Is extreme regulation jeopardizing the profitability of digital health applications (DiGAs)? Recently, further proof of data protection and data security must be provided at short notice – this means new costs for product adaptations and certifications, which are likely to hit not only digital health start-ups but also manufacturers of already listed DiGAs hard.
“That doesn’t have to be the case – there is a plan B,” says Christoph Eberhardt, CEO of fluidmobile GmbH. Together with his team, he has developed a cost-effective solution that ensures digital therapies are fully compliant with MDR and DiGAV right from the start, as well as the BfArM (Federal Institute for Drugs and Medical Devices) test criteria for data protection and proof of data security in accordance with TR-03161: The infrastructure platform mHealth Suite.
Your digital therapeutic agent CE-ready in 8 weeks – this slogan pretty much sums up the mHealth Suite program: “We have thus removed a blocker to innovation,” explains the entrepreneur, “because the product development from our indication-agnostic software technology is watertight from a regulatory perspective. “Sustainable value!”, emphasizes Christoph Eberhardt – because the product grows effortlessly with further development and scaling requirements.
“We can pass onthe cost benefits of our structured and highly automated requirements and documentation management to the therapy providers.” MDR-compliant technical documentation can be created for the respective medical purpose in the shortest possible time – creating customized healthcare products for the specific medical content and therapy logic.
This means that more patient-centered therapy offerings can finally be brought into healthcare – whether as a prescribable digital health application (DiGA) for the German reimbursement model, possibly with planned scaling to other European markets, or as a serious medical product in selective contracts or B2B with the option of later submission for DiGA approval. Decentralized therapies, therapy support, the promotion of health literacy and application optimization as digital offerings – with and without the involvement of medical technology devices – are a real added value for patients.