consulting and advisory services in health law
Our consulting and advisory services in health law cover those key areas of health regulations that affect companies and professionals in the sector. With an in-depth knowledge of the risks associated with care activities and working with patients, our experts guarantee precise solutions to comply with regulatory requirements depending on the process involved, and deal with the different responsibilities that may arise along the way.
Health-related data (RGPD) and National Security Scheme (ENS)
The protection of health-related personal data is essential in the healthcare sector. Compliance with both the General Data Protection Regulation (GDPR) and the Data Protection Act (DPA). regulating patient autonomy and the rights and obligations regarding clinical information and documentation. is essential to avoid penalties and protect patient privacy. Our services include the implementation of security measures, as well as process management to ensure proper and ethical treatment of health-related data.
Likewise, Lentisco accompanies in the implementation process of the National Security Scheme (ENS), at its highest level, mandatory for all those companies that work or relate to public health administrations.
Liability in clinical trials
The procedures and legal framework for experimental research, known as “clinical trials”, are vital to healthcare development and require a careful approach due to the associated legal risks. We offer advice and support to manage responsibility in all phases of clinical trials, from the authorization procedure to the execution of the trials.
Our team ensures that studies are conducted in a transparent and compliant manner, protecting the interests of sponsors and participants.
Research and clinical trials
Clinical research is the key to the development of new therapies and health technologies. We offer comprehensive support that includes the review of protocols and the management of contracts with research centers (CRO). Each phase of the process is supervised to ensure that the highest legal and ethical standards are met, promoting scientific development under a framework of transparency and compliance.
Likewise, our advice is aimed at materializing the content of the Code of Conduct regulating the processing of personal data in the field of clinical trials and other clinical research, as well as pharmacovigilance and other health regulations.
Health civil liability
Liability in the healthcare field is a relevant concern for both professionals and institutions. We provide preventive advice in order to help companies and health institutions to identify and minimize the risks derived from professional practice, facilitating, in addition, both representation and defense in all kinds of proceedings or claims for health liability.
We work to protect both the reputation and the interests of our clients, carrying out the pertinent risk assessments and implementing management systems or precautions to ensure compliance with health liability regulations.