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mHealth

25
May 2021

Updated Evidence Standards Framework for digital health technologies and the launch of a new Office for Digital Health by NICE

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.
11
May 2021

Three more health apps obtained reimbursement in Germany

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.
30
Apr 2021

Ongoing health technology assessments related to eHealth by NICE

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.
19
Apr 2021

Swedish MTP Council will evaluate more technologies for self-monitoring of atrial fibrillation

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.
16
Apr 2021

Med Tech-related technology assessments and clinical guidelines from NICE in March 2021

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.
01
Apr 2021

MedTech-related health technology assessments from UK NIHR in March 2021

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.
26
Mar 2021

Digital innovations selected to join NHS Innovation Accelerator award-winning program in 2021

On March 08, 2021, Academic Health Science Networks (ASHN) announced twelve innovators ("Fellows") and innovations selected to join NHS Innovation Accelerator (NIA) award-winning program in 2021. NIA is an NHS England and Improvement initiative delivered in partnership with England's 15 AHSNs, hosted at UCLPartners. All awarded technologies are related to eHealth, including digital platforms, mobile applications, artificial intelligence (AI), wearables for home-based diagnostic.
12
Mar 2021

NHSX launched a new simple and fast assessment process for digital health technologies

On February 23, 2021, NHSX launched Digital Technology Assessment Criteria for health and social care (DTAC), the new national criteria designed to provide suppliers and healthcare organizations a clear direction on building and buying good digital health technologies. DTAC will apply to all types of digital health technologies, from public-facing health apps to digital systems used within hospitals. The assessment criteria are focused on five areas: digital technologies will receive a pass or fail in four categories - clinical safety, data protection, technical security and interoperability, and a score on usability and accessibility.