Orthopy: knee injury app's DIGA approval

Patient information, relief for practitioners, support for rehabilitation exercises at home: the "Orthopy for knee injuries" app has recently become available as a prescription app to support anterior cruciate ligament tears and meniscus damage therapy. The app is backed by a dedicated team that has seen through its demanding approval process.

In an interview with MEDICA-tradefair.com, Hauke Rienhoff describes the app's area of application and functions as well as the approval process as a digital health application (DIGA) in Germany.

Mr. Rienhoff, for which patients is the app suitable and when?

Hauke Rienhoff: The app is suitable for accompanying therapy in the event of a rupture of the anterior cruciate ligament and meniscus damage. Both indications can occur in isolation and as a combination injury.

The app can be prescribed and used once the diagnosis has been confirmed. There is often a waiting period of between four and eight weeks for surgical procedures. It can be used to provide information, mobilization exercises and preparation for the operation. Full recovery takes up to twelve months, and the app can be used for up to a year.

What functions are there and how does the app support therapy?

Rienhoff: First and foremost is education. Through numerous knowledge articles in the blog, the app also provides information in video format about the injury and the upcoming treatment.

The second pillar of the app is the training plans. Here, patients can find out which exercises are medically advisable for them in which phase of treatment. Videos show the exact movements to be performed and the recommended number of repetitions. The third area is the progress analysis, in which training progress and improvements in pain behavior are recorded.

What advantages does the app offer for practitioners and patients?

Rienhoff: It is important to use waiting times effectively and close any gaps in care. Treatment times for acute orthopaedic injuries are long and patients are often left to their own devices. They can use the app to work on their mobility, functionality, strength and coordination as well as to alleviate symptoms and pain.

The app is free of charge for all people with statutory health insurance in Germany. Many private health insurance companies also cover the costs of the app. Prescribing the app does not affect doctors' budgets for remedies and medicines.

Patients are sent an activation code after submitting the prescription to their health insurance company. With access to the app, they can then carry out exercises flexibly and independently at home.

The app is intended as an add-on to physiotherapy and is not intended to replace it. It relieves the burden on practitioners because training at home is encouraged and therapists can concentrate on other aspects in the practice. For data protection reasons, the app data is not automatically shared with therapists. However, patients can share data independently in the form of a health report if they wish. They can also add their own videos or training plans as required.

How did the approval process for the app as a digital health application work?

Rienhoff: We received our provisional DIGA approval from the Federal Institute for Drugs and Medical Devices (BfArM) in September 2023. The preliminary clinical study required for approval took a particularly long time. The approval process is well structured and time-limited by the BfArM: As a rule, the BfArM decides on the application three months after submission.

The requirements for safety, quality and data protection are enormous. The app must comply with data protection regulations, and quality management and risk classification are also checked.

The company has grown to almost 15 employees today. We have secured external support for the approval process.