Transforming Healthcare with AI-native EHR
InterSystems IntelliCare has become the first AI-native electronic health record (EHR) to receive Class IIa Medical Device Regulation (MDR) certification under the European Union’s Regulation (EU) 2017/745. This announcement was made on 19th May 2026.
Based in Boston, InterSystems is a data technology provider that powers over a billion health records worldwide. The EHR solution’s compliance with stringent EU safety and quality standards marks a pivotal advancement in healthcare technology.
InterSystems achieved this certification for its IntelliCare, a next-generation EHR designed with native artificial intelligence capabilities, and TrakCare, a globally used unified healthcare information system. The AI features are embedded into the platform’s core data layer, unlike conventional third-party AI applications.
Don Woodlock, President of InterSystems, stated, “Healthcare organisations are rightfully demanding that AI be more than just an experimental add-on. By securing the EU’s first MDR certification for an AI-native EHR, we are establishing a standard that AI should be at the core of all healthcare applications.”
Enhancing Healthcare Systems
IntelliCare simplifies governance and provides tools aimed at reducing clinician workload and burnout. It offers instant patient summaries, AI-driven clinical documentation, and intelligent workflows. Features like ambient clinical orchestration capture and structure clinical data in real-time.
The platform integrates smoothly with existing health IT infrastructures, leveraging InterSystems’ deep expertise in integration and data management capabilities. This ensures that AI capabilities are fully accessible and functional within current systems.
Founded in 1978, InterSystems continues to lead innovation in healthcare, finance, manufacturing, and supply chain management. Its technology solutions are implemented in over 80 countries, solving interoperability, speed, and scalability challenges for large organisations.
The certification of IntelliCare as a Class IIa medical device reinforces InterSystems’ position as a leading provider of enterprise-grade AI applications, instilling confidence among healthcare providers and regulators. This milestone highlights the importance of building trust in AI technology within the healthcare sector.
InterSystems’ approach moves beyond fragmented AI add-ons, providing a holistic solution that allows healthcare organisations to scale AI responsibly. The company’s commitment to integrating AI at the core of healthcare applications sets a new benchmark in the industry.
Last updated: 20 May 2026, 12:35 am
