Latest DiGA Approval Makes HelloBetter Global Leader in Prescription Digital Therapeutics (PDTx)

Berlin, 20 April 2022 – HelloBetter Panic has recently secured approval as HelloBetter’s fifth DiGA (Digital Health Application). This is a milestone in the global accessibility of evidence-based digital mental health care. No other company has received a greater number of regulatory approvals for prescription digital therapeutics (PDTx). More HelloBetter products have and will be filed for approval in the coming months.

HelloBetter Panic is a digital therapy programme, offering quick and easy access to effective psychological support, tailored to people with a panic disorder or agoraphobia with panic disorder. HelloBetter Panic has been clinically proven to reduce the severity of panic symptoms and agoraphobia and is now available free of charge on prescription for 73 million residents of Germany.

 How Panic Disorder Impacts People’s Lives

2-3 percent of adults are affected by panic disorders and during the pandemic, this has increased significantly¹. People who suffer from panic attacks experience short periods of extreme anxiety, which is accompanied by physical symptoms, including tachycardia, dizziness and shortness of breath. Panic disorders are recurring panic attacks that usually lead to an excessive fear of future attacks, known as anticipatory anxiety. Although there are specialized treatments for panic disorders, those affected often wait a very long time for therapy or have to travel long distances for outpatient treatment. But if the symptoms remain untreated, they can take on a life of their own. Moreover, such treatments are lengthy and, therefore, considerably more expensive for the insurance provider.

“Many people affected develop various avoidance tactics over time that can encourage the maintenance of panic attacks. For example, places, situations or activities classified as supposedly risky are avoided or no longer visited alone, but only accompanied by another person,” explains Verena Schmitz, a psychotherapist at HelloBetter. Direct access to effective online programmes is of enormous therapeutic benefit, as Verena Schmitz reflects: “HelloBetter Panic offers those affected immediate and highly effective support, which they can use anytime, anywhere. This is a great help towards once again leading a full and varied life.”

 How HelloBetter Panic works

HelloBetter Panic offers straightforward and wait-free access to individualised psychological help for people suffering from panic disorders or agoraphobia with panic disorder. Based on clinically proven methods, drawn from Cognitive Behavioural Therapy (CBT), this 12-week digital therapy programme includes a total of six units, each of which takes about an hour to complete and can be completed flexibly. In addition to clinically informed psychoeducation using texts, videos and audios, the online programme conveys effective coping strategies drawn from cognitive behavioural therapy. These include, repeated confrontations with internal and external fear-inducing stimuli, cognitive restructuring, relaxation exercises, and relapse prevention. These therapeutic exercises are incorporated into the online programme and can be easily integrated into everyday life. Goals are formulated in such a way that they are individualised, realistic and achievable. After each unit, programme participants receive personal, written feedback from HelloBetter’s in-house psychologists. The online diary function, companion app and multiple symptom-checks empower the patient by allowing them to record, monitor, and evaluate their own progress.

 Effectiveness of HelloBetter Panic proven in a clinical study

Over several years and in dialogue with patients, a team of experts from science, psychotherapy and psychology has developed and successfully evaluated HelloBetter Panic. The effectiveness of HelloBetter Panic has been proven in an independent clinical study, which showed that upon completion of the programme, the severity of the patients’ panic disorders dropped by one third, on average. After six months, the symptoms’ severity had reduced even more – by an average of 52%².

 Public coverage of Prescription Digital Therapeutics in Germany and the US

HelloBetter Panic has been tested by the German Federal Institute for Drugs and Medical Devices (BfArM, Germany’s equivalent of the FDA) and marks the fifth DiGA approval in six months – a record-breaking number that proves HelloBetter’s ability to operate in highly regulated healthcare systems.

Although the public coverage of prescription digital therapeutics in Germany is still in its nascence, prescription numbers are increasing. But in order to allow for the mass prescription of DTx, prescribers and patients will need to become aware of their existence, and believe in their value. HelloBetter is tackling this challenge through investment in educating the public and medical profession about the massive therapeutic potential of its innovative products.

Germany’s DiGA model drew considerable attention to universally reimbursed prescription digital therapeutics and countries, including France and the US, are building similar frameworks. Recently, the introduction of bipartisan legislation to enable public coverage of prescription digital therapeutics in the US was announced³. The bill will establish benefit categories for digital therapeutics (DTx), and create a coverage and reimbursement framework that will provide access to millions of beneficiaries of Medicare and Medicaid.

Building the leading mental health portfolio of digital therapeutics and prescription digital therapeutics, HelloBetter is at the forefront of making evidence-based mental health care universally accessible. The company intends to introduce their digital therapy programmes into international markets.

Further information


[1]World Health Organization. (2022, March 2). Covid-19 pandemic triggers 25% increase in prevalence of anxiety and depression worldwide. World Health Organization. Retrieved April 28, 2022, from

[2] Ebenfeld, L., Lehr, D., Ebert, D. D., Kleine Stegemann, S., Riper, H., Funk, B., & Berking, M. (2021). Evaluating a Hybrid Web-Based Training Program for Panic Disorder and Agoraphobia: Randomized Controlled Trial. Journal of medical Internet research, 23(3), e20829.

[3] The Digital Therapeutics Alliance welcomes introduction of bipartisan legislation to enable public coverage of Prescription Digital Therapeutics. Digital Therapeutics Alliance. (2022, March 16). Retrieved April 28, 2022, from 



HelloBetter is one of the world’s leading providers of digital therapy programmes. The company was founded in 2015 by the psychologists, Prof. David Ebert, Dr. Hanne Horvath and Dr. Elena Heber. David Ebert, Professor of Psychology & Digital Mental Health Care at TU Munich, is an internationally recognised expert and global pioneer of digital interventions for mental health conditions. HelloBetter prevention and treatment programmes cover eight major mental health issues, including depression, anxiety, insomnia and panic. Five of the company’s digital therapeutics can be prescribed free of charge by doctors and therapists to more than 70 million people with statutory health insurance in Germany. More than 30 randomised-controlled studies on the effectiveness and cost-effectiveness of their therapy programmes have been published in peer-reviewed journals. Globally, no other provider has a comparable body of clinical evidence for the effectiveness of its solutions. HelloBetter is based in Berlin and Hamburg and employs more than 100 people. For more information, please visit 

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