Germany's new law allows doctors to prescribe apps with health benefits
Germany has passed a law allowing doctors to prescribe digital apps with health benefits, which can be reimbursed by the country’s health insurance system.
The new system is made possible by the Digitalisation and Innovation Act (Digital Supply Act), drawn up in draft by federal health minister Jens Spahn and approved by the federal cabinet yesterday.
Germany is following the example of the US, which over the last few years has introduced a system where the FDA is able to approve apps that have trial evidence showing clinical benefits.
Pear Therapeutics in 2017 became the first company to get a “digital therapeutic” approved by the FDA, for patients trying to fight addiction to opioid drugs.
Germany’s new law recognises that patients already use health apps to help them take medicines regularly, or document blood sugar levels.
Under the new rules these apps can be prescribed by their doctor, with costs picked up by statutory health insurance.
Germany’s drug regulator, the Federal Institute for Drugs and Medical Devices (BfArM) will check for issues such as data security, data protection, and functionality, and after that apps will be provisionally reimbursed by statutory health insurance.
During this first year the manufacturer must prove to BfArM that the app improves patient care, and if successful negotiate a price with cost effectiveness arbiter GKV-Spitzenverband.
Germany also wants patients to be able to use digital services such as electronic patient records as soon as possible.
Pharmacies have until the end of September next year, and hospitals have until 1 January 2021 to get affiliated with the country’s Telematics Infrastructure (TI).
Midwives, physiotherapists, as well as nursing and rehabilitation facilities can voluntarily join the TI, and costs for every connection will be reimbursed.
Doctors who do not want to join have to accept an increased fee deduction of 2.5% from 1 March 2020 – those already not signed up are already subject to a fee deduction of 1%.
Other digital strategies include doctors making patients aware of any video consultation services and a system where doctors receive lower rates of reimbursement for fax-based medical correspondence.
Until now, doctors had received more money for sending faxes than using emails.
A separate privacy law governing sensitive health data is due to come into effect in January 2021.