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2020 in a Nutshell


Dear International Digital Health Community,

An exhausting 2020 is coming to an end and we look back with a shiver but also a strong sense of hope. Worldwide, nearly all healthcare systems are operating at their maximum capacity and our doctors, nurses, pharmacists, vaccine researchers as well as all other healthcare professionals have our deepest respect and appreciation for their enduring work and commitment.

But 2020 is also the year in which digital health solutions showed even very traditional healthcare systems (like the one in Germany) how much healthcare providers, patients & the healthcare system overall can benefit from digital innovation.

And in 2020 Germany (of all countries!) introduced a structured market access pathway for qualified digital health applications. Since October, these can be prescribed to German patients by their physicians and psychotherapists.

This English Newsletter is a first - to inform you from now on and regularly about the digital transformation of the German healthcare system. Enjoy the reading and please send your feedback to so that we can learn & improve.

For now, I wish you and your loved ones a very merry Christmas, as well as a good start to a healthy and happy 2021 – and all of us a safe winter until mass-vaccination is available.

Yours, Henrik Matthies

Figure of the Month

DiGA (digital health applications) are now approved by BfArM: view all of them in the DiGA registry. The latest are M-Sense (migraine) and Selfapy (mental health).

hih Events

February 2nd - 4th 2021

Digital Medicine Week (DMW)

Four virtual conferences in one week will bring together the entire German-speaking digital health ecosystem as well as international experts and guests:

  1. Medical Venture Validation – helping patient & medical entrepreneurs transform their ideas into solid digital health businesses
  2. Evidence Con – developing novel approaches for reliable DiGA / digital health evidence study designs (in English)
  3. MDR Con – applying the MDR to digital health products
  4. DiGA Con – showcasing all approved DiGA to health care providers and health insurance funds in a structured format

Evidence Con will be held in English and will include an interactive Research-a-thon format (Research-a-thon application). The Research-a-thon will include a study design sprint that will give aspiring medical entrepreneurs and researchers a chance to learn from international experts and gain hands-on experience in the design of novel, high quality evidence generation studies for DiGA. All other conference tracks will be held in German. More information about the entire DMW and a link to the registration (free of charge) can be found here. All conference tracks will be streamed, however the sessions with interactive formats will be held in closed Zoom groups.

We will inform you via this newsletter regularly about our (English language) events. All past events are summarized in blog posts in our English language Journal, including a link to the recorded video as well as most slide decks.

Regulatory Overview

DiGA Fast Track

Since October 2020, German physicians and psychotherapists can prescribe DiGA to the 73 million statutorily insured German citizens. BfArM, the governing authority in charge of the approval process, has published an excellent English language Guide for digital health companies to explain the Fast Track process for market access. In September, the hih’s International DiGA Summit attracted a large international audience and set the stage for the Ministry of Health, BfArM and other key actors to outline the Fast Track in greater detail and discuss how its pilot character may be informative for other markets.

In December, the Ministry of Health proposed a new law (the DVPMG), which will further develop the Fast Track process, expand its scope to include DiPA (digital applications for elderly care), connect DiGA with the electronic patient record (see below) and reimburse midwifes and other health care providers’ DiGA related work. The law will also further strengthen telemedicine and the safe exchange of healthcare data. The proposal must pass both houses of parliament, which is expected to take place in in Q2 of 2021, before becoming law. The entire proposal and a German summary can be found here.

Electronic Patient Record (ePA)

As of 01.01.2021, all statutorily insured German citizens have a right to setup their individual Electronic Patient Record (ePA). The ePA will be provided, paid for and orchestrated by their respective statutory health insurer. It is a patient-led system, thus the patient must opt-in in order to have the ePA set up by their doctor. The patient can decide which documents should be included and additionally which providers will have access.

There is an ongoing public debate in Germany about data privacy vs. health benefits, and it is estimated that ePA will be in widespread use rather in 2022 and beyond. But the underlying secure, intranet-like data exchange infrastructure (in German ‘Telematik-Infrastruktur’) has been set up and will soon connect all doctors, pharmacies and hospitals in Germany in a separate, safe environment. Over time, the ePA will include also all other health care providers.

The Telematik-Infrastruktur is governed by the organization gematik, which has provided a comprehensive overview of the various aspects around ePA on their new website, only in German for now.

Hospital Digitization (KHZG)

Germany has more than 1800 hospitals and the vast majority of these are hardly digitized. The Covid-19 pandemic has generated momentum to establish a new national budget for their digital transformation. A few weeks ago, Germany’s parliament passed the KHZG law (‘Krankenhauszukunftsgesetz’), providing 4.3 billion Euro for the rapid digitization of all hospitals.

The hih has summarized key elements of KHZG on our new website (unfortunately, also only in German for now) and organized the KHZG Arena last week to discuss the law and its implications with all major hospital chains and representatives from the Ministry. This is an important time to ask how we can make the best use of this once-in-a-lifetime opportunity for digital transformation and innovation.

@Further Reading

DiGA Vademecum

The hih’s DiGA experts have summarized all that they know and learned about DiGA and the Fast Track in a book that follows a digital health founder from starting his healthcare business in Germany through establishing a successful digital health product in the German healthcare system – along the way, incorporating perspectives from outpatient doctors, hospital managers, legal and interoperability experts.

The DiGA Vademecum is already available in German and an English language version will be published in the coming months.

Everyday Mood Booster

Meet Marvel’s Newest Heroes: Nurses

To honor the heroes of 2020, the Allegheny Health Network (AHN) and Marvel Comics are teaming up to tell the story of "The Vitals: True Nurse Stories" which will feature stories of nurses from AHN and patient care during the COVID-19. The Comic tells the true heroic stories of nurses on the frontlines of COVID-19.


Digital Around the World

For those who want to spend some time traveling the world over the holidays, despite travel bans and visit restrictions, we recommend the many online guided tours of the world's museums. Visit the Rijskmuseum in Amsterdam, the British Museum in London or the Tokyo Fuji Art Museum to breathe the big wide world once again.

Good News

DiGA and the hih in the Harvard Business Review

Earlier this month, the hih published its first article in the Harvard Business Review. We summarize some of the unique opportunities associated with the roll-out of DiGA and what health care leaders worldwide will be able to learn from Germany. We think the title speaks for itself: Want to see the future of digital health tools? Look to Germany.


A New Partnership Between the hih and the U.S. Digital Medicine Society (DiMe)

This week, an international group of researchers and experts in the use of real-world data and real-world evidence joined the hih and DiMe in the first of a series of expert discussions and in launching the organisations’ partnership. The goal of the partnership is to accelerate innovation in evidence generation related to digital health applications and speed the use of high quality digital medicine products in routine care.

Please take good care of yourself & those around you!


Your hih-Team

More information on our English website and on LinkedIn

hih - health innovation hub
des Bundesministeriums für Gesundheit

Torstraße 223
10115 Berlin
+49 30 847 11 340

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