E-Health Act (2016): inaugurates the digitalization of the German Healthcare system by:
- Launching the new ICT infrastructure for the health sector, with focus on interoperability, patient data protection and secure communications;
- Expanding the applications of the ‘electronic health card’ to include patient’s health record, medication plan, emergency treatment data and other voluntary info to be shared with healthcare professionals (HCPs);
- The existing ban on remote consultations and telemedicine is finally loosened.
Digital Care Act (2019): expands the e-health services covered by ‘public health insurance’ and further promotes healthcare digitalization:
- Doctors can now officially prescribe ‘health apps’ (the so-called DiGAs)
- Only ‘health apps’ certified as ‘software medical devices’ (SaMDs) and approved by the competent authority (BfArM) can qualify for reimbursement!
- Such news comes as no surprise to those familiar with the global digital therapeutics (DTx) market, as Germany is already at the forefront in this field, fostering start-ups & companies whose solutions are sold and prescribed worldwide – from a SaMD that helps treat tinnitus with music, to CBT-based tools for depression & other psychiatric conditions, to an AI-enhanced app for management of chronic pain.
- All hospitals and pharmacies must join the ICT infrastructure by the end of 2020, while other healthcare professionals (e.g. midwives, physiotherapists) and incentivized to join.
- Fully functional and interoperable EHRs must be available to all publicly-insured citizens by 2021
- In 2018, Germany ranked #13 out of 20 European countries surveyed about EHR activation, losing 2 positions since 2016!
- HCPs now receive economic incentives for favoring paperless data transmission and EHR transition (e.g. e-prescriptions, electronic medical reports).
- Telemedicine is further encouraged through economic incentives and by allowing doctors to advertise video-consultations and prescribe treatments remotely.
- Patient data is made available, in anonymized form and only for research purposes (NO for-profit uses) to public authorities and universities.
The privacy issue
Patient advocates are criticizing the Digital Care Act as it doesn’t allow patients to opt out of sharing their data for research purposes. Since the timeline outlined by the new law also implies that all publicly-insured citizens shall have a comprehensive EHR by 2021 – making refusal to share personal data even less of an option –, the Ministry of Health agreed to commit to a separate law (due to come into effect in January 2021) on the protection of health data and sensitive information (including billing data) in electronic patient files.
How this issue unfolds will be crucial for Germany, which plans to make digital health a European priority during its upcoming presidency of the EU Council. The German agenda, strongly supported by President of the European Commission Ursula von der Leyen, aims to create a European Health Data Space to promote health data exchanges and research on prevention and treatment. The biggest challenge will be how to achieve this monumental goal while ensuring that EU citizens maintain control on their data – as opposed to other countries like US and China where commercial interests tend to prevail over those of individuals when it comes to digitalization of healthcare.