e-Health

In March 2023, a new ‘AI and Digital Regulations Service’ for developers and adopters of artificial intelligence (AI) and digital technologies was launched in England. Four organizations provide this multi-agency advisory service: NICE, Care Quality Commission, Medicines and Healthcare products Regulatory Agency, and Health Research Authority. The website is currently in public beta and focused on information for developers.

The Ministry of Health has commissioned the Agency for Health Quality and Assessment of Catalonia (AQuAS) to develop, with the collaboration of the various agencies that make up the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits (RedETS), a specific methodological framework for the evaluation of digital health technologies that would allow a comprehensive assessment of this type of technology. The methodological framework is in the final phase of development.

In February 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transvenous obliteration for gastric varices, biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer), one new Health Technology Evaluation (guided self-help digital cognitive behavioural therapy), and two new Medtech Innovation Briefings (LIVERFASt, and Ambu aScope 4 RhinoLaryngo). Also, one new clinical guideline was published, and one was updated.

On February 23, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, recommending the transfer to standard care for another three completed projects. The projects relate to preventing the family risk of colorectal carcinoma, shared decision-making in the hospitals, and digitally supported drug therapy management.

In January and February 2023, five 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 sickness funds.

In January and February 2023, Ordering Forum for the “New Methods” framework invited interested parties regarding several technologies proposed for evaluation within the framework. The technologies concern arteriovenous fistula for hemodialysis, deep brain stimulation, epidural spinal cord stimulation, and digital chest drain. Ordering Forum will decide whether the technology undergoes evaluation at the national level.

On February 1, 2023, the Treatment Council made its first two recommendations based on the major analysis reports regarding handheld focused ultrasound in emergency medicine and artificial intelligence as decision support for colonoscopy. The adoption of these technologies was not recommended.

In February 2023, NICE completed its first early value assessment (EVA) within the medical technologies evaluation program concerning digital cognitive behavioral therapy. EVA guidance aimed to provide quicker conditional recommendations on promising medical technologies (digital products, medical devices, and diagnostics) that address unmet national needs while more evidence is generated.

In February 2023, it was announced that the Basque Office for Health Technology Assessment (OSTEBA) initiated several HTAs, including evaluations in the e-health, radiology, nephrology and urology, cardiovascular, IVD, obstetrics and gynecology, diagnostic imaging, radiotherapy, neurovascular, ENT, interventional radiology, surgical procedures, and some other fields.

In the fourth quarter of 2022, Health Technology Wales published three MedTech-related guidance (Left atrial appendage occlusion in patients with atrial fibrillation, continuous topical oxygen therapy, and virtual reality distraction therapy). Four Topic Exploration Reports were released as well (virtual wards, genetic testing for prostate cancer, autofluorescence imaging, and geniculate artery embolization); however, Health Technology Wales decided not to proceed with complete appraisals on these topics.

In January 2023, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (percutaneous image-guided cryoablation of peripheral neuroma, laparoscopic insertion of a magnetic ring, transcutaneous electrical stimulation of the trigeminal nerve, and trabeculectomy with a biodegradable collagen matrix implant ), two new Diagnostic Guidance (devices for remote monitoring of Parkinson's disease, MRI-based technologies for assessing non-alcoholic fatty liver disease), and three new Medtech Innovation Briefings (PredictSURE IBD, Ambu aScope 4 Broncho, and Aquablation robotic therapy). One MedTech-related clinical guideline was updated.

The updated German Uniform Evaluation Standard (EBM) catalog came into force on January 1, 2023. The EBM catalog (Einheitlicher Bewertungsmaßstab) regulates the reimbursement of services in the public outpatient sector in Germany and is updated once a quarter (four times a year). Among other changes, a new code for "zanadio" health app for follow-up and evaluation was introduced in the catalog.