e-Health

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.

On January 19, 2021, Belgian Health Care Knowledge Center (KCE) published a health services research report "Barriers and facilitators for eHealth adoption by general practitioners”. Findings from the research show that there is a wide range of factors contributing to the uptake of eHealth technology by healthcare professionals. These factors range from the quality of the eHealth technology, use, and user satisfaction, net benefits, individual, organizational, and implementation characteristics to country-specific factors (such as governance, standards, funding, or trends).

In January 2021, the NHS AI Lab has launched the guide to good practice for digital and data-driven health and care technologies to support innovators to understand what the NHS is looking for when it buys digital and data-driven technology for use in health and care. It is an update of the initially published guide in 2018, and now also reflect new initiatives, for example, the creation of the Centre for Improving Data Collaboration.

On January 20, 2021, the National Institute for Health and Disability Insurance (INAMI-RIZIV) announced the reimbursement pathway for health apps. Health apps can now reach level M3 of the validation pyramid.

On December 30, 2020, the French National Authority for Health (HAS) published a report "Economic evaluation of telemonitoring to inform public decision-making", based on the systematic literature review. According to the results of the review, telemonitoring can be considered as a way to improve the organization of care and reduce care costs.

In December 2020, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Zio XT for detecting cardiac arrhythmias), three Medtech innovation briefings (ReStore Soft Exo-Suit for gait rehabilitation, Cytosponge for detecting abnormal cells in the esophagus, and Evoke Spinal Cord Stimulator for managing chronic neuropathic or ischemic pain). Also, nine clinical guidance documents were updated.

In early January 2021, the new reimbursable health app was introduced on the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM). These applications can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers.