Using health apps as part of a patient’s treatment regime requires evaluation and a common model of intervention and reimbursement, as with drugs. Germany already published its evaluation model (DiGA) in 2019, according to which apps can be offered to patients through national evaluation and reimbursement. France followed suit by publishing a modified version of the German model in spring 2023. Finland should also join these pioneers, the sooner the better.

According to Sitra’s studies and pilot projects, digital therapies, such as health apps, offer new ways to make an impact at the all stages of the care path, from health maintenance to disease treatment and rehabilitation. They make everyday life easier for patients and healthcare staff, provide real-time data about the progress of rehabilitation and help contain healthcare costs.

Sitra has recommended a national Finnish model for using digital apps in healthcare. However, the current situation is confusing in Finland: it is unequal for patients and opaque for companies that develop health apps. The digital therapies available to patients depend on where they live. Wellbeing services counties duplicate a lot of work in their procurement. A model based on county-specific procurement procedures is not attractive for businesses. A model based on individual procurement procedures does not encourage the creation of innovative solutions, as policies are mainly based on existing needs and not completely on new approaches. Such obstacles can be overcome through strong collaboration.

There is evidence of the use of health apps in several countries, and evaluation and reimbursement models already exist in two European countries. Using the lessons learned in other countries would be a good opportunity for us join the leaders in the field. This requires collaboration, which we are good at, and can be guided by our studies, the experience and lessons learned from our pilots – which will end later this spring – and the tried and tested models used in Germany and France.

This is how evaluation and reimbursement work in Germany and France

In Germany, the producer of a health app first applies for an evaluation from the medical regulatory body (Bundesinstitut für Arzneimittel und Medizinprodukte, abbreviation BfArM). BfArM evaluates the safety, usability, quality and compatibility of the digital therapy for three months. If the app under evaluation is supported by clinical or operational evidence, such as cost savings or greater operational efficiency, these can also be evaluated. In the absence of evidence, the applicant may collect it over a 12-month period part of normal healthcare.

Once approved, an app is included in the DiGA registry and will be granted reimbursement covering all German healthcare funded through health insurance. At this stage, healthcare professionals – in practice, doctors – may prescribe the approved digital therapeutic to their patients in the same way as a drug. The health insurance fund pays the costs.

The French PECAN model also includes remote monitoring besides health applications. PECAN also facilitates preliminary approval in case there is no sufficient evidence, similar to Germany’s model. There are some differences between the models. The German model includes class I and IIa medical devices, while the French model also includes class IIb and III devices. A higher figure indicates higher risk and requirements. In addition to broader applicability, the price of the app is determined differently in the models. In Germany, the company manufacturing the app is free to set the price for the first year. In France, the authorities have set fixed prices for different types of apps.