| 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.
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