The health care system, especially the pharmaceutical and medical technology industries, are subject to strict regulation in all areas of their economic activity. This applies especially to re-search and development. Due to the networked use of service providers and IT, which has also become indispensable in the healthcare sector, all data processing procedures are be-coming more complex. This increases the relevance and significance of the data to be pro-cessed and its protection, both as a trade secret and against unauthorised processing, espe-cially in the case of patient health data.
The protection of health data is necessarily strict and therefore covers many more legal and technical areas than just data protection law. We provide advice on the basis of comprehen-sive legal and technical concepts and are therefore able to provide efficient advice on both the legal and technical design of processes in compliance with the strict requirements.
Our consulting services include in particular
- Auditing of companies and business areas
- Legal support for compliance and data protection departments
- Drafting and negotiation of contracts in cooperation with trial centres and CRO
- Consulting on technical security standards and possible applications of cloud service providers and software outsourcing
- Examination and conception of non-clinical and clinical research projects according to data protection law
- Cooperation with regulatory and data protection authorities
Furthermore, our expertise in the pharmaceutical, medical devices and healthcare sector co-vers the following areas:
- Pharmaceutical and healthcare compliance
- Pharmaceutical, medical technology and product law
- Cooperation in the healthcare sector
- Accompaniment of approval and licensing procedures
- Telemedicine/E-Health/Mobile Health/Patient Communication
- Purchasing/contracting of medical devices