Digital medicine: apps on prescription

In the future, the doctor can prescribe medical applications for cell phones or PCs at the expense of statutory health insurance

Digital helpers: Whether on cell phones, tablets or computers - special health applications can help patients cope better with illnesses

© GettyImages / Sitthiphong Thadakun, W & B / Dr. Ulrike Möhle

Germany wants to be a pioneer. And that of all things in the field of digital medicine - where Germany has lagged behind other countries for years. With the Digital Supply Act, the Bundestag paved the way for digital health applications (DiGA) in 2019.

In the future, doctors should be able to prescribe them like drugs at the expense of statutory health insurance. So apps on prescription. A world first. But what is behind the applications? How are they approved? And how does the patient get the applications?

Low risk medical devices

Even experts find it difficult to answer these questions in detail. "We are breaking new ground," says Dr. Henrik Matthies, Managing Director at the Health Innovation Hub of the Federal Ministry of Health. "The next few months will be very exciting."

DiGa are programs or other digital technologies that are mostly operated using a mobile phone, tablet or PC. "They can be used to detect, alleviate or treat diseases," says Henrik Matthies.

"These are low-risk medical devices." They help, for example, to deal with pain better, remind you to take medication, document blood sugar levels or provide support with speech or physiotherapy.

Certification as a medical device

"Many doctors are open to the use of health apps. But here it is important to separate the wheat from the chaff," says Norbert Butz, digitization expert at the German Medical Association in Berlin. Strict standards would have to apply. Health applications are a risk if they do not work, work incorrectly or transmit confidential data to third parties.

So that DiGA can be prescribed on prescription, they must be checked by the Federal Institute for Drugs and Medical Devices (BfArM) and added to the "DiGA directory". The BfArM should prepare this by January 2021. Both doctors and psychotherapists who prescribe the apps and patients have access to it - via the Internet.

The exact test criteria for DiGA are currently being determined. "The technology has to be certified as a medical product in Europe, so function and safety have already been tested," says Henrik Matthies. The BfArM also looks at quality, user-friendliness, data protection and security.

Demonstrate medical benefit

The provider must plausibly demonstrate that his product has a positive supply effect - i.e. it improves the health and / or quality of life of the user. If a manufacturer cannot prove this when submitting the application, but the DiGA fulfills the other requirements, the application can be temporarily included in the directory. "Within a year, the provider must explain the positive effects, otherwise the DiGA will be removed from the list," says Matthies.

Many medical professionals criticize this regulation. "It is imperative that digital health applications demonstrate their medical benefits before they can be used in standard care. How else should doctors and patients trust them?", Says Norbert Butz.

Health applications could still be prescribed in 2020

The National Association of Health Insurance Funds joins the criticism. He also fears that the cash registers will face expenses that are difficult to calculate. Because if a DiGA is in the directory after the first check, it must be financed for one year for the time being - at the price specified by the manufacturer. At the same time, price negotiations between the umbrella association and the provider begin.

The BfArM assumes that the first test procedures will start in the second quarter of 2020. If the manufacturer provides all the necessary documents, they should not take longer than three months. This means that the first digital health applications could be prescribed in the course of the year.