Coronavirus

In September 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis, transapical transcatheter mitral valve-in-ring (TMVIR) after failed annuloplasty for mitral valve repair, and lateral elbow resurfacing for arthritis), and two new Medtech Innovation Briefings (Carnation Ambulatory Monitor, OrganOx metra for liver transplant). Also, one clinical guideline was updated.

Health Information and Quality Authority (HIQA) develops national HTA guidelines to support decision-making in Ireland. In the third quarter of 2021, Health Information and Quality Authority published three reports in relation to in-vitro diagnostics, including newborn bloodspot screening, tests for hepatitis C and SARS-CoV-2.

In late July 2021, two new COVID-19 antigen tests were added to the Laboratory Test Nomenclature (Laboratoriotutkimusnimikkeistö) in Finland.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2021. Three biomarker tests in breast cancer, a number of services related to cryopreservation of egg and sperm cells in young cancer patients, new services dedicated to prenatal testing of the fetal rhesus factor, services concerning the delivery of brachytherapy in prostate cancer were introduced.

In June 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned tibial nerve stimulation for urinary incontinence treatment, imaging in ophthalmology, in-vitro diagnostics, and eHealth. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS, and informs National Institute for Health and Care Excellence (NICE) guidance.

In June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.

In April 2021, the Austrian Institute for Health Technology Assessment (AIHTA) initiated several new research projects. The projects are related to IVD tests for early detection of colon cancer, telemedical care in diabetes field, health apps, screening methods, consequences of coronavirus pandemic, and other topics.

On May 10, 2021, NHS Artificial Intelligence Laboratory (AI Lab) announced an open call to test AI-driven COVID-19 models using the National COVID-19 Chest Imaging Database (NCCID), collected over 40,000 X-rays, CT, and MRI images from people with and without coronavirus. The NHS AI Lab is now inviting research institutions and technology companies that develop AI-driven models using COVID-19 chest imaging data. The deadline for applications is May 28, 2021.

On December 22, 2020, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced a pilot project which concerns the remote monitoring of COVID-19 patients before and after their hospitalization as part of an integrated medical approach supported by digital applications.

The Danish Health Authority (Sundhedsstyrelsen) updates the Health Care Classification System (Sundheds-væsenets Klassifikations System, SKS) quarterly. It publishes the updates on its website two weeks before the implementation, while the files with the changes are sent to the hospital systems. The most significant changes include new codes in the fields of ophthalmology, gynecology, COVID testing, and radiological imaging.

At the beginning of August 2020, the French National Authority for Health (HAS) issued a favorable opinion on the inclusion of the genome detection of SARS-CoV-2 by gene amplification on saliva samples to the innovation package (forfait innovation) according to the article L. 165-1-1 of the social security code. The package is approved by the Ministry of Solidarity and Health, after consultation with HAS.

The Corona warning app, developed on behalf of the German government, has been available for download in the Google and Apple stores since June 16, 2020. It is intended to help identify and break infection chains at an early stage. Users of the app receive a notification if they have been for a long time in the vicinity of a person who was later found to be infected with the coronavirus.