Arendalsuka invites you to a debate about patient apps. How can such apps become a safe and integrated part of the healthcare services of the future? Experience the event online or in person in Arendal!
Caption: Patient apps can support disease management – but the road to safe use is long. How can apps with proven efficacy benefit patients faster? Photo: Nicolas Tourrenc/ Diakonhjemmet Hospital
Research at Diakonhjemmet Hospital shows that many patients want apps that make it possible to be followed up wherever they are – at home, at the cottage or at work. With the right support, patients can save travel time, avoid absences and receive just as good follow-up from specialist healthcare services as in traditional solutions.
But the path from research to actual use in healthcare is long – characterized by unclear and poorly adapted regulations.
Germany has come a long way along the path, but we will come back to that.
Happy Hands – an app that helps, but faces obstacles
At Diakonhjemmet Hospital, researchers have developed Happy Hands. The app is designed to support people with hand osteoarthritis in managing their everyday lives. It was developed in collaboration with the Norwegian Rheumatology Association and the patients themselves. It provides knowledge, exercises and tools that can be used at home.
“Patients who have used the app have experienced less pain, better hand strength and increased function,” says advisor Marie Skovli Pettersen. She works at the Unit for Health Services Research and Innovation at Diakonhjemmet Hospital. She adds that patients who have been involved in the research project want to continue using the app.
They can't.
Although it has been tested in clinical research and is classified as low-risk, it is still defined as a medical device. This means that it must be CE marked on the same level as medical devices that are more advanced and associated with greater risk – such as hip replacements. It is a time-consuming and expensive process, which makes the path to patients long.
Pettersen says that researchers are finding that apps that are safe, in demand and documented to be useful for patients end up in the pilot graveyard because it becomes too challenging to certify and operate them.
App jungle without a compass
Today, there is a plethora of such apps on the market. Some provide general health advice, while others in practice offer the processing and sharing of sensitive information – without necessarily meeting strict quality standards.
– Different requirements are placed on apps depending on whether they are defined as medical devices or not, explains Pettersen.
This allows developers to avoid regulation by defining the app's purpose as, for example, exercise or entertainment - even if the app is in reality used for health purposes.
The purpose of the app therefore determines which regulations apply. Apps with medical purposes must be classified as medical devices and are then subject to strict EU regulations. This applies in particular to disease-specific apps that provide the user with feedback based on recorded data.
Health apps without a medical purpose fall outside of these regulations and meet far fewer requirements before they can be offered to patients and users.
– Many developers choose the easiest and cheapest route to market, without considering risk. Others give up on getting good solutions approved because the regulations are too cumbersome and costly. This can affect both patient safety and innovation, says Pettersen.
Experiences with apps from Germany
During a recent visit to Diakonhjemmet Hospital, German Dr. Johannes Knitza gave a presentation on artificial intelligence and digital tools in patient care. He is one of Europe's most influential researchers in digital rheumatology.
Germany is one of the first countries in the world to create a public scheme to approve and finance patient apps as part of the public healthcare system. This scheme is called the DiGA system. DiGA stands for "Digitale Gesundheitsanwendungen" (digital health applications) and is part of the Digital Healthcare Act, which came into force in Germany in 2019.
Knitza said that this gives approved apps the status of medical aids. This allows doctors to prescribe them with a prescription, with reimbursement from public health insurance. However, he said that it was not as easy to get reimbursement. This may be one of the reasons why the apps are not as widespread in patient care.
– We're getting there, but it's going slowly, said Knitza.
It seems that a national scheme with clear criteria makes it easier for both developers and healthcare services to know what is required. Fast-track solution for low-risk apps means that innovation is not so easily stifled by strict regulation. Patients can access documented, safe digital tools – with support from the healthcare system. With regulation, healthcare services have better control over which apps are used and how they work.
– But to achieve this, we need politicians and health authorities on the team, says Pettersen.
Debate during Arendal Week
Tuesday, August 12th at 8:00–8:45 am, Diakonhjemmet Hospital and the University of Agder will host a debate during Arendal Week: "Patient Stages – the New Wild West?"
📍 UiA tent, Langbryggen 13
Here, the specialist health service at Diakonhjemmet Hospital, the patient represented by the Norwegian Rheumatology Association, the Directorate of Health and politicians will discuss these issues.
👉 We ask questions like:
- How can we ensure patient safety without stifling innovation?
- How should app-supported healthcare be organized – and who should pay for what?
- Should Norway follow Germany's example and introduce a fast-track for low-risk apps?
