At the end of June 2023, a draft Health Data Use Act (“GDNG”) and a draft Digital Act (“DigiG”) of the German Federal Ministry of Health have become public. These drafts are part of the German government’s digitalization strategy for the health sector. The Health Data Use Act plans to grant industry companies an access right to patient health data for research purposes. The Digital Act envisages significant restrictions for the pricing and reimbursement of Digital Health Apps. Below, we summarize key aspects of these two legislation proposals.
- Health Data Use Act – Expansion and facilitation of access to health data for Research
The proposed Health Data Use Act generally aims to facilitate the use of health data for research purposes. In this respect, the act would also have positive effects for the pharmaceutical and medical device industry. The GDNG also wishes to prepare Germany for the European Health Data Space (EHDS).
In Germany, health data are currently not sufficiently available for further use outside the immediate health care context. Most health data is effectively filed and siloed decentrally and not available at a central place. Further, the access to health data of patients by pharmaceutical and medical device companies is particularly restricted. Overall, the situation is recognized to inhibit research and innovation. To improve the situation, the GDNG aims to make the currently decentralized data easier available and more accessible for research use by industry companies. Key points of the GDNG include:
- The Health Data Lab at the agency BfArM (Forschungsdatenzentrum Gesundheit) will be further developed. In addition, access to the data of statutory health insurers stored there will be expanded. For this purpose, data from the electronic patient file (ePA) will be forwarded to the Health Data Lab with an opt-out option for patients.
- Health data access for researching industry: The new law will allow research-based pharmaceutical, medical device and other industry companies access to the health data and to use it for research and development of medicinal products, medical devices and treatment methods etc. The companies need to submit specific data access requests to the Health Data Lab. However, such health data may not be used for market research, advertising or sales activities.
- Data access and coordination points for health data will be established at BfArM to support researchers with the application procedure and the data use. The Health Data Lab may refuse applications under certain conditions.
- Restructuring of data protection supervision: The data protection supervision for research projects with health data that span over several German states will be concentrated in one state authority. This is expected to increase efficiency in practice.
- Preparation for EHDS: As noted, the GDNG also aims to prepare the German health data landscape to the era under the EHDS regulation as currently Germany would not be able to comply with the envisioned EHDS requirements.
Overall, for the medical research community and the life sciences industry, the GDNG would be a significant improvement as it would allow more access to health data for research purposes.
- Digital Act plans new pricing & reimbursement rules for Digital Health Apps
The second legislation draft that became public at the end of June is the so-called Digital Act (“DigiG”). Among other things, this new act aims to amend the current rules for the pricing and reimbursement rules for Digital Health Apps (DiGA). The draft contains the following regulations and amendments:
- First of all, the scope of the DiGA rules will be extended to medical devices with risk class IIb.
- The pricing and reimbursement rules for DiGAs will be amended. Under the DigiG, it is envisaged that DiGAs are stronger reimbursed based on performance and success criteria. As such, the new law proposes that the reimbursement contracts for DiGAs should include at least 20% performance-based price components. In conjunction with this, the parties can establish and use data from the real-world use of the DiGAs to measure its performance.
- Hence, in the future, DiGAs are expected to become subject to agreements that are more pay-for-performance contracts and that are accompanied by registries or other real-world-data collection to measure the performance. In light of the experiences and difficulties with such pay-for-performance agreements, this concept deserves particular attention by the DiGA sector.
- The DiGA manufacturer’s claim for compensation shall expire if the patient indicates within 14 days that he/she does not use the DiGA on a permanent basis. This would also be a quite fundamental new rule and very disadvantageous for the DiGA manufacturers.
- The DigiG also expects that DiGA manufacturers should provide certain technical equipment for free.
- Further, DiGA manufacturers will be subject to stricter compliance requirements. They may not enter into agreements with pharmaceutical or medical device companies that would likely restrict the patient’s free choice to select certain medicines or medical devices. The law does not want a DiGA to be designed in such way that it is only suitable for accompanying a therapy with a specific drug or medical device. Corresponding agreements or concerted practices by manufacturers will be inadmissible.
- Telemedicine offerings in Germany shall be expanded under the DigiG.
- The DigiG also aims tighten requirements for cybersecurity in the health care sector. Cybersecurity has become a significant concern and the legal regulation is getting accordingly stricter.
- Next Steps of the Legislation Process
The two legislation drafts we discussed here are still unofficial and leaked drafts. The German government plans to align on them within the government during the summer months. Afterwards, the drafts would be submitted to the German Parliament (Bundestag) and the Federal Council (Bundesrat) to initiate the formal legislative process which has not yet started. The Life Sciences Team of Covington & Burling LLP in Frankfurt (Germany) will monitor the next steps and will keep you posted about the next developments.