InterSystems has achieved certification showing the company’s AI-native EHR had met stringent EU safety and quality standards.

The company’s electronic health record (EHR) solutions have become the first fully-unified AI-native EHR to achieve Medical Devices under Regulation (MDR) Class IIa certification in the European Union under Regulation (EU) 2017/745. 

InterSystems President Don Woodlock said it was a “key milestone that has significant implications for how healthcare organisations can responsibly scale AI while building confidence among healthcare providers and regulators.”

Mr Woodlock said healthcare organisations were “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.”

Intellicare platform

InterSystems secured MDR certification for its IntelliCare platform, a next-generation EHR build with native artificial intelligence capabilities, as well as TrakCare – a unified healthcare information system used by healthcare systems globally. 

In a statement, InterSystems said IntelliCare differentiated itself by delivering AI capabilities that are “fundamentally designed into the platform’s data layer, rather than bolted on as third-party applications.”

“By moving beyond fragmented AI add-ons, InterSystems IntelliCare provides organisations with simplified oversight for their own governance and clinicians with tools designed to reduce workload and burnout,” the company said, noting the platform delivered “instant patient summaries, AI‑driven clinical documentation, full chat experiences and intelligent workflows that maintain a critical ‘human-in-the-loop’ safeguard.”

“Features such as ambient clinical orchestration automatically capture, structure and save clinical data in real-time and suggest clinical documentation and orders for clinician approval. InterSystems IntelliCare also seamlessly connects with existing health IT infrastructures, leveraging InterSystems deep history in integration and data management capabilities.”