e-Health

In September 2023, the following method assessments were initiated as a part of a framework for the managed introduction of innovations "New Methods" for cardiovascular, e-health, endocrine, gastrointestinal, IVD, men’s health, neurology and neurosurgery, neuromodulation, robotic surgery, and some other fields.

In September 2023, several ongoing mini-HTA assessments for e-health, gastrointestinal, IVD, neurology and neurosurgery, peripheral vascular, pulmonary and airways, and some other fields are evaluated as a part of a framework for the managed introduction of innovations "New Methods" in Norway.

Between late May and early September 2023, two 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, 49 health apps are currently available in the DiGA Directory, and six health apps were delisted from the Directory.

In September 2023, the Galician Agency for Health Technology Assessment (AVALIA-T) is working on several HTAs, including the evaluations in the cardiovascular, e-health, endoscopy, extracorporeal treatment, ICU/OR, nephrology and urology, IVD, obstetrics and gynecology, orthopedics, peripheral vascular, pulmonary and airways, surgical procedures, and some other fields.

In August 2023, Danish Regions supported establishing a new Board for Health Apps proposed by the Ministry of the Interior and Health. It is expected that recommendations from the Board will significantly impact the adoption of health apps.

In July 2023, Dutch Organization for Health Research and Development (ZonMw) awarded 13 projects under the 2024 Round of the Efficiency Research program, including four projects in surgery, two projects for imaging diagnostics and one project on the AI-based algorithms in emergency settings.

In August 2023, the Basque Office for Health Technology Assessment (OSTEBA) is working on several HTAs, including the evaluations in the cardiovascular, diagnostic imaging, e-health, ENT, ICU/OR, nephrology and urology, IVD, neurovascular, obstetrics and gynecology, surgical procedures, and some other fields.

In August 2023, NHS England announced the first technology (AposHealth) that will be supported by the MedTech Funding Mandate (MTFM) in 2023/24. MTFM supports NICE-approved, clinically effective, and cost-saving medical devices, diagnostics, and digital technologies, making it mandatory for commissioners and providers to implement them.

On July 31, 2023, the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS) at the French National Authority for Health (HAS) published the first positive opinion on the “Early coverage of digital medical devices” (PECAN) framework. The positive opinion is provided to CUREETY TECHCARE medical telemonitoring solution, which is used for medical telemonitoring of adult cancer patients under systemic treatment and/or treated with radiotherapy.

In June 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (irreversible electroporation for treating prostate cancer) and one new Diagnostic Guidance (AI-derived computer-aided detection (CAD) software for detecting and measuring lung nodules in CT scan images). Also, three clinical guidelines were updated.

On July 07, 2023, the Ministry of Health and Prevention announced the implementation of the transitional period for innovative technologies following the experiment under Article 51 of the Social Security Financing Act.

In July 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) significantly updated the process to obtain reimbursement for health apps. More stakeholders, including the industry, can now submit an application to INAMI-RIZIV for temporary or permanent reimbursement. The new process will come into force on October 1, 2023.