It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German population. At the end of August, the current German Government agreed on two concrete legislative projects.
The Act to Accelerate the Digitization of Healthcare aims to integrate more digital solutions into everyday healthcare in Germany (so-called “Digital-Gesetz”; see the German draft version). The Health Data Utilization Act aims to improve the exchange and use of health data in order to advance research in this field (so-called “Gesundheitsdatennutzungsgesetz”; see the German draft version).
Three key regulations for stakeholders in the e-health sector
The two draft laws contain three key takeaways that are of particular interest to providers and manufacturers of e-health solutions:
1. Medical apps move into the spotlight
There are currently 48 digital health applications (so-called “digitale Gesundheitsanwendungen” or “DiGA”) listed on the so-called DiGA register that can be prescribed by a doctor and are reimbursed by German healthcare insurance. According to the proposed draft law, digital health applications shall be integrated more effectively into healthcare processes and their use will be made more transparent. As of now, only low-risk medical device software (MDR risk class IIa and lower) is suitable for being accepted as a reimbursable DiGA. Hence, the majority of these digital health applications are focusing on mental health issues. With the extension of such applications to medical devices of risk class IIb, it will be possible to get digital health applications for more complex treatment processes like telemonitoring admitted.
2. Telemedicine to be expanded
Telemedicine is set to become an integral part of healthcare. In particular, video consultations with doctors are to be used more extensively and more easily. For a long time, the German medical professional laws assumed that medical treatment for the insured person had to take place in the same place at the same time. In 2018, the laws that set out the professional legal framework for doctors in Germany were amended by the German Medical Association to allow remote treatment. However, German medical professional law continues to be based on the principle that doctors generally must treat patients in person, whereas communication media can be used to support this. Exclusive counselling or treatment via communication media is only permitted in individual cases if this is medically justifiable and the necessary medical care is maintained. To foster video consultation, the draft proposal of the Digital Act is supposed to lift these current restrictions on video consultations and to make patient treatment exclusively over video consultation more accessible to the public.
3. Use of health data will be simplified
The legislative initiative also aims to simplify the use of health data and remove any hurdles or ambiguities that might currently exist. The draft Health Data Utilization Act will establish a decentralized health data infrastructure with a central data access and coordination office. An independent body will be set up at the Federal Institute for Drugs and Medical Devices (“BfArM”) for this purpose. The statutory health and long-term care insurance funds will be enabled to make greater use of their data if this serves to improve care, for example, by verifying the safety of drug therapies or facilitating the detection of cancer or rare diseases.
The statutory health insurance funds’ billing data available at the Health Research Data Center (“Forschungsdatenzentrum Gesundheit,” “FDZ”) at the BfArM will be made more widely and quickly available for use by third parties. There are also plans to link data from the FDZ with data from the clinical cancer registries of the federal states.
In an effort to make the data from the electronic patient file (for more information, see below) more usable for research purposes, it is foreseen that patients would have to opt out if they wish to object to such uses. To facilitate this, the draft bill requires an easy-to-use objection management system to be set up.
Further regulations
Another important step towards a digital healthcare system is the introduction of the electronic patient file (“ePA”). From the beginning of 2025, all people with statutory health insurance will have such an ePA and will be able to access online, for example, diagnoses and information on current medication, which they may decide to share with the practitioners of their choice. In addition, from January 2024, it will be mandatory for doctors to make prescriptions for medicines available online.
Outlook
The two draft laws still need to be passed by the German Parliament. As the Government has agreed on the drafts, the laws have a sufficient majority to be passed. It is expected that the laws will come into force in 2024. In addition, the German Federal Ministry of Health plans to present a Medical Research Act later this year to comprehensively accelerate clinical trials. Watch this spot for more information on the ongoing legislative process and don’t miss our blog post on “Key Considerations for Sponsors of Clinical Trials Under the EU Clinical Trial Regulation,” if you are interested in this topic.
MoFo Research Assistant Tim Stripling has contributed to this article.