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Risks



1. Risk Management Plan

1.1 Customer Risks

1.1.1 Reluctance to exercise and/or use our software

Probability: Moderate
Consequences: Severe
Solution: We will emphasize a strong marketing
campaign designed to enlighten cardiac rehab patients about the importance of exercising in order to increase their well-being and to decrease the risk of repeat cardiac issues.

1.1.2 Users incorrectly using our software

Probability: Moderate
Consequences: Moderate
Solution: Our system will include functionality
allowing the transmission of measured vital stats from external measuring devices connected to the user’s computer through a USB cable. This will limit the possibility of user’s incorrectly manually entering in their vital stats. Furthermore, we will keep the GUI simple and intuitive to use, enabling even those with limited computer knowledge to be able to successfully use our system. We will be explicit as possible with easy-to-follow on screen exercise instructions and directions. We will also be hiring a Documentation Specialist to ensure that the user manual that we include with our software is thorough and precisely detailed.

1.1.3 Hospitals and Clinics reluctant to use our system

Probability: Moderate
Consequences: Severe
Solution: Through our marketing campaign we will
convince hospitals and cardiac rehabilitation centers that our system is an ideal way to distinguish themselves from other cardiac centers and a means to attract new patients to their center thus bringing additional business and revenue.

1.2 Legal Risks

1.2.1 Lawsuits resulting from user being injured/dying

Probability: Moderate
Consequences: Severe
Solution: Clear and unambiguous terms of use
agreements that the user must read and agree to before installing the software. Included in the terms of use will be statements absolving C Group from any liability and/or responsibility to any possible bodily injury that the user might incur. A legal advisor will also be hired in order to handle all the cases that might be filed against our company, and to ensure that we are adequately protected from lawsuits.

1.2.2 Lawsuits resulting from users’ health not improving

Probability: Moderate
Consequences: Severe
Solution: Clear and unambiguous disclaimer, that
makes it clear that our company makes no guarantees concerning the results and outcomes of using our product. Again, our lawyer will take care of any lawsuits that might be filed against our company.

1.2.3 Lawsuits accusing us of violating patient’s privacy

Probability: Moderate
Consequences: Severe
Solution: To govern how we collect data from the
hospitals and clinics running our software, we will closely adhere to the rules set forth by the HIPAA (Health Information Portability and Accounting Act of 1996), and its Privacy Rule put in effect in April 2003

1.3 Technical Risks

1.3.1 Data sent between nurse and patient prone to hackers

Probability: Moderate
Consequences: Severe
Solution: While the information sent back and foth
between the user and the nurse/exercise specialist is not especially useful if a third-party gets ahold of it, it does violate privacy rules detailed in the HIPAA. Thus, our software will use PGP encryption technology to protect the data sent and received by our software system.

1.3.2 Scope of product considered too limited

Probability: Moderate
Consequences: Moderate
Solution: The scope is intentionally limited in the
beginning. Once our product starts being used, and we begin to see a steady revenue flow, we will obviously update our product to add more functionality to it. Not only does this allow our company to roll out a product earlier, albeit a somewhat limited scope version, it also allows for new streams of revenue. Included in future phases of the product will be a heart rate/blood pressure wrist monitor that works directly with our software, and nutritional advice and feedback.

1.3.3 Software bugs causing software to not function as intended

Probability: Low/Moderate
Consequences: Moderate
Solution: Design phase to minimize the possibility of
design errors, and a lengthy testing phase to ensure that the critical and addressable software bugs are found and fixed.

2. Personnel

2.1 Project Manager

The project manager will lead all aspects of the project, managing the product development process from concept to commercialization. He will monitor work flow and deadlines, while providing leadership, coaching, and mentoring for the development staff.

2.2 Software Manager

The software manager will lead the team of software engineers to design and develop the software. He will lead a team consisting of a level 3 software engineer III, 3 level 2 software engineers, a software quality assurance person, and a database architect. Additional responsibilities include writing product requirement documents, and implementing and tracking development timelines.

2.2 Software Engineer III

This software engineer will be the main programmer, working on the most critical parts of the project. He will report to the software manager, while providing assistance to the other software engineers.

2.3 Software Engineer II

Three level 2 software engineers will be part of the team. These engineers will report to the software manager, working on the less critical aspects of the software.

2.4 Software Quality Assurance

The function of this position is to ensure the quality of the software. Some of the responsibilities of this position are developing, publishing, and implementing test plans, writing and maintaining test automation, developing quality assurance standards, and defining and tracking quality assurance metrics such as defect densities and open defect counts.

2.5 Data Architect

The Data Architect is responsible for designing and developing the patient database that will be part of the server side software run at the cardiac rehab centers. The Data Architect will report to the software manager.

2.6 Financial Analyst

The Financial Analyst is responsible for developing the project’s budget, as well as finding sources for funding.

2.7 Product Marketing Analyst III

The Product Marketing Analyst III will be responsible for developing the marketing plan for our project, overseeing its implementation, determining potential customers for our system, and convincing those potential customers why they should purchase our software.

2.8 Web Developer

The web developer will be responsible for designing, creating, and maintaining the product’s website.

2.9 Sr. Documentation Specialist

The Sr. Documentation Specialist will be responsible for creating precise, and thoroughly detailed user manuals, technical specifications, and other product documents as necessary.

2.10 Medical Advisor

The medical advisor will assist the software engineers during the design phase to ensure that the software doesn’t include any incorrect medical advice or information, that could lead to undesired consequences.

2.11 Legal Advisor

The legal advisor will be responsible for creating unambiguous the disclaimer and terms of use agreement for our product, assuring that our product adheres to HIPAA, and the FDA software policy.

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