Study Guide

Objectives (course unit)

In the course, students delve deeper into the current state and future prospects of digitalization and technology in the health care sector. The practical implementation of the course emphasizes customer-oriented implementation of application requirements specification and understanding of programming. Students evaluate and innovate digital solutions in the health care sector, applying their theoretical understanding and expertise to problems in the health care sector.

After completing the course, the student
- knows the most common technologies driving digitalisation and understands the potential of digitalisation in the design of applications in the health sector
- knows the stages of implementing applications utilizing ICT technologies throughout the project life cycle
- knows the stages of requirement specification in software engineering and knows the most common methods of requirement analysis
- know the stages of concept design for UI applications
- know the most common implementation methods for application

Content (course unit)

Concepts and key technologies of digitalisation: digital forms of information, sensors, Internet of Things, data transfer technologies, cyber security aspects.
Software life cycle stages: requirements analysis, system design, software design, implementation, testing, commissioning and maintenance.
Application requirement specification
Application UI design and application prototyping

Assessment criteria, satisfactory (1-2) (course unit)

The student
- know the technologies driving digitalisation and their impact on the health sector
- knows the most important stages of application production as well as production methods
- knows the areas of application requirement specification and their key contents
- knows the design and prototyping methods of user interfaces

Assessment criteria, good (3-4) (course unit)

The student
- knows the technologies driving digitalisation and their impact on the health sector in the region and is able to identify potential applications in the field
- knows the most important stages of application production and production methods and understands their key contents
- knows the areas of software requirement specification and is able to implement the most important elements of customer-oriented requirement specification
- is able to design application user interfaces and implement user interface prototypes

Assessment criteria, excellent (5) (course unit)

The student
- knows the technologies driving digitalisation and their impact on the health sector in the region, is able to identify potential applications in the field and is able to critically assess the development targets of digitalisation and their feasibility
- knows the most important stages of application production and production methods and understands their key contents
- knows the areas of software requirement specification and is able to implement the most important elements of customer-oriented requirement specification
- is able to design application user interfaces and implement functional user interface prototypes fluently and in a user-oriented manner

Assessment scale

0-5

Objectives (course unit)

2. Implementing the Thesis (after gate 4), 20 cr
Goals and contents

- keeping up with and advancing the development of their field, applying the knowledge, theories, central terms, methods, and principles of their field critically in their own thesis
- being able to apply the suitable research approach in their thesis
- being able to implement the thesis according to plan, while taking advantage of the guidance offered.

Content (course unit)

Implementation parts depend on the degree programme
- implementing empirical and/or theoretical part and writing the report
- methodological studies
- data privacy statement
- participation in thesis seminars and guidance events and peer evaluation

Assessment criteria, satisfactory (1-2) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, good (3-4) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, excellent (5) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment scale

0-5

Assessment scale

0-5

Objectives (course unit)

1. Thesis Planning (gates 1-3), 5 cr
Goals and contents
- being able to select and delimit a topic for a working life based thesis, which supports the student’s own learning, and to write a thesis plan according to TAMK’s thesis instructions
- being able to use national and international sources and adhere to copyrights in planning the thesis,
- being able to choose the proper data collection and analysis methods, to consider the matters regarding data protection as well as the ethical principles of the field in question.

Content (course unit)

Implementation parts
- idea paper, data search, preliminary literature review
- thesis plan
- thesis contract/permission
- peer review

Assessment criteria, satisfactory (1-2) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, good (3-4) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, excellent (5) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment scale

0-5

Objectives (course unit)

The course provides the skills to take into account the regulatory requirements of health technology in product development, sales and professional use.

After completing the course, the student
- broadly masters entirety of regulatory requirements and documentation requirements for medical devices and medical device software
- is able to apply regulatory requirements in design and development of medical devices and medical device software
- knows how to implement the CE marking and conformity assessment process for medical devices and medical device software.

Content (course unit)

Key terminology and concepts of health and wellbeing technology
Regulatory requirements for medical devices and medical device software
Obligations of manufacturers, supply chain operators and professional users
Classification of medical devices and medical device software
General safety and performance requirements
Clinical evaluation and clinical investigations
Device risk management
Conformity assessment of medical devices and medical device software
CE marking of medical devices and medical device software

Assessment criteria, satisfactory (1-2) (course unit)

The student
- is able to describe the entirety of regulatory requirements of medical devices and medical device software
- can prepare a basic level description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, but is not able to classify devices
- is able to describe requirements for medical devices and medical device software in different phases of their life cycle

Assessment criteria, good (3-4) (course unit)

The student
- is able to describe and prepare the regulatory requirements of medical devices and medical device software
- is able to prepare a description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, and is able to classify devices
- is able to describe and interpret requirements for medical devices and medical device software in different phases of their life cycle

Assessment criteria, excellent (5) (course unit)

The student
- is able to describe, prepare and apply regulatory requirements of medical devices and medical device software
- is able to prepare and evaluate a description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, and is able to choose and justify the classification of and conformity assessment procedure for devices
- is able to describe, interpret and apply requirements for medical devices and medical device software in different phases of their life cycle
- knows how to work in different organizations to ensure safety and safe use of devices

Assessment scale

0-5

Objectives (course unit)

The course provides the skills to take into account the regulatory requirements of health technology in product development, sales and professional use.

After completing the course, the student
- broadly masters entirety of regulatory requirements and documentation requirements for medical devices and medical device software
- is able to apply regulatory requirements in design and development of medical devices and medical device software
- knows how to implement the CE marking and conformity assessment process for medical devices and medical device software.

Content (course unit)

Key terminology and concepts of health and wellbeing technology
Regulatory requirements for medical devices and medical device software
Obligations of manufacturers, supply chain operators and professional users
Classification of medical devices and medical device software
General safety and performance requirements
Clinical evaluation and clinical investigations
Device risk management
Conformity assessment of medical devices and medical device software
CE marking of medical devices and medical device software

Assessment criteria, satisfactory (1-2) (course unit)

The student
- is able to describe the entirety of regulatory requirements of medical devices and medical device software
- can prepare a basic level description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, but is not able to classify devices
- is able to describe requirements for medical devices and medical device software in different phases of their life cycle

Assessment criteria, good (3-4) (course unit)

The student
- is able to describe and prepare the regulatory requirements of medical devices and medical device software
- is able to prepare a description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, and is able to classify devices
- is able to describe and interpret requirements for medical devices and medical device software in different phases of their life cycle

Assessment criteria, excellent (5) (course unit)

The student
- is able to describe, prepare and apply regulatory requirements of medical devices and medical device software
- is able to prepare and evaluate a description of technical documentation for medical devices and medical device software
- knows the CE conformity assessment procedures of medical devices and medical device software, and is able to choose and justify the classification of and conformity assessment procedure for devices
- is able to describe, interpret and apply requirements for medical devices and medical device software in different phases of their life cycle
- knows how to work in different organizations to ensure safety and safe use of devices

Assessment scale

0-5

Objectives (course unit)

In the course, students delve deeper into the current state and future prospects of digitalization and technology in the health care sector. The practical implementation of the course emphasizes customer-oriented implementation of application requirements specification and understanding of programming. Students evaluate and innovate digital solutions in the health care sector, applying their theoretical understanding and expertise to problems in the health care sector.

After completing the course, the student
- knows the most common technologies driving digitalisation and understands the potential of digitalisation in the design of applications in the health sector
- knows the stages of implementing applications utilizing ICT technologies throughout the project life cycle
- knows the stages of requirement specification in software engineering and knows the most common methods of requirement analysis
- know the stages of concept design for UI applications
- know the most common implementation methods for application

Content (course unit)

Concepts and key technologies of digitalisation: digital forms of information, sensors, Internet of Things, data transfer technologies, cyber security aspects.
Software life cycle stages: requirements analysis, system design, software design, implementation, testing, commissioning and maintenance.
Application requirement specification
Application UI design and application prototyping

Assessment criteria, satisfactory (1-2) (course unit)

The student
- know the technologies driving digitalisation and their impact on the health sector
- knows the most important stages of application production as well as production methods
- knows the areas of application requirement specification and their key contents
- knows the design and prototyping methods of user interfaces

Assessment criteria, good (3-4) (course unit)

The student
- knows the technologies driving digitalisation and their impact on the health sector in the region and is able to identify potential applications in the field
- knows the most important stages of application production and production methods and understands their key contents
- knows the areas of software requirement specification and is able to implement the most important elements of customer-oriented requirement specification
- is able to design application user interfaces and implement user interface prototypes

Assessment criteria, excellent (5) (course unit)

The student
- knows the technologies driving digitalisation and their impact on the health sector in the region, is able to identify potential applications in the field and is able to critically assess the development targets of digitalisation and their feasibility
- knows the most important stages of application production and production methods and understands their key contents
- knows the areas of software requirement specification and is able to implement the most important elements of customer-oriented requirement specification
- is able to design application user interfaces and implement functional user interface prototypes fluently and in a user-oriented manner

Assessment scale

0-5

Assessment scale

0-5

Objectives (course unit)

1. Thesis Planning (gates 1-3), 5 cr
Goals and contents
- being able to select and delimit a topic for a working life based thesis, which supports the student’s own learning, and to write a thesis plan according to TAMK’s thesis instructions
- being able to use national and international sources and adhere to copyrights in planning the thesis,
- being able to choose the proper data collection and analysis methods, to consider the matters regarding data protection as well as the ethical principles of the field in question.

Content (course unit)

Implementation parts
- idea paper, data search, preliminary literature review
- thesis plan
- thesis contract/permission
- peer review

Assessment criteria, satisfactory (1-2) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, good (3-4) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, excellent (5) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment scale

0-5

Objectives (course unit)

2. Implementing the Thesis (after gate 4), 20 cr
Goals and contents

- keeping up with and advancing the development of their field, applying the knowledge, theories, central terms, methods, and principles of their field critically in their own thesis
- being able to apply the suitable research approach in their thesis
- being able to implement the thesis according to plan, while taking advantage of the guidance offered.

Content (course unit)

Implementation parts depend on the degree programme
- implementing empirical and/or theoretical part and writing the report
- methodological studies
- data privacy statement
- participation in thesis seminars and guidance events and peer evaluation

Assessment criteria, satisfactory (1-2) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, good (3-4) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment criteria, excellent (5) (course unit)

Assessment criteria can be found from TAMK's web pages: https://intra.tuni.fi/en/handbook?page=3104. In the thesis guide there is seperate master's thesis assessment criteria. During the process 'Thesis plan' is assessed as failed/passed. In the end of the thesis process failed/passed is turned to a general rating.

Assessment scale

0-5