Following the publication of their Viewpoint article (Open Access) in the Journal of Medical Internet Research, JMIR mHealth uHealth, CHI+MED researchers Chris Vincent and Katarzyna Stawarz from UCL’s Interaction Centre have written the blog post below to introduce it. The JMIR article was jointly written with their colleagues Gerrit Niezen from Swansea University’s FIT Lab and UCLIC’s Aisling O’Kane.
The article looks at the tension between patient benefit from and regulatory oversight for newer, innovative technologies using as examples 3D printing, customisable medical devices and smartphone apps.
The full paper can be read freely at the journal’s website, which also keeps a record of its popularity on Twitter, with a ‘Tweetations‘ (Twitter citations) tab.
New Viewpoint: Can Standards and Regulations Keep Up With Health Technologies?
3D printing, customisable medical devices, and smartphone apps are creating new opportunities for personalised healthcare and changing the ways people manage their health. Some of these new technologies are supporting a move away from hospital-centred care towards the home, increasing patients’ independence and helping to control the burden on healthcare providers.
Health related technologies: Brave new world?
There are many benefits to the above technologies, but changes in health management also create challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly. On one hand, putting in place checks to make sure that solutions work seems obvious. We all get annoyed when software fails to work in the way we need it to or gives the wrong results. In healthcare, the consequences can be serious, for example an app might incorrectly detect a cancerous mole which can cause unnecessary stress.
Although such accounts can be concerning, no one wants to delay the introduction of new technologies when people are likely to find benefits. It could be wrong to get in the way of new processes or technologies that are suitable but don’t yet fit in with existing approaches to regulation.
In our latest viewpoint article, Can Standards and Regulations Keep Up With Health Technology?, we discuss some of the challenges to regulating new types of health technologies. We give three examples of novel medical technologies (3D printed medical technologies, customisable medical devices and smartphone apps) that illustrate the types of issues that can arise and suggest opportunities for improvement.
Below we highlight some of the main points, but invite you to read the whole article.
Open hardware and 3D printed devices
Open source hardware is an increasingly popular way to create medical devices within the maker community. Although existing mechanisms of control might not fit well with the rapid turnaround that 3D printing technology provides, the benefit in allowing for a customisable prosthesis or bespoke medical devices is huge. By opening up the design documentation, and making it publicly available, not only can others benefit from a solution but they can also help to review it.
Our article also examines the way that medical technology is evaluated in terms of social needs. Allowing customisation of a medical device can improve its fit with people and their surroundings. For example, changing the exterior shell of a device so that it looks less like a piece of hospital equipment and more like a consumer product, or adapting appearance to be discrete (or indiscrete, depending on circumstances) can make people feel more comfortable and at ease during many social situations. Usability evaluation processes don’t always accommodate these aspects and we discuss what could be done to address this.
Regulating smartphone apps
Finally, we discuss issues with regulating smartphone apps. As the number of available health apps is increasing, it becomes more difficult to decide which ones are suitable and what sort of evaluation is required. Although regulatory guidance has been updated to address this, using medication adherence technology as an example, it can be tricky to know when the device regulations do and don’t apply. As a result, such apps are more or less unregulated. We outline the confusion that can arise when following classification schemes and highlight the fact that developers often side-step the process through use of disclaimers. This makes this topic a difficult one to address and we give suggestions regarding an increasing need for in situ monitoring.
These are just some of the challenges that are introduced by new medical technologies. We hope our article is a starting point to bigger discussion.
Can Standards and Regulations Keep Up With Health Technology? by Chris Vincent, Gerrit Niezen, Aisling O’Kane and Katarzyna Stawarz