A new multi-agency advisory service (MAAS) is currently under development by the National Institute of Health and Care Excellence (NICE). This new cross-regulatory service will be a “one-stop-shop” for support, information, and guidance on the regulation and evaluation of AI technologies. The launch of the new service is scheduled for summer 2022.

In January 2022, the Scottish Health Technology Group released a recommendation of the closed-loop systems and the artificial pancreas for type one diabetes mellitus. The limited use of closed-loop systems in routine clinical care makes it difficult to estimate device-related adverse event rates. No evidence was identified for artificial pancreas systems (multi-hormone closed-loop systems) available on the UK market.

On January 26, 2022, the HAS published standards for medical telemonitoring of four chronic pathologies (chronic respiratory failure, chronic heart failure, chronic renal failure, and diabetes). These standards must be met by technologies in order to be reimbursed by the new reimbursement framework for telemonitoring, which is expected to enter into force in July 2022.

Dutch Healthcare Institute (ZIN) has issued a Pilot Horizon Scan of 39 new diabetes-related MedTech products that are expected on the Dutch market in 2022 or 2023. Patients with diabetes could benefit significantly from the use of these devices. However, available data on their effectiveness and efficiency is limited.

On January 20, 2022, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for the use of a stent retriever (pRELAX by femtos) to treat vasospasm of cerebral arteries after subarachnoid hemorrhage.

The French Ministry of Solidarity and Health constantly announces the new experiments initiated under Article 51 of the Social Security Financing Act. These experiments are focused on various topics concerning medical technologies and the organization of care. At the beginning of January 2022, new experiments were announced which relate to geriatric care, autonomy loss prevention, physical rehabilitation during and after cancer treatment.

On January 18, 2022, NHS England and Improvement released guidance on point-of-care testing (POCT) in community pharmacies. It describes the consistent standards and safe environment for the use of POCT equipment and devices for diagnosis, monitoring, and screening in community pharmacy, to guide both commissioners of NHS services and community pharmacies.

The "New Method" is currently developing criteria for which methods other than drugs shall be prioritized for assessment within the framework at the national or local levels. On January 17, 2022, the project status was presented at the Ordering Forum for "New Method." It was reported that the project would require more resources and time than initially thought.

At the beginning of January 2022, the INAMI published a convention for 2022-2023 related to the financing of dialysis. The convention regulates the modalities of reimbursement for dialysis of patients with chronic renal failure.

On January 20, 2022, the Academy of Medical Royal Colleges (AoMRC) launched a consultation on the latest set of guidance (List 3) of the Evidence-based Interventions (EBI) Programme. EBI program develops guidance sets (Lists) for tests, treatments, and procedures based on recommendations from the Expert Advisory Committee and NICE assessments. Proposed List 3 covers 17 interventions across a range of medical specialties, including cardiology, ophthalmology, urology, and others. The deadline for comments submission is March 31, 2022.

On December 26, 2021, the new health app was 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, 28 health apps are now available at the DiGA Directory.

On December 17, 2021, the Belgian Health Care Knowledge Center (KCE) published a health services research report “Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions”. In this report, KCE examined the lack of comparative evidence health technology assessment (HTA) agencies and payers face in evaluating new medicinal products and high-risk medical devices at market entry.