e-Health

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.

On March 19, 2025, the NHS Innovation Accelerator (NIA) announced 28 new innovators (“Fellows”) with healthcare solutions awarded to join the program in 2025. NIA provides intensive, tailored support to proven healthcare solutions, helping to accelerate their adoption and maximize their impact across the NHS. Awarded innovations concern e-Health, in-vitro diagnostic, gynecology, neuromodulation, and sustainability.

Between late February 2024 and early March 2025, seven more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, 59 health apps are currently available in the DiGA Directory, and ten health apps were delisted from the Directory.

In February 2025, SBRI Healthcare, funded by the NHS Accelerated Access Collaborative, announced the results of three competitions. Funding of £1.3m was allocated for the development of 14 innovations that support women’s health, £1m for the development of 11 innovations that improve infection prevention and control to mitigate the spread of antimicrobial resistance, and £3 million to support four innovations that improve the health and well-being of children and young people who have asthma, epilepsy, or diabetes.

In February 2025, the MTP Council announced national evaluations of two technologies within the Orderly introduction framework in Sweden. The Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation of rectal spacers (SpaceOAR Hydrogel and Barrigel) used during radiotherapy in prostate cancer (re-evaluation) and AI-based solution (Stratipath Breast) for breast cancer risk assessment.

On February 4, 2025, the French National Authority for Health (HAS) published its 2025-2030 strategic project. The document outlines current challenges and opportunities in the health system, defines three strategic priorities, and identifies three key areas in which HAS intends to increase its investment over the next five years.

In February 2025, seven health apps reached Level 3+ of the mHealthBelgium validation pyramid, meaning regular reimbursement. These apps can only be reimbursed within the specific care pathway “Remote monitoring and therapeutic guidance in chronic heart failure”.

On January 24, 2025, the Innovation Committee at the Federal Joint Committee (G-BA) published the determined funding priorities for projects on new forms of care (for single-stage process – open topic and for two-stage process – nine topics).