INIT3SD1_Formal representation of policies and regulations

Date: 

01/13/2010

Requirement # unique id <SemCon Ops Initiative>.<analysts initials><requirement number>
e.g. Init1dbw1
(eventually linked to Use Cases)

Init3SD1

Originator/Customer's Name:

Hannes Neidner                                                                                  

Originator/Customer's Company:

San Diego Supercomputer Center

Summary of requirement pre-interview, by Reviewer:

Due to the plethore of legal, regulatory, policy,proprietary, and contractual barriers to data exchange in caBIG, the set of guidelines that define compliance to caBIG should reflect the regulatory framework under which the data exchange would happen so that it createsa synergy amongst all regulatory and compliance obligations.
Primary actor is Information Technologist (System Architect) who is required to design a system that complies to regulatory requirement for data exchange.
The business goal is to make regulatory compliance simple and machine understandable.
Requirement: Their should be a computable abstraction of regulatory requirement policies for data exchange to make it simple and non-ambiguous.  

Recommended Next Step Enter one: Follow-up interview, Observe, Use Case Template (text), Use Case Model (formalized/UML diagram), Group Discussion, Prototype, Waiting Room

Interview

1

Hello, my name is NAME. I am calling you today because NCI and caBIG are working toward a new and improved version of the semantic infrastructure to better support integration scenarios.
Our first step was to organize requirements collected over the past year. Your organization has expressed a requirement/need for BRIEF STATEMENT OF USER REQUIREMENT.  This has been identified as potentially a critical component to support application/data and service integration, and we need more information in order to enable us to meet this requirement.
Do you have about 30 minutes to talk about this?

If yes, proceed. If no, note a good time to call back.
                                                                                                                    

2

Do you have any solution integration needs? If so, what are they? Have you envisioned new ways of interacting with existing or new parts of the semantic  infrastructure?
(prompt to elicit changes/new ways of using the infrastructure)

Notes describing potential interactions

3

Are there any business changes you are assuming we will be able to deal with? 
(prompt to elicit changes/new ways of using the infrastructure) 

Notes on anticipated business changes

4

Are there any capabilities you are expecting to be available to support your needs? 
(prompt to elicit expectations/dependencies)

Notes that identify capabilities, tools, and/or services expected

5

Do you use any of the existing software/services? If so, what do you like or dislike about it?
(if related to existing capability)

Yes OR No/ Notes that fully describe the requirement

6

If this requirement in met, what would be the benefits? If you do not have it, what would be the negative impact?
(prompt to elicit benefits/value - will help to prioritize)

Summary of perceived benefit or negative impact

7

If, for any reason, we were not able to create that solution, do you think there might be another way to solve this issue? Can you think of an alternative solution?
(prompt to elicit alternative solutions/workarounds)
(to be prepared by the Requirement Analyst)

Description of any other solution that customer can envision

8

Would you agree that we can summarize your requirement like this?
(Summarize one requirement in 2-3 lines and read back to interviewee for confirmation.)

Requirement statement accepted by interviewee

9

How important is this requirement to the interviewee? Required: Customer Priority/Annotationrement Analyst
(Provides concrete assessment of the relative importance for the requirements specification)

Select:

1. Must have
2. Should have
3. Nice to have but not essential
4. Other (describe)

10

On a scale from 1 to 3 with 1 being "not satisfied" to 3 "completely satisfied", how would you rate your overall satisfaction with the product if this requirement was met?  (Relative rating/ranking of how satisfied or dissatisfied interviewee would be if this requirement were met/not met)

Select:

1. Not satisfied
2. Mostly satisfied
3. Completely satisfied 
4. Other (describe)

11

Are there other requirements that you would like to share with us? I'd be more than happy to call you back another time, or if you have another 10 minutes, please share other issues you can think of.
(prompt to elicit any hidden - potentially higher priority requirements if they exist)

(If yes, take notes to use in on a new page with this template; if time not available now, try to make appointment for another call.)

12

Who else should we talk to in order to elicit more information about this need?

Name of contact(s)

For specific service enhancement or requirement from Forum entry:

13

Can you or someone else give me a step-by-step description of how you would describe the expected performance/behavior of the software in order for you to feel that your requirement is met? 
(Required: Fit Criterion - will help us create test cases and user acceptance criteria - to be prepared by the Requirement Analyst)

Well defined measurable verifiable expectation

14

Forum Link:

VKC or other forum where this requirement is discussed

15

URLs (optional):

Links to pages or applications related to this requirement

16

References (optional):

Links to articles, papers or presentations related to this requirement

Stakeholder Community:

Enter appropriate category of stakeholder from Primary Stakeholders:  

• Software and Application designers and architects
• Software and Application engineers and developers
• Scientific and medical researchers
• Medical research protocol designers
• Clinical and scientific research data and metadata managers
• Clinicians
• Patients
• Medical research study participants
• Broader Stakeholders: caBIG® Community WS NIH projects and related commercial COTS vendors (caEHR, SDO's (HL7, CDISC); International Collaborators (e.g NCRI, cancerGrid, China), Government and regulatory bodies (FDA, CDC, ONC)
  (link to view SemConOps Stakeholders description).
  

Requirement Type (required)

Analyst's assessement of the most appropriate category/type of requirement (no need to ask interviewee):

• Functional: Fundamental or essential to the product - describes what the product has to do or what processing is needed
  
• Nonfunctional: properties the functions must have such as performance, usability, training or documentation
  
  • Project constraint: schedule or budget constraints
    
  • Design constraint: impose restrictions on how the product must be designed, such as conformant to ISO 11179, utilizes 21090 or is able to work on a particular type of device
    
  • Project driver: business-related forces such as descriptions of stakeholders or purpose of the product/project
    
  • Project issue: conditions that will contribute to the success or failure of the project

ConOp Initiative(s)
Requirements Analyst/Business Analyst

• Select most appropriate initiative: (click for descriptions) 
• Initiative 1 - Distributed, federated metadata repositories and model repositories and operations
• Initiative 2 - Automated generation of metadata from line-of-business artifacts
• Initiative 3 - Rules management and contracts support (behavioral semantics)
• Initiative 4 - Semantics support for W3C service oriented architecture resources
• Initiative 5 - HL7 CTS II/ OMG MIF compliant federated terminology services
• Initiative 6 - Controlled biomedical terminology, ontology and metadata content
• Initiative 7 - Assessment of semantic unification of compositional and derivational models
• Initiative 8 - Other

High Level Use Case Summary)
Requirements Analyst/Business Analyst

Please write a short descriptive narrative use case. 

Use Case Linkage (required)
Business Analyst

Which use case(s) is this requirement linked to?  (should follow Use Case numbering scheme <SemCon Ops Initiative>.<analysts initials><requirement number>.<use case number>, for example Init1dbw1.1, Init1dbw1.2, Init2dbw2.1, 2.2, etc.

Use case Number(s):

Conflicts / Dependencies(required)
Requirements Analyst/ Business Analyst

Are there any conflicts with other requirements / use cases? 

Yes OR No - If yes, what and why?

Next Step (required)
(Requirement Analyst / Business Analyst)

After reviewing the results of the interview, the forum, and all other materials related to this requirement, the analyst should recommend the next step, then attach the Tiny Link (on the Info tab) for this page to the Master List table.

Enter one: Follow-up interview, Observe, Use Case Template (text), Use Case Model (formalized/UML diagram), Group Discussion, Prototype, Waiting Room