e-Health

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, 32 NHS trusts received funding through the NHSX Digital Aspirant program, which was initiated in 2020, and already supports 27 NHS trusts for their digital transformation. Seven of the newly added NHS trusts will receive up to £6 million over the next three years, while the remaining 25 are receiving funding of £250,000 to develop their digital strategy and business case.

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.

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.

The Dutch Healthcare Institute (ZIN), in collaboration with the Ministry of Health, Welfare and Sport (VWS), Dutch Health Authority (NZa), and Health and Youth Care Inspectorate (IGJ), implemented an extension of existing digital healthcare innovation programs called "ZorgZandbak" to demonstrate how digital care could become an integral part of regular care.

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.

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) systematically evaluates healthcare technologies and practices from medical, economic, ethical, and social standpoints. Currently, the SBU is working on assessments of treatment methods of gastrointestinal conditions, musculoskeletal disorders, pain treatment, medical aids, e-health technologies, and other topics.

On February 4, 2021, the guide on dossier submission to the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) for the inclusion of the device in the List of Reimbursable Products and Services (LPPR) was published in English. Furthermore, the guide was recently updated with the information dedicated to the technologies falling within the scope of artificial intelligence.

On January 28, 2021, the Innovation Committee at the Federal Joint Committee (G-BA) published the first overview of the 28 innovative projects on new forms of medical care that will be funded. The projects concerning the technologies belonging to the cardiovascular, eHealth, orthopedic, neurology, nephrology, and other technology groups received funding.

On January 26, 2021, NHS Accelerated Access Collaborative published the MedTech Funding Mandate policy for 2021/22, which will come into force in April 2021. According to the NHS Long Term Plan, introducing a MedTech Funding Mandate will support getting innovative medical devices, diagnostics, and digital products to patients faster. Four technologies will be supported in 2021/22 - HeartFlow FFRCT, gammaCore, SecurAcath, and PIGF-based testing.

In January 2021, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (self-expanding implant insertion into the intersphincteric space for faecal incontinence and minimally invasive radical hysterectomy for early stage cervical cancer), two new medical technologies guidance (the PLASMA system for transurethral resection and haemostasis of the prostate, and the VAC Veraflo Therapy system for acute infected or chronic wounds), and six Medtech innovation briefings (Optilume for anterior urethral strictures, AI in mammography, AI for analyzing chest CT images, AcQMap for mapping the heart atria to target ablation treatment, and others). Also, two clinical guidelines were updated.