Patient Monitoring Systems
System Type PatientCard orRecord
Register(s) QuarterlyCross-Sectional
and CohortReports
District orRegional
Coordinatorand Up
Paper-based system withelectronic entry of reports
Paper Paper Paper Paperelectronic
Paper-based systemwith electronic entry of registers
Paper Paperelectronic
Electronic Electronic
Electronic medical record (EMR)
with electronic entry of paperrecords
Paper
electronic
Electronic or
may beprinted fromelectronicdatabase
Electronic Electronic
EMR with direct electronic entrywithout paper when managingpatients
Electronic Electronic orN/A
Electronic Electronic
Source: WHO - Patient Monitoring Guidelines for HIV Care and Antiretroviral Therapy (ART)(http://www.who.int/3by5/capacity/ptmonguidelinesfinalv1.PDF)
2.7 Establishment of Project Teams/Working Groups
Given the scope of implementing national-scale EMR
systems, it is important to designate teams with
responsibility for discrete facets of the project, including
time parameters and resources needed. If countries have
not already done so, they are encouraged to establish a national EMR working group comprised
of representatives of all major stakeholders in the National AIDS Program (NAP). Analyses should
Recommendation
Establish a national EMR workinggroup.
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be carried out to identify all major stakeholders and their needs and roles in EMR system
implementation. The national EMR working group may include:
All members of the NAP who are assigned responsibility for EMR system development and
coordination
Ministry of Health (MOH) technical staff members responsible for disease surveillance,
reporting, and HMIS oversight
Technical staff members who have access to population demographic and life expectancy
data
Leaders of all major nongovernmental organizations and faith-based organizations that
operate HIV/AIDS programs and/or services
Researchers from universities and research groups involved in (or who will become involvedin) various special studies and targeted evaluations
Major donors that support the NAP
People living with HIV/AIDS
Representatives of UN agencies (Joint United Nations Programme on HIV/AIDS [UNAIDS],
the World Health Organization [WHO], United Nations Childrens Fund [UNICEF])
Consultants working with NAP, as appropriate
Further Reading
The composition and role of a national EMR working group, the Electronic Data System Task
Force in Malawi, was described in the presentation, Overview of the Development, Piloting, and
Evaluation of a National Electronic Data System for ART M&E in Malawi
(http://www.globalhivevaluation.org/meetings/zambia2007/PresentationMaterials.aspx?id=1_1630_1710).
Other working groups might include:
Information Security Group
The steering committee should appoint a team to deal with medico-legal aspects, including
privacy and confidentiality issues. This group should develop and maintain a medico-legal
checklist, incorporating government regulations, to guide the implementation and ongoing use of
the EMR. Measures should be taken to ensure appropriate security and storage of information to
prevent improper disclosure.
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Education and Training Group
A training team needs to be in place to develop education and training programs. As previously
discussed, onsite training must be planned and budgeted for in order to develop a group of
competent users who are confident in their knowledge of the proposed system and ready to
accept the change. The steering committee may identify the need to have more trainers than staff
members onsite during early preparation for the introduction of an EMR system.
The education and training group should:
Prepare a training program with clearly stated learning objectives. The program should aim at
not only educating staff members in using the new system, but also ensuring that the value of
the EMR system in health care delivery is understood.
Start training sessions with a training of trainers program to enable the development of atraining workforce.
Present the programs clearly and enthusiastically and enable hands-on experience.
Encourage members of the health services to commit to reviewing work practices and
endorse the changes required to implement the EMR system for maximum efficiency gains.
Prepare staff members to participate in defining the new work practices and developing
policies and guidelines to promote user-ownership and increase compliance.
Quality Assurance Group
A quality assurance coordinator and team should be established to ensure that the data collected
and processed are accurate, reliable, and organized in such a way that they are both readily
understood and available when needed by health care providers. To ensure that documentation
meets the required standards, quality assessments must be undertaken beforehand and
continued on an ongoing basis. Poor data quality is a major hindrance to planning and making
decisions and is an important concern for health care institutions and governments, regardless of
how data are recorded and processed.
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More groups may be required. The steering committee, in conjunction with the implementation
coordinator and team, should identify any additional areas needing special attention, including:
Design and development
System testing Pilot testing
Implementation
Monitoring and evaluation
Team leaders are responsible for coordinating the activities of their respective teams with those of
the other project teams. Team leaders report activity and progress to the steering committee who
in turn report to the executive committee.
Figure 1. Sample Structure of an EMR Oversight Team
EMR Executive Committee
Provide high-level oversight and bridge the
project team with government health officials
Steering Committee
Coordinate the planning and
development of the EMR system
National EMR Working Group
Insert function of the national
EMR working group
Information
Security Group
Quality
Assurance Group
Education and
Training Group
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Individual Roles
Individuals will have different roles within the different working groups depending on their position.
Some suggested roles for key members of the working groups are presented in Table 3.
Table 3. Suggested Roles and Responsibilities for Members of the EMR Working Groups
Individual/ Position Suggested Roles and Responsibilities
MOH Representat ive Serves on the national EMR working group
Plans and arranges system-provider visits
Prepares and disseminates requests for proposals
Develops evaluation criteria for selecting provider and system
Chooses provider and system
Provides input on budget and high-level needs
Provides input on desired schedules and standards development, length
of pilot project, etc.Chief of Party or
Designee
Serves on an EMR working group
Provides input on budget and high-level needs
Program Manager Serves on an EMR working group
Provides input on high-level and detailed requirements
Project Manager Serves on an EMR working group
Leads project team
Establishes and manages project plan
Ensures that development or customization of EMR is on time and within
budget
IT Projec t Lead May serve on project team
Provides detailed requirement input
Establishes installation plan (software project plan)
Ensures that development or customization of software meets high-level
and detailed requirements
Ensures that corrections and changes are made
IT Implementer Builds or adapts software to meet requirements
Provides training to customers/users
IT Staff Serve as end users of EMR system
Representatives may serve on project team
May test EMR before release
Attend training in order to use EMR efficiently
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B. Pre-Implementation: Analysis, Requirements/
Specification, Design, and Testing
As has been noted, implementing a national-scale EMR system is a complex undertaking. To
ensure that stakeholder and user needs are addressed, a structured approach that provides aframework within which several critical phases can be completed is needed.
This framework is commonly referred to as a Software Development Life Cycle (SDLC). Adhering
to a formal SDLC is the best approach for creating an EMR system that meets requirements from
the outset and within project budget and schedule. Figure 2 illustrates a typical SDLC.
Critical Phases of an SDLC
Analysis of existing capacity Development of detailed functional and technical requirements
Design of a solution that addresses requirements
Development of the designed solution
Testing
Implementation
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Figure 2: Typical Software Development Life Cycle
The following sections provide more detail on the various stages of implementation, from initial
assessments, to the analysis phase, and to implementation of the system.
Further Reading
A Modified Capability Framework for Improving Software Production Processes in Jamaican
Organisations by Chevers and Duggan
(http://media.shs.net/globalaids/pdf/Article%2015a%20-
%20Chevers_A%20Modified%20Capability%20Framework.pdf)
A Simple and Low-Cost Internet-Based Teleconsultation System that Could Effectively Solve
the Health Care Access Problems in Underserved Areas of Developing Countries by Kuntalp
and Akar. (http://media.shs.net/globalaids/pdf/Article%2015b%20-
%20Kuntalp_Simple%20Low-Cost%20System.pdf)
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3.0 Exist ing Systems Assessm ent
3.1 Inventory of Existing Health Information Systems
Existing medical record system(s) should be reviewed to assess the quality of current records andmedical record services, to identify problems, and to prepare a formal report summarizing results.
The first step in developing an inventory of existing systems is to gather system information from
regions and districts within a country that describes their current technical capacity. This can be
achieved through the distribution of a standardized questionnaire that asks system managers at
medical facilities to document each system used to manage patient data.
Table 4. Suggested Data Points for Assessment Questionnaires
System Overview Type of software (EMR, Data Management)
Whether the system can be easily modified
Whether the system uses free, open source software
Single user, local area network (LAN), and wide area network (WAN) systems
Scope of ClinicalServices
Prevention of mother-to-child transmission (PMTCT)
ART
Tuberculosis (TB)
General clinical care
ART disease management (guidelines, patient advice)
Reporting/OutputCapability
Patient-level reporting
Clinic-level reporting Custom reporting
Exportable data/standard format
Links to external systems
Hardware andSoftwareRequirements
Client computer requirements (e.g., 500 megahertz [MHz] processor or higher,
1 gigabyte [GB] of random access memory [RAM], 1.5 GB of available hard
drive space for software installation)
Server computer requirements (e.g., Pentium III 700 MHz central processing
unit [CPU] or equivalent, 1 GB RAM, network adapter)
Operating system
Database
HR Requirements Country-level development, support, maintenance
Security andQuality Checks
Security level (e.g., minimal or none, password, or multilevel access control)
Data validation level (e.g., minimal or none, some field level, or extensive [rules
based])
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The questionnaire ensures that the same data are collected from each facility in a standard
fashion. Data reported on questionnaires should be stored electronically in a simple database to
facilitate analysis of results and report writing. Data collected will be used to develop an
understanding of current systems, including areas of strong and weak technology capacity,
systems common to multiple facilities, systems unique to an individual facility, and systems that
exchange data. The analysis will help identify potential pilot sites during the later implementation
phase. It might also identify systems that offer the potential to serve as the foundation for a
national-scale patient monitoring system.
Further Reading
The Botswana HIV/AIDS Response Information Management System (BHRIMS) District
Informatics Assessment describes instruments used to assess IT capacity and IT use and a
report on national IT capacity in Botswana. (Section 6, items A-F,http://globalhivevaluation.org/meetings/zambia2007/Bibliography.aspx)
The presentation, Zambia Case Study: SmartCare Implementation, discusses results of an
assessment of health information systems in Zambia.
(http://media.shs.net/globalaids/ppt/DJM%2035127-
01%20Zambia%20Workshop%20Presentation%20Template%20DJM.ppt)
An additional resource that may be useful is the ART Software Inventory which can be found
at the Routine Health Information Network Web site. (http://www.rhinonet.org).
3.2 Determining the Maturity of the Data Management Process
One of the first steps in developing a project strategy is to conduct an initial assessment to
determine the state of readiness to implement an EMR system. Countries should, at a minimum,
do the following:
Take inventory of existing health information systems
Determine the maturity of data management processes
Document data standards
Review the technical competence of staff members expected to use EMR system; this will
provide input into the development of training strategies and the selection of sites to
participate in the EMR system roll out
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Evaluate the strength of the technical infrastructure, its coverage, and so forth
Evaluate facilities within the health enterprise to determine whether they are physically
capable of supporting an EMR system.
Key Questions to Ask When Reviewing Existing Medical Record Systems
Are medical records currently kept on all
patientsinpatients, outpatients, and accident
and emergency (A&E) patients?
What type of medical record is kept?
How is information released for medical or legal
purposes?
Are there problems with duplicate medical
records?
Is the medical record system centralized using a
unit numbering system? Are all admissions,
outpatient notes, and A&E records filed under one
number in a single medical record?
If the patients medical record cannot be
found, and the patient has visited the hospital
previously, do staff members prepare a new
or duplicate medical record? How are patients identified?
Do all persons have a national identificationnumber?
Is this used to uniquely identify the patient? If a national identification number is not issued,
what information is used to identify eachpatient?
How are medical records filed?
Are medical records filed by the medicalrecord/hospital number?
What system of filing is used?
Are medical records well documented?
What is the quality of the medical records? Is allessential information recorded? Are all entriessigned and dated?
Are quality checks performed on current paper-based or electronic records? If so, have anydocumentation problems been identified?
Are medical records returned to the medical
record department upon discharge of the
patient?
If they are returned promptly, have theybeen completed or are they usuallyincomplete and without a dischargesummary?
How do staff members handle incompletemedical records?
Are daily admissions and discharge lists
produced?
Are inpatient morbidity statistics collected and
compiled by medical record staff members?
Are they responsible for the submission ofmonthly returns and the annual report ofhospital activity? What about outpatient
statistics?Are there any problems with the collection of
morbidity statistics and are they completedwithin the anticipated time?
When the medical record has been completed
by the doctor, do medical record staff
members code the main condition using a
classification system such as International
Classification of Diseases (ICD)-10?
Are procedures coded?Are coders trained in coding using ICD-10?Are the codes currently indexed to enable
the retrieval of medical records for research,health statistics, and epidemiologicalstudies?
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3.3 Data Standards
Countries should document any data standards that are employed by medical facilities at national,
regional, and district levels. Data standards are agreed-upon rules that govern the way that
patient information is electronically stored and exchanged. They allow data to be exchanged
among different information systems, and they ensure that the data have consistent meaning from
system to system. In addition to creating consistent ways to classify data (e.g., using ICD-10 for
diagnostic codes and Logical Observation Identifiers Names and Codes [LOINC] for coding lab
results), messaging standards that define consistent ways to send data back and forth between
organizations are also critical. The most widely used messaging standard in public health and
health care is Health Level 7 (HL7).
Some standards will be internationally recognized like HL7 or International Classification of
Diseases (ICD). Others will be developed locally and will be considered a standard at individualfacilities. Understanding what data standards are in use will help create database models for a
national-scale EMR system that leverages existing designs, complies with standards, and
contains the linkages that will allow for the seamless transfer of data between systems at different
levels. This interoperability between health systems will be a key contributing factor to the
success of a national-scale EMR system.
Interoperability requires the creation, acceptance, and
implementation of clinical data standards to ensure that data in
one system are available and meaningful in another system.
Interoperability depends upon two important concepts: syntax
and semantics. Syntax refers to the structure of a
communicationthe equivalent to the rules for spelling and
grammar. Data exchange (or messaging) standards, such as
HL7, are examples. Semantics convey the meaning of the
communicationthe equivalent of a dictionary or thesaurus. Terminologies such as Systematized
Nomenclature of Human and Veterinary Medicine (SNOMED) and LOINC, and document
standards such as HL7 Clinical Document Architecture are examples of semantic standards.
Without semantic interoperability, data can be exchanged but there is no assurance that they can
be used or understood by the receiving system.
Standards have been created by a variety of health care organizations. Typically, the
development of a standard involves technical committees that define methods and groups
Sample InternationallyRecognized Data Standards
ICD-10
LOINC
HL7
ICD
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organized around communities of interest. Setting health standards is typically a voluntary effort
and the success of a standard depends on the developing organizations credibility and ability to
gain acceptance in the industry. The standard is accredited or given a seal of approval by an
external source. Two such accrediting organizations are the American National Standards
Institute and the International Organization for Standardization.2
Further Reading
The presentation, Overview of the Development, Piloting, and Evaluation of a National
Electronic Data System for ART M&E in Malawi, provides an example of how a country has
developed and implemented two different EMR systems against national specifications for
electronic data systems, and has developed national data transfer standards (HL7) to ensure
interoperability of data. As a result, the ART M&E EMR systems can serve as a platform upon
which other electronic medical information systems can be built (e.g., TB, PMTCT).(http://globalhivevaluation.org/meetings/zambia2007/PresentationMaterials.aspx?id=1_1630_
1710)
ART Messaging: Transfer and Report of Patient Health Record Implementation Standard
Document Using HL7/XML Message with HL7 Version 2.5
(http://media.shs.net/globalaids/doc/Article%204b%20-%20Malawi_ART_HL7_v1.3_Doc.doc)
Standardization of Health Information Systems in South AfricaThe Challenge of Local
Sustainability by Jacucci, Shaw and Braa.
(http://media.shs.net/globalaids/pdf/Article%202c%20-
%20Jacucci_Standardization%20of%20HIS%20in%20South%20Africa.pdf
Developing Health Information Systems In Developing CountriesThe Flexible Standards
Strategy by Braa, et al. (http://media.shs.net/globalaids/pdf/Article%2019a%20-
%20Braa_Developing%20HIS%20in%20Developing%20Countries.pdf)
2For more information please see the document in the Annotated Bibliography of EMR Implementation: Clinical Data Standards in
Health Care: Five Case Studies by K. Kim (http://www.globalhivevaluation.org/meetings/zambia2007/Bibliography.aspx).
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3.4 Unique IDs
Countries should document patient identifiers that are
employed at national, regional, district, and facility levels.
One of the major difficulties in creating a comprehensive
longitudinal patient health record (electronic or paper)
system in many countries is that health care information
may be collected at separate locations, different times,
and for different purposes and, as a result, health records usually are fragmented records at
multiple locations. The way to overcome this problem is through the development and use of
unique identifications (UIs). Some countries may have national identification systems in place that
will facilitate the process of assigning UIs. Once a UI system has been put in place, it can be
difficult to connect fragmented health records and prevent the assignment of multiple UIs to one
person. When this occurs, a process of record deduplication and reconciliation must take place to
address the problem.
Further Reading
Presentation, An Overview of Patient Matching
(http://globalhivevaluation.org/meetings/zambia2007/PresentationMaterials.aspx?id=1_1110_
1150)
Presentation, Unique Patient Identifiers
(http://globalhivevaluation.org/meetings/zambia2007/PresentationMaterials.aspx?id=1_1150_
1220)
3.5 Documenting Health Data Policies
Existing policies relating to medical record practice should be reviewed to identify areas which will
require updating to cover EMRs. Questions that should be revisited include those relating to
policies for record retention, for release of information, for patient access to health care
information, and in determining who has the authority to make and enforce policy changes that
were discussed under Policy and Governance (Section 2.0).
Recommendation
Develop a unique patient
identification system that can beapplied at national, regional,district, and facility level.
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4.0 Heal th Management Info rmat ion System (HMIS) User As sessm ent
4.1 Engaging Users
There are several benefits to involving individuals who will be
the ultimate users of a system during the SDLC. Their
understanding of the work that the system is designed to
support is important to the overall design, but it is the less
tangible aspects of their engagement in the process that can
have most value. For example, users involved in the design
and testing phases are more likely to be open to the introduction of a new system to complete
their work. They will develop a sense of ownership in the system and, through use of the system
during testing phases, develop a familiarity with the system before implementation. Some of these
users might even become trainers who can be part of the implementation phase.
4.2 Determining User Needs
The success of a system can depend upon the appropriate level of user involvement during the
various phases of the SDLC. When developing an understanding of a process being automated
and gathering requirements, it is important that systems architects speak to all stakeholders, not
just high-level supervisors. Perhaps the most important stakeholders are the individuals who will
use a system to complete the day-to-day functions of their jobs. These users will be responsible
for using new tools following their implementation. Knowledge of workflow and process during the
initial analysis and requirement specification phases will enable systems architects to design
systems that not only automate the existing workflow, but also introduce efficiencies and provide
benefits such as improved quality of health care delivery and improved quality of patient data by
reducing data errors.
4.3 Follow-Up Assessments of Users
Post implementation, countries can consider implementing processes that gather information on
how a system is being used, its effectiveness, training needs, and potential system
enhancements. For example, a group charged with ongoing assessment of user expectations andexperiences with the EMR system would engage users by soliciting feedback. User feedback
would inform the ongoing development of a national-scale EMR system.
Recommendation
Involve key stakeholdersinclude system users andmanagers in the SoftwareDevelopment Life Cycle (SDLC).
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5.0 Risk As sessm ent/Management Strategy
A risk assessment and risk management plan is necessary to ensure the success of any technical
endeavor. The steering committee should identify a coherent risk profile that takes into account
the following:
Risk Assessment
What could go wrong?
What is the likelihood that it will go wrong?
What are the consequences if it goes wrong?
Risk Management
What can be done and what are the options?
What are the trade-offs for each option in terms of project budget, schedule, and technical
performance?
What are the impacts of current project decisions on future options?3
Project risk assessment is ongoing throughout the life of the EMR system. It is not performed
early on and then forgotten. The ability to anticipate risks and develop alternative scenarios will be
instrumental in ensuring that this project is completed on time, on budget, and exceeds
performance requirements.
3 Haimes, Y. (2004). Risk modeling, assessment, and management. Hoboken, NJ: John Wiley & Sons Inc..
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Further Reading
Software Development Risk: Opportunity, Not Problem, by R. L. Van Scoy
(http://media.shs.net/globalaids/pdf/Article%2016d%20-
%20Van%20Scoy_Software%20Development%20Risk.pdf).
5.1 Safeguards
Safeguards must be in place to ensure against loss, destruction, tampering, and unauthorized use
of electronic records. Some safeguards may include plans for the following:
Data backupas in any computer system, there must be an efficient backup system
available.
Contingencyplans for disaster recovery need to be in place in the case of an electrical
breakdown or other emergency.
Examples of Areas of Risk Within a Project
Failure to understand who the project is for
Failure to identify a champion responsible for sponsoring the project
Failure to appoint a fully qualified and supported project manager
Failure to define the objectives of the project
Failure to secure commitments from people who are needed to assist with the
project
Failure to develop a process that includes contingency plans that can be readjusted
and a process to make changes as needed
Failure to estimate costs accurately
Failure to specify very precisely the end users' requirements
Failure to provide a good working environment for the project
Failure to tie in all the people involved in the project with contracts or documents of
understanding
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Storagedata storage must anticipate changes to storage technology over the anticipated
lifespan of the data system. As HIV therapy is expected to be a life-long activity for infected
patients, stored data (including backups) must be periodically migrated to newer storage
media.
Securityworkstations should be secured and passwords required for all users. Passwords
should be changed regularly to maintain security.
Access controlhealth records should be available when needed for patient care and other
official purposes but not accessible by unauthorized persons.
Confidentialitywithin each country, institutions must develop guidelines to ensure
confidentiality and security of HIV-related information, covering all levels operative within that
countrys or institutions health care system, and the different types of data collected, stored,
and used.
System monitoringprocedures should be in place to monitor the use of the system where
the data are stored in order to detect potential or actual security breaches.
Record keepingall additions, deletions, and modifications to electronically stored data must
be recorded at all times in a separate file or log. Logs generated during this process must be
secured, regularly reviewed, and safely stored.
Countries should develop and maintain an IT security plan for their national-scale EMR system.
The security plan should identify systems, key roles, and controls (management, operational, andtechnical) that have been implemented to ensure a level of security that is commensurate with the
risk and magnitude of the harm that could result from the loss, misuse, disclosure, or modification
of the information gathered and stored in a national-scale EMR system.
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Further Reading
Analyzing the Problem of Unsustainable Health Information Systems in Less-Developed
Economies: Case Studies from Tanzania and Mozambique by Kimaro and Nhampossa.(http://media.shs.net/globalaids/pdf/Article%202g%20-
%20Kimaro_Analyzing%20the%20Problem%20of%20Unsustainable%20HIS.pdf)
Key Factors for Small and Medium Enterprises in Taiwan to Successfully Implement
Information Systems by Wong and Lu.
Interim Guidelines on Protecting the Confidentiality and Security of HIV Information:
Proceedings From a Workshop from UNAIDS.
(http://media.shs.net/globalaids/pdf/Article%2023a%20-
%20UNAIDS_Security%20and%20Confidentiality%20Guidelines.pdf)
6.0 Infrastruc ture As sessm ent
The required infrastructure components can be determined on the basis of the EMR system being
implemented and the implementation strategy. Some infrastructure components may already be
in place, others may have to be ordered via an internal department or purchased directly from
suppliers. In both cases, there are practical questions that will need to be addressed (i.e., What is
the lead time? When should these be ordered? Have the suppliers, products, and or services
been identified?).
An infrastructure assessment can reveal opportunities to use technology in innovative ways to
resolve problems. For example, in Rwanda the expanding cell phone network allowed the
introduction of data collection and transmission using cell phones.
Technical infrastructure will vary at national, regional, and district levels. An assessment would
entail meeting with technology managers at each level to review operations, procedures, and
documentation. Data can be gathered through the use of questionnaires developed to reflect the
differences among the three levels (national, regional, and district). Data collected at each level
should be analyzed and used to formulate reports. Resulting reports from districts can then be
consolidated at the regional level. Regional reports can be consolidated at the national level to
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provide an overall assessment of a countrys technology capacity to support a national-scale EMR
system.
The infrastructure assessment report should be used to address the following issues regarding
communication, hardware configurations, operating system, and software requirements.
Infrastructure Issues to Assess
Communication What communication systems are currently in place?
How robust are communication links between health clinics within districts,
from a countrys health enterprise to the national level?
Are there technical and or geographic challenges that hinder the timely
exchange of patient and supplies information?
HardwareConfiguration
If hardware is going to be purchased, what hardware configuration should be
purchased? What configuration(s) are required at which phase of
implementation? Are the future implications and requirements beingconsidered?
For existing hardware, are there any configuration changes required? If so,
what are they? Who will make the changes? When are they going be done?
What impact might there be on other systems?
How will hardware and software be designed? Options include the following: Stand-alone systems Local area network (LAN) systems Wide area network (WAN) systems Internet-based systems
Operating
Systems
What operating system(s) are currently in use?
What operating system(s) will the proposed system be able to run? Will servers and desktops run different operating systems?
6.1 Software Requirements
Before a software system is developed or modified, it is important to describe the requirements of
the system to be implemented. It can be helpful to develop a use case that describes the
interactions that the users will have with the software. Be aware that some application software
may use other applications for security facilities, backup facilities, reporting facilities, and so forth.
If this is the case, these should be outlined within the system architecture.
Further Reading
BHRIMS District Informatics Assessment, and the instruments that were used to conduct the
assessment (Section 6 A-E,
http://www.globalhivevaluation.org/meetings/zambia2007/Bibliography.aspx).
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7.0 Conf id ent ial ity and Securi ty
Three interrelated concepts have an impact on the
development and implementation of protections for
sensitive data: privacy, confidentiality, and security. Privacy
is both a legal and an ethical concept. The legal concept
refers to the legal protection that has been afforded to an
individual to control both access to and use of personal
information and provides the overall framework within which
both confidentiality and security are implemented.
Confidentialityrelates to the right of individuals to protection
of their data during storage, transfer, and use, in order to
prevent unauthorized disclosure of that information to third
parties. Security is a collection of technical approaches that
address issues covering physical, electronic, and
procedural aspects of protecting information collected as
part of the scale-up of HIV services.
The public health goal is to safeguard the health of communities through the collection, analysis,
dissemination, and use of health data, which must be carefully balanced with the individuals right
to privacy and confidentiality. Guidelines must allow for consideration of relevant cultural norms
which may influence these policies, while ethical principles should guide decision-makingregarding the appropriate use and dissemination of data. Overall, guiding principles should be
based on human rights principles.
The purpose of defining health information confidentiality and security principles is to ensure that
health data are available and used to serve the improvement of health, as well as the reduction of
harm, for all peoplehealthy and not healthy. Pursuing this goal involves an ongoing process of
refining the balance between the maximization of benefits, which can and should come from the
wisest and fullest use of data, and protection from harm, which can result from either malicious or
inadvertent inappropriate release of individually identifiable data. Appropriate policies, procedures,
and technical methods must be balanced to protect both individual and public rights.
The risk of harm following a breach of confidentiality varies with the national or local context
according to levels of stigma, lack of comprehensive public health safety nets, legal traditions of
respect of privacy, religious perspectives, and other local conditions.
Privacythe legal protectionof an individuals control of
access to and use of personalinformation.
Confidentialitythe ethicalprinciple or legal right that ahealth professional will holdsecret all information relatedto a patient, unless patientgives consent permittingdisclosure.
Securitythe collection oftechnical approaches that
address issues coveringphysical, electronic, andprocedural aspects ofinformation protection.
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Within countries, privacy and confidentiality laws
should be in place (or developed if not already in
place) and relevant parameters of privacy or
confidentiality laws must be reviewed and known
by those involved with data at all administrative
levels.
Countries and organizations at all levels of the
health care system should have a written policy
that defines security procedures concerning the
way data are collected, stored, transferred, and
released. The policies need to be implemented
at all relevant levels, and staff members must
understand the policies and sign an agreement stating that they will implement them as part of
their work. This will also require training new staff members and updating all staff members on the
relevant procedures.
Organizations at all levels of the countrys health care system along with international
organizations must identify a confidentiality and security officer to be ultimately responsible for the
confidentiality and security of HIV information within their respective organization.
Development and review of confidentiality and security laws and procedures should include activeparticipation from relevant stakeholders, including people living with HIV, members of
communities affected by HIV, health care professionals, information technology specialists, and
legal and ethical experts.
Funding organizations should comply with these standards and have an obligation to make
adequate funding available to implement them, sufficient to ensure protection of the data collected
and used. Funding organizations must also require that maintaining these standards is a condition
for funding of any implementing partners or agencies.
Recommendations
Develop written privacy and confidentialitylaws and policy on how data are to becollected, stored, transferred, and
released. Procedures for protecting alltypes of data (paper-based andelectronic) must be explicitly described.
Ensure that all staff members are trainedin all privacy and confidentiality laws andhave signed a contract to abide by theselaws.
Engage relevant stakeholders in thedevelopment of privacy and confidentialitypolicies.
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The greatest threats to electronic information systems are generally not from outside attack, but
rather from issues inherent in the system design and implementation. These threats fall into two
categories: nonavailability of data due to system failure and user errors. The different types of HIV
informationpersonal identified, pseudo-anonymized, anonymized, aggregated, and nonpersonal
datarequire protection. Procedures for protecting each different type of data must be explicitly
described.
A number of organizational procedures need to be followed to ensure safeguards for the
collection, transfer, storage, use, dissemination, and disposal of personal identified data and other
information. Policies and procedures developed must cover both paper-based and electronic
systems.
Further Reading
Presentations: Guidelines on Protecting the Confidentiality and Security of HIV Information:
Proceedings from a Workshop in Geneva, May 2006 and Applied Security and Confidentiality
Elements in the SmartCare EHR,
(http://globalhivevaluation.org/meetings/zambia2007/PresentationMaterials.aspx?id=2_0900_
1000)
Negotiating Multiple Rationalities in the Process of Integrating the Information Systems of
Disease-Specific Health Programmes by Chilundo and Aanestad.
(http://media.shs.net/globalaids/pdf/Article%202l%20-
%20Chilundo_Negotiating%20Multiple%20Rationalities.pdf)
E-health Progresses in Romania by Moisil and Jitaru.
(http://media.shs.net/globalaids/pdf/Article%202f%20-%20Moisil_E-
health%20Progresses%20in%20Romania.pdf)
Standardized Exchange of Medical Data Between a Research Database, an Electronic Patient
Record and an Electronic Health Record Using CDA/SCIPHOX by Gerdsen, et al.
(http://media.shs.net/globalaids/pdf/Article%2010a%20-
%20Gerdsen_Standardized%20Exchange%20of%20Medical%20Data.pdf)
Interim Guidelines on Protecting the Confidentiality and Security of HIV Information:
Proceedings From a Workshop from UNAIDS.
(http://media.shs.net/globalaids/pdf/Article%2023a%20-
%20UNAIDS_Security%20and%20Confidentiality%20Guidelines.pdf)
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8.0 Requirements /Use of Data Ass essment
Systems requirements will be gathered through meetings with stakeholders at various levels
throughout the health enterprise. Government ministers will provide an understanding of high-
level goals and objectives. Senior managers will describe their responsibilities and requirements
around throughput and reporting. System users will provide the granular detail that can only be
gained through actual interface between service providers and service recipients/patients.
Information from these various stakeholder groups can be gathered through the use of
questionnaires tailored for each target audience. Questionnaires can be provided before meetings
so that participants can come prepared with the data that are being requested. Requirements can
also be gathered from work manuals, documented standard operating procedures, and by
observing clinicians as they process patient data.
Documented requirements will not only inform system design, but also provide the basis for
detailed testing requirements that clearly define how the system will be tested to ensure that all
functional requirements are met. Testing starts as soon as a requirement is qualified by
determining its specified met criterion. This is an objective measure that must be accomplished
in order to evaluate whether or not a given solution meets the requirement. If a criterion to be met
cannot be adequately specified, then the requirement is ambiguous. If there is no criterion or
benchmark for success, then there is no way of knowing if a solution meets the requirement.
Further Reading
Negotiating Multiple Rationalities in the Process of Integrating the Information Systems of
Disease-Specific Health Programmes by Chilundo and Aanestad
(http://media.shs.net/globalaids/pdf/Article%202l%20-
%20Chilundo_Negotiating%20Multiple%20Rationalities.pdf).
8.1 Reporting on EMR System Implementation
Government ministers, project champions, sponsors, and stakeholders need to be regularlyinformed of progress and outcomes during the implementation. Regular reports ensure that key
individuals are kept abreast of developments as the project moves forward. Each type of system
user will have different reporting requirements. These requirements are typically associated with
an individuals role within the organization. For example, a data analyst will need access to a
different level of report detail than that of a health minister. While a health minister is looking for
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summarized information, the analyst often needs access to granular transactional data. In
determining the enterprise-wide user query and reporting needs, it is important to define the user
communities, what information they need, the level of detail, and how the information should be
presented to them, as well as existing reporting mechanisms that could be leveraged for this
project.
8.1.1 Routine vs. Ad Hoc Reports
Routine reports are those that are produced on a regular frequency (e.g., weekly, monthly, or
quarterly). These types of reports are typically designed and accessed via a system interface that
allows users to create the report by simply selecting it from a menu. More sophisticated systems
may allow filters to be applied that limit the scope of content within a report. Routine reports may
also be automated so that they are generated and distributed on a regular schedule by the system
without the need for a user to initiate the process.
Ad hoc reports are created in response to unexpected calls for information or to answer questions
that cannot be resolved by analyzing routine reports. Ad hoc reports will be created to meet
requests made by data analysts for specific data variables that are not stored together within the
database. This type of report will require that a data query be developed by someone familiar with
the reporting systems database design. This knowledge will be required to understand how data
tables are linked so that information can be drawn from multiple tables within the database.
An ad hoc report may become routine if it is determined that it contains data that are usefulenough to be created on a regular basis.
8.1.2 Reporting Arrangements
Early in the process of EMR system development, a list should be made of what project-specific
reporting arrangements are in place. Identify how regularly reports will be prepared (e.g., weekly,
monthly, quarterly); the level at which reporting will be directed (e.g., health minister, sponsor,
visionary, steering committee); and the form reports will take (at a minimum, reports should detail
successes, challenges, schedule slippage, and budget issues). Identify whether progress in
implementing the EMR system could be captured by existing Government reporting systems or if
a new reporting system needs to interact and exchange information with any external reporting
systems.
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8.2 Other Data Use Requirements
Beyond routine reporting requirements of system users, it will be important to consider other
potential uses of data gathered and stored by the EMR system and build in the mechanisms that
will support those requirements. Researchers and analysts will want to conduct studies to answer
epidemiological questions regarding ART treatments for HIV/AIDS. It may be a requirement to
exchange data with external data systems. When documenting these requirements, it will be
necessary to determine common data variables that allow disparate databases to interact and
identify data standards that are in use.
Further Reading
Improving Imperfect Data From Health Management Information Systems in Africa Using
Space-Time Geostatistics by Gething, et al.
(http://media.shs.net/globalaids/pdf/Article%2021a%20-%20Gething_Improving%20Imperfect%20Data.pdf)
Understanding PACS Development in ContextThe Case of China by Xue and Liang.
(http://media.shs.net/globalaids/pdf/Article%2022a%20-%20Xue%20and%20Liang%20-
%20Understanding%20PACS%20Development%20In%20China.pdf)
9.0 Data Ent ry
Once an EMR system is implemented, existing patient
data from paper-based (or electronic, if they exist)
systems will need to be entered into the new system.
This process is known as backlog data entry. Data entry
will need to be planned and a strategy developed that
ensures that data integrity is maintained within the
receiving EMR system database. An important factor in
entering the data is the question of who will be
responsible for the data entry. Another consideration is
the amount of data that should be transferred from existing paper-based systems. Depending on
volume and quality of the data, a cut-off date may be implemented. For example, should data only
from a certain point in time going forward be entered? This decision may be driven by the medium
within which data are stored. Electronic data may be easier to transfer, while paper-based records
might present difficulties depending on their condition and completeness.
Data Entry Considerations
Are data entry clerks available?
Will staff members at clinics needto enter data in addition to theirregular duties?
Will data entry training beneeded?
How much backlog data entry willbe needed?
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Backlog data entry is discussed further in Section 12.8.
10.0 Design
10.1 Database Design
The key process in this step is to develop logical and physical data models that will support the
functionality detailed in the requirements specification document. Data modeling tools can be
used to develop these models. Database designs should be normalized to at least third normal
form (3NFensures each table contains unique data) to provide for efficient and effective data
storage. Data models should be checked to ensure integrity and consistency and that they adhere
to relational database modeling standards. This type of validation should be applied following
every database change and prior to implementation to ensure that the integrity of database
models has not been compromised by the proposed change4.
When developing a database design, it is important to consider reporting requirements. What
types of data outputs will health