BOSTON — InterSystems said its electronic health record systems have been certified as Class IIa medical devices under the European Union’s Medical Device Regulation, marking a regulatory milestone for the Boston-based health data technology company.
The company said the certification applies to InterSystems IntelliCare, its next-generation AI-native electronic health record platform, and InterSystems TrakCare, a unified healthcare information system used by health systems around the world.
InterSystems said IntelliCare is the first fully unified AI-native EHR to receive MDR Class IIa certification in the European Union. The certification indicates the platform meets EU safety and quality standards for medical devices, a step the company said could help health care organizations adopt artificial intelligence more responsibly while building confidence among clinicians and regulators.
“Healthcare organizations are rightfully demanding that AI be more than just an experimental add-on,” said Don Woodlock, President, InterSystems. “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.”
InterSystems said IntelliCare is built on TrakCare’s interoperability foundation but differs from conventional EHR systems by embedding artificial intelligence into the platform’s data layer rather than relying on third-party add-ons.
The company said the platform is designed to help health care organizations oversee AI use while giving clinicians tools intended to reduce administrative burden and burnout. Features include instant patient summaries, AI-driven clinical documentation, chat-based experiences and intelligent workflows with human review safeguards.
InterSystems said IntelliCare can also support ambient clinical orchestration, which captures, structures and saves clinical data in real time while suggesting clinical documentation and orders for clinician approval. The company said the platform is designed to connect with existing health IT infrastructure, drawing on InterSystems’ background in integration and data management.
