Interoperability in old medical devices
Are we finally seeing momentum in telemedicine with interoperable products? The latest initiatives in the Nordic countries have brought an actual market closer than ever before. It is time to consider what needs to happen to existing equipment held by citizens and hospitals.
In Denmark, the use of telemedicine has gradually become a natural element, thanks to courageous decisions and some excellent pilot projects, and not least due to a strong determination within all links of the chain. However, it is no secret that it has been a long haul to get this far, as implementation of telemedicine is far from being just a question of technology. It has been said for a long time that the technology is in place, and it is all about using the technology present. It is also a fact that there are – and have been – countless products for the measurement of the physiological parameters, which have been the focus of the projects, but when you shift just slightly away from the main focus, then the number of products becomes considerably less, especially the number of interoperable products. By interoperable we mean products capable of exchanging data through a standardised interface, enabling exchange of a product of the same type with one from another manufacturer without having to make adjustments to the receiving system.
The world we live in is becoming increasingly data-driven, and in Denmark we are at the forefront when it comes to digitalisation, so the foundation to carry out data analysis across many different kinds of data already exists. However, not all data is available, far from it, and a large amount of the collected data is stored in ‘data silos’ at a public body, a private provider, or a company in a specific segment. Many of us have tried collecting exercise data from fitness trackers and heart rate monitors. If, at some point, we change to a different model of fitness tracker and then wish to transfer the data from the old one to the new, we often find this is not possible, and that we have to start over with the recording of data, or to keep hold of the old system in order to see data. The problem is simple, but it is a real challenge for data collection in the health sector and for data about our health. There are many valid reasons for keeping data in separate storage facilities without the option of being able to combine them. This could for example be security considerations, or it could be in regard to business or competitors. The true value of interoperability becomes evident when the market is established and the number of interoperable products available is sufficient for the consumer to choose from a wide range of products or use their own device (BYOD), as well as when telemedicine is so widespread that a regular replacement of old products does not lead to a need to change existing interfaces.
What should and could happen to existing products?
In connection with the dissemination of telemedicine, more money is invested in equipment, devices, tablets and software – an investment that should be able to last for some years. Without doubt, the next generation of products will be interoperable, and with a limited lifetime for many of the products, regular replacements will be inevitable. Meanwhile – until the replacements have been implemented – there will be a need for collecting data from existing equipment. Several solutions to this problem exist, but the most obvious one would be to establish a translator from a proprietary format to a standardised format. Fortunately, most existing solutions use a mobile app solution for the collection and transfer of data, so that an update can be made in the app, and there are therefore excellent opportunities to future-proof existing products.
Increasing interest and new requirements
It is now five years since Denmark decided to base its reference architecture for collecting health data from citizens on Continua Design Guidelines, which describes the technical implementation needed to reach interoperability. This was a brave and foresighted decision, which has since been followed by many other countries, with the Nordic region at the forefront. Norway also decided in 2014 to base its reference architecture on Continua Design Guidelines, while Sweden is considering how this should be done – as are Finland, Switzerland, and Austria – while countries such as France and Spain have expressed an interest, and the UN’s standardisation organisation ITU has adopted the design guidelines as an ITU standard. The latest initiative is a joint Nordic reference architecture that was published for feedback in March 2017. However, this does not replace the national guidelines, but seeks to unify the architecture across the Nordic countries. This standardisation opens up a larger market, which is far more attractive for manufacturers of telemedical devices than just one country alone, and there is thus the prospect of more, new interoperable products on the market. One important parameter in this context is that it will be a requirement in the upgrade of the interoperability standards in the Danish Health Data Authority’s standard catalogue that interoperability and compliance with the standards will be a parameter in the forthcoming tenders of telemedicine products.