Specialisms
Kaleidoscope Consultants specializes in providing expert guidance and advice on EU/UK Data Protection Laws related to health, life sciences, biotech, digital health, clinical trials, health AI, and medical devices. We offer the following services to our clients:
• Data Protection Officer as a service
• Clinical Safety Officer as a service
• EU Data Protection Representative
• UK Data Protection Representative
• Advice and guidance
Introduction
Kaleidoscope Consultants is a globally recognized expert in EU data protection laws when processing health data. We work with global pharmaceutical, medical device, and CRO clients, providing outsourced statutory officers, advice, and regulatory compliance services. Our clients range from Alphabet companies to the smallest AI-based start-up, and we are proud to be retained advisors for Microsoft Research Labs (UK).
Data Protection Law
Despite the introduction of the General Data Protection Regulation (GDPR), every EU country has different health and data privacy laws that vary from GDPR when processing citizens' health data. Kaleidoscope has a deep understanding of the interaction between local health and privacy laws when undertaking clinical trials and developing medical devices. We specialize in advising our clients on the various data protection laws related to health and provide expert guidance to ensure regulatory compliance.
Clinical Trials
The EU Clinical Trials Regulation specifically engages EU GDPR. We act as the Data Protection Officer and EU Representative (under GDPR), draft data management procedures for trial protocols, engage with study sites on mCTA and mCIA reviews, complete data transfer risk assessments for international data transfers, and complete supply chain due diligence to the latest standards required following recent court decisions on offshoring EU data. Kaleidoscope is currently supporting clinical trials in almost every EU member state.
Medical Devices
Kaleidoscope Consultants are widely respected specialists in EU/UK data protection laws in health, and clinical safety risk assessment in medical devices and deployment. Our team of data protection consultants focus on emerging health AI regulation, and we have a team of clinical safety officers to support access to UK markets and compliance with NHS England Digital Technology Assessment Criteria (DTAC). Kaleidoscope’s Data Protection and Clinical Safety Teams work together to support clients to comply with NHS England’s Digital Technology Assessment Criteria (DTAC) incorporating clinical risk assessment of Health Information Technologies in design (DCB0129) and deployment (DCB0160).
Training
We provide customized training for teams engaged with European studies or developing medical devices for the EU on the application of data protection laws. In response to demand, we are now planning open sessions in various locations across the USA. If you are interested in attending one of these open sessions, please register your interest with us, and we will send you dates and locations.
People
Our team members hold master’s degrees in law, or equivalent in relevant subjects, and have real-world experience working in various health settings. This practical experience allows us to advise our clients on how to apply the law to achieve their business objectives.
Global clients
Kaleidoscope’s client base spans the world, with currently active clients in the USA, Canada, Australia, New Zealand, PR China, Singapore, Rep. South Korea, Middle East, and Europe. We provide advisory services, fulfil statutory officer roles, and handle regulatory compliance for our clients.
Conclusion
Kaleidoscope Consultants is your ideal regulatory affairs partner when undertaking clinical trials or selling medical devices in Europe. We are recommended by leading international law firms to their own clients. Come and talk to us at booth 2379 at Bio2023 in Boston in June to find out how we can help you, or alternatively, meet us afterwards in the area.
Kaleidoscope Consultants specializes in providing expert guidance and advice on EU/UK Data Protection Laws related to health, life sciences, biotech, digital health, clinical trials, health AI, and medical devices. We offer the following services to our clients:
• Data Protection Officer as a service
• Clinical Safety Officer as a service
• EU Data Protection Representative
• UK Data Protection Representative
• Advice and guidance
Introduction
Kaleidoscope Consultants is a globally recognized expert in EU data protection laws when processing health data. We work with global pharmaceutical, medical device, and CRO clients, providing outsourced statutory officers, advice, and regulatory compliance services. Our clients range from Alphabet companies to the smallest AI-based start-up, and we are proud to be retained advisors for Microsoft Research Labs (UK).
Data Protection Law
Despite the introduction of the General Data Protection Regulation (GDPR), every EU country has different health and data privacy laws that vary from GDPR when processing citizens' health data. Kaleidoscope has a deep understanding of the interaction between local health and privacy laws when undertaking clinical trials and developing medical devices. We specialize in advising our clients on the various data protection laws related to health and provide expert guidance to ensure regulatory compliance.
Clinical Trials
The EU Clinical Trials Regulation specifically engages EU GDPR. We act as the Data Protection Officer and EU Representative (under GDPR), draft data management procedures for trial protocols, engage with study sites on mCTA and mCIA reviews, complete data transfer risk assessments for international data transfers, and complete supply chain due diligence to the latest standards required following recent court decisions on offshoring EU data. Kaleidoscope is currently supporting clinical trials in almost every EU member state.
Medical Devices
Kaleidoscope Consultants are widely respected specialists in EU/UK data protection laws in health, and clinical safety risk assessment in medical devices and deployment. Our team of data protection consultants focus on emerging health AI regulation, and we have a team of clinical safety officers to support access to UK markets and compliance with NHS England Digital Technology Assessment Criteria (DTAC). Kaleidoscope’s Data Protection and Clinical Safety Teams work together to support clients to comply with NHS England’s Digital Technology Assessment Criteria (DTAC) incorporating clinical risk assessment of Health Information Technologies in design (DCB0129) and deployment (DCB0160).
Training
We provide customized training for teams engaged with European studies or developing medical devices for the EU on the application of data protection laws. In response to demand, we are now planning open sessions in various locations across the USA. If you are interested in attending one of these open sessions, please register your interest with us, and we will send you dates and locations.
People
Our team members hold master’s degrees in law, or equivalent in relevant subjects, and have real-world experience working in various health settings. This practical experience allows us to advise our clients on how to apply the law to achieve their business objectives.
Global clients
Kaleidoscope’s client base spans the world, with currently active clients in the USA, Canada, Australia, New Zealand, PR China, Singapore, Rep. South Korea, Middle East, and Europe. We provide advisory services, fulfil statutory officer roles, and handle regulatory compliance for our clients.
Conclusion
Kaleidoscope Consultants is your ideal regulatory affairs partner when undertaking clinical trials or selling medical devices in Europe. We are recommended by leading international law firms to their own clients. Come and talk to us at booth 2379 at Bio2023 in Boston in June to find out how we can help you, or alternatively, meet us afterwards in the area.
BIO DOUBLE HELIX SPONSORS
BIO HELIX SPONSORS
