Accessibility engineering in the mhealth industry - A multi-case study

Abstract

Abstract Medical apps, i.e. apps that fall under the EU Medical Device Regulation (MDR), are increasingly becoming a relevant part of healthcare in European countries. This is particularly evident in the numerous partnerships between app vendors and insurers as well as in the launches of national reimbursement programs. However, when it comes to enabling as many patients as possible to benefit from the medical advantages associated with the use of these apps, funding is only one part of the equation. It is up to the app vendors to develop barrier-free user interfaces so that people - regardless of individual characteristics such as cognitive abilities, physical limitations or language skills - can interact successfully with the app. Little is known about how these companies approach the topic of accessibility, what challenges they face and how big the impact of medical device legislation and other regulations on accessibility is. Against this background, we are undertaking a case study in several companies offering apps on the German market that are certified as medical devices and targeted at patients. Through interviews with employees with various roles (e.g. business, engineering, design) we are aiming at reconstructing the development processes of the apps with a focus on accessibility. We plan to expand the results by interviews with experts, e.g., in the area of MDR conformity assessment. 20 interviews in four companies have revealed that accessibility only plays a minor role during development. As a result, the topic is not systematically addressed, but only a few features are implemented. The app’s compatibility with screen reader or voice control was not explicitly addressed in any of the companies. There was also no deliberate involvement of people with disabilities in user studies. The preliminary results also indicate that the influence of medical device legislation on the implementation of accessibility is negligible. Key messages • User interface accessibility has a very low priority in the mhealth companies we have examined so far. • The current regulations are not sufficient in enforcing the basic implementation of accessibility features requiring more guidance and detailed regulations, given our sample of companies.