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					Center for Biomedical Informatics and
              Information Technology


                          caEHR Project

      Quality Requirements


                Version 0.01 (Draft Document)
                                 Prepared by:
                         caEHR Project Team




                                 June 11, 2010
caEHR Project – Quality Requirements                           Page 1




Revision History
 Version        Date                   Name            Reason For Changes

 0.01           June 11, 2010          Marti Velezis   Initial version




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caEHR Project – Quality Requirements                                                                                 Page 2




Table of Contents
1. Introduction ............................................................................................................. 3
   1.1. Background ........................................................................................................ 3
   1.2. Document Purpose ............................................................................................ 3
   1.3. Audience ............................................................................................................ 4
2. Quality Requirements ............................................................................................. 5
    2.1.1 General Principles .................................................................................................. 5
      2.1.1.1 General ........................................................................................................... 5
      2.1.1.2 Usability .......................................................................................................... 6
      2.1.1.3 Supportability .................................................................................................. 7
    2.1.2 Non-Functional requirements .................................................................................. 8
      2.1.2.1 Industry Standards and Compliance ............................................................... 9
      2.1.2.2 Deployment Scenarios .................................................................................... 9
      2.1.2.3 Auditing ..........................................................................................................10
      2.1.2.4 Data Integrity..................................................................................................10
      2.1.2.5 Data Security .................................................................................................10
    2.1.3 Qualitative and Quantitative Characteristics...........................................................11
      2.1.3.1 Reliability .......................................................................................................11
      2.1.3.2 Performance ..................................................................................................13
Appendix A              Compliance Areas ............................................................................ 15




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caEHR Project – Quality Requirements                                                                         Page 3




1. Introduction
1.1. Background
The National Cancer Institute’s (NCI) Cancer Electronic Health Record, or “caEHR”, project will
develop reference implementations and service specifications that will work in concert with
existing EHR systems to address the unique requirements of the ambulatory oncology
community and addresses, in particular, the need for that community to work effectively within
the broader research and oncology care environments.

A semantically-aware Service Oriented Architecture will be developed in an iterative manner
that leverages the HL7 Service Aware Interoperability Framework (SAIF)1 in order to produce
not only service specifications, business capability services and Reference Implementations
(RIs), but also the appropriate layered interoperability specifications that will enable broad
adoption of the architecture and, as applicable, the software components by a wide variety of
stakeholders.

The overarching goal is to serve the American Oncology community by achieving one or more
of the following objectives:

         Architectural Adoption by Industry: Industry – namely software solution vendor –
          consumption of platform independent level caEHR specifications in the development /
          extension of their own products and services.
         Solution Adoption by the Open Health Tools (OHT) Community: Business
          Capabilities and/or Reference Implementation consumption by the OHT (open health
          tools) community to integrate and/or repackage for the health IT market.
         Clinical Community Adoption: Business Capabilities and/or Reference Implementation
          consumed being used in a daily production setting at an ‘in scope’ implementation site.

As a project funded under the American Recovery and Reinvestment Act (ARRA), its mission is
also to offer a solution with strong alignment with the requirements and vision of the associated
Health Information Technology for Economic and Clinical Health (HITECH) Act.

1.2. Document Purpose
The purpose of this document is to describe the various types of quality requirements that need
to be documented for the caEHR project to achieve all of its objectives. This document will
provide the basis for the caEHR team members to collect or identify and document quality
requirements in each of the categories outlined in the next section of this document. When
possible, the document will provide oncology research and healthcare- related sources of
requirements as a starting point, but it will not provide an exhaustive list of such information.

This document does not include any examples of the required fit metrics/success criteria
necessary to measure the execution of the requirements. However, this is a significant
undertaking for the analysis and deployment teams. Note that the actual quality requirements


1
    The SAIF is also known as the Services Aware Enterprise Architecture Framework (SAEAF). For further information about the
    SAIF (or SAEAF) please consult the links and references listed in the reference section of this document.




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caEHR Project – Quality Requirements                                                                           Page 4




will be maintained in the caEHR requirements management tool and the description of the
requirements management processes are located in the caEHR Analysis Management Plan. 2

1.3. Audience
The audience for this document is the caEHR stakeholders that need to understand the types of
quality requirements that will be used on the caEHR project. Whether it to be to provide the
detailed requirements or analysis around the requirements, the types of quality requirements
outlined in this document will serve a basis for much for the compliance, conformance
assertions and conformance statements for the team that do not fall in the functional
requirements domain.




2
    The caEHR Analysis Management plan is still under development, as well as the selection of a requirements management tool.




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caEHR Project – Quality Requirements                                                 Page 5




2. Quality Requirements
The objective of this document is to provide a basis for making architectural and engineering
decisions as well as ensuring quality when developing the specifications and/or reference
implementations of the caEHR project.

This document provides sufficient input for making architectural, engineering and quality trade-
offs during the life of the caEHR project. The document includes the following types of
requirements that need to be considered during the development of services specifications
and/or reference implementations:
   General Principles - These are a set of high-level and important requirements that must be
    applied when defining and developing the overall solution. They will set the domain-specific
    priorities and guidance, but are not part of either the specifications or implementations.
   Non-Functional Requirements - These are the actual “requirements” that must be met,
    and are largely non-negotiable.
   Qualitative and Quantitative Characteristics - These are a set of descriptions of facets of
    the system that are not functional in nature, but which are nevertheless very important.
    These describe the desired state of the solution, but are inherently treated as negotiable
    inputs to a discussion on architecture trade-offs.

In each of the above areas, this covers end user and customer requirements for the total
solution offerings as well as constraints and expectations for the internal service-oriented
architecture (SOA) components.

2.1.1   General Principles

The following general principle requirements are organized in the following categories:

       General
       Usability
       Supportability

Detailed descriptions and subparts to these general principles are outlined in the following
sections. The descriptions are to serve as a guideline as to the subject of the quality
requirements, but do not serve as the requirements themselves.

2.1.1.1 General
Name          Description
Cost of       Total cost of ownership of the solution. This includes capital spending
Ownership     and ongoing operational expense required to acquire and operate the
              solution, as well as maintenance costs, which is impacted by
              maintainability and flexibility of the system.
Return on     The financial metrics used by the customer to justify the level of
Investment    investment in the solution compared with expected savings or
              increases in revenue for the customer’s business.




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caEHR Project – Quality Requirements                                                        Page 6




Name                     Description
Standards-               The set of applicable standards, whether de facto or formal industry
compliance,              standards required in the construction of the solution or the operating
certification3           environment for the solution, in addition to the level of compliance
                         with the standards such as validation testing and certification.


2.1.1.2 Usability
Name              Description
Consistency of    User interfaces will use common look and feel guidelines which are
User Interfaces   shared with industry norms such as for common desktop and/or
                  web applications, and especially across the suite of applications.
                  Similar features in multiple user interfaces will be performed in the
                  same way.

Efficiency and               The most important measure of Usability is how well the user can
Effectiveness for            perform tasks. This is measured in terms of efficiently and
Performing                   productivity such as the time to perform a task or the number of
Tasks and                    steps that are required to complete a business process. Effectiveness
Processes                    includes additional metrics for measuring the outcomes or results
                             from using the solution. A solution may be efficient for entering
                             data but not necessarily effective for ensuring that the best
                             information is captured or that is it correct.
Flexibility in               Flexibility is measured by how well the same solution can be used
How User                     in a variety of contexts without requiring separate and distinctly
Accesses                     different instances of solution components. Experienced “power”
Functionality                users may be able to select personalized behavior to optimize
                             frequent usage while occasional or novice users may require more
                             system-provided prompting or “wizards” to guide the user
                             interaction.
Intuitive                    Intuitive and understandable behavior in a solution means that the
Understandable               user is able to achieve the desired results, without unintended and
Behavior                     unexpected results or side-effects. Purely functional requirements
                             may be validated when the solution performs the actions and
                             behaviors specified for the particular component. The behavior
                             should be validated with actual users and conform to the expected
                             results or more importantly, with the expected sequence of actions
                             required to accomplish a task. A particularly important aspect is the
                             ability of locate a desired tool or piece of information within the
                             solution in a logical, readily-identified place.




3
    Note: Standards will also be included in the non-functional requirements




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caEHR Project – Quality Requirements                                               Page 7




Name               Description
Learnability       The ability for users to learn how to use the solution effectively is
/Training          measured by how much time is required to be taught the key
Complexity         principles and the major tasks. The amount of training required is
                   proportional to the complexity of the tasks being performed and the
                   frequency of performing the tasks (repetition). Simple or common
                   tasks should be easily learned and retained, while more complex or
                   less frequent tasks should be straightforward for the user to learn.
                   The learn-ability of the solution should not depend excessively on
                   the skills required for the knowledge domain. (Ideally, the solution
                   should enhance the capabilities of the knowledgeable user in the
                   domain).
Open Interfaces    Open interfaces facilitate specialized integration and customization
Useful for Other   scenarios without requiring modifications to the underlying
Applications       solution. This measures the effectiveness of a class of users with
                   requirements outside the limited scope of typical end user
                   interactions
                   This is extremely important to the business case that the solution
                   will be modular enough to provide the core set of activities, and
                   organization-specific (i.e., configurable) open scenarios to meet the
                   needs of various customers.


2.1.1.3 Supportability

Name               Description
Maturity           Maturity is a measure of how well elements of a solution have held
                   up over time in light of changes or extensions. While the solution
                   will be validated as part of any integration and release cycle, the
                   Maturity of the solution measures the relative stability of older
                   established parts of the solution compared with newer components
                   which may be more vulnerable to quality issues.

Adaptability /     An adaptable or re-usable solution is essentially the same solution
Customization /    deployed in multiple customer environments, with minimal or no
Reusability        substantial modifications to the core solution. The measure of
                   effectiveness of reusability is how well the solution or component is
                   used in diverse application environments as well as how easily it
                   may be deployed with only minimal changes.

Configurability    Configurability is the ability to affect the performance and behavior
                   of the solution or component as part of its installation, through
                   post-installation actions, and through run-time parameters.

Extensibility      A solution is extensible when it provides a mechanism for
                   augmenting or replacing functionality and behavior with new
                   functionality.




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caEHR Project – Quality Requirements                                                             Page 8




Name                          Description
Installation                  The ability for specific individuals to install the solution within a
Complexity                    specified set of time and resource constraints is defined and
                              measured as the Installation Complexity. Additionally, for certain
                              solutions the ability to get started with a new customer or to add
                              new users is clearly defined.
Maintainability               The assumptions about how the solution is maintained, including
                              frequency and process of upgrades, how errors in the solution are
                              fixed, and how many releases are supported are clearly specified.
Portability /                 The solution and components are able to be deployed in
Replace-ability               conjunction with multiple platforms or system variations. Services,
of Components /               capabilities and interfaces may accommodate multiple alternatives
different                     for providing functionality with equivalent behavior, and without
Environments                  requiring substantial modifications to the solution or completely
                              separate solutions.

Regulatory4                   The solution and components are able to comply with any relevant
                              regulatory requirements in any jurisdiction where the solution is
                              deployed. Regulatory requirements may include any governmental
                              requirements as well as any policies internal to the customer
                              organizations or user communities

Resource                      Resource Efficiency measures the amount of critical physical
Efficiency                    system resources are required in order to support a population of
                              users, maintain an aggregate base of information, and take
                              advantage of computational resources to perform tasks.
                              Resources include database, file system and other storage related
                              resources to contain and manage all of the critical data, as well as
                              computational resources for performing tasks. Lastly, human
                              resources are leveraged through the use of technology. Because
                              most computer-based solutions trade-off between space utilization,
                              computational resource utilization and human utilization, the
                              purpose of this metric is to identify when such tradeoff
                              assumptions are being made.
                              To tie the different types of resource efficiencies together, it is
                              expected that the solution would be gathering metrics (including
                              Key Performance Indicators) to sort out the system inefficiencies
                              from the people inefficiencies. For example, the time it takes a
                              person to process complete a workflow action versus how long it
                              takes the system to recall the case information at execution of
                              such operation.

2.1.2       Non-Functional requirements

The non-functional requirements are organized in the following categories:

           Industry Standards and Compliance
           Deployment Scenarios

4
    Regulatory requirements may also surface non-functional requirement – i.e., non-negotiable




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caEHR Project – Quality Requirements                                                    Page 9




       Auditing
       Data Integrity
       Data Security


2.1.2.1 Industry Standards and Compliance
The following
Rating: H = High Business Importance M= Medium Business Importance L= Low Business Importance

Name                     Description
HL7 Reference            The caEHR information models shall utilize the HL7 RIM.
Information Model
(RIM)
CBIIT Enterprise         The CBIIT ECCF IG shall be utilized to ensure the artifacts on
Conformance and          the project adhere to the implementation guide as well as
Compliance               establish the model for conformance and compliance for caEHR.
Framework IG
(ECCF IG)
ISO Data types           The caEHR information models and specifications shall utilize
(ISO 21090)              the ISO DT (21090) standard.
Meaningful Use           The caEHR services and reference implementations shall ensure
                         compliance with the meaningful use criteria.
                         Note: There will be compliance criteria in the future – this is still
                         being defined. Source - http://edocket.access.gpo.gov/2010/E9-
                         31217.htm
HIPAA
508 Compliance           The caEHR services and reference implementations shall ensure
                         compliance with Section 508. For HHS guidance -
                         http://www.hhs.gov/web/508/index.html and also an excellent,
                         comprehensive source
                         (http://web508.gsfc.nasa.gov/developing/checklist/index.cfm)
21 CFR Part 11           The caEHR services and reference implementation need to be
Electronic Records;      compliance with the technical requirements from the regulation
Electronic               need to be met. There are other requirements that will need to
Signatures;              be met by the deployment site/organization.
Electronic
Submissions;



2.1.2.2 Deployment Scenarios

Name                     Description
Deployment               The deployment topology of each deployment site needs to be
Topology                 understood.
Technology               The deployment technologies shall be well understood. Any non-
Inventory                negotiable technologies will need to be explicitly stated as
                         requirements.
Service                  The use of service specifications will need to be understood for
Specifications           each of the deployment scenarios.



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caEHR Project – Quality Requirements                                             Page 10




Service Provider     The use of services will need to be understood for each of the
                     deployment scenarios.
Jurisdictional       The jurisdictional domains need to be well understood for each of
Domains              the deployment scenarios.


2.1.2.3 Auditing
Name                 Description
Access               The requirements for accessing the services and/or reference
(login/logout)       implementation will need to be documented.
Audit Logs –         The requirements for reporting and querying on the audit logs will
Reports and          need to be documented.
Queries
Account              The requirements for role-based access controls and
Management logs      assignment, modification and deletion will need to be
                     documented.
Event Logging        The requirements for all entries, queries, retrievals, and updates
                     to data graphs will need to be documented.


2.1.2.4 Data Integrity
Name                 Description
Transaction          All transactions must commit all data completely, or avoid
integrity            committing any data in the event of an exception or interruption
                     of the transaction. All access to data after a commit is to the
                     most recently committed data.
Data Validation      For reference implementations, the data inputs shall be validated
                     for format, data type and allowable ranges or enumerations.




2.1.2.5 Data Security
Name                Description
Need to add




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caEHR Project – Quality Requirements                                                Page 11




2.1.3   Qualitative and Quantitative Characteristics

The following categories provide the organization for the qualitative and quantitative
characteristics to be used on this project:

       Reliability

       Performance

2.1.3.1 Reliability
Name                        Description
Accurate                    Accuracy measures the level of detail and tolerances
                            required to perform a task effectively. For solutions where
                            precision of data and the ability to narrow down potential
                            choices and alternatives is critical, accuracy is used to
                            quantify circumstances where any type of “fuzzy” results
                            must be eliminated, or whether they must be tolerated and
                            even encouraged. (This is especially critical for statistical
                            and analytic solutions).
Availability and Uptime     Availability is measured in terms of any time windows
                            where the solution must be available, and must include the
                            tolerance for scheduled and un-scheduled interruptions to
                            the availability of the solution.
Completeness                Completeness defines the elements and variations of use
                            cases implemented in the solution which are required to
                            satisfy customer needs for a specific set of functionality. In
                            general, it defines which sets of capabilities must be
                            provided together, and which capabilities may be
                            considered optional for a set of user situations.

Correctness                 Correctness defines the level of errors or incomplete results
                            which may be tolerated across a population of data, users
                            or transactions (events).
Diagnostics                 Diagnostics includes the ability to detect potential problems
                            and analyze the underlying causes of something which
                            leads to unanticipated results or behavior in the solution.
                            Diagnostics may be considered secondary user
                            functionality beyond the core of the solution capabilities.
Fault-tolerance             Fault-tolerance is the ability to react to a specific set of
                            abnormal solution events in order to restore solution state,
                            resume processing, and to continue to operate without
                            introducing errors or preventing availability of the solution.
Maturity                    Maturity is a measure of how well elements of a solution
                            have held up over time in light of changes or extensions.
                            While the solution will be validated as part of any
                            integration and release cycle, the Maturity of the solution
                            measures the relative stability of older established parts of
                            the solution compared with newer components which may
                            be more vulnerable to quality issues.




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caEHR Project – Quality Requirements                                                Page 12




Name                      Description
Mean Time Between         All solution components must be measured in terms of
Failure                   frequency of failures or terminations (including planned
                          downtime or maintenance upgrades) in order to measure
                          the overall reliability and stability of the solution in terms of
                          continuous operation. While availability and uptime may
                          measure the time between interruptions for a single
                          solution, the MTBF is a broader measure across the entire
                          population of solution components.
Recovery                  Recovery measures the time to re-establish operation for
                          users after an interruption. It may include re-connecting
                          low-level communication sessions across a network, the
                          time to restart an application or service, the time to fail-over
                          to an alternate server platform, or the total time to restore a
                          backed up storage subsystem and rebuild a database.
Robustness                Robustness measures the ability of the solution to
                          withstand specific types of exceptions and error-handling
                          circumstances. While fault-tolerance defines the specific
                          classes of system component failures, robustness
                          encompasses a wider range of more granular and varied
                          set of conditions especially at the higher levels of the
                          solution, such as the ability to enable the user to continue
                          to work on tasks without complete information, and the
                          ability to perform reasonably with incorrect information.
                          Most importantly, it is a measure of how well the solution
                          continues to operate without failure and without introducing
                          errors in the presence of low-level programming and logic
                          errors.
Transaction Integrity     Transaction Integrity measures how well the solution
ACID (Atomic,             components are able to acquire and store stable and
Consistent, Isolated,     consistent data, and especially how well the solution is able
Durable)                  to modify shared information with stable and predictable
                          results.




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caEHR Project – Quality Requirements                                            Page 13




2.1.3.2 Performance
Name                           Description
Bandwidth                      Bandwidth measure the volume of data which can
                               continuously pass through a solution component. It is
                               generally measured in terms of input volume and
                               output volume. It is generally limited by the narrowest
                               logical or physical data path in a sequence of
                               interconnected paths. It is general affected by latency,
                               frequency of transactions, and any type of concurrency
                               or parallelism.
Raw Capacity                   Raw Capacity of resources such as processing power,
                               memory utilization, storage capacity, I/O channels, and
                               networking connections is measured for all physical
                               system components as well as individual services and
                               application components. Capacity may be measured
                               by aggregate capability of the component (supply) or
                               across a range of users, clients and transactions
                               (demand).
Concurrent Users               Concurrent Users are measured in terms of peak loads
                               and average loads. Concurrent Users may be human
                               beings or surrogate applications. Concurrent Users are
                               measured in terms of what are acceptable
                               measurements of the user experience such as
                               response time, transaction rates, I/O per second.
Response Time/Latency          Response Time is the most sensitive measurement of
                               the user experience. It is generally measured from the
                               perspective of the end user. Internal components are
                               measured as Latency of the operations as measured
                               by other software components in the solutions.
                               Latencies and Response Times are generally
                               measured across increasing loads to identify where the
                               overall solution performance boundaries lie.
Parallel Processing Activity   In a distributed solution environment that serves a
                               potentially large community of users and concurrent
                               applications, key components of the solution are
                               identified which are capable of exploiting real-time
                               concurrency. Some of these activities are parallel for
                               the purpose of increasing system throughput, while
                               other activities are parallel for improving business
                               process workflows in order to optimize human
                               performance.




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caEHR Project – Quality Requirements                                            Page 14




Name                          Description
Resource Efficiency           Resource Efficiency measures the amount of critical
                              physical system resources are required in order to
                              support a population of users, maintain an aggregate
                              base of information, and take advantage of
                              computational resources to perform tasks. Resources
                              include database, file system and other storage related
                              resources to contain and manage all of the critical
                              data, as well as computational resources for
                              performing tasks. Lastly, human resources are
                              leveraged through the use of technology. Because
                              most computer-based solutions tradeoff between
                              space utilization, computational resource utilization and
                              human utilization, the purpose of this metric is to
                              identify when such tradeoff assumptions are being
                              made.
Scalability                   Scalability measures the range of resources required
                              to address a specific set of processing objectives in the
                              solution. In addition to measuring how the solution is
                              “sized” for a given set of users and anticipated
                              demands, Scalability measures how seamless or
                              disruptive the process of expanding a solution can be.
                              Scaling units may be large or very granular. Scaling
                              may require active systems administration to re-
                              allocate resources or it may be transparent to the
                              users. Availability expectations may require that
                              scalability is non-disruptive without incurring any
                              solution downtime.
Throughput/Transaction        Throughput and Transaction Rates measure how may
Rates                         operations per unit of time are required to satisfy the
                              needs of the user population. Transactions may be
                              measured from a user perspective, or they may be
                              measured internally as operations on information
                              objects within a component of the solution.




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caEHR Project – Quality Requirements                                                 Page 15




Appendix A Compliance Areas
The following is a list of potential mandates and/or regulations that need to be investigated as
part of the Compliance activities.

       Health Insurance Portability and Accountability Act (HIPAA)
       21CFR – Part 11 - Electronic Records; Electronic Signatures; Electronic Submissions;
        the technical requirements from the regulation need to be met. There are other
        requirements that will need to be met by the deployment site/organization.
       CCHIT – Ambulatory EHR Certifications – this will need to be reviewed and understood
        in the context of caEHR
        (http://www.hhs.gov/healthit/documents/AEHRRecognizedCertCriteria.pdf)
       Meaningful Use – we will need to ensure we are in compliance with the meaningful use
        criteria. There will be compliance criteria in the future – this is still being defined.
        Source - http://edocket.access.gpo.gov/2010/E9-31217.htm (EHR Certification - We
        need to follow this as well – it is part of the regulation:
        http://www.govhealthit.com/newsitem.aspx?nid=73707)
       Public Company Accounting Reform and Investor Protection (Sarbanes-Oxley Act) of
        2002 – this relates to “internal controls” for security of the system and data contained
        within it. The Act doesn’t specify the requirements for the controls – that is up to the
        organizations implementing – we will probably be covered with all of the other data
        protection requirements.
       Financial Modernization (Gramm-Leach Bliley) Act of 1999 – this relates to the financial
        aid and insurance business capabilities that may be required. We will need to do
        additional research on this when we get to Billing and Insurance requirements.
       Privacy Act – related to PII data – this should be in conjunction with HIPAA.
       Physician Self-Referral (Section 1877 of the Social Security Act (the Act) (42 U.S.C.
        1395nn), also known as the physician self-referral law and commonly referred to as the
        "Stark Law") – includes “the proposed and final rules to include nuclear medicine within
        existing DHS categories and a proposed and final rule related to electronic prescribing
        technology and electronic health records technology.”
        (http://www.cms.gov/PhysicianSelfReferral/30_Law.asp#TopOfPage) also HHS
        information (http://www.hhs.gov/healthit/certification/stark/)
       508 Compliance – we will need to understand this in the context of both services and
        reference implementations. For HHS guidance - http://www.hhs.gov/web/508/index.html
        and also an excellent, comprehensive source
        (http://web508.gsfc.nasa.gov/developing/checklist/index.cfm)
       FDA Medical Device/Certification – I am not sure if we have this in scope, but it was
        mentioned in the Tolven requirements.
       These are items that need to be further understood in the context of the organizational
        (deployment) boundaries:
       The Patriot Act of 2002 – this may have some implications if we get into genomics data
        and some of the population health or surveillance topics – as they would need to be
        protected at the organization level – we want to make sure we don’t jeopardize the
        deployment sites.

Note: ECCF is the framework for describing/defining the conformance and compliance for a
service-aware interoperability project such as ours – and it is the ECCF Implementation Guide
that will dictate what the Enterprise will need to comply, conform, trace and certify for the project




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caEHR Project – Quality Requirements                                              Page 16




and any others that aim to reach the highest level of the Working Interoperability (through the
use of service specifications and/or reference implementations).




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