What evidence do you need to board Germany’s DiGA Fast-Track?

Digital healthcare regulators, experts and developers discussed the Digital Health Applications (DiGA) process, and yesterday’s (24 Feb) ‘Evidence Con’ session was designed to help innovators find out more about the new evidence requirements for the assessment of digital products in Germany.

The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for the DiGA Fast-Track, which is now up and running. Fifty-five medical apps to help treat a range of conditions, such as tinnitus and insomnia, have already been listed.  


The DiGA Fast-Track was created by the 2019 Digital Healthcare Act and legislative changes mean that apps can now be prescribed by doctors and costs will be reimbursed through German health insurance. However, there are legal and regulatory hurdles to overcome before the apps can be listed and Data Protection Standards within German healthcare are strict.

Healthcare tools must meet specified criteria to be recognised as DiGA under the Digital Healthcare Act. They must conform to data protection legislation and information security; they must be interoperable and provide preliminary data on the benefits they provide. They also need to be CE-certified as medical products in the EU’s lowest-risk classes.  

Dr Wiebke Löbker, head of Innovations at BfArM said: “The idea is to gain experience with low-risk products and then go ahead with higher-risk products. We want to be in close exchange with stakeholders to improve digital health systems in Germany and Europe.”


The Digital Healthcare Act (DHA), which supported digital health innovation in Germany, will enable digital transformation of the healthcare market.


“How can we cross-pollinate the use of real-world data with the precocious policymaking in Germany?” asked Jennifer Goldsack, executive director of the Digital Medicine Society (DiMe), who was on the Evidence Con panel. She urged delegates to take the “greatest advantage” of recent changes in Germany and suggested using DiMe’s Library of Digital Endpoints and Playbook to help generate evidence.

Dr Ariel Stern, director of International Health Care Economics, at Germany’s Health Innovation Hub, has called for innovation in evidence generation to support the broad acceptance of digital health applications. She said even though the science community had previously focused on randomised control trials when it came to innovation and there was limited experience with novel designs, there were real opportunities now:

“In the US, experience and expertise is using real-world data and novel study methodologies, the international community has developed new approaches to challenges and there is an opportunity to connect the global health research community with the innovative DHA policy in Germany.”

According to Dr Richard Platt, President of the US Harvard Pilgrim Health Care Institute and Principal Investigator of the Sentinel Program, “there is an enormous opportunity to use embedded pragmatic clinical trials”. He said studies should be designed with input from health system stakeholders, interventions should be incorporated into clinical workflow, data should be collected through the electronic health record in healthcare settings, and there should be diverse representative study populations and outcomes should be important to decision makers.

Platt implemented a large randomised-control trial to improve treatment with oral anticoagulants in patients with atrial fibrillation. He said the key to conducting trials was not having to develop data on your own: “Make sure there are clinical partners who are really interested in taking this on, so you can offload to clinical services…Let the study team be responsible for outreach.

“The inference can only be as good as the underlying data, so there’s a big reward in understanding data quality,” Platt commented.

“Digital tools represent a great opportunity to improve care of people with mental health disorders. A pre-requisite is careful testing of efficacy and possible undesirable effects,” said Dr Silvia Schneider, professor of Clinical Child and Adolescent Psychology at Ruhr-Universität Bochum.

Schneider found digital tools helped improve mental health in refugee families with young children and helped improve anxiety in children with phobias. She said this was because they offered a good cost-benefit ratio, unlimited 24/7 access, high effectiveness, and blended approaches, combining face-to-face interventions with digital tools.    

Bakul Patel, director of the FDA’s US Digital Health Center of Excellence, said there were five principles of regulatory performance: patient safety, product quality, clinical responsibility, cybersecurity responsibility and proactive culture.  

He concluded: ““There needs to be transparency for the user and regulator. What level of information is appropriate? We have to look at all pieces of the puzzle, that allows us to give confidence in the product.”

The International Summit continues until tomorrow (26 Feb). 

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