e-Health

In October 2022, Ordering Forum for New Methods framework in Norway invited interested parties regarding hand-held electrocardiogram (ECG) devices connected to an app for diagnosing atrial fibrillation in adults (e.g., KardiaMobile). Information shall be submitted no later than November 29, 2022. Ordering Forum will be held on December 12, 2022, to decide whether the method will undergo evaluation at the national level.

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.

On October 11, 2022, the Treatment Council (Behandlingsråd) announced the selection of two topics for major analyses (større analyser) for 2023, including the use of home non-invasive ventilation and the use of internet-based cognitive behavioral therapy.

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 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.