e-Health

On September 26, 2022, the health app “Rehappy” was delisted from the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM).

In August 2022, the Scottish Health Technology Group, SHTG, released two MedTech-related assessments: vCreate Neuro for the diagnosis and management of adults and children with epilepsy and other neurological disorders and Bluetooth Tagging of medical equipment.

In August 2022, the Finnish Coordinating Center for Health Technology Assessment published an article regarding the implementation of a new Digi-HTA process for digital health technologies in Finland. This study aimed to determine whether it would be possible to use Digi-HTA recommendations to support healthcare decision-makers. Secondly, from the perspective of companies offering different types of digital health technology products, this study assessed the suitability of using the Digi-HTA framework to perform HTAs for their products.

On August 26, 2022, Swedish Medical Technologies Product (MTP) Council announced ongoing horizon scanning within the Orderly introduction framework for products that promote the transition to so-called “Close care” (Nära vård). Products of interest should enable diagnosis, treatment, and follow-up outside a healthcare facility, for example, remote monitoring. The Dental and Pharmaceutical Benefits Agency (TLV) initiated a theme survey, accepting suggestions until September 28, 2022.

On August 01, 2022, Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) launched a new reimbursement framework for remote medical consultations. The Nomenclature was changed accordingly: a new article 37, “Remote care,” was introduced with four new codes and fees for video and telephone consultations by physicians.

On August 09, 2022, NICE updated the Evidence standards framework for digital health technologies, initially published in 2018. Artificial intelligence and data-driven technologies with adaptive algorithms are now included in the framework and user guide. NICE also aligned digital health technology classifications with regulatory requirements and outlined a subset of early deployment standards that can be used within evidence generation programs.

In the second quarter of 2022, Health Technology Wales (HTW) published four MedTech-related guidance (extreme hypofractionated radiotherapy for localized prostate cancer, video laryngoscopes for use in pre-hospital care, electronic blood management systems, and stereotactic ablative radiotherapy for the treatment of renal cell carcinoma). A total of 12 MedTech-related Topic Exploration Reports (TERs) were released in Q2. Based on the TERs conclusions, HTW decided to proceed with a full appraisal on three topics – photobiomodulation, topical oxygen therapy (NATROX) in chronic wounds, and video feedback interventions.

The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency providing advice to NHSScotland on using new and existing health technologies, likely to significantly impact healthcare. In July 2022, SHTG published three reports (KardiaMobile for detecting atrial fibrillation, complex endovascular aneurysm repair, and Togetherall platform). Currently, the SHTG is working on assessments of technologies in the field of cancer, radiotherapy, musculoskeletal diseases, transplantation, and other topics.

In July 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transcatheter tricuspid valve annuloplasty for tricuspid regurgitation, and transcatheter tricuspid valve leaflet repair for tricuspid regurgitation), one new Diagnostic Guidance (PLGF-based testing to help diagnose suspected preterm pre-eclampsia), and four new Medtech Innovation Briefings (ProciseDx point-of-care platform for IBD, RespiraSense for continuously monitoring respiratory rate, Lenus COPD Support Service, and cyanoacrylate glue for hernia mesh fixation). Also, five clinical guidelines were updated.

In May-July 2022, two 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 health insurers.

In July 2022, the Finnish Coordinating Center for Health Technology Assessment (FinCCHTA) published on its website five Digi-HTAs in the fields of eHealth and in-vitro diagnostics.

On June 27, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) published the determined funding priorities for healthcare research projects (seven topics) and clinical guidelines (four topics).