Health Care & Life Science | LUTHER Rechtsanwaltsgesellschaft mbH

Luther.Solutions supports the transformation of legal departments at every stage – from strategic dialogue to process and organizational design, including the implementation of legal tech. Interdisciplinary teams and proven methodologies ensure measurable improvements in quality, efficiency, and transparency in day-to-day operations as well as in complex mandates.

Health Care &
Life Science

Luther stands for focused legal and tax advice in the entire Health Care & Life Science sector in Germany and Europe. This includes health care structures, inpatient and outpatient, regulatory issues, the safeguarding of complex research projects, up to and including transactions and litigation.

The highly regulated healthcare sector in Germany is constantly changing. Demographic developments are increasing the demand for medical services. Thanks to technological progress, pharmaceuticals medical devices research, production and therapy are linked with big data, gene sequencing, AI and biogenetics. Large technology companies and highly specialised start-ups have contributed to the fact that old structures in the health sector, biotechnology and chemistry have altered and now have to be redefined. Numerous challenges, therefore, that our clients are now facing.

We can meet these challenges head on together with you and ensure that you are well advised in your competitive environment on all legal and tax issues relating to the healthcare and life science industry. Our experts are familiar with the structures within the healthcare market, know the regulatory conditions and understand the economic goals of our clients. This allows them to concentrate fully on their core business: be it patient care, research into new pharmaceuticals or the development of state-of-the-art medical technology.

Our range of advisory services:

For (dentists) doctors/medical-care centres

Professional law for the healthcare professions (doctors, dentists, etc.)
Panel doctor law/panel dentist law including remuneration law and licensing procedures
Opening a surgery and medical-care centre, developing medical-care centre group structures, advice on taking over a surgery
Law on medical services, including liability and accounting issues

For hospitals/clinics

Hospital planning law, administrative/court planning law proceedings
Hospital subsidization and hospital financing law
Public procurement procedures, advising construction projects for outpatient facilities
Law of hospital remuneration and accounting disputes
Employment law in hospitals, senior consultant service contracts
Approval issues for psychiatric and rehabilitation medical facilities (inpatient, outpatient)

For all service providers

Drafting and reviewing co-operation agreements between service providers
Employment law for service providers as well as the public sector
Company pension plans/law regarding Federal and State Government Employees Retirement Fund (VBL), supplementary pension fund (ZVK), church supplementary pension fund (KZVK)
Structural personnel measures, outsourcing, collective bargaining law
German pharmaceutical advertising law, German competition law, German copyright law
Data protection laws
Anti-corruption law, compliance advice

Law regarding (inpatient/outpatient) care
Proceedings before arbitration boards according to the German Social Insurance Code XI (SGB XI)
Legal advice regarding setting up co-operations and management systems/interface consulting
Drafting contracts (transfer/release management; ordinance management)
Law regarding remuneration of care fees
Advice regarding real estate law (including construction/development, transactions)

Advising complex, structured bidding procedures, company acquisitions and transactions
(Partial) privatisation, developing individual investment solutions
Restructuring, insolvency advice for service providers
Advice on transformation law (hive-downs, mergers), insourcing and outsourcing
Advice regarding creating a cooperation and holding (private, public as well as non-profit organisations)
Public procurement law (structuring public procurement processes, tenders, litigation), PPP projects
Subsidy law
European and German merger control in the hospital and insurance markets
Antitrust law advice regarding co-operations
Further developing university medicine, monitoring of legislative processes
Financing and reorganization-related advice
Tax law advice relating to transactions and co-operations
Non-profit law

Pharmaceutical law (national, European)
Approval of pharmaceuticals, clinical trials
Drafting pharmaceutical supply contracts
Legal advice during the market launch of new pharmaceuticals
Import and cultivation permits for medical cannabis
Pharmaceutical remuneration law (reimbursement)
Supplier and service contracts
Research funding and co-operation with national, European and international organisations
Joint ventures/co-operations
Pharmaceutical advertising law, competition law, copyright law
Protection of Intellectual Property
M&A

For manufacturers/importers

Advice on all regulatory aspects of medical device law (national and international)
Providing support when dealing with the competent authorities
Certification of medical devices, conformity assessment, risk classification, clinical trials
Launch market access of new medical devices
Support in dealing with Notified Bodies regarding the clinical verification of medical devices
Advising on product recall actions
Legal structuring of distribution channels in Germany and abroad
Reference against claims asserted against the manufacturer under manufacturer liability act
Law regarding remedies and aids (German Social Insurance Code V (SGB V)
Supplier and service contracts
Joint ventures/co-operations

For operators/users

Advice on legal obligations regarding the use and operation of medical technology
Providing legal advice and support in the procurement process of medical devices from the competitive bidding stage, through the dialogue phase, to the drafting of the contract and the selection procedure
Individual and innovative drafting of contracts for the procurement, management, maintenance and renewal of medical equipment
Advice on all aspects of liability law and on the enforcement and defence of liability claims
Comprehensive advice on employment law including advice on occupational safety, special safety regulations for employees dealing with medical technology and the implementation of training courses

Digitisation in the healthcare sector opens up new opportunities for diagnostics and therapy, quality enhancement and the acceleration of research processes. Artificial intelligence as a key technology enables decision-making based on big data and can thus support physicians as a tool in everyday treatment as effectively as patients in self-monitoring of chronic diseases and researchers in identifying suitable targets as well as in the context of clinical trials.

More and more players in healthcare are therefore committing to digital health and want to drive digitisation supported by AI in their area of responsibility.

The German Hospital Future Act (Krankenhauszukunftsgesetz, KHZG) gives a boost to the digitisation of hospitals with a funding volume of EUR 4,3 billion.
Platform providers offer digital services such as making appointments in the practice or video consultations.
A growing number of patients are using health apps.
The German healthcare system has a unique selling point as it allows for the prescription and reimbursement of BfArm-listed Digital Health Applications (DiGAs).
Projects such as GAIA X and, in the future, the European Health Data Space, for which the EU Commission has presented a draft, are intended to optimise the use of data for new health solutions.

Nevertheless: There are numerous legal hurdles to overcome when introducing innovative digital solutions in the healthcare sector. In the highly regulated healthcare sector, some regulations are not compatible with digital requirements and would have to be dropped or, in some cases, replaced; liability law has to be observed; data protection and data security raise particular issues in the case of sensitive healthcare data.

Luther's experts accompany clients into the digital world with their expertise on the requirements according to the German Social Code (SGB V), medical device law and IT/data protection law.

Regulatory requirements for digital health applications (medical device law, SGB V, data protection law)
Cooperation agreements of medical device manufacturers with health insurance companies according to Sec. 68a SGB V
Market access and reimbursement for e-health apps and e-health platforms via pilot projects, innovation funds, selective contracts pursuant to Sec. 140a SGB V
Prescribability and reimbursement through listing as DiGA according to SGB V, new requirements for validation (proof of evidence)
Legal support for established service providers (pharmaceutical industry, medical devices/IVDs) in the digitisation of their products and business models, as well as data protection advice on the use of big data
Designing contracts with IT service providers and hyperscalers, cloud-based offerings and healthcare solutions in the metaverse
Joint ventures of medical service providers for innovative digital care
Funding programmes, KHZG: Application and implementation, procurement law
Establishment of competence centres, incubators and accelerators
Telemedicine centres

As a full-service law firm, Luther also offers legal advice to providers of digital health solutions in numerous other areas of law, such as competition law, compliance, intellectual property, public procurement law, commercial agreements, employment law and transactions.

>> Your contacts for Digital health

Advice on patents and trademarks
Know-how protection and IP
Representation in arbitration and court proceedings and in dispute settlement negotiations
Preparing and supporting tender procedures both on the part of the tendering company and on the part of the bidders

Advice on all antitrust issues (prohibition of cartels and abuse of a dominant market position), e.g:
- Co-operations with competitors (co-promotion / co-marketing, R&D co-operations, production agreements)
- Information exchange / notification systems / market information systems
- Measures to restrict parallel imports
- Pricing and discounting
- (Late) life cycle management
- Distribution channels (direct-to-pharmacy, direct-to-hospital, exclusive distribution, cooperation with selected wholesalers)
Representation in antitrust investigations and proceedings by the European Commission, the German Federal Cartel Office and the state antitrust authorities
Antitrust compliance and internal investigations
German and EU merger control and coordination of merger control proceedings worldwide
German Foreign Direct Investment (FDI) law
EU state aid law (in particular FSR)

News

26.05.2025

The Josefs-Gesellschaft on course for expansion: Luther advises on the acquisition of the Evangelisches Krankenhaus Kalk

24.03.2025

Luther advises hVIVO plc. on the acquisition of two German research units from CRS Clinical Research Services

04.02.2025

Biotechnology company Medix Biochemica succeeds in a strategic acquisition with Luther's support

28.01.2025

Consolidation of the hospital landscape: Nephrological Hospital becomes part of the University Hospital Heidelberg

17.01.2025

Luther advises on sale of Elisabeth Hospital Kassel

Key Contact

Dr Oliver Kairies

Partner

T +49 511 5458 17643

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Prof. Dr Christian Burholt, LL.M.

Partner

T +49 30 52133 10589

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Referenzen

Land Schleswig-Holstein - Vorbereitung und Durchführung eines Markterkundungsverfahrens zur Zukunftssicherung des Universitätsklinikums Schleswig-Holstein

Universitätskliniken des Landes Baden-Württemberg - Kritische Würdigung und Erarbeitung von Vorschlägen zur Verbesserung des Universitätsmedizingesetzes Baden-Württemberg

Carl von Ossietzky Universität Oldenburg, Klinikum Oldenburg gGmbH, Pius-Hospital Oldenburg, Evangelisches Krankenhaus Oldenburg - Rechtliche und steuerliche Beratung bei der Gründung der „European Medical School Oldenburg - Groningen (EMS)", in Kooperation mit der Universität Groningen und dem Universitätsklinikum Groningen

Universitätsklinikum Freiburg / Herz-Zentrum Bad Krozingen - Konzeption und Begleitung der Umsetzung der Fusion der kardiologischen Bereiche

Universitätsklinikum Aachen / academisch ziekenhuis Maastricht - Erstellung einer Machbarkeitsstudie über die Errichtung eines Europäischen Universitätsklinikums sowie Umsetzung des Konzepts

Ministerium für Bildung, Wissenschaft und Kultur des Landes Mecklenburg-Vorpommern - Konzeption und Umsetzung eines „Integrationsmodells" (Fachbereich Medizin und Krankenversorgung werden zusammengelegt), Begleitung des Gesetzgebungsverfahrens

Universitätskliniken des Landes Baden-Württemberg - Erstellung eines Konzeptpapiers „Zukunftsfähige Trägermodelle" unter rechtlichen und steuerlichen Gesichtspunkten

Ministerium für Bildung, Wissenschaft, Jugend und Kultur des Landes Rheinland-Pfalz - Konzeption und Umsetzung eines „Integrationsmodells" (Fachbereich Medizin und Krankenversorgung werden zusammengelegt), Begleitung des Gesetzgebungsverfahrens

Universitätsklinikum Essen - Optimierung der Organisations- und Rechtsform des Universitätsklinikums Essen aus wirtschaftlicher, rechtlicher und steuerlicher Sicht

Land Hessen - (Teil-)Privatisierung der Universitätskliniken Gießen und Marburg

Klinikum Osnabrück GmbH und Stadt Osnabrück - Erwerb der Diakonie-Klinikum Osnabrücker Land gGmbH

Deutsche Kliniken Holding GmbH - Transaktionsberatung, Erwerb der Hochrhein-Eggberg-Klinik gGmbH und der Rehaklinik Sankt Marien gGmbH

Stadt Alfeld, Landkreis Hildesheim und Krankenhaus Alfeld GmbH - Veräußerung von Geschäftsanteilen des Krankenhauses Alfeld und Restrukturierung der Konzerngesellschaften

Landkreis Holzminden - Veräußerung der Beteiligung an der Krankenhaus Charlottenstift Stadtoldendorf GmbH nebst transaktionsbegleitender Restrukturierungsberatung

Kreis Bergstraße - Durchführung eines Markterkundungsverfahrens zur Zukunftssicherung des Kreiskrankenhauses Bergstraße

Hochtaunus-Kliniken GmbH - laufende rechtliche Beratung

AWO Krankenhausbetriebsgesellschaft mbH - Erwerb diverser (kommunaler) Krankenhäuser, z.B. Psychiatrisches Krankenhaus Halle (Saale), Stadtkrankenhaus Calbe; beabsichtigter Erwerb der Kreiskrankenhaus Belzig gGmbH; beabsichtigter Erwerb der psychiatrischen Fachpflege Schleswig GmbH und der Hesterberg & Stadtfeld GmbH

Bürgerhospital Frankfurt am Main und Clementine Kinderhospital - Fusion zweier Krankenhäuser

Sana Kliniken AG - Erwerb von Beteiligungen an kommunalen Krankenhäusern (z.B. Klinikum Hoyerswerda)

Klinikum Osnabrück GmbH - beabsichtigter Erwerb der Johanniter-Krankenhaus Bramsche GmbH

Health Care &
Life Science

Our range of advisory services:

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Key Contact

Team Health Care & Life Science

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