Digital Healthcare Act

The Act to Improve Healthcare Provision through Digitalisation and Innovation (Digitale-Versorgung-Gesetz) came into force in Germany on 19 December 2019. Also known as Digital Healthcare Act - it is another important component in driving the digital transformation of Germany’s healthcare system.

What’s the story?

The digitalisation of our society is an inexorable trend. This digitalisation trend is also noticeable in the healthcare industry: for example, not only are the healthcare participants (hospitals, physicians, health insurance, patients, etc.) becoming more interlinked, but also more and more health applications are being developed which use digital components. The quality of healthcare is thereby improved and gaps in care provision are plugged. However, the need for regulation is also increasing. In particular, the reimbursement of new health services as well as the protection of the health data concerned must be ensured.

Not least because of that, the federal government, in its coalition agreement, regarded the digitalisation of health services as ‘one of the greatest challenges for healthcare in the next few years.’ Following the E-Health Act, which came into force on 1 January 2016, the Digital Healthcare Act is another component in driving the digital transformation of Germany’s healthcare system.

Content of the Digital Healthcare Act

The Digital Healthcare Act includes the following innovations:

Reimbursement of costs for health apps

Probably the best-known change of the Digital Healthcare Act is the reimbursement of costs for health apps by statutory health insurers. Patients now have the option of being refunded for the costs of digital health applications. Digital health apps are medical products of a low-risk category whose main function is based essentially on digital technology and which are intended to support the recognition, monitoring, treatment or alleviation of illnesses or the recognition, treatment, alleviation or compensation for injuries or disabilities among insured patients or in care provision by healthcare providers. These include in particular the health apps which are already regularly used in everyday life. The statutory health insurance company bears the cost of such digital health applications if the respective health app is prescribed or the costs are approved in advance.

However, in order for the digital health application to be reimbursable, the manufacturers concerned must demonstrate that the health application provides a guarantee of safety, functionality, quality, data security and data protection, as well as that the app has the oval effect to improve patients’ care. If the health application fulfils these conditions, it will be included in the list of reimbursable digital health applications, following an application to the Federal Institute for Drugs and Medical Devices (BfArM). If the manufacturer is not yet able to demonstrate positive care provision effects at the time of application, it may also request that the digital health application be included in the test list for up to 12 months. In this case, the positive care provision effects are to be submitted to the BfArM by the end of the trial period at the latest.

Promoting telemedicine services

The use of telemedicine services is further enhanced by the Digital Healthcare Act. In order to make it easier for patients to search for doctors who offer video consultations doctors are now able to promote the offer of remote treatment. To date, the ban on advertising in section 9 of the Medical Products Advertising Act (HWG) has stood in the way of this, although the model professional code for doctors has already considered remote therapy admissible in certain cases since 2018.

Extending the telematics infrastructure

The draft Digital Healthcare Act provides for an extension of the telematics infrastructure (TI). Patients should soon be able to make use of digital services, such as electronic medical records, around the country. Pharmacies are obliged to join the TI by the end of September 2020 and hospitals are obliged to do so by early January 2021. Midwives and physiotherapists, nursing and rehab facilities may join voluntarily. The costs of voluntary connection will be reimbursed. Due to the Digital Healthcare Act, the fee deduction for doctors who do not want to join is now 2.5% (instead of only 1%).
 

Summary and prospects

With the Digital Healthcare Act, the federal government is implementing some of its plans announced in the coalition agreement. These include in particular the possibility of using ‘Mobile Health’, the application and billing of telemedicine services and the development of the telematics infrastructure. However, there is still a need for legislation on data protection in order to ensure the best possible protection of the health data of those concerned. The legislator promises to do so in a timely manner, in order to be able to introduce the electronic medical record by 1 January 2021. In addition, other legislative projects are aimed at modernising the German health system: On 13 February 2020, the Fair Health Insurance Competition Act (FKG) was passed by the Bundestag. This may be followed in the foreseeable future by the Act to Strengthen Local Pharmacies (GSVOA).

However, the ongoing digitalisation of healthcare is already opening up space for many new business areas. Market potential exists especially for vendors of health apps, telemedicine software and hardware. As digitalisation grows, the online platform model will become increasingly important as a marketing and sales solution. In order to make the most of this market potential and to be prepared for upcoming innovations, we recommend that entrepreneurs continue to closely follow the legal developments in the healthcare sector in the future. 

Further links:
Information from the Federal Ministry of Health website on the Digital Healthcare Act
E-Health-Legislation in Germany- Update