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Evidence standards framework for digital health technologies (ECD7)
This document describes an evidence standards framework (ESF) for digital health technologies (DHTs). It was developed by NICE between June 2018 and February 2019 in collaboration with NHS England, Public Health England and MedCity. The work was commissioned by NHS England.
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- Overview
- Introduction
- Section A: Technologies suitable for evaluation using the evidence standards framework
- Section B: Classification of digital health technologies
- Section C: Evidence standards tables
- Terms used in the evidence standards framework
- How to meet the standards
- Section D: Early deployment standards for evidence-generation programmes
NICE has developed a medtech innovation briefing (MIB) on OrganOx metra for liver transplant .
Axumin for functional imaging of prostate cancer recurrence (MIB172)
NICE has developed a medtech innovation briefing (MIB) on Axumin for functional imaging of prostate cancer recurrence .
NICE has developed a medtech innovation briefing (MIB) on CentriMag for heart failure .
Stretta System for gastro-oesophageal reflux disease (MIB74)
NICE has developed a medtech innovation briefing (MIB) on the Stretta System for gastro-oesophageal reflux disease
ViewSite Brain Access System (VBAS) for the surgical management of deep brain lesions (MIB295)
NICE has developed a medtech innovation briefing (MIB) on ViewSite Brain Access System (VBAS) for the surgical management of deep brain lesions .
NICE has developed a medtech innovation briefing (MIB) on MiraQ cardiac TTFM with high-frequency probe for assessing graft flow during coronary artery bypass graft surgery .
Evidence-based recommendations on cabozantinib (Cabometyx) for previously treated advanced differentiated thyroid cancer unsuitable for or refractory to radioactive iodine, in adults.
Evidence-based recommendations on sebelipase alfa (Kanuma) for long-term enzyme replacement therapy in Wolman disease (rapidly progressive lysosomal acid lipase deficiency) in people aged 2 years and under when treatment starts.
Linzagolix for treating moderate to severe symptoms of uterine fibroids (TA996)
Evidence-based recommendations on linzagolix (Yselty) for treating moderate to severe symptoms of fibroids in adults of reproductive age.
Etranacogene dezaparvovec for treating moderately severe or severe haemophilia B (TA989)
Evidence-based recommendations on etranacogene dezaparvovec (Hemgenix) for treating moderately severe or severe haemophilia B in adults.
Evidence-based recommendations on icosapent ethyl (Vazkepa) with statin therapy for reducing the risk of cardiovascular events in adults with raised triglycerides.
Gemtuzumab ozogamicin for untreated acute myeloid leukaemia (TA545)
Evidence-based recommendations on gemtuzumab oxogamicin (Mylotarg) for untreated acute myeloid leukaemia in people aged 15 years and over.
Everolimus for advanced renal cell carcinoma after previous treatment (TA432)
Evidence-based recommendations on everolimus (Afinitor) for advanced renal cell carcinoma after previous treatment.
Enzalutamide for treating hormone-sensitive metastatic prostate cancer (TA712)
Evidence-based recommendations on enzalutamide (Xtandi) for treating hormone-sensitive metastatic prostate cancer in adults.