Our clients

We advise middle-sized and large companies, economic institutions and corporations of different sizes governed by public law as well as private clients in all matters relating to health law.

Who Are Our Clients in Health Law?

As health lawyers, we represent a diverse range of clients across the healthcare sector. Our expertise allows us to serve individuals, organizations, and institutions operating within highly regulated environments. Below is an overview of the typical clients we assist and the services we provide for them.

1. Healthcare Providers

1.1. Hospitals and Clinics

• Private Hospitals:
  We assist with licensing, financing, and compliance with regulatory standards, such as those under the Krankenhausfinanzierungsgesetz (KHG).
• Public Hospitals:
  Support with state funding processes and inclusion in hospital planning.
• Specialized Clinics:
  Assist with contracts for outsourced services, collaborations, and clinical trials.

Examples of Services:

• Advising on data protection under GDPR for patient records.
• Drafting agreements for partnerships with other institutions or health networks.

1.2. Physicians and Medical Practices

• General Practitioners (GPs):
  Legal support for setting up private practices or joining group practices.
• Specialists (e.g., Surgeons, Radiologists):
  Assistance with employment contracts, liability issues, and licensing.
• Group Practices and Medical Centers (MVZ):
  Structuring joint ventures and ensuring compliance with professional regulations.

Example Client Need:
Defending a physician in a medical malpractice claim or assisting with licensing renewals.

1.3. Pharmacies

• Legal support for individual pharmacists or pharmacy chains.
• Advising on compliance with the Apothekengesetz (ApoG), licensing, and advertising rules under the Heilmittelwerbegesetz (HWG).

Example Client Need:
Representing an online pharmacy in regulatory disputes over cross-border e-commerce.

2. Pharmaceutical and Medical Device Companies

2.1. Pharmaceutical Manufacturers

• Assisting in market approval applications under the Arzneimittelgesetz (AMG) and EU directives.
• Advising on compliance with advertising restrictions and competition laws.
• Providing legal support for post-market surveillance and pharmacovigilance obligations.

Example Client Need:
Securing EU market approval for a novel cancer treatment.

2.2. Medical Device Companies

• Advising on compliance with the Medical Devices Regulation (MDR) and the Medizinprodukterecht-Durchführungsgesetz (MPDG).
• Structuring licensing agreements and intellectual property protection.

Example Client Need:
Guiding a startup through regulatory approval for an AI-powered diagnostic tool.

2.3. Biotechnology Companies

• Providing legal guidance on genetic engineering, stem cell research, and personalized medicine.
• Ensuring compliance with laws such as the Embryonenschutzgesetz (ESchG) and the GenDG (Genetic Diagnostics Act).

3. Health Insurance Providers

3.1. Statutory Health Insurers (GKV)

• Advising on benefit coverage, reimbursement policies, and compliance with SGB V regulations.
• Representing insurers in disputes with healthcare providers or insured individuals.

3.2. Private Health Insurers (PKV)

• Assisting in structuring insurance plans under the Versicherungsvertragsgesetz (VVG).
• Representing insurers in litigation over policy disputes or premium adjustments.

4. Patients

We advocate for individual patients in legal matters related to healthcare access, patient rights, and medical malpractice.

Services for Patients:

• Medical Malpractice:
  Representing patients in claims for diagnostic errors, surgical negligence, or delayed treatments.
• Insurance Disputes:
  Assisting with denied claims for necessary treatments or medications.
• Patient Rights:
  Ensuring access to medical records and compensation for harm caused by inadequate care.

Example Client Need:
Representing a patient whose cancer diagnosis was delayed due to negligence, resulting in compensation.

5. Public and Government Institutions

We advise public bodies and government agencies involved in healthcare policy, regulation, and public health initiatives.

Services for Government Clients:

• Drafting health-related legislation or regulations (e.g., telemedicine frameworks).
• Advising on public health policies, including pandemic response measures under the Infektionsschutzgesetz (IfSG).
• Representing government entities in disputes related to healthcare financing or compliance.

Example Client Need:
Assisting a public health authority in creating a legal framework for vaccination mandates.

6. Research and Academic Institutions

6.1. Universities and Research Institutes

• Supporting medical research projects, including clinical trials and collaborations with private companies.
• Ensuring compliance with ethical standards, such as those under the Declaration of Helsinki.

6.2. Clinical Trial Sponsors

• Drafting clinical trial agreements between sponsors, investigators, and institutions.
• Advising on patient consent processes and liability for adverse events.

7. Digital Health Companies

We assist digital health startups and established companies navigating the growing field of telemedicine, health apps, and digital therapeutics.

Services for Digital Health Clients:

• Securing approvals for digital health applications (DiGA) under Germany’s Digital Health Act (DVG).
• Ensuring GDPR compliance in data collection and storage.

Example Client Need:
Guiding a telemedicine platform on regulatory requirements for providing cross-border services in the EU.

8. International Clients

8.1. Cross-Border Companies

• Supporting foreign healthcare companies entering the German or EU market.
• Advising on compliance with German and EU laws for pharmaceuticals, medical devices, and telemedicine.

8.2. Multinational Pharmaceutical and Medical Device Firms

• Assisting with EU regulatory approvals and post-market surveillance obligations.

9. Advocacy Groups and Non-Profits

We work with organizations advocating for patient rights, public health, or healthcare reforms.

Services for Advocacy Groups:

• Advising on compliance with lobbying laws and non-profit regulations.
• Supporting public health campaigns and policy initiatives.

Conclusion

Our clients come from all sectors of the healthcare ecosystem, including hospitals, physicians, pharmaceutical companies, insurers, patients, and government agencies. We provide tailored legal services that address their unique challenges, ensuring compliance, resolving disputes, and fostering innovation. Whether navigating complex regulations, advocating for rights, or supporting strategic growth, we are committed to delivering expert legal solutions in the healthcare field.