Digital health from a standardised perspective
Sharing data is still a challenge in the healthcare system. If we want an even more effective healthcare system we need to put emphasise on data sharing without compromising on the security aspect. Continua, a reference architecture, focuses on how to solve this interoperability.
However, there are many challenges in getting health care systems to interlink. Data formats must fit together, received data should be reliable, and there should be an overall control of who has access to which data. This is particularly important when it comes to potentially sensitive data, such as medical histories and personal ID numbers.
There are many different solutions to this problem; Sundhedsplatformen ("The Health Platform") is the newest on the block. Here, a significant proportion of the healthcare sector's and hospitals' administrative systems are combined in a single package, making it easier to access journals and to book appointments.
New technology, more effective treatments
The new "super-hospitals" are designed to take advantage of many of the latest technologies,so that the patients can receive the most effective treatment. This results in shorter hospital visits, and a reducion in costs per patient. From a financial perspective, this is extremely important to the healthcare system. Furthermore, there will be less beds in the new hospitals, which will count on out-of-hospital treatment (e.g., in the patient's own home) to minimise the need for beds.
Based on the above, we can draw two important conclusions:
- There is a growing need to make health data easily shareable between different parts of the healthcare sector.
- Patients need opportunities to manage their own treatment outside hospitals.
For this to be possible, an infrastructure is needed that will allow e.g. glucose monitors and EKG devices to share measurements directly with the healthcare sector's systems, so that doctors and specialists easily and quickly can react when necessary. From the perspective of public finances, these solutions must not all originate from a single supplier, since one cannot expect a single supplier to be capable of delivering the best solutions within every area. It should also kept in mind that a solution provided by a single equipment supplier could lead to the healthcare sector being monopolised by this supplier, with no opportunity for small and medium-sized businesses to participate.
An external solution with a standardised reference architecture
Technology exists, however, to make this data sharing, or interoperability, possible, using devices located outside of hospitals. This interoperability works across systems, technologies, and suppliers. It is called Continua.
Continua is a reference architecture working on solutions for interoperability in the field of "telemedicine", developed by the Personal Connected Health Alliance (PCHA). The main goal is to create a standardised reference architecture that developers can follow to ensure that their solution will be able to communicate with others developed in the same way. This is accomplished through three main elements: the Continua Design Guidelines (CGD), the Continua Enabling Software Library (CESL), and the Continua Test Tool. Of these, the Design Guidelines are the most important.
The Design Guidelines describe the requirements imposed on each area of the product one wishes to develop. These requirements may include the type of metadata that must be present for a particular measurement, or what kind of security must be used for a Bluetooth connection. These requirements are all based on existing, recognised international standards, such as IEEE-11073, the USB specifications, HL7, and others. These standards are profiled by the Personal Connected Health Alliance (PCHA), and collected in the Continua Design Guidelines (CDG).
Sample software and test solution offer support
To help developers get started, there is a software package called the Continua Enabling Software Library. This package contains reference implementations for a large portion of the solutions described in the CDG. These are available both as small sample programs that can be run on a Windows PC, such as to test a solution in development; as well as in the form of source code that can be freely used in one's own implementation, in one's own product.
To ensure that a newly created implementation conforms with the CDG, the Continua Test Tool is useful. This testing tool verifies that a particular solution meets the requirements that apply to an individual product. The testing tool is also used for product certification. Once a product has been developed, it can be sent to Continua's testing laboratory. If the product passes, the developer receives a certificate and the right to use the Continua logo on the product, signalling that it meets the applicable requirements and can function in the Continua system, together with other Continua devices.
Together, the guidelines, testing tool, and software references provide information about how to implement a product within the reference architecture. They also ensure that a product complies with the requirements for the particular type of product being developed.
Exchanging measurement data and documents
Besides implementation guidelines, Continua also works with three categories of functionality within the reference architecture:
- Personal Health Devices Interface, which covers measurement apparatus like blood pressure meters, EKG devices, glucose meters, etc.;
- Services Interface, which covers the exchange of metadata and questionnaires over a network connection;
- Health Information Service Interface (HIS), which allows for the exchange of documents like blood test results, patient journals, etc.
The three functionality categories makes it possible to deliver a small part of a large system without requiring deep insight or co-operation with other actors or designers of the systems an individual solution will need to communicate with.
It is possible to combine Continua-compliant products from different providers into a single solution that can be used e.g. for monitoring COPD patients in their own home, ensuring that elderly patients take their medicine each day, or that they get out of bed.
Continua influences national strategies
Continua has already made an appearance in various national strategies for telemedicine solutions. Denmark's National Action Plan for Expanding Telemedicine (2012) refers to Continua, and the Health Data Administration is a member of the PCHA. In general, Continua has many followers in the Nordic countries. Norway has been represented in the PCHA since 2014, and Sweden has been a member through its Association of Local Authorities and Regions since 2016. Other countries, such as Finland, Austria, France, Spain, Switzerland, and India have also expressed interest.
A lack of followers is where Continua comes up short. There have been a number of successful pilot programmes using Continua solutions in Denmark, but finding the right products for a solution is often a problem, since there are few that meet the requirements. One of the reasons for this might be that there are no formal, legal requirements regarding product interoperability. This leads producers to see no incentive to implement Continua in their products. The lack of Continua products in turn means that public bodies cannot or do not wish to require Continua solutions when creating telemedicine offerings.
One of the arguments against producers certifying their products has been the costs associated with doing so. Recently, the PCHA has responded by creating a branch of the certification programme that allows producers to independently declare compliance with the guidelines, at no cost. However, this means that the business itself then bears the risk of ensuring that the supporting documentation is enough to make that declaration valid.
The challenges posed by a lack of clear requirements for product interoperability include the costly intermediaries that must constantly be developed (and maintained) in order to ensure that systems will be able to communicate without requiring manual, copy-paste work.
In the long term, it is difficult to say whether the solution will be Continua or something similar, but it is fairly certain that neither Denmark nor other European countries will support the appearance of monopoly-like conditions in the healthcare sector, allowing options (and costs) to be dictated by a single supplier.
However, producers of technical medical equipment have good reasons to look further into Continua if a more digitalised product is desirable:
- Best-practice standards are referenced
- There is a single architecture for the various elements of a system
- Digitalising a product leads to knowledge of the challenges one faces.
The reference architecture can also be used as inspiration for how a digital healthcare system can be put together in such a way as to ensure that the best products from different suppliers can be connected, without requiring large amounts of resources to get them all "talking to each other", or requiring burdensome work copying data between different systems.