
Improved feedback mechanisms in DHTs could serve to improve patient safety by making warnings about potential safety issues clear at an earlier point in time. Credit: SOMKID THONGDEE / Shutterstock
Recent years have seen a broad range of artificial intelligence (AI)-assisted Digital Health Technology (DHTs) come to market. However, there is no system in place for real-time data reporting for these devices, which could highlight incidents where there are safety issues.
In a paper published in February in Nature Medicine, a research team including authors from the Else Kröner Fresenius Center (EKFZ) for Digital Health at TUD Dresden University and the UK’s Nuffield Department of Surgical Sciences at the University of Oxford, have proposed the integration of transparent and mandatory feedback collection mechanisms directly into the user interfaces of DHTs, with feedback linked to a national platform.
According to the paper, such measures could significantly improve user experience, increase patient safety by the early identification of any problems, reduce the administrative burden in monitoring tools, and heighten public confidence in devices of this nature.
A core idea of the paper is that implementing real time feedback into DHTs device around potential issues could enable them to be addressed sooner, before significant adverse events (AEs) resulting in severe injury or even death could occur.
Medical Device Network sat down with Rebecca Mathias, lead author of the paper and a researcher in the team of Professor Stephen Gilbert at Else Kröner Fresenius Center (EKFZ) for Digital Health at TUD Dresden University of Technology to learn more about the paper’s rationale.
Mathias discussed the drawbacks of current AE reporting, the barriers towards implementing real-time feedback, and the advantages such a plan could realise in enhancing the safety of AI-enabled DHTs.
Ross Law: What concerns currently exist around how DHTs are monitored?
Rebecca Mathias: The regulations we have that govern DHTs were primarily made for more traditional medical devices like hip implants or pacemakers.
But with DHTs, there is a world of difference. It is not that the European Union’s Medical Device Regulation (EU MDR) does not take this into account to some extent, but there are aspects of digital devices that still behave quite differently, and regulation doesn’t keep pace with the nature of digital devices, including in how quickly they can change, be modified, and the general pace at which they are being developed.
One of the biggest problems areas identified in our paper relates to device problems. Within the EU, manufacturers of devices classified as low risk do not have to do an in-human trial as part of their market approval process. Most digital medical devices will likely fall into this category, meaning a lot of the problems identified are only identified post-market. This puts a lot of pressure on post-market surveillance and feedback and ensuring that manufacturers observe and follow the safety of their devices once they have launched on the market.
If there is an AE, most countries have a requirement where they can be reported in a national system or on a governing platform. However, the scope of what constitutes an AE event may be unclear to users and clinicians.
The point we try to make in the paper is that if we start to gather data around potential issues with a DHT early on, there’s strength in numbers. If you have one or two users reporting a problem, maybe you don’t take it as seriously, but if there is a large number of people reporting a problem, then that’s probably something wrong with the device, and something worth paying attention to.
We consider feedback from direct users, like patients or healthcare providers, to be very powerful, and we don’t believe that their voices are being heard enough in the healthcare system that we have as it is. Regarding DHTs, rather than calling this a gap, the provision of real time feedback is really more of an advantage that digital devices could offer due to their digital nature. What’s to stop a bidirectional flow of information where users can also provide their feedback?
With this feedback, hopefully the manufacturer takes it seriously and does something about it, but there have been cases where that has not been done. If feedback was linked to a national platform, this would create some kind of accountability in the system, just by making this information public. And it’s not an improbable solution. It’s actually quite feasible in terms of technical capacity. We have an idea that we think can work; and we just need the right people, such as the regulators or those who run the national platforms, to implement it.
Ross Law: Why has this provision not been considered as more DHTs have come to market?
Rebecca Mathias: Feedback is integrated in some digital health applications, but what’s being done with that feedback really matters. It’s not enough to get feedback if it falls on deaf ears. In cases where it is present, it has not always been given the attention it deserves.
Another factor is the likelihood of pushback. In talking about radical transparency, there are going to be players in the system who would not be in favour of making data public regarding problems with their devices.
Our paper points to the prospect of app store style ratings for DHTs that exist in other marketplaces; and if companies have a good device, this degree of transparency should not be much of a concern and could even give them a competitive edge.
Ross Law: What are the biggest barrier towards implementing a real time feedback system?
Rebecca Mathias: I would say that it comes down to the plain regulatory will to make it happen. And it would not necessarily even have to be a change in legislation. If you follow the MDR, for example, within the EU, you could have an implemented act and guidance to clarify.
Feedback and post-market reports, like prompts and outcome measures are already required. We just don’t have a structured way of doing this, so I wouldn’t even say we would have to change the fundamental purpose of legislation like the EU MDR, but rather the way it is currently implemented.
This could be done in the form of guidance, but it could also be done in other ways, to incentivise manufacturers to use this approach. If we make other options seem less feasible, and we incentivise the option where manufacturers integrate this feedback into their systems, this could be a way of making it work. For example, the provision of implementing a feedback system could be made a requirement for reimbursement.
We envision this as a two-part system, in which feedback is gathered and also linked to a national platform where some amount of this data is made public and transparent.
Ross Law: What could the advantages of a system like this be?
Rebecca Mathias: With the implementation of a system like this, patients would have a voice, which has not always been given due consideration before, and this would help in identifying safety issues early on. Considering the processing power we have now, it can be just from simple thresholds and maybe even towards predictive analysis. If you bring AI in, that’s a whole different stream of how you can analyse data.
Such a system could also potentially be integrated, on a much later scale, with a patient’s health record. When we talk about unifying the patient’s data in one place, the system could also be more tailored towards extracting data from hospital systems.
A big difference between current AE platforms is that a system like this could also be used for positive feedback, where manufacturers can use it to improve the usability of their device, see what features work better and generally learn from their direct user requirements.
But the strongest factor, I would say, is that a system like this could result in improved safety for patients, which of course ends up being the most critical point in terms of life and death or injury or harm.
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