Unit information: Responsible Innovation and Research Methods in Digital Health in 2020/21

Unit name	Responsible Innovation and Research Methods in Digital Health
Unit code	EENGM0023
Credit points	20
Level of study	M/7
Teaching block(s)	Teaching Block 4 (weeks 1-24)
Unit director	Dr. Brigden
Open unit status	Not open
Pre-requisites	None
Co-requisites	None
School/department	School of Engineering Mathematics and Technology
Faculty	Faculty of Engineering

Description including Unit Aims

The aim of this unit is to provide students with a thorough grounding in research methods used in the development and validation of digital devices and associated algorithms in health and care. Ethical issues associated with the design, development, evaluation, distribution and application of digital technology will be introduced, along with concepts such as privacy, safety, device regulation and the law.

Unit content:

• The main forms of data held by health and social care organizations
• Issues around interoperability, governance and GDPR.
• The value of working with communities, participatory design, Public Engagement and Public Patient Involvement (PPI) will be explained in terms of anticipating acceptability issues, de-risking subject recruitment to a trial and thinking through the impact of a new technology on wider society.
• Introduction to issues that may arise relating to protected characteristics (such as race, gender and disability) and ensuring that research and product development is undertaken in an inclusive manner, making use of PPI and user-centred/participatory design.
• Opportunities to develop technologies that specifically address health problems in e.g. vulnerable or minority groups.

Intended Learning Outcomes

Having completed this unit, the student is expected to:

1. Be able to explain and justify how data is collected, stored and responsibly shared in and between health and care settings
2. Discuss processes relating to clinical trials
3. Explain and be able to apply the current regulatory guidelines associated with data collection and sharing between industry and research organisations, and health and care settings
4. Critically discuss the major societal challenges around ensuring that the needs of diverse health communities are adequately represented in novel technologies.

Teaching Information

This unit will consist of a combination of teaching and learning methods including key lectures, workshops, group seminars and structured reflection.

Assessment Information

Group Project where ethical questions linked to responsible innovation in digital health will be posed. Each group will need to discuss their views and ideas by means of an online collaborative space and formulate a video or report response that represents a balanced answer to the problem. 50% (All ILOs).

500 word report detailing main concepts and ideas arising from TB2 workshop activities. 50% (ILO 4)

Reading and References

Selected literature, references and online material will be provided at the start of the unit