e-Health

On August 03, 2020, King’s Fund issued a report on technology and innovation for long-term health conditions. It was commissioned by Academic Health Science Networks (AHSNs) in England to explore four different digital innovations in health services from the UK and the Nordic countries to demonstrate transformative potential and compare and contrast themes across geographies.

The Ministry of Health has adjusted the regulatory nomenclature of medical devices, separating software, which is a medical device, into a separate group. The classification of software is given depending on the potential risk of its use. A potential risk class is assigned to software regardless of the potential risk class of the medical device in combination with which it is used. The order does not apply to medical products previously submitted for state registration.

In August 2020, mHealthBelgium announced two more health application accomplished M2 validation - Well@Home and AirView. After achieving M2 level, developers will get access to more options, like risk assessment framework, test centers, a lot of useful information.

On the 28th of July 2020, in the Official Journal of French Republic (JORF), an Order for the inclusion of the web application MOOVCARE POUMON intended for the medical telemonitoring of relapses and complications in patients with non-progressive lung cancer in the French List of Products and Healthcare Services Qualifying for Reimbursement (LPPR) was published. The application is already included in the LPPR list in section 1, “Materials and treatments in the home, dietary products, items for dressings,” chapter 1, section 7, and a specific sub-section 7, which has been created for web applications and software for remote monitoring.

The temporary reimbursement for telemedicine and digital care in all healthcare sectors has been extended by the Dutch Healthcare Authority (NZa) until December 31, 2020. In some sectors, the temporary extension will be converted into a structural extension by 2021.

The German Association for Digital Health Care (Spitzenverband Digitale Gesundheitsversorgung e.V.) published the list of companies that submitted applications for inclusion in the directory of digital health apps (DiGA) in the first phase.

In July 2020, two new apps entered the level 1 of the mHealthBelgium validation pyramid. Healthentia is an eClinical platform to record Real World Data, that can be used either in clinical trials or by healthy individuals. Sunrise (class IIa) sleep testing device allows rapid and at home diagnosing respiratory sleep disorders.

On July 14, 2020, the Belgian National Institute for Health and Disability Insurance (INAMI-RIZIV) announced a new framework for reimbursement of the app supporting rehabilitation program for the total hip or knee replacement (moveUP app). The pilot study will start on October 1, 2020, in 15 hospitals. Reimbursement to other patients is planned to be established by September 2021.

The Corona warning app, developed on behalf of the German government, has been available for download in the Google and Apple stores since June 16, 2020. It is intended to help identify and break infection chains at an early stage. Users of the app receive a notification if they have been for a long time in the vicinity of a person who was later found to be infected with the coronavirus.

On 05 June 2020, mHealthBelgium announced the activation of Level 2 of the validation pyramid. This indicates that health applications that meet certain criteria can achieve Level 2. The National Institute for Health and Disability Insurance (INAMI) is working on the next step (level 3) - to introduce a structural framework for funding.

In June 2020, two new apps entered the level 1 of the mHealthBelgium validation pyramid. Guardian Connect smartphone application is a component of the Guardian Connect Continuous Glucose Monitoring (CGM) system for diabetes management. The icompanion software is a decision-making tool that helps physicians to choose medication for patients with multiple sclerosis.

From June 2020, NHS England will provide patients with cystic fibrosis and those recovering from coronavirus with devices and apps so physicians can track their condition remotely as part of the NHS drive to deliver connected, assisted, personalized care to more individuals in their own homes.