ARTICLE SUMMARY:
Germany’s high-profile DiGA legislation has successfully encouraged digital therapeutics innovation, according to two new studies, although critics say it still leaves room for improvement. The US company Enovis, which embraces digital therapeutics as a promising business, and its German start-up partner Orthopy are testing the DiGA waters in what Enovis considers to be an important ex-US market opportunity.
“Digitale Gesundheitsanwendung,” the name of Germany’s digital health legislation (DiGA for short), is complicated—especially for English language speakers. Its goals, however, are to simplify and standardize the daunting process for evaluating the plethora of rapidly evolving digital therapies—a challenge that faces regulatory bodies, including the FDA, healthcare systems, and entrepreneurs worldwide. (See “New German Digital Health Law Kick Starts Adoption of Tools and Services,” Market Pathways, March 1, 2020.)
Almost four years ago, Germany implemented DiGA, a fast-track regulatory and reimbursement pathway for products that the US would classify as software as medical devices. At the time, German public health insurers, known as statutory sickness funds, were grappling with how to assess the value of an overwhelming number of new healthtech apps, most launched with little evidence to support their clinical or operational utility. By laying out a guidance of this type, authorities hoped to encourage the development and faster uptake of new technologies that would have a meaningful impact on the care of 73 million insured persons, almost 90% of Germany’s population.
