mHealth

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.

On October 28, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) reported that 231 applications were received for innovation funding of healthcare research projects.

In October 2022, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (YAG laser vitreolysis for symptomatic vitreous floaters, transcutaneous electrical stimulation of the supraorbital nerve for treating and preventing migraine), one Medical Technologies Guidance (Magtrace and Sentimag system for locating sentinel lymph nodes for breast cancer) and three new Medtech Innovation Briefings (O2matic PRO 100, Daylight, Signatera). Also, one new clinical guideline was published on osteoarthritis.

In late September – early October 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.

Rehabilitation before or after a primary knee or hip replacement using a health app is temporarily reimbursed in Belgium under a specific agreement with the National Institute for Health and Disability Insurance (INAMI-RIZIV). Reimbursement was limited to patients participating in the clinical study. From October 01, 2022, all patients eligible for rehabilitation before and after a primary knee or hip replacement will receive it using a health app in combination with a certain minimum number of classic face-to-face physiotherapy sessions. Certain health apps must be included in the list of reimbursable mobile applications. For now, only one app (MoveUP Coach) is included.

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 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 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.