Health technology assessment

In April 2025, the proposals to improve the New Methods framework processes were published by the Norwegian authorities. The key changes include revised enter pathways and selection criteria for assessment of medical devices within the framework. The proposals are open for public comment until May 18, 2025.

On March 4, 2025, the Member State Coordination Group on Health Technology Assessment (HTACG) published submission (‘briefing’) templates for Joint Scientific Consultations (JSC) of medical devices and in-vitro diagnostics under the EU HTAR framework. Health Technology Developers submit completed briefing templates as part of the briefing package to be considered for JSC. The JSC Outcome Document template was published as well.

In March 2025, the Health Sciences Institute in Aragon released a document that provides guidance on incorporating real-world data into health technology assessment, focusing on the preadoption phase for evaluating new technologies in the Spanish Network of HTA Agencies (RedETS) framework. It outlines a workflow aligning with RedETS practices, identifying key milestones where RWD adds value and offering methods and tools to integrate RWD into decision models.

On February 25, 2025, the Institute for Quality and Efficiency in Health Care (IQWiG) presented an updated draft version (8.0) of its general methods. Interested parties can submit written comments until April 29, 2025.

In February 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in cardiovascular, endoscopy, pulmonology, and general surgical fields.

On February 7, 2025, the National Institute for Health and Care Excellence (NICE) published a manual for a new HealthTech program and launched a consultation. The HealthTech program will produce two types of guidance: Interventional Procedures guidance and HealthTech guidance (replacing former Medical Technologies guidance and Diagnostics guidance). The deadline for comments submission is March 6, 2025.

On January 24, 2025, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the EU HTAR framework.

In January 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in surgical procedures, ophthalmology, men’s health, and orthopedics.

Starting January 12, 2025, Norway joined the EU Health Technology Assessment Regulation (HTAR) framework, a collaborative European initiative for method assessments. In 2024, a national working group assessed how to integrate HTAR into the "New Methods" framework. The Norwegian Medical Products Agency (NOMA) will be the key organization representing Norway and contributing to the development of Joint Clinical Assessments (JCAs) of medicines and medical devices.

On December 3, 2024, the Member State Coordination Group on HTA released the 2025 Annual Work Programme for the new joint EU-level HTA framework (Regulation on Health Technology Assessment, HTAR). The framework will be fully operational from January 12, 2025.

In December 2024, the Skåne University Hospital (HTA South) is working on health technology assessments in several areas, including men’s health and neurology.

In November 2024, the HTA body of the Tuscany Regional Healthcare published five rapid HTA reports (four new assessments and one reassessment) of medical devices in the cardiovascular, ophthalmology, ENT, and dermatology areas.