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.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 3844 of March 02, 2023, Tuscany Regional Healthcare has published assessments of four medical devices in the cardiovascular and neurovascular treatment areas.

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.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 1756 of January 25, 2023, Tuscany Regional Healthcare has published assessments of two medical devices in the orthopedics, surgical procedures, and cardiovascular treatment areas.

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.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in February 2023. Twenty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, neurovascular, ophthalmological, spine, and orthopedic devices, surgical procedures, as well as medical aids.

On February 17, 2023, the National Agency for Regional Health Services (AGENAS) invited applicants to submit proposals for the evaluation of medical technologies within the National HTA Program for Medical Devices (PNHTADM).

In February 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the completion of a pilot project for gene expression profiling (GEP) tests in early-stage breast cancer, which ran from 2019. The pilot showed significant benefits, and INAMI-RIZIV launched a reimbursement for certain tests under the specific agreement (GEP convention) with healthcare providers.

Australia is a complex country from a market access perspective. The main aspects of the healthcare system are centralized, with minor differences among states and territories. Hospitals are financed by both the states/territories and the Australian Government, and they receive budgets adjusted for DRG and outpatient activities. Physician activities are reimbursed separately according to the Medicare Benefits Schedule. HTA framework is incorporated in the process of inclusion of new services in the Medicare Benefits Schedule.

On February 7, 2023, the entity working on the new out-patient flat-rates, Solutions Tarifaires Suisses AG, announced the beginning of the consultation process for the work on version 0.3 of the new out-patient flat-rate reimbursement system. The comments can only be submitted by the tariff partners that established this body (associations of health insurers curafutura and santésuisse, as well as the association of hospitals H+, an association of physicians FMH, and medical tariff commission MTK/CTM). The consultations can be submitted until March 31, 2023.

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.