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Regulation EU 2025/327 has been in force since March 2025. The first hard obligations land in 2029. The architecture decisions that determine your cost are already on the table. The European Health Data Space (EHDS, Regulation (EU) 2025/327, entered into force on 26 March 2025. If you’re building a digital health product in Austria and this hasn’t changed anything in your architecture discussions, […]

3 years in, many digital health engineering teams spend more roadmap time on rebuilds than on new features. The cause is usually the same. When a CTO calls us in year three, the situation usually looks the same. The product is growing, the team is stretched, and a closer look at the roadmap shows that a significant share of it is fixing […]

Austria is finalizing a reimbursement pathway for digital health applications. Most applications will fail and not for clinical reasons. We work with healthtech teams across the DACH region, and when the news about Austria’s DiHA framework started circulating in early 2026, we saw a familiar pattern in how teams responded. Founders forwarded the announcement to their product leads. Product leads told their […]

Building a regulated health product in Austria means navigating ELGA, MDR, and EHDS before writing a single line of code. Here’s what separates the right partner from an expensive lesson. A healthcare software development partner for an Austrian digital health startup should have production experience with ELGA integration, working knowledge of EU MDR software classification, and awareness of the EHDS […]

The Digital Omnibus gave healthtech teams more time on paper. In practice, if you’re building AI into a medical device, the work was already overdue. On June 29, 2026, the Council of the EU formally approved the Digital Omnibus package, pushing the compliance deadline for high-risk AI systems from August 2, 2026 to December 2027, or August 2028 for AI embedded in products […]

In most industries, an MVP can be scrappy. In healthcare, scrappy has a regulatory meaning and it usually costs more to fix than to get right the first time. What Is MVP development for a healthcare startup? MVP development for a healthcare startup is the process of building the smallest version of a digital health product that can be safely deployed to real users, validated with […]

Across production projects including mySugr/Roche (1M+ users, 52 countries) and 9amHealth, healthcare system integration breaks in predictable ways. Teams build the technically interesting layer first and discover months later that insurance billing or pharmacy connectivity was the actual revenue gate. Compliance requirements treated as late-stage tasks become re-architecture problems. AI pipelines create PHI exposure nobody modeled. These patterns […]

Austria’s electronic health record system has specific integration requirements that most development teams discover only after their architecture is already set. Here’s what to decide before you write the first line of code. Most founders building digital health products for the Austrian market spend the first few months focused on MDR classification and GDPR compliance and discover […]

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 […]