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Digital Health

Deprexis DiGA approved! 11th Digital Therapeutics (DTx) reimbursed in Germany

Deprexis – Digital therapeutics (DTx) for depression has received DiGA fast track approval for DTx prescription and reimbursement in Germany.

The innovative DiGA process allows for fast-track approval of digital therapeutics and is the first such program in the world. It was created by the 2019 Digital Healthcare Act and allows apps to be prescribed by doctors while costs will be reimbursed through German statutory health insurance. 

DiGA is managed by the federal regulator, BfArM. To get through DiGA, there are certain conditions:

  • Safety and Suitability for Use confirmed by CE-certification as a medical product in the lowest-risk classes
  • Data Protection Conformity to data protection legislation (EU-wide GDPR and German Federal Data Protection Act (BDSG)) 
  • Information security Assessment is based on the recommendations of the German Federal Office for Information Security (BSI) and specific parts of  IT-Grundschutz (ITbasic data protection) catalogs designated for healthcare apps. 
  • Interoperability Related to German central IT standards directory available via online platform vesta, managed by gematik
  • Availability of preliminary data on the health benefits provided. Data must show that patient-relevant endpoints, in particular morbidity, mortality, or quality of life, are positively influenced.

Check out the full guide for DiGA here.

Results of the assessment of applications within the BfArM's DiGA fast-track procedure
Results of DTx DiGA assessment as of March 2021. Source: BfArM.

At the time of writing this, there were 59 applications for DiGA listing, 40 for provisional listing, and 19 for the final listing. So far BfArM has approved 11 applications and rejected one. 25 applications have been withdrawn. In theory, the full approval process should take three months.

Deprexis, the 11th DiGA approved application is interesting on its own. The manufacturer of the app is GAIA Group, an offspring from Airbus which builds its products on a proprietary AI-platform called broca.

Deprexis, Digital Therapeutics (DTx) for depression. Source: GAIA Group AG


The focus here is clearly not on UX, but on medical benefits. Deprexis may not have the nicest UX, but is a proper DTx providing a three-month-long highly individualized Cognitive Behavioral Therapy support program for patients with depression. Application is able to perform a dialogue with the patient, learning from the input on the way. It contains 10 content modules and is available online via desktop and mobile app interface. 

Deprexis is backed by clinical data from at least nine studies, one of which had a sample of 3,800 patients, which does not sound much in pharmaceuticals, but it is a lot in DTx. While in Germany it just received reimbursement, in the US the price for treatment is $400 one-time payment, or $540 in three monthly installments of $135 each.

Categories
Digital Health

Big Data, AI and Coronavirus COVID-19 (NCov-2019)

Coronavirus COVID-19 (NCov-2019) has tested some of the digital health capabilities such as AI-based predicitive models and real-time big data visualization. As a positive side effect, it has also allowed public to learn about epidemiology via video games.

 

AI-based predictive models caught COVID-19 faster than us

According to the news reports, two AI-based and one human volunteer-based warning systems were first to alert humanity about the threat coming from Wuhan.

HealthMap Project Website

The first to react was the automated HealthMap system at Boston Children’s Hospital, which scans online news and social media reports for signals of spreading disease. Its warning was very quick and accurate (pneumonia cases in Wuhan) – raised at 11:12PM local time on December 30, but it did not assign significance high enough to the message.

The second report came from a human. Marjorie Pollack from the Program for Monitoring Emerging Diseases (ProMed)  has based on similar social media reports received about 4 hours before the HealthMap warning. ProMed team’s analysis was more detailed than the first warning from AI but came about half an hour later.

BlueDot Explorer (screenshot from the website)

The third and most publicized report came from another AI-based model called BlueDot. BlueDot first became aware of the pneumonia cases in Wuhan on December 31st, and in addition to notifying their clients and government stakeholders directly, they publicly released their findings in the Journal of Travel Medicine on January 14th. While it was not truly the fastest, it is worth hearing how Kamran Khan, a Canadian MD, and founder of BlueDot explains the process behind.

Big Data Visualization to track Coronavirus COVID-19 (NCov-2019)

Dashboards showing the number of infected people, geographical spread and trends of the disease are useful to HCPs but also journalists and the public. This use case, although unfortunate, shows how important it is to be able to see and not only read data.

coronavirus covid19 dashboard
Screenshot of the COVID-19 dashboard by Johns Hopkins CSSE

The first and most known dashboard came from the team at Johns Hopkins University. The dashboard, first shared publicly on Jan 22, illustrates the location and number of confirmed COVID-19 cases, deaths, and recoveries for all affected countries. It has been accompanied by an article in The Lancet.

Currently, there are multiple dashboards showing diverse aspects of the epidemic of COVID-19. The list of dashboards with working links can be found at ESRI website.

Coronavirus virally spreads a game for people want to know

Due to the virus business slows down. Except for Ndemic Creations, a studio that in 2012 developed Plague Inc. A game that simulates a viral epidemic.

Plague Inc. is a game, but it is based on science and realistically shows the spread of viral infections amongst the human population. In the game, the player is supposed to infect all humans before the cure is available. It is so successful in teaching about epidemiology, that it has been endorsed by the CDC. During the COVID-19 outbreak, it has reached the top of charts on the Apple Store. According to its developers, similar peaks in popularity have accompanied the Ebola outbreak in Africa in 2014-2016.