HTA

On July 14, 2025, NICE published a HealthTech program manual. A new program will combine the former Medical Technologies Evaluation and Diagnostic Assessment programs and the Interventional Procedures program. The HealthTech program will produce two types of guidance: HealthTech guidance for devices, diagnostics, and digital products, and Interventional Procedures guidance. A life-cycle approach will be utilized for assessment and recommendations: early use, routine use, and existing use (late stage assessment).

In June 2025, the Skåne University Hospital (HTA South) is working on health technology assessments in several areas, including diagnostic imaging, e-health, in-vitro diagnostics, men’s health and neurology.

On June 2, 2025, the submission period for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework opened. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future Joint Clinical Assessment (JCA). Requests related to both medical devices and medicines can be submitted until June 30, 2025.

On May 5, 2025, the Belgian Health Care Knowledge Centre (KCE) opened its annual call for topic proposals for the 2026 research program, which includes Clinical Guidelines, Health Technology Assessments, and Health Services Research. Interested stakeholders can submit the proposals by June 30, 2025.

In the first quarter of 2025, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) published two health technology assessments in the robotic surgery field and proceeded with working on HTAs in the e-health, endocrine, and neurosurgery fields.

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 21, 2025, the “New Method” framework published an annual summary of the Decision Forum and Ordering Forum work in 2024. Among 109 coverage decisions in 2024, only one was for Med Tech (Oncotype DX), while all others concerned pharmaceuticals.

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.

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.