mHealth

In mid-June 2021, the document "Changes and innovations in the 2022 LKF model" (Änderungen und Neuerungen in den LKF-Modellen 2022) was published. The document summarizes the most significant changes and innovations in the LKF model for inpatient and outpatient care. The newly added procedure codes concern mainly the cardiovascular, e-Health, and gastrointestinal area.

The application portal for inclusion in the Health App Directory at the Federal Office for Drugs and Medical Devices (BfArM) in Germany has been online since May 27, 2020. The first reimbursable health apps were introduced on the Directory in early October 2020. As of May 27, 2021, a total of 74 applications were received, 51 of which for provisional listing and 23 for final listing. Fifteen applications (20%) were introduced on the Directory.

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s).

On May 10, 2021, NICE announced the update of the evidence standards framework (ESF) for digital health technologies with changes in response to an ESF user survey that ran from October to December 2019. Furthermore, NICE launched a new Office for Digital Health to coordinate its digital health activities and strategic projects and manage collaboration with external partners.

In late April 2021, NHSX released a "2020-21: A year in the life of the NHS AI Lab" report representing NHS Artificial Intelligence Laboratory (AI Lab) achievements and work progress. Among other things, NHSX published results of the 2021 AI in Health and Care Survey, which shows that the diagnostic area remains the most popular for AI-based technologies compared to 2019.

In late April and early May 2021, 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 health insurers. In total, fifteen health apps are now available at the DiGA Directory.

The National Institute for Health and Care Excellence (NICE) is currently developing health technology assessments concerning eHealth technologies in its Medical Technologies Guidance, Diagnostic Guidance, and Medtech Innovation Briefing programs. As of late April 2021, there are thirteen ongoing assessments.

The Dutch Organization for Health Research and Development (ZonMw) will accept applications for subsidies under the incentive scheme "eHealth at Home" until the end of 2021. This scheme is intended for digital apps that support the provision of care at home for the elderly and people with chronic illness or disability.

On April 09, 2021, the Swedish Medical Technologies Product (MTP) Council decided to add more technologies to the ongoing evaluation for self-monitoring of atrial fibrillation within the Orderly introduction framework, initiated in December 2020. MTP Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health-economic evaluation of five products (Coala, KardiaMobile, CardioMem CM 100 XT, PhysioMem PM 100, Zenicor). MTP Council will then make recommendations to the regions on whether to adopt these technologies or not.

In March 2021, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids, extracorporeal whole liver perfusion, free-functioning gracilis transfer to restore upper limb function, cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy), two Medical Technologies Guidance (Danis stent for acute oesophageal variceal bleeding, Alpha-Stim AID for anxiety disorders), two Medtech Innovation Briefings (Sonata system for symptomatic uterine fibroids, Butterfly iQ+ for diagnostic ultrasound), and one Diagnostic Guidance (QAngio XA 3D QFR and CAAS vFFR imaging software for assessing coronary stenosis). Also, five clinical guidelines were updated.

In March 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned sacral nerve stimulation and magnetic sphincter augmentation device for fecal incontinence treatment, patch augmentation surgery for rotator cuff repair, 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 inform National Institute for Health and Care Excellence (NICE) guidance.

On March 17, 2021, the Evaluation Committee (Bewertungsausschuss) has decided to introduce two new EBM (German Uniform Evaluation Standard) codes related to prescription of health apps with retrospective effect from January 1, 2021.