Health & Life Science: Legal Advice on Healthcare Digitalisation
Digitalisation in healthcare, in the form of healthcare apps, wearables, electronic patient records and healthcare platforms, offers enormous benefits to patients and healthcare organisations. However, both the users - i.e. doctors, hospitals, etc. - and the providers of such services face a number of legal challenges. - as well as the providers of such services, they pose a number of legal challenges in terms of data protection and data security. We can advise you on all aspects of legally compliant development and use of digital healthcare services.
We advise:
In principle, we advise all organisations, institutions and companies in the healthcare sector. Our focus is on the legally compliant development and use of digital services. Our clients include:
- Pharmaceutical companies
- Hospitals & Clinics
- eHealth companies
- Insurance companies
- Health insurance companies
- IT service providers
- Research organisations
In these cases, we offer advice:
- eHealth:
eHealth encompasses a wide range of applications that are digitally transforming the healthcare system and improving care for both patients and healthcare providers. These include health apps, wearables, telemedicine, cloud solutions and telematics infrastructure (TI). - Research & Data Use:
In the area of research, we advise institutions in particular on the legally compliant use of data. New directives such as the EHDS, the GDNG or the forthcoming Research Data Act, as well as regulations from the Social Code, play a decisive role in this. - Digital Medical Devices:
We advise companies and organisations on the development and use of digital medical devices with regard to legal standards such as DiGA and DiPA, data protection and IT security, contract drafting or competition and medicinal product advertising law. - Privacy & Data Security:
We offer comprehensive data protection and data security advice in all areas, as this plays a crucial role in almost all cases, especially in relation to sensitive health data. - Regulations:
We advise you on all regulations relevant to your constellation - whether GDPR, EHDS, GDNG, SGB, DNG or other directives, regulations and laws.
How we can help you in the Health & Life Science sector
- Comprehensive data protection and information security advice:
We help you comply with GDPR and other data protection regulations, as well as IT security to ensure the protection of sensitive healthcare data. - Privacy audits, DPIAs and concepts:
We can carry out privacy audits and compliance assessments, including privacy impact assessments. We can also provide access, authorisation and deletion policies, and help you with anonymisation and pseudonymisation processes. - Contract drafting and review:
We draft and review contracts specifically tailored to the needs of healthcare services and technologies (e.g. service provider agreements, AVVs or joint controller agreements). - Apps & wearables support:
We help you develop, distribute and use health apps and IoT products. - AI compliance:
We work with you to develop AI governance structures for your AI solutions (use and/or development) and prepare you for the requirements of the AI Regulation. - Telemedicine and platform advice:
We can help you implement telemedicine services and comply with platform regulations. - Audit of cloud solutions:
We assess the legal implications of using the cloud, define the necessary measures and assist with implementation. - TI consulting:
We advise you on the specific requirements of the telematics infrastructure and help you with the implementation. - Digital medical device consulting:
We can help you use and develop digital medical devices in a legally compliant manner. From identifying relevant regulatory requirements and implementing compliance requirements to drafting contracts and competition law. - Representation in and out of court:
We represent you in the enforcement and defence of claims, as well as in administrative and judicial proceedings. - Advice on procurement procedures:
We advise both contracting authorities and IT service providers or technology companies on procurement procedures in the healthcare sector (e.g. in the area of telematics infrastructure). - Compliance training:
We provide customised training for your team to ensure that all employees are aware of healthcare regulatory requirements.
Why Schürmann Rosenthal Dreyer is your partner for healthcare solutions
Schürmann Rosenthal Dreyer combines 16 years of legal expertise with in-depth technical know-how to provide you with comprehensive solutions in the field of healthcare. Our firm not only has experienced lawyers, but also technology experts who work together to make your digital health projects legally compliant and future-proof. As initiators of the Health & Law network, we are deeply involved in the field of healthcare law and are committed to the legal protection of innovative healthcare solutions.
Our expertise has been recognised many times: We have won the prestigious JUVE award for Law Firm of the Year in Data Protection and IT and are ranked in The Legal 500's top 2024 law firms.
Put your trust in Schürmann Rosenthal Dreyer - the partner with the unique combination of legal excellence and technical understanding to make your eHealth projects a success.
Non-binding initial consultation in the field of health & life sciences
Why not arrange a no-obligation initial consultation with one of our specialist solicitors to discuss your situation and the advice you require?
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