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The EU’s Digital Omnibus agreement pushes high-risk AI obligations for medical devices from August 2027 to August 2028, and standalone Annex III systems from August 2026 to December 2027. For healthtech teams in Germany, Austria and Switzerland, that extra year is a planning gift, not an architectural reprieve. TL;DR – what changed and what didn’t The provisional Digital Omnibus […]

We’ve built two production mental health platforms under both regulatory regimes. Mentalyc – an AI-powered therapy documentation tool operating under HIPAA and SOC 2 Type II in the US. Selfapy – a CBT-based digital therapeutics platform certified under BSI IT-Grundschutz in Germany, with over 120 individual security requirements met before launch. Here is what building under both frameworks actually […]

What this article covers: The technical architecture behind employer-sponsored GLP-1 benefit platforms, including multi-party insurance integration, prescription flow orchestration, eligibility verification, and the backend decisions that determine whether a platform survives at scale. Based on five years of production experience building 9am.health, a virtual clinic serving clients including Amazon, Novo Nordisk and the State of Georgia. What is a GLP-1 […]

What this article covers: The specific challenges of test automation for AI healthcare applications, including HIPAA-compliant test environments, testing audio processing and AI-generated output, BDD implementation for regulated products, and CI/CD pipelines for health apps. Includes a real case from building a QA framework for Mentalyc, an AI-powered therapy documentation platform. What is test automation for AI […]

Healthcare software in Germany, Austria, and Switzerland operates under a completely different set of rules than anywhere else in Europe. The regulatory stack is deeper, the compliance timelines are longer, and a developer who treats a healthcare project like a standard SaaS build will fail, not because they can’t code, but because they don’t understand what they’re actually building. This article […]

The healthcare industry is entering a new phase In 2025, companies developing AI solutions captured 55% of all healthtech sector funding, compared to 37% the year before (Bessemer Venture Partners, State of Health AI 2026). This growth clearly reflects the direction healthcare investment is heading and has a direct impact on how medical products are built. The focal point of […]

The healthcare startup ecosystem in the DACH region (Germany, Austria, Switzerland) is growing rapidly. Digital therapeutics, remote patient monitoring, and AI-driven medical analytics are becoming key components of modern healthcare platforms. However, building a scalable healthcare product is far more complex than developing a typical SaaS solution. HealthTech companies must manage sensitive medical data, integrate with specialized devices, […]