The health sector and the pharmaceutical industry are subject to strict regulation in all areas of its economic activities. This applies in particular to research and development. The use of service providers and network IT in the healthcare sector has become indispensable and is making all data processing more complex. This automatically increases the relevance and significance of data itself as well as its protection. both as trade secrets and against unauthorized processing, especially when this concerns patient (health) data. The greater the importance of this data, the greater the relevance of its protection.
The protection of health data is necessarily strict, which is why it covers far more legal and technical areas than just data protection law. We therefore advise on the basis of comprehensive legal and technical concepts and are thus in a position to provide efficient advice on both the legal and the technical design of processes in compliance with the strict requirements.
- Our consulting services include:
- Auditing of companies and business areas
- Legal support for compliance and data protection departments
- Drafting and negotiating contracts in cooperation with (clinical) research centres and CROs
- Consulting on technical security standards and cloud service providers / software outsourcing
- Data protection auditing and conception of non-clinical and clinical research projects
- Cooperation with licensing and data protection authorities However, the sectors regulation goes far beyond data protection law. Therefor our expertise in pharmaceuticals, medical devices and healthcare furthermore also includes the following areas:
- Pharmaceutical and healthcare compliance
- Pharmaceutical, medical technology and product law
- Cooperations in the healthcare sector
- Consulting regarding approval and licensing procedures
- Telemedicine / eHealth / mobileHealth / patient communication
- Purchasing / procurement of contracts related to medical products and research purposes