Digital Health

digitalhealth@skwschwarz.de

Master the challenges of digitalisation in the healthcare sector with SKW Schwarz

The digitalisation of society continues to advance, and the healthcare industry is no exception. In fact, in the field of Life Sciences & Health, digitalisation stands as one of the central challenges and opportunities for companies in the coming years. This transformative process demands expertise in the ever-increasing complexity of regulations, a deep understanding of the underlying fields of law and their intersections, combined with the necessary innovative strength and creativity, all of which we, as a law firm, combine.

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Transform the healthcare industry with us:

Our specialists will advise you on your challenges - digitalisation is our core expertise.

We think ahead and, with our focus on Life Sciences & Health, IT & data protection and IP, combine all relevant areas for the digitalisation of the healthcare sector in our "Digital Health" focus group, from expertise in regulatory and compliance, IT law, IP law and data privacy law to procurement, commercial and corporate law. This makes SKW Schwarz your ideal partner in all areas related to "Digital Health". We combine the knowledge and experience of our experts for your digitalisation projects to provide advice from a single source

From start-ups to transactions

Innovative business ideas with digital products and services for the healthcare sector have the potential to reshape our society. We understand the needs of the healthcare industry and assist you, whether your company is in the start-up phase or involved in a transaction – always keeping an eye on the bigger picture. Our corporate law specialists work closely with our experts in Life Sciences & Health and IT/data protection law.

Digitalisation of medical devices

Precisely because legal regulations often cannot keep pace with the innovative power of companies in the field of digitalisation, it is important to keep an eye on current developments and find practical solutions. Our goal is always to make your business model legally compliant.

  • Which digital functions are permissible and how can they be implemented securely?
  • What should be considered when using AI?
  • What opportunities and risks arise from new European regulations?

Successful with tenders for digital health services

Statutory health insurers increasingly have to put Digital Health services out to tender. Our specialists have been successfully supporting the resulting specific challenges in the interaction between public procurement law and IT law in the healthcare sector for years.

Focus on health apps

Developing a health app has great potential , but what needs to be considered?

With one of the strongest IT and data protection legal teams on the market, we ensure that you set the right course for your products and ideas at an early stage. After all, in addition to knowledge of the regulatory framework, the correct handling of particularly sensitive patient data is a special challenge.

From health apps to digital health applications (DiGA)

When are health apps medical devices or in vitro diagnostics? What requirements must be met for a DiGA? What needs to be considered in terms of regulation, compliance and application? We support you with the realistic assessment of risks, costs and benefits and we find the best path for you. We accompany you from development to market launch and expansion, helping you to achieve your goals.

Social Media Marketing and Healthcare

Social media and influencer marketing quickly reach numerous legal boundaries in the healthcare sector. Collaborations with health influencers are, therefore, complex and challenging. With our focus on branded content and influencer marketing on the one hand and the extensive experience of our experts in healthcare compliance and pharmaceutical advertising law on the other, we provide comprehensive advice and show you how to use social media and health influencers efficiently and in a legally compliant manner for your marketing.

Digitalisation in the hospital sector

Digitalisation is rapidly advancing in the hospital sector. At the same time, the requirements that have to be met by the hospital's IT infrastructure and the processing of patient data are ever-increasing. In addition, the number of technical links - for example between AIs and individual medical technology applications - is also increasing. The legal issues quickly become more complex if AI-based applications or apps with far-reaching access options are used. Where is the data located and how does the data exchange actually take place? Our experts will also be happy to help you establish legally compliant data protection in hospitals.

Exclusive Whitepaper - The Interaction of Regulatory Affairs, AI and Data Protection in Medical Technology – 20 Questions and Answers
 

In addition to the requirements of the MDR (Medical Device Regulation) and data protection, medical technology companies must now also comply with the new provisions of the AI Act. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology?

Exclusive Whitepaper - Healthcare Compliance for Medical Device Manufacturers

Get our whitepaper on Healthcare Compliance for medical device manufacturers. Discover valuable tips on legally compliant ways to provide medical equipment, reduce risk and avoid legal pitfalls.

Exclusive Whitepaper - Data protection in the use of medical devices

Looking for in-depth information and concrete strategies on data protection for medical devices? Our exclusive whitepaper offers valuable insights and tangible advice from our experts.

Our expertise: Life Sciences & Health

With one of the strongest IT law teams in the market and excellent experts in the field of IP law, as well as profound knowledge in medical / pharmaceutical law and excellent industry expertise, our experienced Life Sciences & Health team is the optimal partner for your company.

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