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)