How to elicit, analyse and validate requirements for a digital health solution

Abstract

This chapter outlines the challenges and the requirements engineering practices we used to address these challenges in the form of a cookbook. The material is intended for RE practitioners, researchers as well as digital health stakeholders, and is prepared as a set of practical guidelines and recommendations, further explained through a specific real-world case of a digital health application developed in cooperation between industry partners and health providers. It covers an overview of the requirements engineering background and the stakeholders specific to digital health, identifying in particular patients, medical personnel and regulators as the crucial actors in digital health RE; and it explains the concrete steps needed to bridge the gaps and engage them throughout the entire process. Next, it provides to the reader pragmatic guidelines for bringing the solution to market through an agile and flexible, digital health-flavoured and oftentimes creative RE process and explains lessons learned during one such attempt, dealing with a system for managing diabetes, which was deployed in the University Hospital of North Norway. Tips for selecting the most suitable RE techniques are given, along with insights into key challenges that should be expected in digital health, including crucial needs for establishing tacit knowledge, security and data handling considerations, engaging patients and medical personnel to increase chances for high adoption of the resulting system, focus on regulatory requirements and acquisition of ethical approvals to conduct the project. Finally, practical experience is shared with the reader based on the real-world diabetes healthcare system case, providing an insight into how such a custom digital health RE process was applied in practice.