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.
In December 2024, the Austrian Institute for HTA published a project report on the threshold values in health economic evaluations and decision-making. It concluded that, despite their complexity, implementing thresholds could enhance transparency and efficiency in health systems.
Since January 1, 2025, the Danish Healthcare Quality Institute has been established, replacing the Health Technology Council and the Regions' Clinical Quality Development Program. The Institute comprises three overall focus areas that contribute to patients receiving high and uniform quality treatment across the country and the best possible health for the money.
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 February 2024, the Skåne University Hospital is working on several HTAs, including evaluations in the cardiovascular, e-health, endocrine, men’s health, neurology and neurosurgery, orthopedics fields.
On February 5, 2024, NICE published proposed methods and processes to include technology appraisal recommendations in the clinical guidelines and launched a consultation. The deadline for submitting comments is March 15, 2024.
In December 2023, the National Institute for Health and Care Research (NIHR) in England released two MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned ablative and non-surgical therapies for hepatocellular carcinoma and hidradenitis suppurativa treatment. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.
In December 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (middle meningeal artery embolization for chronic subdural hematomas), one Technology Appraisal Guidance (Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes, and one new clinical guideline.
Continuous glucose monitoring (rtCGM) and flash glucose monitoring (FGM) for adults with type 1 diabetes have been evaluated within the "New Methods" framework since June 2023. In November 2023, a simplified method assessment report was published. On December 11, 2023, the Decision Forum for "New Methods" recommended introducing rtCGM and FGM.