mHealth
07
Jun 2023
In May 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries), two new Diagnostic Guidance (MRI fusion biopsy systems for diagnosing prostate cancer, automated ankle-brachial pressure index measurement devices to detect peripheral arterial disease), and three new Health Technology Evaluations (Digitally enabled therapies for adults with anxiety disorders / with depression, and point-of-care tests for urinary tract infections). Also, four clinical guidelines were updated.
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30
May 2023
On April 5, 2023, the Innovation Committee at the Federal Joint Committee (G-BA) announced the selection of thirty-five applications for Innovation Funding of healthcare research projects were accepted. A total of 231 applications were received in response to the funding announcement of June 27, 2022 (changed on September 20, 2022), and thirty-five of them were accepted.
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24
May 2023
Between late April and May 2023, 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, 47 health apps are currently available in the DiGA Directory, and six health apps were delisted from the Directory.
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17
May 2023
In March 2023, Health Technology Wales published an Evidence Appraisal Report (EAR) and Guidance on photobiomodulation for the prevention and treatment of oral mucositis. Furthermore, seven Medtech-related Topic Exploration Reports (TER) were published, including single-pulse transcranial magnetic stimulation and AI-assisted ultrasound for deep vein thrombosis; however, Health Technology Wales will proceed with a full appraisal on one topic only - digital wound management tools.
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21
Apr 2023
The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests.
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07
Apr 2023
In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published.
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30
Mar 2023
In March 2023, two 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.
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23
Mar 2023
In February 2023, the Scottish Health Technology Group, SHTG, released three MedTech-related assessments: selective internal radiation therapies (SIRT) for treating primary hepatocellular carcinoma, Feeling Good app, store-and-forward teledermatology for triage of primary care referrals.
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16
Mar 2023
In January-February 2023, Health Technology Wales published sixteen Medtech-related Topic Exploration Reports (TER), including stereotactic radiosurgery, percutaneous implantation of pulmonary artery pressure sensors, ambulatory patch ECG devices, and others; however, Health Technology Wales will not proceed with full appraisals on these topics. No Guidance was released for Medtech in January-February 2023.
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15
Mar 2023
In March 2023, a new ‘AI and Digital Regulations Service’ for developers and adopters of artificial intelligence (AI) and digital technologies was launched in England. Four organizations provide this multi-agency advisory service: NICE, Care Quality Commission, Medicines and Healthcare products Regulatory Agency, and Health Research Authority. The website is currently in public beta and focused on information for developers.
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14
Mar 2023
The Ministry of Health has commissioned the Agency for Health Quality and Assessment of Catalonia (AQuAS) to develop, with the collaboration of the various agencies that make up the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits (RedETS), a specific methodological framework for the evaluation of digital health technologies that would allow a comprehensive assessment of this type of technology. The methodological framework is in the final phase of development.
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10
Mar 2023
In February 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transvenous obliteration for gastric varices, biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer), one new Health Technology Evaluation (guided self-help digital cognitive behavioural therapy), and two new Medtech Innovation Briefings (LIVERFASt, and Ambu aScope 4 RhinoLaryngo). Also, one new clinical guideline was published, and one was updated.
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