In late 2019, Germany’s parliament passed the Digital Health Care Act (Digitale-Versorgung-Gesetz, or DVG) — an ambitious law designed to catalyze the digital transformation of the German health care system, which has historically been a laggard in that area among peer countries.
It is already leading to meaningful changes and will be a boon to the development and evaluation of digital health tools as well as the generation of insights into the value they create.
In the immediate wake of the DVG’s passage, the Covid-19 pandemic has further underscored the need for safe and effective digital tools to support remote patient monitoring and care delivery worldwide.
The timely introduction of the DVG means that Germany is poised to set an example for other countries in seeing what works (and what does not) in the adoption and diffusion of digital technologies for improving patient outcomes.
Perhaps the DVG’s most important provisions are its formalization of “prescribable applications” (Digitale Gesundheitsanwendungen, or DiGA), which include standard software, SaaS, and mobile as well as browser-based apps, and the creation of the Fast-Track Process, an accelerated regulatory path for companies to take their digital health applications to market.
Following a streamlined review, an app can be added to a central registry of apps that can be prescribed by physicians and psychotherapists and will be reimbursed by all of Germany’s statutory health insurance providers, which cover 90% of the population, or roughly 73 million individuals.
The Fast-Track process is run by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, or BfArM), which plays many of the same roles in Germany that the FDA does in the United States); BfArM also maintains the DiGA registry.
The first five apps have already been added to the registry and offer support for patients to manage conditions including tinnitus, obesity, agoraphobia, osteoarthritis, and insomnia.
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