Author: Florian Stieglitz, Consultant, Market Access

Artificial intelligence (AI) is reshaping how regulators, payers, and manufacturers interact with evidence. The Joint Clinical Assessment (JCA) under the new EU HTA Regulation will soon demand faster, more coordinated, and more transparent assessments than ever before. 
At Kintiga, we believe AI is indispensable to achieving this ambition — not just supportive, but foundational. 

The Shift: How Regulators Are Embracing AI 

Across Europe, the direction is unmistakable: 

• The German Federal Institute for Drugs and Medical Devices (BfArM) is leveraging AI for safety signal detection, interoperability, and real-world data analytics, creating the technical foundation for smarter regulatory processes. 

• The German Federal Joint Committee’s (G-BA) Innovation Fund is exploring AI acceptance among physicians and patients and piloting machine learning in quality measurement. 

• The EMA, together with national agencies, has launched its Data and AI in Medicines Regulation to 2028 work plan — preparing for AI-assisted benefit assessments and dossier evaluations similar to the FDA’s AI-driven scientific reviews. 

These initiatives all point to one truth: the future of health technology assessment will be AI-augmented. 

Why AI Is Essential for the JCA 

The JCA will challenge every stakeholder, national authorities and industry alike, to deliver robust, harmonized assessments under unprecedented time pressure. Traditional processes will no longer suffice. 

New technological approaches are required to: 

• Free resources and reduce manual burden 

• Enable iterative, strategic decision-making 

• Simplify complexity and ensure consistency 

• Maintain accuracy and high-quality value communication under tight timelines 

• Avoid waste and duplication of effort 

AI enables precisely that, driving both efficiency and quality at scale. 

Kintiga’s AI Suite: Redefining What’s Possible 

At Kintiga, we are defining tomorrow through our AI Suite, a modular ecosystem designed to combine scientific rigor with digital speed. 

• Automation Scripts – Execute predefined tasks such as renaming files or querying databases to streamline repetitive workflows.
• Prompt Engineering – Craft precise, domain-specific inputs that guide large language models (LLMs) toward accurate, regulator-ready outputs.
• Agentic AI – Our autonomous systems leverage LLMs and retrieval-augmented generation (RAG) to handle complex workflows like pricing and reimbursement analytics.
• High-Tech AI Tools (EPRI) – Our innovative solution, EPRI (EndPoint Result Interpreter), transforms clinical data into structured, accurate, and compliant HTA dossier content with exceptional precision and speed. 

With EPRI, we are already achieving what health authorities are still piloting, automated yet expert-supervised interpretation that ensures efficiency without compromising scientific integrity. 

AI in health authorities is no longer experimental, it is a signal of what’s next. In the EU HTA era, mastering the JCA efficiently and without waste will depend on the strategic use of AI. 

At Kintiga, we are ready to combine deep regulatory insight with the next generation of agentic AI to deliver faster, smarter, and high-quality assessments for Europe’s evolving healthcare landscape. 

Sources:  

1. BfArM: BfArM – Pressemitteilungen des BfArM – Gesundheitsstandort Deutschland: „Nicht nur innovativ bleiben, sondern Vorreiter sein“
2. G-BA: Versorgungsforschungsprojekte: Neue Erkenntnisse zur Akzeptanz von KI-Anwendungen, zu Hybrid-Qualitätsindikatoren und zur Barrierefreiheit bei Autismus-Spektrum-Störungen – Gemeinsamer Bundesausschuss
3. Tagesspiegel: Künstliche Intelligenz (KI): Große Offenheit für KI-unterstützte Zulassungs- und Nutzenbewertung – Tagesspiegel Background