Digital health in Germany boosted by new law

Out-Law News | 06 Dec 2019 | 1:34 pm | 1 min. read

German law makers have approved a new law which will boost innovation in digital health care, experts in life sciences have said.

Marc L. Holtorf and Dr. Julia Traumann were commenting after the new Digital Supply Act was passed by the Bundesrat, the second house in Germany's parliament, on 29 November. It was earlier approved by the Bundestag. It will take effect after it has been signed by Germany's president and published in the Federal Gazette.

The Digital Supply Act is broad ranging legislation.

A major change will see doctors able to prescribe the use of health apps to patients. App developers will need to have their solutions tested by the Federal Institute for Drugs and Medical Devices (BfArM) for safety, functionality, quality, data security and data protection before doctors would be free to prescribe their use. The cost of the initiative will be paid for through Germany's statutory health insurance regime, although automatic funding will be removed after a year and app developers will need to be able to show that their app has improved patient care to continue to be eligible for reimbursement.

Under the new Act, health insurance funds will also be given greater freedom to team up with venture capitalists to invest in digital health innovations.

Further, the new Act aims to remove data silos in Germany's health system and pave the way for electronic patient health records to become the norm.

To help achieve this, the new law requires pharmacies and hospitals to join doctors in connecting to Germany's central health care infrastructure. Pharmacies have until the end of September 2020 to do so, while the deadline for hospitals is 1 January 2021. Doctors are already obliged to connect to the system, but the new law introduces financial penalties for those that are not connected by 1 March 2020.

Increased use of health data in new medical research is also envisaged under the new Act, as the legislation provides that health data is shared in pseudonymous form with the Central Association of Statutory Health Insurance for research purposes, with anonymised results to be published by research centres.

The new legislation also supports improved data sharing between general practitioners and specialists to reduce the need for patients to consult directly with the specialists, and doctors will also have greater scope to promote their video consultation hours to patients.

A move away from paper-based processes is also planned. This includes changes to the model of reimbursement to incentivise doctors to move away from paper-based processes like fax to electronic means of communication.