e-Health

On June 5, 2025, the French National Authority for Health (HAS) published its favorable opinion on the coverage of AI-assisted digitalized urine cytology using VisioCyt Bladder, an in-vitro diagnostic medical device, under the renewed Repository of Innovative Procedures outside the Nomenclature of Biology and Anatomocytopathology (RIHN) 2.0.

In May 2025, the National Institute for Health and Care Excellence (NICE) published two new Early Value Assessments (Digital therapy for chronic tic disorders and Tourette syndrome, AI technologies for skin lesions) and one new Late Stage Assessment (Drug-eluting stents for coronary artery disease). Furthermore, three clinical guidelines were updated.

On May 13, 2025, the Common Package of Benefits of the Spanish National Health System (NHS) was amended. The med tech-related updates mostly concerned in-vitro diagnostics, gastrointestinal, e-Health, cardiovascular, ENT, ophthalmology, oral health, and neurology fields.

In May 2025, the Dutch Healthcare Institute (ZIN) published the Trendwatch Report on Healthcare Innovations in Specialist Medical Care, identifying 316 MedTech innovations across 11 clusters, with AI-driven diagnostics, predictive models, and image-guided therapy predicted to have the highest impact in the medical specialist care, while also highlighting significant risks associated with assistive robotics and wearable monitoring technologies for inclusion in basic health insurance.

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.

On May 01, 2025, the Dutch Healthcare Authority (NZa) published the first release of the 2026 DRG package (RZ26a). Three new procedure codes, seven new supplementary payments (OZPs), one new diagnosis code, and two new DRGs will be implemented across in-vitro diagnostics, obstetrics and gynecology, neurology and neurosurgery, cardiovascular and other technology groups.

In April 2025, the National Institute for Health and Care Research (NIHR) in England released five Med Tech-related assessments in its HTA Journal, which concerned the evaluation of prognostic models of metastasis in colorectal cancer, assessment of e-Health platform for low back pain and the results of the “CONtact TrAcing in Care homes using digital Technology” trial. 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 NICE guidance.

The French National Authority for Health (HAS) released new recommendations regarding the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) following the April 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Eleven favorable opinions were published concerning the registration of new devices or modifying conditions/indications for existing ones in the LPPR List. The recommendations relate to devices in the fields of endocrine, e-health, neuromodulation, peripheral vascular, and medical aids.

On April 1, 2025, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) published its report on the utilization and development of digital health applications (DiGA) covering the period from September 1, 2020, to December 31, 2024. The report presents GKV’s key findings along with recommendations aimed at optimizing the current framework for DiGA reimbursement and regulation.

In March 2025, Small Business Research Initiative (SBRI) Healthcare announced innovations awarded through Competition 26 Phase 3 for Urgent & Emergency Care, launched in July 2024. A total of £3.9 million was allocated for the development of nine innovations, of which eight were concerned with e-health and one with in-vitro diagnostics.

On April 1, 2025, the revised EBM (German Uniform Evaluation Standard) catalog for the second quarter of 2025 came into force. The main changes introduced concern updates of the contents (services legends, preambles of several EBM subchapters) and the introduction of new EBM codes related to follow-up and evaluation of another reimbursable health app and second-opinion consultations.

On March 26, 2025, the Law to accelerate the digitalization of the healthcare system (Digital Law, DigiG) came into force.