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.

  1. 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.

  1. 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.
  1. 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.

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Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is…

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is recognized as a “leading lawyer for pharma and medical devices law” (JUVE 2021).

Adem helps clients on a wide range of EU and German law issues, including regulatory, compliance, privacy and liability matters. He also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • „Great professional and human competence, good team player.“ (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “Adem Koyuncu is not only a lawyer but also a doctor and has worked in industry. He knows the perspectives that also move in-house lawyers.” (Legal 500 2022)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.“ (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

  • “Medical Device Liability and Risk Transfer 2.0 | A liability issue for the Management?!,” BVMed, Webinar (3/24/2023)
  • “Data Protection Requirements and Open Issues in the Pharma Sector – Status quo,” Speech at conference, 26. Marburger Gespräche zum Pharmarecht, Marburg (3/16/2023)
  • “Vendor Oversight & Vendor (Quality) Management in the Pharma Industry,” FORUM-Institut, Online Seminar (4/19/2023)