mHealth

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 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.

On January 25, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, recommending the transfer to standard care for another two completed projects. The projects relate to the improvement of the management of peripheral arterial occlusive disease (PAD) patients and the aftercare of pediatric patients suffering from chronic pain.

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.

On December 31, 2022, the Decree defining the reimbursement of medical telemonitoring activities via the new framework was published in the Official Journal of the French Republic. The Decree determines the methods of evaluation of digital solutions, registration for reimbursement, modification of the registration conditions, removal and invoicing of medical telemonitoring activities, as well as the conditions for setting the reimbursement packages.

On December 26, 2022, three 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.

On November 18, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) announced the selection of twenty-eight project ideas for Innovation Funding of the new forms of care within the framework of the two-stage application process. A total of 114 project ideas were received in response to the funding announcement of March 3, 2022, and only twenty-eight were accepted.

On November 18, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) announced that sixteen applications for Innovation Funding of the new forms of care were accepted. These applications relate to the funding announcement of March 17, 2021. Most projects relate to interdisciplinary or cross-sectoral care and pathways.